The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

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

These products are intended to achicve fixation without the use of bone cement.

Device Description

The device patellar components of a total knee system. These components are used for the replacement of the articulating surfaces of the patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, primarily focusing on determining substantial equivalence for a medical device (Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating) to a predicate device. As such, it does not contain the kind of detailed information typically found in a clinical study report that directly describes acceptance criteria, device performance, and study methodologies with sample sizes, expert qualifications, or detailed ground truth establishment for an AI/CADe device.

The document mentions "risk analysis and research and development testing" to demonstrate equivalence. It also lists several types of testing performed, but these are engineering and material science tests, not clinical studies in the context of AI/CADe performance.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device approval (a knee implant) and a different methodology (510(k) substantial equivalence based on engineering and material testing, not AI performance).

Here's a breakdown of what can be inferred or is directly stated, and what cannot be found:

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

Cannot be provided in the context of AI/CADe performance. The document describes engineering tests for a knee implant. The "performance" being assessed is mechanical and material integrity, not diagnostic accuracy in an AI sense.
What is mentioned: "risk analysis and research and development testing" including "porous coating characterization, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPE material properties... safety testing for the Peri-Apatite coating."
Implied Acceptance Criteria (for the engineering tests): The tests were performed "in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. This guidance document would contain the specific acceptance criteria for each test.
Reported Device Performance (for the engineering tests): "The results demonstrate that the Duracon Conversion Patella with Porous and Peri-Apatite coatings is safe and effective for use in total knee replacement without bone cement." This is a summary statement, not detailed quantitative performance data as one would expect for an AI device.

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

Cannot be provided. This document does not describe a clinical study in the typical sense of testing a diagnostic algorithm against a patient dataset. The "testing" refers to mechanical and material characterization of the knee implant.

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):

Cannot be provided. This is not relevant to the type of device and testing described.

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

Cannot be provided. Not relevant.

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:

No, it was not done. This document pertains to a knee implant, not an AI/CADe system.

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

No, this is not an AI algorithm.

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

Not applicable in the AI/CADe sense. For the engineering tests, the "ground truth" would be established by validated test methods and physical measurements comparing the device's properties against established material science and biomechanical standards defined in the guidance document.

8. The sample size for the training set:

Cannot be provided. This is not an AI device that would have a "training set."

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

Cannot be provided. Not applicable.

In summary: This document is an FDA 510(k) clearance letter for a knee implant. The "study" mentioned refers to engineering and material testing to demonstrate substantial equivalence to a predicate device, not a clinical performance study of an AI/CADe system. Therefore, the specific information requested about acceptance criteria, sample sizes, expert involvement, and ground truth for AI performance is not present in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 corporate Boulevard Rockville MD 20850

MAR 3 0 2005

Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howrnedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K043374

Trade/Device Name: Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint, patellofemorotibial, metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: December 2,2004 Received: December 8,2004

Ms. Duchene:

This letter corrects our substantially equivalent letter of February 16, 2005 regarding the incorrect received date of January 8,2004. The correct received date is shown above.

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 (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

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Page 2- Ms. Denise Duchene

comply with all the Act's requirements, including, but not limited to: registration and listing (21' CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

This letter will allow you to continue marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Complianceat (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Styp A. Charles

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of 1

510(k) Number (if known): K043374

Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Device Name:

Indications for Use:

The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

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

These products are intended to achicve fixation without the use of bone cement.

Prescription Usc

Over-the-counter Usc_

(c43374

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark A. Milken

and Neimingica

ਾਂ ਅਤੇ ਅੰਗ੍ਰੇ ਦੇ ਬਲਵ

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FEB | 6 2005

Summary of Safety and Effectiveness

K 043374

Contact Person:	Denise DucheneSr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate Dr.Mahwah, NJ 07430(201) 831-5612 (Phone)(201) 831-6038 (FAX)
Date:	November 12,2004
Device:	Duracon® Conversion and X-Small Symmetric Patella with Peri-Apatite® Coating
Classification:	Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;Uncemented prosthesis - Class II - 21 CFR 888.3565 --ProductCode: MBH
Predicate Devices:	Duracon® Conversion and X-Small Symmetric Patella with PorousCoating for uncemented use.
Indications for Use:	The Duracon® Patella components are for use in total kneearthroplasty to relieve pain and restore knee function forindications such as: noninflammatory degenerative joint diseaseincluding osteoarthritis, traumatic arthritis or avascular necrosis;rheumatoid arthritis; correction of functional deformity; revisionprocedures where other treatments or devices have failed; posttraumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,irreparable fracture of the knee.
	These products are intended to achieve fixation without the use ofbone cement
Proposed Modification:	To add a Peri-Apatite® coating to the Conversion and X-SmallSymmetrical Patella components.
Device Description:	The device patellar components of a total knee system. Thesecomponents are used for the replacement of the articulatingsurfaces of the patella to relieve pain, instability and the restrictionof motion due to degenerative bone disease, includingosteoarthritis, rheumatoid arthritis, failure of other devices ortrauma.

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Summary of Data:

A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPE material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Conversion Patella with Porous and Peri-Apatite coatings is safe and effective for use in total knee replacement without bone cement.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.