The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:

. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
Rheumatoid arthritis. .
. Correction of functional deformity.
. Revision procedures where other treatments have failed.
. Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
. Irreparable fracture of the knee.

Device Description

The subject 25mm Duracon Inset Patellar Component is identical to the commercially-available Duracon Inset Patellar Components (available in sizes 27, 29, 31, and 33mm), except for its smaller diameter.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML medical devices. The document describes a 510(k) submission for an additional size of an existing patellar component (Duracon Inset Patellar Component, 25mm).

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for AI/ML device evaluation:

Acceptance Criteria and Reported Device Performance: This information is not present. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance metrics as an AI/ML system would. The "Performance Data" section briefly mentions "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product," but no specific numerical acceptance criteria or detailed results are given.
Sample Size for Test Set and Data Provenance: Not applicable. This is a physical medical device (knee implant), not an AI/ML algorithm evaluated on a dataset. The "comparative testing" likely refers to mechanical stress tests on the physical component.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant here.
Adjudication Method: Not applicable.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. There is no AI assistance involved with human readers for this physical implant.
Standalone Performance: Not applicable. This is a physical implant; its "performance" would be related to its mechanical properties and biocompatibility, not an algorithm's standalone output.
Type of Ground Truth Used: Not applicable in the context of AI/ML evaluation. The "ground truth" for a physical implant's safety and effectiveness relies on established engineering principles, material science, and clinical outcomes data from similar devices. The comparative testing mentioned focuses on wear resistance, which would be measured directly from mechanical tests, not an "expert consensus" on data labels.
Sample Size for Training Set: Not applicable. There is no AI/ML model being trained.
How Ground Truth for Training Set was Established: Not applicable.

Summary based on the provided text:

The submission is for a physical medical device (knee implant), specifically an additional size (25mm) of an already cleared patellar component. The 510(k) process for such devices relies on demonstrating substantial equivalence to a predicate device.

The key points from the provided text are:

Device: Duracon Inset Patellar Component, additional 25mm size.
Predicate Device: Existing Duracon Inset Patellar Components (27, 29, 31, 33mm sizes) cleared via K961482 and K965173.
Basis for Substantial Equivalence:
- Identical intended use and indications for use.
- Identical materials.
- Identical design, except for the smaller diameter.
Performance Data (limited details): "Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product." This suggests that the wear performance of the new 25mm size was found to be comparable to the existing, cleared sizes.

Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods (which are typical for AI/ML device evaluations) are not applicable to this 510(k) submission for a physical knee implant component.

Summary

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DEC = 2 1999 510(k) Summary

Duracon Inset Patellar Component: Additional Size

Submission Information

Name and Address of the Sponsor:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Terry Sheridan Powell
Date of Summary Preparation:	October 29, 1999

Device Identification

Proprietary Name: Duracon Inset Patellar Component Common Name: Artificial Knee Component

Classification Name and Reference:

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

Predicate Device Identification

The Duracon Inset Patellar Component, in sizes 27, 29, 31, and 33mm, were determined Substantially Equivalent via 510(k) #K961482. They were then cleared in a Duration-stabilized version via K965173. This Special 510(k) covers an additional size component: 25mm.

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The intended use of the subject component is unchanged from that of the commercially-available Duracon Inset Patellar Components. The indications are specified in the Indications for Use attachment, and are the same as those cleared via K961482.

Device Description

Statement of Technological Comparison

The materials for the subject and predicate devices are identical. The indications for use of the subject and predicate devices are identical. The design of the subject and predicate devices is the same, except that the subject device is a new, smaller size: 25mm diameter. The performance testing is sufficient to demonstrate that the subject and predicate devices are Substantially Equivalent with regard to design.

Performance Data

Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product.

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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Ms. Terry Sheridan Powell Regulatory Affairs Department Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K993692 Duracon Inset Patella, 25mm Trade Name: Regulatory Class: II Product Code: JWH Dated: October 29, 1999 Received: November 2, 1999

Dear Ms. Powell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action ially 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 redical boundance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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 Failure to Administration (FDA) will verify such assumptions. 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.

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Page 2 - Ms. Terry Sheridan Powell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.R. Ogden
James F. Dillard III

James E. Acting 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): K_993692

Device Name: Duracon Inset Patellar Component, Additional Size (25mm)

Indications For Use:

. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
Rheumatoid arthritis. .
. Correction of functional deformity.
. Revision procedures where other treatments have failed.
. Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
. Irreparable fracture of the knee.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	ARO for
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993692

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use ________

(Optional Format 1-2-96)

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.