The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

Device Description

The HemiCAP™ Patello-Femoral Resurfacing Prosthesis incorporates a distal femoral trochlear surface articular component that mates to a fixation stud via a taper interlock, and an allpolyethylene patella component. The prosthesis is intended to be used in cemented arthroplasty.

The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The component has a bone contact surface that is coated with a spray-applied CP Titanium coating and a polished articular bearing surface. The fixation stud component is a short tapered cylinder, 13mm in length, manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The stud has a tapering helix, a full-length cannulation, and a proximal female taper bore. The patella prosthesis component is comprised of ultra-high-molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM F 648-04, Type I. The materials, manufacturing methods, and surface finish requirements for these components are identical to those used for the Sponsor's previously cleared devices (K021549, K023096, K031859, K050373).

AI/ML Overview

The provided document is a 510(k) summary for the HemiCAP™ Patello-Femoral Resurfacing Prosthesis. It discusses the device's description, indications for use, and a statement regarding performance testing. However, it explicitly states that clinical data was not needed for this device as part of its substantial equivalence determination.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report on device performance against them.
Sample size used for the test set and the data provenance: No clinical test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
Adjudication method for the test set: No test set adjudication is mentioned.
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: This device is a medical prosthesis, not an AI diagnostic tool, so an MRMC study with human readers and AI is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a prosthesis.
The type of ground truth used: No clinical ground truth is discussed.
The sample size for the training set: No training set (clinical or otherwise for an AI/diagnostic algorithm) is mentioned.
How the ground truth for the training set was established: Not applicable.

The document highlights Non-Clinical Performance Testing was completed as part of the Arthrosurface Design Control Procedure to demonstrate safety and substantial equivalence to predicate devices. However, details of these non-clinical tests (e.g., specific acceptance criteria, test results) are not provided in this summary. The materials and manufacturing methods are stated to be identical to those used for the Sponsor's previously cleared devices, implying reliance on the established safety and effectiveness of those predicates.

Summary

{0}------------------------------------------------

MAR 1 5 2006

Kobo127 page 1 of 2

HemiCAP™ Patello-Femoral Resurfacing Prosthesis

510(K) Summary

Of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Food and Drug Administration of this information serves as a Medical Devices Act of 1990 and in Conformance with 21 Of Poor, Che Michilder Status Prosthesis.

Submitted By:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038(508) 520-3003
Date:	16 January 2006
Contact Person:	Steven W. EkChief Operations Officer
Proprietary Name:	HemiCAP™ Patello-Femoral Resurfacing Prosthesis
Common Name:	Knee Joint Patellofemoral polymer/metal semi-constrainedcemented prosthesis
Classification Name:	Knee Joint Patello-femoral Resurfacing ProsthesisOrthopedic21 CFR § 888.3540 (2003)Class II
Product Code:	KRR
Indications for Use:	The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

K060127; HemiCAP® Patello-Femoral Resurfacing Prosthesis

{1}------------------------------------------------

<060127

Device Descripition:

Performance Testing:

Non-Clinical Performance Testing completed as part of the Arthrosurface Design Control Procedure has demonstrated that the device is safe and substantially equivalent to the predicate devices.

Clinical data was not needed for this device.

K060127; HemiCAP® Patello-Femoral Resurfacing Prosthesis

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three bodies, representing the department's commitment to health, human services, and well-being. 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 1 5 2006

Arthrosurface, Incorporated c/o Mr. Steven W. Ek Chief Operations Officer 28 Forge Parkway Franklin, Massachusetts 02038

Re: K060127

R000127
Trade/Device Name: HemiCAP™ Patello-Femoral Resurfacing 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: January 16, 2006 Received: January 24, 2006

Dear Mr. Ek:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 3 ro(x) premaily equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for tise stated in the encrosule, to regary mancess province Americal Device American Food. Food Days commerce prior to May 26, 1776, the enactined with the provisions of the Federal Food, Drug, devices that have been recuire in accessoried of a premarket approval application (PMA). alle Cosment Act (Act) that do not requent of the general controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial cquivalence determination does not mean Frease of advised that I DTS instance or our device complies with other requirements of the Act that I DA has made a acterized by other Federal agencies. You must or ally it cacal statutes und regulations and limited to: registration and listing (21 Comply with an the Act stequirements) (1) cood manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Steven Ek

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rainment on begin marketing your device as described in your Section 510(k) rins letter will and will your he FDA finding of substantial equivalence of your device to a legally promance noticate 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 it you attire 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 other Ectoral 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.

Herbert Spencer

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K060127

Device Name: HemiCAP™ Patello-Femoral Resurfacing Prosthesis

Indications for Use:

The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

No Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lenoir

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K060127

(Posted November 13, 2003)

Fage / of /

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.”