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The Cuff Repair Plate™ is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.

The Cuff Repair Plate (CRP) is a fixable suture anchor plate that is designed to improve anchorage-to-bone strength during rotator cuff tendon-to-bone repair. When assembled, the device consists of a contoured, D-shaped buttress bone plate that is coupled to two anchor bolts. The plate is available in both right and left configurations. Anchor bolts are available in various lengths. Both the plate and the anchor bolts are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use. The CRP is for use with #2 or #5 polyethylene-based high-strength non-absorbable braided suture.

The provided text describes a medical device, the Cuff Repair Plate (CRP), and its regulatory clearance through a 510(k) submission. However, it does not contain information about acceptance criteria, efficacy studies, or performance compared to specific metrics. The document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness based on mechanical testing.

Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets (e.g., minimum pull-out strength, maximum bending). The document implies that the acceptance criterion is "substantial equivalence" to the predicate device in terms of performance.
• Reported Device Performance: The document states that "Testing of the CRP device to demonstrate substantial equivalence included construct pull-out testing, CRP static three-point bending, and testing to evaluate the anchor bolt's torsional strength, insertion driving torque, and axial pull-out." However, no specific numerical results or comparison data from these tests are provided. Therefore, a table cannot be populated as requested.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned. It's safe to assume the mechanical testing was conducted in a laboratory setting, likely in the US, but this is not explicitly stated. The study is a pre-clinical mechanical study, not a clinical study involving human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable. This information is relevant for studies involving subjective assessment (e.g., image interpretation by radiologists). The described studies are mechanical performance tests, where "ground truth" is determined by objective measurements of force, torque, and displacement.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication is relevant for subjective assessments where multiple experts might disagree. Mechanical tests are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is a type of clinical study. The provided document describes pre-clinical mechanical testing, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Mechanical Test Results (Objective Measures): The "ground truth" for the tests mentioned (pull-out testing, three-point bending, torsional strength, insertion driving torque, axial pull-out) would be the objective measurements obtained from these physical tests. There is no subjective ground truth like expert consensus, pathology, or outcomes data mentioned in relation to these tests.

8. Sample Size for the Training Set:

• Not Applicable. This question is relevant for AI algorithms. The device described is a physical implant, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As explained above, this device does not involve an AI algorithm with a training set.

Summary based on the provided text:

The 510(k) submission for the Cuff Repair Plate (CRP) relied on pre-clinical mechanical testing to demonstrate substantial equivalence to a predicate device (Synthes Button Plate). The tests included construct pull-out, static three-point bending, anchor bolt torsional strength, insertion driving torque, and axial pull-out. The document asserts that these tests showed the CRP to be safe and effective and substantially equivalent to the predicate device, implying that the performance met unstated acceptance criteria by being comparable to the predicate. No specific quantitative acceptance criteria or detailed numerical performance data from these tests are provided. The study did not involve human readers, clinical cases, or AI algorithms; therefore, many of the requested points are not applicable.

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