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The Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

The device is designed with a corkscrew style thread 3.0 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.

The Model 3000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

The provided 510(k) summary for the Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the way a clinical or diagnostic performance study would.

This document focuses on establishing substantial equivalence to existing legally marketed devices, primarily through in vitro mechanical testing. The goal of this type of submission is to demonstrate that the new device is as safe and effective as a predicate device, not necessarily to meet pre-defined performance thresholds for diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as they are not relevant to a 510(k) submission based on substantial equivalence and in vitro testing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "summaries of in vitro studies" without providing specific numbers of anchors tested.
• Data Provenance: The studies were "in vitro," meaning conducted in a lab environment. The country of origin is not specified but is presumably where Axya Medical, Inc. (Beverly, MA, USA) conducted its research. The studies would be considered prospective in the sense that they were designed and executed to generate specific data for the submission, even if it's not a clinical trial.

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

• Not applicable. For in vitro mechanical testing, "ground truth" is established by the standardized methods of the test itself (e.g., precise measurement of force, observation of failure mode). There are no human "experts" establishing a diagnostic ground truth in this context.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data with subjective elements, which is not the case for material property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study (MRMC) is for evaluating the impact of a diagnostic tool on human reader performance, typically in imaging or clinical decision-making. The Axya Bone Anchor is a surgical implant, not a diagnostic device.

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

• Yes, in spirit. The in vitro mechanical testing essentially represents "standalone" performance of the device's physical properties. It's the performance of the device itself under controlled conditions, not involving human interpretation in a clinical setting.

7. The Type of Ground Truth Used:

• Standardized Mechanical Measurements/Observations. The "ground truth" here is objective physical data (e.g., force in Newtons, precise description of fracture or pull-out). This is established by the methods outlined in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)."

8. The Sample Size for the Training Set:

• Not applicable. The concept of a "training set" is relevant to machine learning algorithms. This device is a physical implant, and its development does not involve training data in that sense. Its design and material choices are based on engineering principles and previous experience with similar devices, not a dataset for training an algorithm.

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

• Not applicable (as explained in point 8).

In summary: The provided document is a 510(k) summary for a medical device (a bone anchor) seeking market clearance based on substantial equivalence. It provides evidence of compliance with an FDA guidance document through in vitro mechanical testing to compare its performance (pull-out strength and failure mode) to predicate devices. It does not contain information about acceptance criteria or studies related to diagnostic accuracy, multi-reader performance, or algorithm training, as these concepts are not applicable to the nature of this device and its regulatory pathway.

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