The Avon® Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and arc intended for implantation with bone cement.

Device Description

The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Avon® PFJ Prosthesis, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the format requested.

The document is a summary of safety and effectiveness, and subsequently, the FDA's letter of substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, largely through comparison of design, materials, indications, and operational principles, often supported by bench testing where relevant. It does not typically involve clinical studies with human subjects that would generate acceptance criteria and performance data in the context of sensitivity, specificity, or similar metrics for diagnostic devices.

Therefore, many of the requested categories concerning acceptance criteria and study details cannot be directly answered from the provided text.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy per se. The "performance" assessment is based on the claim of substantial equivalence to a predicate device.

Acceptance Criteria Category	Reported Device Performance/Rationale	Explanation from Document
Safety and Effectiveness	Substantially Equivalent	The device is deemed as safe and effective as the predicate device based on comparison of design, materials, indications, and operational principles.
Design	Equivalent to predicate	"Avon® Patello-femoral Joint Prosthesis is substantially equivalent to the predicate Avon® PFJ Prosthesis in regards to design..."
Materials	Equivalent to predicate	"...materials..." (specifically cobalt-chromium for femoral, all-polyethylene for patellar components).
Indications	Equivalent to predicate	"...indications..." (e.g., degenerative arthritis in distal femur and patella, history of patellar dislocation/fracture, failed previous surgery where pain persists).
Operational Principles	Equivalent to predicate	"...operational principles."
Compatibility	Patellar components are compatible with femoral components.	"Testing demonstrated that the patellar components from the Duracon®, Triathlon® and Scorpio® Knee Systems are compatible with the femoral components in Avon® PFJ Prosthesis." This is a key "performance" aspect cited.

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

Not applicable. The document describes a 510(k) submission for a medical device (prosthesis), which typically relies on bench testing and comparison to a predicate device, rather than patient-based test sets with a specific sample size. The "testing" mentioned refers to compatibility testing, not a clinical trial or performance study on patient data.

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)

Not applicable. There is no mention of a ground truth established by experts as this is not a diagnostic device or a study involving human-in-the-loop assessment of images or clinical findings.

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

Not applicable. No test set or expert adjudication is described in the context of this device 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 device is a prosthesis, not an AI-powered diagnostic tool, so an MRMC study is not relevant here.

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

Not applicable. This is a physical implantable device, not an algorithm.

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

Not applicable in the sense of a clinical or diagnostic study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, and the demonstrating that the new device meets the same standards through design, material, and functional equivalence, often supported by bench testing.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI device.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K051948" in a handwritten style, followed by what appears to be a fraction symbol. Below this, the text "510(k) Premarket Notification" is printed in a smaller, more formal font. The image seems to be a document or label with a reference number and a brief description of its purpose.

OCT 2 1 2005

510(k) Summary of Safety and Effectiveness Avon® PFJ Prosthesis

Submission InformationName and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430
For Information contact:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared:	July 15, 2005
Device IdentificationProprietary Name:Common Name:Classification Name and Reference:Device Product Code:	Avon® Patello-femoral Joint ProsthesisPatello-femoral arthroplastyKnee joint patellofemoral polymer/metal semi-constrainedcemented prosthesis,21 CFR 888.3540OR (87) KRR

Description:

Intended Use:

The Avon" Patello-femoral Prosthesis is a single-use device intended for replacement of the femoral side of the patello-femoral joint. Indications and are listed below.

Indications for Use

The Avon" Patello-femoral Joint Prosthesis is intended to be used in cemented patcHofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tuberele elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement.

Substantial Equivalence:

Avon * Patello-femoral Joint Prosthesis is substantially equivalent to the predicate Avon" PE1 Prosthesis in regards to design, materials, indications and operational principles. Testing demonstrated that the patellar components from the Duracon", Triathlon" and Scorpio" Knee Systems are compatible with the femoral components in Avon" PFJ Prosthesis.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the circular seal. The profiles are arranged in a row, with each one slightly overlapping the previous one.

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051948

Trade/Device Name: Avon Patello-Femoral Joint Prosthesis Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: II Product Code: KRR Dated: October 14, 2005 Received: October 17, 2005

Dear Ms. Kelly:

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 application (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 such 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.

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Page 2 - Ms. Vivian Kelly

You must 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 begin 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 Compliance at (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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051948

Device Name: Avon® PFJ Prosthesis

Indications for Use:

These components are single use only and arc intended for implantation with bone cement.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

(Division Sign-Off)	Office of Device Evaluation (ODE)
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Division of General, Restorative, and Neurological Devices

510(k) Number	K051948
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Regulation Number and Section

§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”