The DePuy AMK 3 Peg Patella is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended 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.

Device Description

AI/ML Overview

This document describes the DePuy AMK 3 Peg Patella, an all-polyethylene patella component for total knee arthroplasty. The provided text is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously cleared devices rather than defining specific acceptance criteria based on performance studies.

Therefore, the following points address the questions based directly on the provided text, and it's important to note that a traditional "acceptance criteria" table as one might find for a diagnostic device or a study proving those criteria are met is not present in this type of regulatory submission for a medical implant like a knee patella component. Instead, substantial equivalence is established through comparing design, materials, intended use, and in vitro testing to predicate devices.

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

As this is a 510(k) submission for a medical implant, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than a specific set of clinical performance metrics. The reported "performance" is primarily in vitro mechanical testing comparing the new device to predicates.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance / Basis of Equivalence
Material Composition: Same as predicate device.	The material (all polyethylene) is the same as the original AMK All Polyethylene Patella.
Intended Use: Same as predicate device.	The intended use is the same as the original AMK All Polyethylene Patella.
Design of Articular Surface: Same as predicate device.	The design of the articular surface is the same as the original AMK All Polyethylene Patella.
Fixation Surface Design: Similar to predicate devices, with demonstrated equivalent mechanical performance.	The fixation surface changed from two circular arcs (original AMK) to 3 pegs. This 3-peg design is similar to the DePuy LCS All Polyethylene 3 Peg Patella.
Fixation Strength: Similar to predicate devices.	Testing indicates that the fixation strength of the AMK 3 Peg Patella is similar to those of the Johnson & Johnson PFC Oval Sombrero Patella and the Zimmer NexGen All Polyethylene Patella.
Compatibility with Existing System: Integrates with the AMK Total Knee System.	Intended for use with the DePuy AMK Total Knee System, utilizing existing femoral components, tibial trays, and tibial inserts.
Clinical Indications: Addresses same conditions as predicate devices.	Intended 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 (same as predicate AMK system).
Cemented Use Only: Must be equivalent for cemented fixation.	The FDA clearance explicitly states the device is "equivalent only to similar devices labeled and intended to be fixed within bone with acrylic 'bone cement'" and may not be labeled or promoted for non-cemented use.

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

The document refers to "testing" regarding fixation strength but does not provide details about the sample size, specific test methods, or the provenance of the data (e.g., in vitro lab testing, animal studies, or clinical data). Given it's a 510(k) for a mechanical implant, the "testing" is almost certainly in vitro mechanical testing performed in a lab, typically to ISO or ASTM standards, comparing the new design feature (3 pegs) to predicate devices. It is therefore not clinical data provenance.

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 question is not applicable to the provided document. A 510(k) for an orthopedic implant like a patella component relies on engineering and mechanical testing data (as mentioned in point 2), not "ground truth" established by clinical experts in the context of diagnostic performance or AI model validation. The "ground truth" for the mechanical testing would be the measured physical properties (e.g., pull-out strength, shear strength) against predefined engineering specifications or comparisons to predicate devices.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is described in this 510(k) submission.

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 document is for a physical medical implant (a knee patella component), not a diagnostic device or an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This document pertains to a physical medical implant, not an algorithm or AI system.

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

Not applicable in the conventional sense of diagnostic "ground truth." For a medical implant 510(k), "ground truth" for the referenced "testing" would relate to physical and mechanical properties, such as:

Tensile strength of materials
Fatigue life
Fixation strength (e.g., pull-out resistance, rotational stability)
Dimensional accuracy
Biocompatibility

These are established through standardized in vitro engineering tests, not typically through clinical pathology or expert consensus on diagnostic assessment.

8. The sample size for the training set

Not applicable. This document is for a physical medical implant, not a data-driven AI/ML model for which "training sets" are used.

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

Not applicable. As above, this is not an AI/ML model.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Inc.
	700 Orthopaedic Drive
	Warsaw, Indiana 46581-0988
510(k) CONTACT:	Cheryl Hastings
	Manager, Clinical Affairs
TRADE NAME:	DePuy AMK 3 Peg Patella
COMMON NAME:	All Polyethylene Patella
CLASSIFICATION:	888.3560 Prosthesis, Knee, PatelloFemorotibial, Semiconstrained, Cemented, Polymer, Metal, Polymer
DEVICE PRODUCT CODE:	87 JWH
SUBSTANTIALLY EQUIVALENT DEVICES:	DePuy AMK All Polyethylene PatellaDePuy LCS 3 Peg PatellaJohnson & Johnson PFC Oval Sombrero Patella

Zimmer NexGen All Polyethylene Patella જુન

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy AMK 3 Peg Patella is an all polyethylene patella component with a domed articular surface and a 3 peg fixation surface. It is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, ioints with correctable varus or valgus deformity and joints with failed previous surgeries where pain, deformity or dysfunction persist.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy AMK 3 Peg Patella is identical to the AMK All Polyethylene Patella which has been previously cleared by FDA except that the fixation surface has been changed from two circular arcs to 3 pegs. The material, intended use and design of the articular surface of the patella are the same as those of the original AMK All Polyethylene Patella. The 3 peg fixation surface is similar to the fixation surface used on the DePuy LCS All Polyethylene 3 Peg Patella. Testing indicates that the fixation strength of the AMK 3 Peg Patella is similar to those of the Johnson & Johnson PFC Oval Sombrero Patella and the Zimmer NexGen All Polyethylene Patella.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1998

Ms. Cheryl Hastings Manager, Regulatory Submissions DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K972643 Re : AMK 3 Peq Patella Requlatory Class: II Product Code: JWH Dated: December 17, 1997 Received: December 19, 1997

Dear Ms. Hastings:

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

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Page 2 - Ms. Cheryl Hastings

Any non-cemented fixation of this device is considered 3. 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 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 requlation (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 requlation 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 Regulations.

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 legally 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 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 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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Page 3 - Ms. Cheryl Hastings

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,

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) _k972643

Device Name AMK 3 Peg Patella

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Acolla

(Div Divisi of General Restorative Devices 510(k) Number. K97264

Prescription Use >>

Over-The Counter Use

(Per 21 CFR 801.109)

000001

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.