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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Ultimate Holding Strength	The Innovasive 3.5mm ROC XS Suture Bone Fastener's ultimate holding strength should be equivalent to or greater than the predicate device.	The Innovasive 3.5mm ROC XS Suture Bone Fastener's holding strength was found to be equivalent to the strength of the predicate device.
Holding Strength with #2 Suture	The Innovasive 3.5mm ROC XS Suture Bone Fastener's holding strength with #2 suture in a bone model should be equivalent to or greater than the predicate device.	The Innovasive 3.5mm ROC XS Suture Bone Fastener's holding strength (implicitly, with #2 suture, as it's part of the same comparison) was found to be equivalent to the strength of the predicate device.

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.

Summary

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FEB 2 4 1997

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229

Contact: Eric Bannon. Vice President of Quality Assurance and Regulatory Affairs Date Prepared: December 4, 1996

2. DEVICE:

Innovasive 3.5mm ROC XS Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC Suture Bone Fastener

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 3.5mm ROC XS Suture Bone Fastener was the Innovasive 3.5mm ROC Suture Bone Fastener

4. DEVICE DESCRIPTIONS:

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

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5. INTENDED USE:

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.

6. COMPARISON OF CHARACTERISTICS:

The Innovasive Devices Rotator Cuff Fastener is comprised of acetal plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through the spreading of the fingers of a crown component resulting in an inverted umbrella design.

The Innovasive Devices ROC Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.

7. PERFORMANCE DATA:

The following performance data was provided in support of the substantial equivalence determination:

Bone model testing: Comparison of the ultimate holding strength and the strength with #2 suture in a bone model compared to the predicate device. The Innovasive 3.5mm ROC XS suture bone fastener holding strength was found to be equivalent to the strength of the predicate device.

Regulation Number and Section

N/A