Precise Image for Musculoskeletal CT

Clinical Study for Precise Image for Musculoskeletal CT for Incisive CT and CT 5300 Systems

The purpose of this clinical study is to evaluate the performance of the Precise Image reconstruction algorithm for musculoskeletal CT imaging (shoulder, hip, knee) of adult patients (>18 years old). Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image.

The study has two objectives:

1. To evaluate the image quality and diagnostic acceptability of Precise Image compared to the standard-of-care reference (iDose4) for:

   o Musculoskeletal CT images (shoulder, hip, knee) of adult patients (>18 years old).

2. To demonstrate non-inferiority of Precise Image to iDose4 for the planned resolution groups.

Inclusion Criteria:

• Subjects scanned by FDA-cleared and marketed Philips Incisive CT or CT 5300 systems, and according to the department standard of care clinical protocols for the applicable anatomies.
• Subject age: Above 18 years old.

Exclusion Criteria:

• Subject age: 18 years old and below.
• Scans that were acquired using generic 'Body' scan type (as Precise Image does not support generic 'Body' scan types).
• Scans that were acquired using a kilovoltage peak of 70 kVp (as Precise Image does not support a kilovoltage peak lower than 80 kVp).
• Scans that the site radiologists have deemed as non-diagnostic image quality in standard practice (e.g. patient movement).
• Scans that failed internal technical checks (e.g., corrupt files, failure to reconstruct).