The Mitek Bio-INTRAFIX Tibial Screw and Sheath is an absorbable fixation implant for the repair of soft tissue grafts during ligament reconstruction. Bio-INTRAFIX is a two-part system designed to fixate soft tissue to bone for ligament reconstruction.

AI/ML Overview

This 510(k) summary (K032167) for the Bio-INTRAFIX Tibial Tapered Screws and Sheaths does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it relies on substantial equivalence to predicate devices and general compliance with standards. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document. The 510(k) summary states that "The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards." It does not list specific performance criteria (e.g., tensile strength, degradation rate, pull-out strength) and corresponding results from a study.	Not specified in document. There are no quantitative performance results presented.

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

Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described.
Data Provenance: Not applicable. No specific study data is presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. No test set requiring ground truth establishment by experts is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set is described.

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 physical surgical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device.

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

Standalone Performance Study: No. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. No specific study with ground truth is described. The approval is based on substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This is a physical implant, not a machine learning model, so there is no "training set."

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

Ground Truth Establishment (Training Set): Not applicable. As there is no training set, there's no ground truth to establish for it.

Summary from the Document:

The document asserts substantial equivalence based on:

A detailed device description.
Conformance to consensus standards and voluntary standards.
Comparison to predicate devices (IntraFIX (K983560) and Biocryl Interference Screws (K013572)).

This 510(k) submission is a "traditional" submission for a physical medical device, where equivalence is primarily argued through similar design, materials, intended use, and existing regulatory clearance of comparable predicate devices, rather than through complex performance studies with specific acceptance criteria as might be seen for novel diagnostic tools or AI/ML-driven devices.

Summary

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OCT 1 5 2003

Koz2167 pye'f2

510(k) Summary of Substantial Equivalence

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Worldwide is required to submit with this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Worldwide chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

1. MANUFACTURER:

Mitek Worldwide A division of Ethicon A Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, MA 02062

Contract: Karen K. Sylvia, Manager, RA Date Prepared: 15 July 2003

2. DEVICE:

Trade name:	Bio-INTRAFIX Tibial Tapered Screws and Sheaths
Classification Name:	Fastener, Fixation, Biodegradable Soft Tissue
Product Code:	MAI
Classification:	888.3040
Common Name:	Orthopedic Screw, Fixation Device

3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Mitek's Bio-INTRAFIX Tibial Screw and Sheaths are IntraFIX (K983560) and Biocryl Interference Screws (K013572) currently marketed by Mitek Worldwide, Norwood, MA 02062.

4. DEVICE DESCRIPTION:

5. INTENDED USE:

The Bio-INTRAFIX Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction.

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6. Safety and Performance:

The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Mitek Bio-INTRAFIX Tibial Screw and Sheath have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Ms. Karen K. Sylvia Regulatory Affairs Manager Mitek Worldwide 249 Vanderbilt Avenue Norwood, MA 02062

Re: K032167

Trade/Device Name: Bio-INTRAFIX Tibial Tapered Screw and Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 15, 2003 Received: July 21, 2003

Dear Ms. Sylvia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Karen K. Sylvia

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) Device Name

Bio-INTRAFIX Tibial Screw and Sheath

Indications for Use

The Bio-INTRAFIX Tibial Tapered Screw and Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Millman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032167

Prescription Use ( (Per 21 CFR § 801/109)

Over-the-Counter Use No

(Optional Format 1-2-96)

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.