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The CinchLock Knotless Suture Anchor and the NanoTack Suture Anchor 1.4mm are intended for the fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee. Please see individual indications for use statements.

The NanoTack® Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis.

The CinchLock™ Knotless Anchor, previously cleared under 510(k) K123651, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization, Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis.

The Pivot Suture Anchors which are part of this expanded indications submission are as follows: Pivot CinchLock Knotless Suture Anchor, Pivot NanoTack Suture Anchor 1.4mm. These anchors are non-degradable suture anchors manufactured from PEEK-OPTIMA® LT1 polymer. The CinchLock and NanoTack Anchors are attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the CinchLock Knotless Suture Anchor and Inserter. The Pivot NanoTack Suture Anchor incorporates a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture. The CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm devices are provided as a single use sterile devices.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria, as it focuses on a medical device clearance (510(k) for suture anchors) rather than an AI/ML device.

Specifically, the document discusses:

• Device Names: CinchLock Knotless Suture Anchor, NanoTack Suture Anchor 1.4mm
• Classification: Bone Anchor, Class II, Product Code MBI
• Predicate Device: Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586
• Device Description: Non-degradable suture anchors made from PEEK-OPTIMA® LT1 polymer, pre-assembled to a stainless steel Inserter, with UHMWPE suture.
• Intended Use: Fixation of soft tissue to bone in various anatomical regions (hip, shoulder, foot/ankle, hand/wrist, elbow, and knee) for specified procedures.
• Technological Characteristics: Identical to previous submissions; the current submission is for expanded indications.
• Performance Testing: Mentions "insertion strength, anchor strength, suture strength, and biocompatibility testing" demonstrating substantial equivalence to the predicate device.
• Substantial Equivalence: Claimed based on indications for use, technological characteristics, and comparison to the predicate device.
• FDA Clearance: A letter from the FDA confirming substantial equivalence and providing clearance.
• Expanded Indications for Use: Detailed lists of procedures for the NanoTack and CinchLock anchors across various joints.

This information pertains to a traditional medical device (suture anchors) and its mechanical and biological performance, not an AI/ML diagnostic or prognostic device. Therefore, the questions regarding acceptance criteria in terms of performance metrics like sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.

This document is a 510(k) premarket notification for a medical device (Knotless Suture Anchor). It does not contain acceptance criteria or a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI device. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than specific performance metrics against pre-defined acceptance criteria through a clinical trial.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as they pertain to a different type of device evaluation.

However, I can provide the information that is present and relevant to the "substantial equivalence" claim:

1. A table of acceptance criteria and the reported device performance:

Instead of formal acceptance criteria and quantitative performance metrics like sensitivity/specificity for a diagnostic device, the "acceptance criteria" here is the demonstration of "substantial equivalence" to predicate devices based on technological characteristics and performance testing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This document refers to "pre-clinical testing" for insertion strength, suture strength, and biocompatibility, but does not provide details on sample sizes for these tests. There is no "test set" in the context of diagnostic performance evaluation.
• Data Provenance: Not applicable in the context of a retrospective/prospective study for device clinical performance. The pre-clinical testing would have been conducted in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device and no clinical efficacy study is detailed in this 510(k) summary. The evaluation focuses on material properties and mechanical performance compared to predicate devices.

4. Adjudication method for the test set:

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI device or a diagnostic device where human reader performance would be a factor.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Mechanical and Biocompatibility Standards / Predicate Device Performance. The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, and the demonstration that the new device meets similar performance benchmarks (e.g., strength, biocompatibility).

8. The sample size for the training set:

• Not applicable. There is no "training set" for an AI model or a device of this nature.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

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