The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.

Device Description

The Innovasive 10mm Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm Ligament Fastener will be offered in a single size, 10mm outside diameter and 20mm long. The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component. The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.

AI/ML Overview

The provided text describes a medical device, the Innovasive 10mm Ligament Fastener, and its 510(k) submission for market clearance. It includes information about the device's comparison to predicate devices and performance data. However, the document is a 510(k) summary and not a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study design specifics, expert involvement, and training set details are not present.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Mechanical Testing: Ultimate holding strength in a bone model compared to the predicate device.	The Innovasive 10mm Ligament Fastener holding strength was found to be equivalent to the strength of the predicate device.

Note: The specific quantitative acceptance criteria for "equivalent" are not provided in this document.

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: Not specified.
Data Provenance: Not specified. This sounds like bench testing ("in a bone model"), so a country of origin for clinical data or a retrospective/prospective designation isn't applicable.

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)

Number of Experts/Qualifications: Not applicable. This was mechanical testing in a bone model, not an expert-driven assessment of clinical outcomes or images.

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

Adjudication Method: Not applicable. This was mechanical testing.

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

MRMC Study: No. This device is a ligament fastener, not an AI-powered diagnostic tool.

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

Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

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

Type of Ground Truth: The "ground truth" for the mechanical testing was the ultimate holding strength of the predicate device in a bone model. This is a comparative mechanical performance rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that would require a training set. The device's "design" is based on the predicate device and engineering principles.

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

Ground Truth for Training Set: Not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a physical medical device. The "study" referenced is a single mechanical test comparing the ultimate holding strength of the new device to a predicate device in a bone model. It is not a clinical study or an AI-related performance evaluation, which explains why much of the requested information is not present or applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K974049" on the top line and "510(K) SUMMARY" on the second line. The text is black and the background is white. The text appears to be handwritten or in a font that mimics handwriting.

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: October 22, 1997

2. DEVICE:

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Innovasive 10mm Ligament Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: innovasive Devices 10mm Ligament Fastener

3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Innovasive Devices 10mm Ligament Fastener were (1) the 8mm Innovasive Devices Ligament Fastener marketed by Innovasive Devices, Marlborough, MA, and (2) the Mitek Ligament Anchor marketed by Mitek Surgical, Norwood, MA.

4. DEVICE DESCRIPTION:

The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.

The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. In addition, the central pin incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue graft. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.

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5. INTENDED USE:

The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.

6. COMPARISON OF CHARACTERISTICS:

The Innovasive 10mm Ligament Fastener utilizes the same basic design for fixation into bone as the currently marketed 8mm Ligament Fastener (K970316). This design utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone.

The outer sleeve is identical for both the 8mm and 10mm Ligament Fasteners. However, the central pin for the existing 8mm Ligament Fastener has a radius at the eyelet designed for direct fixation of the soft tissue graft; whereas the central pin for the proposed 10mm Ligament Fastener incorporates a "side-plate" with two transverse pegs to hold a bone plug for bone-patella-bone fixation of the soft tissue graft.

7. PERFORMANCE DATA:

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

1. Mechanical Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive 10mm Ligament Fastener holding strength was found to be equivalent to the strength of the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB | 8 1998

K974049 Re : LinX BT 10mm Ligament Fastener Trade Name: Regulatory Class: II Product Codes: MBI, HRX, and HWC Dated: January 23, 1998 Received: January 26, 1998

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 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 Regulations, 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 regulation (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 requlation may result in requlatory 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. 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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

a 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 10mm Ligament Fastener

The 10mm Ligament Fasteners are intended for use in the fixation of ligament and tendon bone block grafts in cruciate ligament reconstruction surgeries of the knee.

Prescription Use
(Per 21 CFR 801.109)

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Sion-Off Divis Division of General Restorative De 974049 510(k) Numb

Regulation Number and Section

N/A