The Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.

Device Description

The Sutureless Anchor is a biodegradable bone anchor intended for soft tissue to bone fixation in the repair of shoulder injuries. The device is offered in one size, 7.0mm. The Sutureless Anchor implant consists of three components: a sleeve, pin and washer. Upon deployment, the pin is driven through the center of the washer into the sleeve, expanding the sleeve radially to gain bone fixation. Simultaneously, a shearing mechanism releases the implant from the deployment shaft. The washer, fastened to the implant by the pin head, remains above the bone surface, tacking the soft tissue to the bone.

AI/ML Overview

The provided text describes specific performance data for the "Sutureless Anchor" device, focusing on its ultimate holding strength compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance
Ultimate Holding Strength	To demonstrate substantially equivalent performance to the predicate device (SureTac).

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

Sample Size: The document does not explicitly state the sample size used for the Bone Model Testing. It refers to "the ultimate holding strength" and "holding strength mean," implying multiple tests were performed, but the number of samples is not given.
Data Provenance: The testing was "in-vitro," meaning it was conducted in a controlled laboratory environment, not on live subjects. The country of origin of the data is not specified but given the submitter's address (Marlborough, MA, USA), it can be inferred the testing was likely conducted in the USA or supervised by the US-based company. The data is retrospective in relation to the submission date as it was performed to support the 510(k) application.

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 provided in the text. The study described is a mechanical performance test (bone model testing), not one requiring expert human interpretation. The "ground truth" here is the measured holding strength, a quantitative metric.

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

This information is not applicable to the described study. The study is a quantitative mechanical test measuring ultimate holding strength, which does not involve human adjudication for ground truth.

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 provided and is not applicable. The provided document describes a pre-market notification for a medical device (Sutureless Anchor) and its mechanical performance testing. It does not involve AI, human readers, or image interpretation.

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

This information is not provided and is not applicable. The device is a mechanical anchor; there is no algorithm involved in its function or performance testing as described.

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

The ground truth for the test set was based on quantitative measurement of ultimate holding strength in a bone model.

8. The sample size for the training set:

This information is not provided and is not applicable. The device is a mechanical implant, not an AI-driven system that requires a "training set."

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

This information is not provided and is not applicable, as there is no training set for a mechanical implant.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for a company called "INNOVASIVE DEVICES". The logo consists of a stylized letter "A" and the company name in bold, sans-serif font. Above the logo, there is a handwritten date "3/1/99".

K984490

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: December 16, 1998

2. DEVICE:

Trade Name: Sutureless Anchor

Common Name: Bone Anchor

Classification Name: Not Classified

3. PREDICATE DEVICE:

(1) the Acufex SureTac - K911837

(2) the Innovasive BioROC EZ Fastener K973381

4. DEVICE DESCRIPTION:

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5. INTENDED USE:

The proposed Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.

6. COMPARISON OF CHARACTERISTICS:

The bone fixation mechanism of the proposed Sutureless Anchor is same as the predicate BioROC EZ: a pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The BioROC EZ is also cleared for the same indications and utilizes the same biodegradable material as two of the proposed Sutureless Anchor implant components.

The predicate SureTac device and the proposed Sutureless Anchor have the same intended use, and are similar in that both devices anchor soft tissue to bone without the use of suture. However, the SureTac is a one piece device that is driven into the bone, while the proposed Sutureless Anchor consists of three components and is deployed into the bone fixated by expansion of the sleeve. The material of these devices also differs.

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 Sutureless Anchor was compared to the currently marketed SureTac. The proposed Sutureless Anchor holding strength mean at time zero, and at six weeks in-vitro, was greater than that of the predicate device, demonstrating substantially equivalent performance between the two devices.

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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 a stylized image of three human figures connected at the shoulders, forming a symbol that resembles a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 1999

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

Re: K984490 Trade Name: Sutureless Anchor Regulatory Class: II Product Code: MAI Dated: December 16, 1998 Received: December 17, 1998

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ 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 requlation 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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Paqe 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 requlation (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. Whitton, Ph.D., M.D.

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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Page _ of _

K98490 510(k) Number (if known):_ Device Name: ك

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_y/2 (Per 21 CFR 801.109)

Over-The-Counter Use $\mathcal{N}a$

(Optional Format 1-2-96)

Division Siralora

Division Sian Division of General Restorative Do 510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.