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The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include:

Shoulder procedures	(e.g. Rotator cuff repair)
Knee procedures	(e.g. Patellar ligament / tendon avulsion repair)
Ankle procedures	(e.g. Achilles tendon reconstruction and repair)
Foot procedures	(e.g. Hallux valgus reconstruction)
Elbow procedures	(e.g. Biceps tendon reattachment)
Bladder neck suspension	(female urinary incontinence due to urethral hypermobility)

The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.

Device Description

The Axya Bone Anchor System consists of an electronic control module and a reusable welding activator with an integral connector cable. The Kit (BAK) consists of a reusable suture welding sleeve packaged together with appropriate and currently approved bone anchors and USP polypropylene monofilament suture. The Kit is intended for use with the reusable system components in order to complete the suture welding process for the attachment of soft tissues to bone anchors in surgical procedures where bone anchors are indicated.

AI/ML Overview

The provided text describes a medical device, the Axya Bone Anchor System and Kit (BAK), and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it relies on demonstrating that the BAK's design and components are similar to existing approved devices and that the core technology (suture welding) has previously been shown to meet performance and safety standards.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a different type of evaluation (e.g., performance of an AI/ML algorithm).

Here's a breakdown of what can and cannot be answered based on the provided document:

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

Acceptance Criteria (Inferred from Predicate Device Statements)	Reported Device Performance (Axya BAK, or core technology)
Suture Knot Strength: Exhibit "knot strength" characteristics substantially above USP requirements for various USP suture materials.	Suture Knot Strength: "Data were presented which demonstrate that sutures placed by means of the suture welding process exhibit 'knot strength' characteristics substantially above the USP requirements for the various USP suture materials tested. These tests confirm that the polypropylene monofilament sutures placed with the ultrasonic suture welding technology are equivalent in holding strength (efficacy) to sutures placed with conventional knotting techniques."
"Data presented in the original Notice for the Bone Anchor System and Kit confirm that USP size 2 polypropylene monofilament sutures secured by a weld formed with the AxyaWeld Tips exceed the USP knot strength requirements."
Strength vs. Angle of Applied Tension: Meet strength requirements regardless of the angle of applied tension between the suture and the bone anchor stem.	Strength vs. Angle of Applied Tension: "Data were presented that demonstrate that strength requirements are met regardless of the angle of applied tension between the suture and the bone anchor stem."
Suture Fatigue and Elongation: Meet suggested criteria following cyclic testing over the functional life.	Suture Fatigue and Elongation: "Suture fatigue and elongation over the functional life were evaluated in bench-test models and the welded sutures have been found to meet the suggested criteria following cyclic testing."
Safety - Histopathologic Change: No significant histopathologic change at suture implant sites.	Safety - Histopathologic Change: "In both animal models there was no histopathologic change seen at the suture implant sites where the suture was sealed with ultrasonic energy. The investigators concluded that there was no significant difference in safety of efficacy between the traditional method of suture placement and the technique which includes replacement of manual knot-tying with suture welding."
Safety - Thermal Injury: No risk of causing thermal injury to the patient.	Safety - Thermal Injury: "Because of design features of the BAK, no portion of the ultrasonic generator comes into contact with human tissues. Because of this, there is virtually no risk of causing a thermal injury to the patient. The suture material is heated and welded by friction and the weld is formed by melting and fusing the polymer. No 'flux' or 'welding rod' is employed and no new chemical entities are introduced or produced in the welding process."
"The design of the AxyaWeld Sleeve also prevents the heated area of suture from coming into direct contact with tissues."
Sterility: Components are appropriately sterilized and validated.	Sterility: "Axya Bone Anchor System and Kit with a reusable sleeve is provided non-sterile. The suture material and bone anchors are sterilized by the original manufacturer as dictated by the type of suture included with a given product configuration. The sterility processes, the manufacturing process, and the packaging process are validated by the manufacturer."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an algorithm evaluation. The document refers to various tests conducted on the predicate devices or the core welding technology, such as "in vivo and in vitro studies" and "bench-test models." The specific number of sutures, animals, or tests performed is not detailed.
Data Provenance:
- In vivo studies: "New Zealand rabbits" were used for studies on the predicate ASLS system.
- In vitro studies/bench-test models: Not specified.
- Retrospective or Prospective: Not explicitly stated, though the animal studies would be prospective at the time they were conducted for the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The "ground truth" here would relate to the assessment of suture strength, tissue reaction, etc., which would be determined by laboratory measurements and histopathological evaluations, likely by veterinary pathologists or engineers, but their number and specific qualifications are not mentioned.

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

Not applicable. This concept (adjudication of expert readings) is relevant for clinical studies involving human interpretation (e.g., radiology studies), not for mechanical or animal safety/efficacy testing described here.

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 device is a surgical tool, not an AI-powered diagnostic or assistive system for human readers. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable. This is not an AI/ML algorithm. The device is a surgical instrument.

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

The types of "ground truth" or evaluative methods used include:

Laboratory measurements of suture knot strength (USP requirements).
Bench-test models for suture fatigue and elongation.
Histopathological evaluation of tissue reaction at suture implant sites in animal models.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, there is no training set for an AI/ML algorithm.

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