The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Device Description

The Meniscal Screw is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a cannulated, threaded member designed to be inserted into the meniscus across the tear. The device is screwed into location with the aid of a sterile, single use driver mechanism constructed of stainless steel. The driver is loaded with the Meniscal Screw and placed through a cannula to access the site requiring repair.

AI/ML Overview

The provided text describes a 510(k) submission for the Innovasive Meniscal Screw, which is a medical device. This document is a premarket notification for a traditional medical device, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, device performance, ground truth, and AI/ML specific studies (MRMC, standalone algorithm) is not applicable to this submission.

The document discusses substantial equivalence to a predicate device (Bionx Arrow) based on material, design, and intended use, supported by bench testing and animal testing.

Here's a breakdown of the relevant information from the provided text, structured as much as possible to address your request, acknowledging the non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a traditional medical device and not an AI/ML algorithm, there are no "acceptance criteria" in the sense of accuracy, sensitivity, or specificity metrics for an algorithm. Instead, the "acceptance criteria" can be inferred as the performance deemed equivalent to the predicate device to ensure safety and effectiveness.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance
Material: Fabricated from L-PLA (same as predicate)	Innovasive Meniscal Screw is fabricated from L-PLA.
Intended Use: Arthroscopic fixation of specific meniscal lesions (same as predicate)	Intended use for the Meniscal Screw is identical to the predicate device (Bionx Arrow).
Fatigue Strength (in vitro): Compared to predicate device.	Bench testing demonstrated comparison of fatigue strength in vitro compared to the predicate device. (Specific results not provided in this summary).
Performance under constant load: Assessed.	Bench testing assessed device performance under constant load. (Specific results not provided).
Weight loss and intrinsic viscosity: Assessed.	Bench testing assessed weight loss and intrinsic viscosity. (Specific results not provided).
Efficacy and function: Adequate to meet intended use.	Animal testing demonstrated efficacy and confirmed the device functions adequately to meet its intended use. (Specific results not provided).

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary.

Test Set Sample Size: Not specified for bench or animal testing.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable here as there is no "ground truth" in the context of expert labeling for an AI algorithm. The studies involve device performance (mechanical and biological), not interpretation of data by experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML algorithms that assist human readers.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the validated measurements and observations from the bench and animal studies to determine the physical and biological performance of the device.

Bench Testing: Mechanical properties (fatigue strength, constant load performance, weight loss, intrinsic viscosity) measured against established scientific standards and comparison to the predicate device.
Animal Testing: In vivo observations of efficacy and proper functioning to meet intended use, likely through histological analysis, gross observations, and potentially biomechanical assessments in an animal model.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set.

Summary

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510(K) SUMMARY

1. SUBMITTER:

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

Contact: Eric Bannon, Vice President of Regulatory Affairs, Quality Assurance Date Prepared: February 10, 1998

2. DEVICE:

Innovasive Meniscal Screw Classification Name: Bioabsorbable Orthopedic Fixation Device Trade Name: Innovasive Devices Meniscal Screw

3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Innovasive Devices Meniscal Screw was the Bionx Arrow marketed by Bioscience Ltd, Malvern, PA

4. DEVICE DESCRIPTION:

5. INTENDED USE:

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6. COMPARISON OF CHARACTERISTICS:

The Meniscal Screw is fabricated from L-PLA, the same material as the Bionx Arrow. The design differs in the use of an external screw thread designed to draw the edges of the tissue together as the device is placed into the meniscus.

The Bionx Arrow uses a different technique to approximate the tear. The Arrow is inserted over a wire using a cannula to establish the device location.

The indications for use of the two devices are identical.

7. PERFORMANCE DATA:

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

1. Bench Testing: Comparison of the fatigue strength of the Meniscal Screw invitro compared to the predicate device. In addition the performance of the device was assessed under constant load as was the weight loss and intrinsic viscocity.
1. Animal Testing: The testing demonstrated the efficacy of the Innovasive Meniscal Screw and confirmed that the device functions adequately to meet its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three curved lines that converge and then split into three wavy lines at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Mr. Eric Bannon ·Vice President of Requlatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

K980681 Re: Trade Name: Meniscal Screw Regulatory Class: HWC and HRX Product Code: II Dated: February 18, 1998 February 20, 1998 Received:

Dear Mr. Bannon:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. . A. ... .......... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 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 requlations.

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Page 2 - Mr. Eric Bannon

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.

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

Prescription Use
(Per 21 CFR 801.109)

( ್ತಿ.

(Division Sign-Off)

(Division of General Restorative Devices K980681 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.