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HIP: Hip capsule repair, Acetabular labrum reattachment

SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis

FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis

The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.

The provided document is a 510(k) premarket notification for a medical device called the "CinchLock Flex Knotless Suture Anchor." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for algorithms or diagnostic tools.

Therefore, much of the information you requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this type of regulatory submission. This document describes the device, its intended use, and then asserts substantial equivalence based on non-clinical verification and validation testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance data in the typical sense for algorithms. Instead, the performance is evaluated by "non-clinical verification and validation testing" demonstrating equivalence to the predicate device. The general acceptance criterion is that the subject device performs at least as well as or similarly to the predicate device for various mechanical properties and safety aspects.

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

• Sample Size: Not explicitly stated as "test set" in the context of an algorithm. The non-clinical verification and validation testing would have involved a sufficient number of device samples to ensure statistically sound results for mechanical and other tests. Specific numbers are not detailed in this summary document.
• Data Provenance: The tests are described as "non-clinical verification and validation testing." This typically means laboratory bench testing, simulations, and material characterization performed by the manufacturer (Pivot Medical). It's not human clinical data or retrospective/prospective patient data.

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

• Not Applicable. This is a mechanical device, not a diagnostic algorithm requiring expert interpretation to establish ground truth. The "ground truth" for the mechanical tests would be established by standardized testing methods and measurement instruments, comparing the results to established norms or the predicate device's performance.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication of results is mentioned or relevant for these types of non-clinical mechanical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is specifically for evaluating the effectiveness of diagnostic or screening tools, particularly with human readers. This device is a surgical implant; an MRMC study is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be objective measurements obtained through calibrated equipment and standardized test protocols. The primary comparison point (the "truth" for demonstrating equivalence) is the performance of the legally marketed predicate device (CinchLock Knotless Suture Anchor, K131769).

8. The Sample Size for the Training Set:

• Not Applicable. As a physical device, there isn't a "training set" in the computational or AI sense.

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

• Not Applicable. See point 8.

Summary based on the document:

The document describes the CinchLock Flex Knotless Suture Anchor as a line extension to an existing device. The study to prove the device meets acceptance criteria primarily involved non-clinical verification and validation testing. The core of this study was to demonstrate substantial equivalence to a previously cleared predicate device (CinchLock Knotless Suture Anchor, K131769). The modifications were to the inserter, handle, and anchor coupling, with no changes to the implantable material.

The testing covered aspects like:

• Insertion Strength
• Anchor Coupling Strength
• Ultimate Tensile Strength
• Anchor Cinch Force
• Inserter Moment Testing
• Design Validation
• Packaging Validation
• Sterilization Validation
• Shelf Life/Stability Validation
• Biological Safety Assessment

The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence for this submission."

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