The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation 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 repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

Device Description

The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.

AI/ML Overview

This document describes the performance data for the RC Multi-Suture Anchor, which is a bone anchor device. The study is a comparison of the RC Multi-Suture Anchor to a predicate device, the ROC EZ Suture Bone Fastener, to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Objective: Demonstrate substantial equivalence in holding strength to the predicate device.	The ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices.

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. The document mentions "Bone Model Testing" and compares the "ultimate holding strength" of the proposed device to the predicate device, implying a quantitative test, but the number of samples or tests performed is not provided.
Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance test rather than involving patient data.

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 applicable to the type of study conducted. The ground truth for device performance in this context is the measured "ultimate holding strength" in a bone model, not expert interpretation of clinical data.

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

This information is not applicable. The study involves direct physical measurement of device performance, not expert adjudication of subjective outcomes.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of a medical device, not on the effectiveness of human readers with or without AI assistance.

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

This information is not applicable. The device is a physical bone anchor, not an algorithm. The study assesses the standalone performance of the physical device.

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

The ground truth used is the measured ultimate holding strength of the devices in a bone model. This is a direct physical measurement of performance.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a physical device performance study, not an AI/machine learning study.

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

This information is not applicable, as there is no training set involved in this type of device performance study.

Summary

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OCT 1 4 1999

510(K) SUMMARY

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Fax: 508-460-6661

Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: July 2, 1999

2. DEVICE:

Trade Name: RC Multi-Suture Anchor

Common Name: Bone Anchor

Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"

3. PREDICATE DEVICE:

The Innovasive ROC EZ Suture Bone Fastener (K970089, K971922).

4. DEVICE DESCRIPTION:

5. INTENDED USE:

The proposed RC Multi-Suture Anchor is intended for soft tissue reattachment to host bone for the following indications:

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SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation 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 repairs Extra-capsular reconstruction ITB tenodesis

ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

6. COMPARISON OF CHARACTERISTICS:

The proposed RC Multi-Suture Anchor utilizes the same materials as the predicate ROC EZ Suture Bone Fastener and the same method of bone fixation. The indications being requested for the proposed RC Multi-Suture Anchor are cleared for the predicate ROC EZ Suture Bone Fastener.

7. PERFORMANCE DATA:

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

Bone Model Testing: the ultimate holding strength of the proposed RC Multi-Suture Anchor was compared to the currently marketed ROC EZ Suture Bone Fastener. The holding strength of the proposed RC Multi-Suture Anchor was greater than that of the predicate device, demonstrating substantially equivalent performance between the devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Kathleen Morahan Requlatory Affairs Specialist Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

Re: K992458 RC Multi-Suture Bone Anchor Regulatory Class: II Product Codes: MBI and GAT Dated: July 19, 1999
Received: July 23, 1999

Dear Ms. Morahan:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸਿ 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 GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 requlations.

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Page 2 - Ms. Kathleen Morahan

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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). 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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications:

SHOULDER

Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair

KNEE

ANKLE

Lateral and medial instability Achilles tendon reconstruction and repair

bicolede

Division ivision of General Restorative De 510(k) Numb

Prescription Use J (Per 21 CFR 801.109)

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.