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The 3.5mm ROC XS Suture Bone Fastener is intended for for use in bladder neck suspension for female urinary incontinence due to urethral hypermobility.

The Innovasive Rotator Cuff Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a three component system comprised entirely of acetal plastic. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener is deployed into the bone by causing a crown component to cam over a stationary anvil causing the fingers of the device to spread. The Fastener comes with various non-absorbable suture material.

In addition to the Fastener, a stainless steel drill, drill guide and awl are available to establish the proper hole for in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Tastener will be available as a sterile, succe in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

This document describes a medical device submission, not a study evaluating an AI algorithm or a diagnostic device with specific performance metrics like sensitivity or specificity. Therefore, many of the requested categories regarding acceptance criteria, sample sizes for AI models, expert adjudication, or MRMC studies are not applicable.

The document describes a mechanical device (suture bone fastener) and focuses on its physical performance characteristics compared to a predicate device to establish substantial equivalence.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Bone model testing" but does not specify the number of fasteners tested or the number of bone models used.
• Data Provenance: Not applicable in the context of human subject or imaging data. The testing was conducted "in a bone model," implying a laboratory-based, synthetic, or ex-vivo model rather than clinical data from a specific country. This would be considered prospective testing of the device's mechanical properties.

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

• Not applicable. This study involved mechanical testing against a predicate device, not the assessment of diagnostic accuracy or expert interpretation. The "ground truth" was derived from the physical measurement of holding strength.

4. Adjudication Method for the Test Set

• Not applicable. This study involved mechanical testing, not expert review or adjudication of clinical cases.

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

• No. This was a mechanical performance comparison of a physical device, not an evaluation of diagnostic effectiveness involving human readers.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Objective Mechanical Measurement: The "ground truth" was established through direct measurement of the ultimate holding strength and holding strength with suture in a bone model. This is an objective, quantitative physical property.

8. The Sample Size for the Training Set

• Not applicable. This study does not involve a training set for an algorithm.

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

• Not applicable. This study does not involve a training set for an algorithm.

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