The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repair Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs BLADDER NECK SUSPENSION Bladder neck suspension for female urinary incontinence due to urethral hypermobility

Device Description

The 3.5mm Metal ROC XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, 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 a 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 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Innovasive 3.5mm Metal ROC XS Suture Bone Fastener". This document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for software or AI-based devices.

The 510(k) notification process is about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical power.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert evaluation is not available in the provided document, as it pertains to a different type of regulatory submission and device.

However, I can extract the following relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The 510(k) process for this device focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria regarding performance like sensitivity or specificity.

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

This information is not available as there is no described performance study in the provided text. The submission is for a physical medical device (bone fastener), not an AI or software product that would typically have a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not available as there is no described study involving ground truth experts in the provided text.

4. Adjudication method for the test set:

This information is not available as there is no described performance study or adjudication process in the provided text.

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 information is not available. The device is a physical bone fastener, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not applicable.

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

This information is not available. The device is a physical bone fastener, not an algorithm.

7. The type of ground truth used:

This information is not available. There is no ground truth concept applied in this 510(k) submission for a physical medical device.

8. The sample size for the training set:

This information is not available as there is no training set mentioned or applicable for this type of device submission.

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

This information is not available as there is no training set or ground truth concept mentioned or applicable for this type of device submission.

Summary of Available Information from the Provided Text:

The provided text focuses on the following aspects for the Innovasive 3.5mm Metal ROC XS Suture Bone Fastener:

Device Description: A 3.5mm metal suture bone fastener with a shear pin, crown, and anvil, designed to expand and fixate into bone upon deployment. It's made of stainless steel.
Intended Use: Reattachment of soft tissue to bone for various indications in the shoulder, knee, ankle, foot, elbow, and bladder neck suspension.
Predicate Devices: Innovasive Devices 3.5mm ROC XS Suture Bone Fastener (plastic) and Innovasive Devices 3.5mm ROC EZ Suture Bone Fastener (plastic). All devices are marketed by Innovasive Devices.
Comparison to Predicate Devices: The key difference is the material (stainless steel for the proposed device vs. plastic for predicates). The Indications for Use are identical to the predicate 3.5mm ROC EZ.
Regulatory Outcome: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.

Summary

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JUN 1 6 1998

510(K) SUMMARY

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: March 31, 1998

2. DEVICE:

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

3. PREDICATE DEVICES:

The predicate devices used to determine substantial equivalence for the modified Innovasive Devices 3.5mm Metal ROC XS Suture Bone Fastener were:

The 3.5mm Innovasive Devices ROC XS Suture Bone Fastener, a. marketed by Innovasive Devices, Marlborough, MA, and
b. The 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener marketed by Innovasive Devices, Marlborough, MA.

4. DEVICE DESCRIPTION:

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 a 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.

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The 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

5. INTENDED USE:

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

SHOULDER

KNEE

Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair

Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repair Extra-capsular reconstruction ITB tenodesis

ANKLE

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

FOOT

Hallux valgus reconstruction

ELBOW

Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

BLADDER NECK SUSPENSION

Bladder neck suspension for female urinary incontinence due to urethral hypermobility

6. COMPARISON OF CHARACTERISTICS:

The existing Innovasive Devices 3.5mm ROC XS and 3.5mm ROC EZ Suture Bone Fasteners are comprised of plastic. The devices are used to secure a suture in a predrilled hole in bone. They remain fixed in the bone through radial compression as the device is deployed.

The proposed 3.5mm Metal ROC XS, as the name suggests, is made of stainless steel. The proposed Indications for Use are identical to those of the existing 3.5mm ROC EZ. As with the existing devices, the proposed 3.5mm Metal ROC XS will be offered with #2 Suture, both with and without stainless steel needles.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three human profiles incorporated into its design.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1998

Mr. Stephen M. Page Manager of Requlatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

Re: K981193 Innovasive 3.5 mm Metal ROC XS Suture Bone Fastener Regulatory Class: II Product Codes: MBI and HWC Dated: March 31, 1998 April 2, 1998 Received:

Dear Mr. Page:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA)* will verify such assumptions. Failure to comply with the GMF regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stephen M. Page

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fu
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

SHOULDER

Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair

KNEE

ﺔ ﺍﻟﻤﺘﺤﺪﺓ

ANKLE

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

FOOT

Hallux valgus reconstruction

ELBOW

Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs

BLADDER NECK SUSENSION -

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

Prescription Use
(Per 21 CFR 801.109)

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A
(Division Sign-Off)
Division of

Division of General Restorative Devices 510(k) Number _ K9811

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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.