The Innovasive 10mm LinX HT 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 LinX HT will be offered in two sizes, 10mm outside diameter x 40mm length, and 10mm outside diameter x 55mm length.

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. 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 510(k) premarket notification for the Innovasive 10mm LinX HT Ligament Fastener. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to establish novel performance through extensive clinical trials. Therefore, much of the requested information regarding acceptance criteria and study details for AI/software devices is not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Innovasive 10mm LinX HT device, as implied by the 510(k) submission, were based on demonstrating equivalence in mechanical performance to its predicate device.

Acceptance Criteria	Reported Device Performance
Ultimate holding strength in a bone model	Equivalent to the strength of the predicate device (8mm LinX HT)

Study Details

The study described is a mechanical testing comparison between the new device and a predicate device. This is typical for demonstrating substantial equivalence for medical devices like ligament fasteners.

Sample size used for the test set and data provenance:
- Test set sample size: Not explicitly stated. The document mentions "mechanical testing," which typically involves multiple samples, but the specific number is not provided.
- Data provenance: The testing was likely conducted in a laboratory setting by the manufacturer (Innovasive Devices, Inc.). The document doesn't specify a country of origin for the data beyond that. The study is prospective in the sense that the new device was tested against the predicate, but it is not a clinical study on human subjects.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic or AI-driven devices. For a mechanical device, the "ground truth" is established by the physical properties and performance metrics determined through testing.
Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (experts) in image interpretation or clinical outcomes, which is not relevant to mechanical testing.
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 is a mechanical device, not an AI software or diagnostic tool that involves human readers interpreting cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- Mechanical performance data: The "ground truth" was the direct measurement of the ultimate holding strength of the devices in a bone model. The predicate's performance served as the benchmark for equivalence.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical device testing. This concept applies to machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

Summary

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K980334

1, 36 agus

APR 27 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: January 26, 1998

2. DEVICE:

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

3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Innovasive Devices 10mm LinX HT Ligament Fastener was the 8mm LinX HT Ligament Fastener marketed by Innovasive Devices, Marlborough, 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.

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5. INTENDED USE:

The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction.

6. COMPARISON OF CHARACTERISTICS:

The Innovasive 10mm LinX HT utilizes the same basic design for fixation into bone as the currently marketed 8mm LinX HT (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.

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 LinX HT holding strength was found to be equivalent to the strength of the predicate device.
  . 30141

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 27 1998

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

K980334 Re: Innovasive 10mm LinX HT Ligament Fastener Trade Name: Requlatory Class: MBI and HRX Product Code: II January 26, 1998 Dated: January 28, 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, 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 Regulations, Title 21, Parts 800 to 895. ਜੋ 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 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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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 one regaration Chercuses, "Milliams".
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 10mm LinX HT

The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.

Prescription Use
X
(Per 21 CFR 801.109)

ﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴ

Bcolley

rative D 1980335

30087

Regulation Number and Section

N/A