The DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components.

The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or posttraumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.

Device Description

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically orthopaedic implants. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria, sample sizes, and ground truth definitions as would be found for AI/ML-based diagnostic devices.

Therefore, the information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, and MRMC studies) is not applicable to this type of regulatory submission for a knee prosthesis and is not present in the provided text.

The closest analogy to "acceptance criteria" in this context are the limitations and conditions placed on the marketing of the device by the FDA:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a substantial equivalence determination for a physical implant, specific performance metrics like sensitivity, specificity, or AUC suitable for a table directly presenting acceptance criteria and device performance as you might see for an AI/ML device are not provided. Instead, the "acceptance" from the FDA is granted based on substantial equivalence and comes with specific limitations.

FDA Limitation (Analogue to Acceptance Criteria)	DePuy Device Conformance (Analogue to Reported Performance)
Thinnest tibial insert available is nominal 10mm insert, with minimum polyethylene thickness under condyles of 6.02mm.	Device met this specification.
Thinnest tibial tray available is nominal 10mm tray, with minimum polyethylene thickness under condyles of 10.5mm.	Device met this specification.
May not be labeled or promoted for non-cemented use.	Labeling must reflect cemented use only.
All labeling must prominently state intended for cemented use only.	Labeling must reflect cemented use only.
Any non-cemented fixation is considered investigational and requires IDE.	Compliance with IDE regulations required if non-cemented use is investigated.

Study Details:

2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, not an AI/ML algorithm requiring a test set of data. Substantial equivalence is determined by comparing the new device's design, materials, and intended use to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of diagnostic AI/ML is not relevant here. The FDA's review is an assessment of technical and clinical equivalence by its own staff.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Explanation of the Study and Substantial Equivalence:

The "study" in this context is the 510(k) premarket notification process itself. DePuy, Inc. submitted this notification to the FDA to demonstrate that their new DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Revision System with cross-linked polyethylene tibial inserts and trays are substantially equivalent to legally marketed predicate devices.

The basis of this substantial equivalence is described as:

Basic Same Design: The new components have the "basic same design" as previously cleared polyethylene tibial inserts and trays.
Same Intended Use: The new components have the "same intended use" as the predicate devices: cemented tricompartmental total knee arthroplasty for severely disabled or painful joints.
Materials: Both the new and predicate devices are manufactured from UHMWPE (Ultra High Molecular Weight PolyEthylene) meeting ASTM F648 specifications.
Difference: The only significant difference is that the new components are manufactured from cross-linked UHMWPE, with "minor design changes" otherwise.

The FDA reviewed this comparison and made its determination based on these engineering and design equivalencies rather than clinical trial data demonstrating performance against specific clinical acceptance criteria for diagnostic accuracy, which is what your questions imply. The FDA's letter (Page 1) confirms that they "determined the devices are substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." subject to the specific limitations listed.

Summary

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5 1098 OCT

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988
510(k) CONTACT:	Sally FoustSr.Regulatory Submissions Associate(219) 372-7455; FAX (219) 267-7098
TRADE NAME:	DePuy AMK® Total Knee SystemDePuy Coordinate Ultra™ Knee Revision System
COMMON NAME:	Knee Device
CLASSIFICATION:	888.3560 Prosthesis, Knee, PatelloFemorotibial,Semiconstrained, Cemented, Polymer, Metal, Polymer
DEVICE PRODUCT CODE:	87 JWH

SUBSTANTIALLY EQUIVALENT DEVICES:

(DePuy) Anatomic Modular Knee (AMK) System (K864671) ●
(DePuy)Anatomic Modular Knee (AMK) Polyethylene Tibial Tray (K910940) .
(DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray (K943299) .
(DePuy) AMK Congruency Posterior Stabilized Insert (K954684) .
(DePuy) Coordinate II (Ultra) Knee Revision System (K955884) .
(DePuy) Duraloc Acetabular Cup System (K972596) t

DEVICE DESCRIPTION-AND INTENDED USE:

The subject DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are available in five sizes (1-5) with five thickness' (10, 12, 14, 16, and 18mm) or ten thickness' (10, 12, 14, 16. 18. 20. 22. 24. 26. and 28mm), depending on the specific device, in each size. The cross-linked polyethylene tibial inserts fasten to a metal tibial tray by means of a central pin and interlocking clip or a tibial stabilizing post. The fixative surface of the cross-linked polyethylene tibial trays have a salt-blasted surface, a round central stem, and cloverleaf patterned recesses to enhance cement fixation to the proximal tibia surface. The DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are intended to be used with the currently legally marketed DePuy AMK Total Knee System and/or Coordinate Ultra Knee Revision System in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject DePuy AMK and Coordinate cross-linked polyethylene tibial inserts and trays are substantially equivalent to the AMK Total Knee System and Coordinate Ultra Knee Revision System polyethylene tibial inserts and trays that have previously been cleared in that they have the basic same design and the same intended use. Both the subject cross-linked polyethylene tibial inserts and trays and the previously cleared polyethylene tibial inserts and trays are manufactured from UHMWPE meeting the specifications of ASTM F648. The only difference, other than minor design changes, between the subject components and the previously cleared components is that the subject components are manufactured from cross-linked UHMWPE.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1998 OCT

Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re : K982585 DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Revision System: Cross-Linked Polyethylene Tibial Inserts and Trays Requlatory Class: II Product Code: JWH Dated: July 23, 1998 Received: July 24, 1998

Dear Ms. Foust:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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, Drug, and Cosmetic Act (Act). This decision is based on these devices being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your devices subject to cement." the general controls provisions of the Act and the following limitations:

The thinnest tibial insert available is the nominal 1. "10mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.02mm.
The thinnest tibial tray available is the nominal "10mm" 2. sized tray, which has a minimum polyethylene thickness under the condyles of 10.5mm.
These devices may not be labeled or promoted for non-3 . cemented use.
All labeling for these devices, including package label 4 . and labeling included within the package, must

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prominently state that the devices are intended for cemented use only.

Any non-cemented fixation of these devices is 5. 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 respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.
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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 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. Please note: concerning your devices in the Federal Register. 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 devices as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, please contact the Office of Compliance at (301) 594-4639. Also, please note

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the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible in the factorers 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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510(k) Number (if known)_K982585

DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Device Name: Revision System: Cross-Linked Polyethylene Tibial Inserts and Trays

Indications for Use:

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Concurrence of CDRH, Office of Device Evaluation

× Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use

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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.