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 tibial 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 document provided is a 510(k) summary for a medical device called the "Intrafix Tibial Sheath." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel performance criteria through a study with the specified details. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this document.

The submission focuses on comparing the new device to existing predicate devices based on design and material characteristics, and verification activities rather than clinical trials with extensive performance metrics against pre-defined acceptance criteria, especially not in the context of an AI/ML device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not present:

Acceptance Criteria and Study Details for the Intrafix Tibial Sheath

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

The document does not specify formal, quantitative acceptance criteria for device performance in the manner you've requested (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the "acceptance criteria" for a 510(k) submission like this are generally satisfied by demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on verification activities rather than clinical outcomes with an established ground truth.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Design Specifications	Substantially equivalent to existing Intrafix Tibial Sheath (K983560) except for sheath material.
Material Composition	Sheath material (Polypropylene - Ethicon Prolene) is the same as the Femoral Intrafix Sheath (K063577).
Technological Characteristics	Same as the predicate cleared device and use similar or identical material and packaging.
Indications for Use	Same as predicate devices. Indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
Safety and Performance (Nonclinical)	Results of performance and safety testing (Insertion Torque, Pullout Strength, Displacement Test) demonstrated substantial equivalence.
Device Classification	Class II medical device, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

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

Test set sample size: Not specified. The document mentions "Verification activities, such as, Insertion Torque, Pullout Strength, Displacement Test were performed on the implant and its predicate device," but does not provide the number of units tested.
Data provenance: Not specified, but these are likely laboratory-based mechanical tests performed by the manufacturer (DePuy Mitek, Inc. in Raynham, MA, USA). The context indicates nonclinical, laboratory testing rather than data from human subjects or clinical settings.

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

Not applicable. The "ground truth" for this type of mechanical device is typically established by engineering specifications and standard test methods (e.g., for torque, pullout strength, displacement), rather than expert consensus on a clinical diagnosis or interpretation.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as the tests are mechanical and quantitative, not qualitative assessments requiring expert review.

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 orthopedic implant, not an AI/ML algorithm or imaging device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used

For the nonclinical testing ("Insertion Torque, Pullout Strength, Displacement Test"), the ground truth would be established by the physical properties measured according to standardized engineering test protocols and specifications for the device and its predicate.

8. The sample size for the training set

Not applicable. This device is a mechanical orthopedic implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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K102443(1/2)

RIFER HER	never stop moving .
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PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

ATTACHMENT 1

5 I O(k) SUMMARY - INTRAFIX TIBIAL SHEATH

SUBMITTER'S NAME AND ADDRESS

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

CONTACT PERSON

Deep Pal Regulatory Affairs Specialist II DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 TELEPHONE 508-828-3359

FACSIMILE	508-977-6911
E-MAIL	dpal3@its.jnj.com
DATE PREPARED	8/25/2010

NAME OF MEDICAL DEVICE

CLASSIFICATION NAME

Fastener, Fixation, Nondegradable, Soft Tissue

COMMON/USUAL NAME

Bone Anchor

PROPRIETARY NAME

Intrafix Tibial Sheath

SUBSTANTIAL EQUIVALENCE

Intrafix Tibial Sheath is substantially equivalent to the following devices.

Intrafix Tibial Sheath (K983560) - Modified Device .

Femoral Intrafix (K063577) .

FDA PRODUCT CODE

MBI

DEVICE CLASSIFICATION

This type of fixation sheath 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.

OCT 2 0 2010

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K102443(²/₂)

Image /page/1/Picture/1 description: The image shows the DePuy Synthes logo with the tagline "never stop moving". The logo is black and white and features the DePuy name in a bold font. Below the name is the text "Synthes Inc. a Johnson & Johnson company". The tagline is in a smaller font and is located to the right of the logo.

PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

Continues ...

ATTACHMENT 1

5 I O(k) SUMMARY - Intrafix TIBIAL SHEATH

DEVICE DESCRIPTION

INDICATIONS FOR USE

Intrafix Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

TECHNOLOGICAL CHARACTERSTICS

The design specifications of the proposed Intrafix Tibial Sheath is substantially equivalent to the existing Intrafix Tibial Sheath cleared under 510(k) K983560, except that the proposed Intrafix Tibial Sheath design include the same Sheath material - Polypropylene (Ethicon Prolene) used in the Femoral Intrafix Sheath cleared under K063577. Technological characteristics including design, packaging and indications are the same as the predicate cleared device and use similar or identical material and packaging as the predicates.

NONCLINICAL TESTING

Verification activities, such as, Insertion Torque, Pullout Strength, Displacement Test 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 Tibial Sheath has 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 Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes stacked on top of each other.

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

DePuy Mitek, A Johnson & Johnson Company. % Mr. Deep Pal Regulatory Affairs Specialist II 325 Paramount Drive Raynham, MA 02767

OCT 2 0 2010

Re: K102443

Trade/Device Name: Intrafix Tibial Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 7, 2010 Received: October 12, 2010

Dear Mr. Pal:

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 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

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Page 2 - Mr. Deep Pal

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.

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/CDRH0ffices/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,

Clabare Buchus

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

Enclosure

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DePuyMitek Inc.a johnson&johnson company	never stop moving-
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PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

ATTACHMENT 2

INDICATIONS FOR USE
----------------------------

510(k) Number (if known):	K102443	OCT 20 2010
Device Names:	Intrafix Tibial Sheath

Indications for Use: Intrafix Tibial Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

Prescription Use	√	AND/OR	Over-The-Counter Use
------------------	---	--------	----------------------

(Part 21 CFR 801 Subpart D)

AND/OR

(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 1

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102443

Regulation Number and Section

N/A