The LinX Tibial Ligament Fastener is intended for use in direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.

The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

Device Description

The Innovasive LinX Tibial Ligament Fastener utilizes a central pin placed inside an outer sleeve resulting in direct fixation of the device into bone. The Innovasive Devices LinX Tibial Ligament Fastener will be offered in five configurations:
#1) 8mm x 40mm
#2) 8mm x 40m Short (short refers to eyelet size)
#3) 8mm x 55mm
#4) 10mm x 40mm
#5) 10mm x 55mm
The central pin has ribs along its length designed to lock into the outer sleeve as it is inserted into the sleeve inside diameter. The central pin has an eyelet through which the soft tissue graft is threaded and four through-holes located above the eyelet that may be used to suture the graft to the pin; or a pin with a short eyelet (8mm x 40mm Short) may be used, that only accepts the suture that is sutured to the 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.

The outer sleeve has a central ID designed to accept the pin component, and an angled plate designed to lay flush against the tibia on the outside of the knee.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Innovasive LinX Tibial Ligament Fastener:

The provided 510(k) summary (K980491) for the Innovasive LinX Tibial Ligament Fastener describes a medical device undergoing regulatory review for substantial equivalence. It is important to note that this document is a 510(k) summary for a premarket notification, not a full scientific paper detailing a comprehensive study. As such, it will not contain all the typical elements of a detailed study report.

Based on the information provided, here’s a breakdown:

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

Acceptance Criteria	Reported Device Performance
Ultimate holding strength (Implicitly, to be substantially equivalent to predicate devices)	The Innovasive LinX Tibial Ligament Fastener holding strength was found to be substantially equivalent to the Soft Tissue Screw and Washer System (a predicate device).

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 explicitly stated. The document mentions "human cadaver," indicating the type of test medium but not the number of cadavers or individual tests performed.
Data Provenance: The study was conducted using "human cadaver." No information about the country of origin or whether it was retrospective or prospective is provided. Given the nature of a 510(k) submission, this would typically involve laboratory testing.

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)

Not applicable. This was a mechanical performance study, not a diagnostic or interpretive study requiring expert consensus for ground truth.

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

Not applicable. This was a mechanical study measuring holding strength, not an interpretation of images or clinical outcomes requiring adjudication.

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

Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

Ground Truth: The "ground truth" in this context is the measured ultimate holding strength of the predicate device (Innovasive Devices Soft Tissue Screw and Washer System). The new device's performance was compared directly to this established performance benchmark. There isn't an "expert consensus" or "pathology" type of ground truth here, but rather a direct physical measurement.

8. The sample size for the training set

Not applicable. This is a mechanical device study, not a machine learning study. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set for this type of study.

Summary of Device Performance and Substantial Equivalence:

The core of the performance data section is the mechanical testing. The crucial aspect for a 510(k) clearance is demonstrating substantial equivalence to existing predicate devices.

Test Performed: Mechanical testing to assess ultimate holding strength.
Test Medium: Human cadaver.
Comparison: The Innovasive LinX Tibial Ligament Fastener was compared to the Soft Tissue Screw and Washer System (another device marketed by Innovasive Devices).
Finding: The holding strength of the new device was found to be "substantially equivalent" to the predicate device. This is the primary acceptance criterion for this type of regulatory submission – that the new device performs acceptably similarly to a legally marketed device for its intended use, without raising new questions of safety or effectiveness.

Summary

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1980491

APR 2 9 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: February 6, 1998

2. DEVICE:

Innovasive 8mm & 10mm LinX Tibial Ligament Fastener Classification Name: Single/multiple component bone fixation appliances and accessories.

Trade Name: Innovasive Devices LinX Tibial Ligament Fastener

3. PREDICATE DEVICE:

. The predicate devices used to determine substantial equivalence for the Innovasive Devices LinX Tibial Ligament Fastener were (1) the 8mm Ligament Fastener, and (2) the Soft Tissue Screw and Washer System, both marketed by Innovasive Devices, Marlborough, MA.

4. DEVICE DESCRIPTION:

#1) 8mm x 40mm #2) 8mm x 40m Short (short refers to eyelet size) #3) 8mm x 55mm #4) 10mm x 40mm #5) 10mm x 55mm
The central pin has ribs along its length designed to lock into the outer sleeve as it is inserted into the sleeve inside diameter. The central pin has an eyelet through which the soft tissue graft is threaded and four through-holes located above the eyelet that may be used to suture the graft to the pin; or a pin with a short eyelet (8mm x 40mm Short) may be used, that only accepts the suture that is sutured to

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the 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.

The outer sleeve has a central ID designed to accept the pin component, and an angled plate designed to lay flush against the tibia on the outside of the knee.

5. INTENDED USE:

The LinX Tibial Ligament Fastener is intended for use in direct bone fixation of ligament and tendon grafts during cruciate ligament reconstruction surgeries.

6. COMPARISON OF CHARACTERISTICS:

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

The central pin of the proposed device differs from the currently marketed central pin only in evelet size, overall length and the presence of four-through holes located above the evelet that may be used to suture the free ends of the soft tissue graft to the pin.

The outer sleeve of the proposed device has a smooth exterior and an angled plate that lays flush against the tibia on the outside of the knee. The angled plate provides the ultimate device fixation since it prevents the device from pulling through the tibial tunnel. The currently marketed outer sleeve has a threaded exterior that is threaded into a tapped bone hole providing the ultimate fixation of the device.

7. PERFORMANCE DATA:

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

Mechanical Testing: Comparison of the ultimate holding strength in human cadaver was compared to the predicate device. As expected, the Innovasive LinX Tibial Ligament Fastener holding strength was found to be substantially equivalent to the Soft Tissue Screw and Washer System.

BOxEBO

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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 consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

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

K980491 Re: Innovasive LinX Tibial Liqament Fastener Trade Name: Requlatory Class: II Product Code: MBI February 6, 1998 Dated: February 9, 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. ਮੁ 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 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 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.

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 LinX Tibial Ligament Fastener

The LinX Tibial Ligament Fasteners are intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

Prescription Use
(Per 21 CFR 801.109)

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Division of General Restorative Devices પ્રવ મધુર 510(k) Number .

30208

Regulation Number and Section

N/A