The proposed INTRAFIX System consists of two components, a non-absorbable INTRAFIX Expansion Sheath and a non-absorbable INTRAFIX Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.

AI/ML Overview

The provided text describes a 510(k) summary for the INTRAFIX® PEEK Tapered Screw, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than a separate clinical study with predefined acceptance criteria for the device itself. Therefore, the questions related to clinical study design, sample sizes, expert involvement, and ground truth for a device performance study are not directly applicable in the context of this 510(k) summary.

However, I can extract the information relevant to non-clinical testing which served as the "study" to demonstrate substantial equivalence, and interpret "acceptance criteria" as meeting the performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance of Predicate Device)	Reported Device Performance (INTRAFIX® PEEK Tapered Screw)
Torque Capability (of predicate INTRAFIX® Tapered Screws)	Demonstrated equivalent Torque Capability
Pullout Strength (of predicate INTRAFIX® Tapered Screws)	Demonstrated equivalent Pullout Strength

Note: The document states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the PEEK Tapered Screw's performance in these non-clinical tests was comparable to or met the performance standards of the predicate devices. The exact numerical values for these metrics are not provided in this summary, but the conclusion is that equivalence was achieved.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified in the provided summary.
Data provenance: Non-clinical testing. The country of origin and whether it was retrospective or prospective is not applicable or specified for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was non-clinical engineering and mechanical testing, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

Not applicable. This was non-clinical engineering and 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

Not applicable. This is a medical device for orthopedic fixation, not an AI diagnostic or image analysis device.

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

Not applicable. This is a medical device for orthopedic fixation.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence in this context was the established performance (e.g., torque capability, pullout strength) of the predicate devices.

8. The sample size for the training set

Not applicable. This is a medical device; there is no "training set" in the context of machine learning.

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

Not applicable. This is a medical device; there is no "training set."

Summary

{0}------------------------------------------------

K 122123 ( 112)

OCT

Image /page/0/Picture/1 description: The image shows the DePuy Synthes logo. The logo includes the company name, "DePuy", in a stylized font, with a circle to the left of the name. Below the name, it says "Mitek Inc." and "a Johnson & Johnson company". To the right of the logo, it says "never stop moving" in a smaller font.

INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL

ATTACHMENT 1 510(k) SUMMARY - INTRAFIX PEEK TAPERED SCREW

SUBMITTER'S NAME AND ADDRESS

DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

CONTACT PERSON

Julie Vafides Regulatory Affairs Specialist II DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

TELEPHONE 508-977-6645 508-977-6911 FACSIMILE jvafides@its.jnj.com E-MAIL DATE PREPARED 7/17/2012

NAME OF MEDICAL DEVICE COMMON CLASSIFICATION NAME

Fastener, Fixation, Nondegradable, Soft Tissue

PROPRIETARY NAME

INTRAFIX® PEEK Tapered Screw

SUBSTANTIAL EQUIVALENCE

INTRAFIX PEEK Tapered Screws are substantially equivalent to the following devices.

INTRAFIX® Tapered Screws (K983560) Modified Device . (previously known as Intraturnel Fixation Fastener, cleared January 28, 1999)
K063577 Femoral INTRAFIX® Screw and Sheath .

FDA PRODUCT CODE MBI

MBI

DEVICE CLASSIFICATION

This type of fixation screw was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the DePuy Mitek Inc. logo. The logo includes the DePuy name in a bold, sans-serif font, with a circle to the left of the name. Below the name, it says "Mitek Inc." and "a Johnson & Johnson company". To the right of the logo, it says "never stop moving" in a smaller, italicized font.

INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL

ATTACHMENT 1 510(k) SUMMARY - INTRAFIX TAPERED SCREW

DEVICE DESCRIPTION

INDICATIONS FOR USE

The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

TECHNOLOGICAL CHARACTERSTICS

The proposed INTRAFIX PEEK Tapered Screws are similar in design and indication to the predicate INTRAFIX Tapered Screws. The proposed INTRAFIX PEEK Tapered Screws are manufactured out of PEEK (polyetheretherketone), a non-absorbable radiolucent high strength thermoplastic material. The proposed PEEK material is a well-known material with a long and safe use in medical devices. A similar PEEK material is used in manufacturing the screw component of the predicate Femoral INTRAFIX Screw and Sheath (K063577).

NONCLINICAL TESTING

Verification activities, such as, Torque Capability and Pullout Strength testing were performed on the implant and its predicate device.

SAFETY AND PERFORMANCE

Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed INTRAFIX PEEK Tapered Screws have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

OCT

DePuv Mitek Incorporated, a iohnson and johnson company % Ms. Julie Vafides Regulatory Specialist II 325 Paramount Drive Raynham. Massachusetts 02767

Re: K122123

Trade/Device Name: INTRAFIX® PEEK Tapered Screw Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 17, 2012 Received: July 18, 2012

Dear Ms. Vafides:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

2012

{3}------------------------------------------------

Page 2 - Ms. Julie Vafides

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

erely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K122123(11)

Image /page/4/Picture/1 description: The image shows the DePuy Mitek Inc. logo with the tagline "never stop moving." The logo is black and white and features the DePuy name in a bold font. The tagline is in a smaller, italicized font. The image is simple and clean, with a focus on the company's branding.

INTRAFIX® PEEK Tapered Screw PRODUCT: SUBMISSION DATE: July 17, 2012 SUBMISSION TYPE: TRADITIONAL

ATTACHMENT 2 INDICATIONS FOR USE

510(k) Number (if known):

Device Name: INTRAFIX® PEEK Tapered Screw

Indications for Use: The DePuy Mitek Tibial Tapered Screw and Tibial Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122123

46 of 93 | P a g e

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.