The P.F.C. Modular Total Knee System is indicated for use in a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.

This damage may also be the result of trauma or failed prior surgical intervention.

The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.

Device Description

The P.F.C. Modular Plus Offset Tibial Tray is part of a modular system for use in total knee replacement. The subject device is a titanium tibial tray component, which is designed to accept snap-in tibial inserts in a range of thicknesses and a variety of surface topographies.

The P.F.C. Modular Plus Offset Tibial Tray and its parent device, the P.F.C. Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment.

The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia.

AI/ML Overview

This document is a 510(k) summary for a medical device (P.F.C.® Modular Plus Offset Tibial Tray), not a study report for an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.

Here's an assessment based on the provided text:

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

The document describes a submission for a new medical device, the P.F.C.® Modular Plus Offset Tibial Tray, to demonstrate substantial equivalence to an existing, legally marketed device. It does not present a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic or AI-powered device.

Instead, the "acceptance criteria" are implicitly the requirements for substantial equivalence to predicate devices. The "reported device performance" is not quantified with specific metrics but is stated as being "similar in performance" to the predicate devices.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Similar in performance to predicate devices	Similar in performance to P.F.C.® Modular Tibial Tray (K884796 and K892394) and P.F.C.® Modular Plus Tibial Tray (K923807), and Zimmer NexGen® LCCK Knee System (K960279).
Similar in intended use to predicate devices	Similar in intended use to predicate devices.
Similar in materials to predicate devices	Similar in materials to predicate devices.
Similar in design to predicate devices	Similar in design to predicate devices.
Similar in performance characteristics to predicate devices	Similar in performance characteristics to predicate devices.
Similar in packaging to predicate devices	Similar in packaging to predicate devices.
Similar in sterilization method to predicate devices	Similar in sterilization method to predicate devices.
Conformance with voluntary performance standards	Conformance with ASTM F136 and the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not applicable and not provided in the document. This is a 510(k) submission for a physical medical device, not a data-driven study of an AI/ML product. The "test set" for substantial equivalence primarily involves comparing specifications, performance characteristics (e.g., mechanical testing), and materials to predicate devices, rather than a clinical dataset in the context of an AI study.

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):

This information is not applicable and not provided. "Ground truth" in the context of expert consensus on data is relevant for AI/ML performance evaluation. For a physical medical device asserting substantial equivalence, the "ground truth" is established through engineering design, material specifications, and performance testing against industry standards, not typically by expert review of a "test set" in the sense of an AI study.

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

This information is not applicable and not provided. Adjudication methods are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the type of device and submission 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:

This information is not applicable and not provided. This document describes a physical medical implant (a knee replacement component), not an AI-assisted diagnostic tool. Therefore, an MRMC study and
AI-driven improvement are not relevant here.

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

This information is not applicable and not provided. As explained above, this is not an AI/ML device.

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

This information is not applicable in the context of AI/ML validation. For this physical medical device, the "ground truth" for its safety and effectiveness is established through:

Engineering design principles.
Material testing (e.g., biocompatibility, mechanical strength as per ASTM F136).
Performance testing (e.g., wear, fatigue characteristics, likely bench testing according to the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses").
Comparison to the established performance and safety profiles of legally marketed predicate devices.

8. The sample size for the training set:

This information is not applicable and not provided. There is no "training set" for this type of device.

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

This information is not applicable and not provided. There is no "training set" or corresponding "ground truth" in the context of AI/ML for this device submission.

Summary

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510(k) Summary of Safety and Effectiveness

P.F.C.® Modular Plus Offset Tibial Tray

Manufacturer: Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

A. Contact Person:

Arlene C. Saull, RAC Sr. Submissions Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 (219) 372-7276

B. Device Information:

Proprietary Name:	P.F.C.® Modular Plus Offset Tibial Tray
Common Name:	Total Knee Prosthesis Tibial Tray Component
Classification Name:	Knee joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Regulatory Class:	Class II, per 21 §CFR 888.3560
Product Code:	87 JWH

C. Indications for Use:

This damage may also be the result of trauma or failed prior surgical intervention.

The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.

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D. Device Description:

The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia.

E. Substantial Equivalence:

The P.F.C. 8 Modular Plus Offset Tibial Tray is similar in performance, intended use, materials, design, performance characteristics, packaging, and sterilization method to the P.F.C.® Modular Tibial Tray (K884796 and K892394), the P.F.C.® Modular Plus Tibial Tray (K923807), and the Zimmer NexGen® LCCK Knee System (K960279).

The determination of substantial equivalence for this device is based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F136 and the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses."

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re : K984158 P.F.C® Modular Plus Offset Tibial Tray Regulatory Class: II Product Code: JWH November 18, 1998 Dated: Received: November 19, 1998

Dear Ms. Saull:

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 This decision is based on Food, Drug, and Cosmetic Act (Act). this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

This device may not be labeled or promoted for non-1. cemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
1. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their

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Page 2 - Arlene C. Saull, RAC

respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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

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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,

Ceia 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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K984158 510(k) Number (if known) Device Name P.F.C.® Modular Plus Offset Tibial Tray

Indications For Use

The P.F.C. Modular Total Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.

This damage may also be a result of trauma or failed prior surgical intervention.

The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Acoea

Prescription Use (Per 21 CFR §801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.