Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.
Patellar ligament and tendon avulsion repairs.
Extra-capsular reconstruction, ITB tenodesis

ANKLE

Lateral instability
Medial instability
Achilles tendon reconstruction and repair
Mid-foot reconstructions

FOOT

Hallux valgus reconstruction

BLADDER NECK SUSPENSION

Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Description

The ROC LF suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve, the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.

In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. 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 Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves a device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, AUC).

Instead, the document is a 510(k) Summary for a medical device, specifically the Innovasive 2.8mm and 3.5mm ROC LF Suture Bone Fastener. The "performance data" section describes mechanical performance tests for this bone fastener, not diagnostic performance.

Therefore, I cannot provide the requested information for acceptance criteria and device performance as if it were a diagnostic AI device.

However, I can extract the information provided about the mechanical performance data which is presented to demonstrate substantial equivalence to a predicate device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria for ultimate holding strength. Instead, the performance reports "equivalence" to a predicate device.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Cadaver study	Ultimate holding strength equivalent to predicate device	Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
Bone model testing	Ultimate holding strength equivalent to predicate device	Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.

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

Cadaver study: The sample size is not specified.
Bone model testing: The sample size is not specified.
Data provenance: Not specified, but generally, cadaver studies are "prospective" in the sense that the test is applied to the cadaver specimen. Bone model testing is a controlled laboratory experiment.

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 question is not applicable. The studies described are mechanical tests of a bone fastener's holding strength, not diagnostic evaluations requiring expert-established ground truth.

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

This question is not applicable as the studies involve mechanical measurements, not expert review or adjudication.

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:

This question is not applicable. This document describes a medical device (bone fastener), not an AI-assisted diagnostic tool.

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

This question is not applicable. This document describes a medical device (bone fastener), not an AI algorithm.

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

The "ground truth" in these studies is the measured ultimate holding strength of the devices. For the cadaver study, this would be the actual physical holding strength in human bone. For the bone model, it would be the physical holding strength in a synthetic bone model.

8. The sample size for the training set:

This question is not applicable. These are mechanical performance tests for a physical device, not an AI model that requires a training set.

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

This question is not applicable as there is no training set mentioned or implied for a physical device's mechanical performance testing.

Summary

{0}------------------------------------------------

MAR 2 5 1997

K970089

510(K) SUMMARY

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 16, 1996

2. DEVICE:

Innovasive 2.8mm and 3.5mm ROC LF Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC LF Suture Bone Fastener

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 2.8mm and 3.5mm Roc LF Suture Bone Fastener was the Innovasive Devices ROC Suture Bone Fastener, marketed by Innovasive Devices, Marlborough, MA.

4. DEVICE DESCRIPTIONS:

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will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.

The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.

5. INTENDED USE:

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

SHOULDER

1. Repair of rotator cuff tears
1. capsular instability
1. slap lesion repair
1. acromio-clavicular separation
1. capsule shift/capsulolabral reconstruction
1. biceps tenodesis
1. deltoid repair

KNEE

Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.
Patellar ligament and tendon avulsion repairs.
Extra-capsular reconstruction, ITB tenodesis

ANKLE

1. Lateral instability
1. Medial instability
1. Achilles tendon reconstruction and repair

Mid-foot reconstructions

FOOT

Hallux valgus reconstruction

BLADDER NECK SUSPENSION

Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

{2}------------------------------------------------

6. COMPARISON OF CHARACTERISTICS:

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.

The ROC LF device consists of similar materials as the ROC fastener. It uses an expander fitted on a shear pin which is drawn up into an expanable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.

7. PERFORMANCE DATA:

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

Cadaver study: Comparison of the ultimate holding strength in the humeral head and gleniod compared to the predicate device. The Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
Bone model testing: Comparison of the ultimate holding strength in the bone model compared to the predicate device. The Innovasive ROC LF Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.