The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).

Participants with partial-thickness or full thickness tears that provided data at the specified time frames.

Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:

1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
3. Was there evidence of bursitis in the shoulder?
4. Does the new tissue resemble normal tendon tissue?
5. Does the underlying tendon resemble normal tendon tissue?
6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:

• 0 to <25%
• 25% to <50%
• 50% to < 75%
• 75% to < 100%
• 100%

Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).

Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:

1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).
2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).
3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).

Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Cumulative number of days index shoulder was in a sling.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Cumulative number of days between discharge and return to work (employed subjects only).

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:

• Strongly Disagree
• Disagree
• Neither Agree or Disagree
• Agree
• Strongly Agree

"Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.

Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.