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The Arthrex Short Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

The Arthrex Short Suture Anchors share the same design features, materials, and intended use as the predicate. The anchors consist of cannulated anchors with an integral or separate eyelet. They are pre-loaded on a handle inserter. Suture, with or without needles, and a suture threader may be provided. The anchors are made from polyetheretherketone (PEEK) and range from 2.0mm - 2.4mm in diameter and 8.6 - 9.0mm in length (including eyelet).

This document (K151092) is a 510(k) premarket notification for a medical device called "Arthrex Short Suture Anchors." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than describing a study with acceptance criteria for a new AI/software device. Therefore, many of the requested fields are not applicable to the content of this document.

However, I can extract the relevant information from the document regarding the device's performance demonstration.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated in the provided document. The document refers to "tensile testing data," but does not specify the number of anchors or tests performed.
• Data provenance: Not explicitly stated. Given that it's a submission for a medical device, it's highly likely that the testing was conducted in a controlled laboratory environment. The document is from the US.
• Retrospective or prospective: Not applicable for mechanical testing of a physical medical device.

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

• Not applicable. Ground truth in this context would be the measured tensile strength, which is objectively quantifiable through mechanical testing, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are typically relevant for subjective evaluations or complex medical interpretations, not for objective mechanical tensile testing.

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 document is about a physical medical device (suture anchors), not an AI or software device.

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

• Not applicable. This is not an algorithm or software. The "standalone" performance here refers to the device's mechanical properties, which were evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth would be the measured tensile strength from mechanical testing.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is a physical medical device, not a machine learning model.

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

• Not applicable. This device does not involve a training set.

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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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