The ConforMIS, Inc., BiCompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as a unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

painful joint disease due to osteoarthritis, traumatic arthritis or . rheumatoid arthritis of the knee
post traumatic loss of joint function .
. failed osteotomies, hemiarhtoplasties and unicondylar implants.
The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofcmoral areas have been affected by one or more of these conditions.
The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

Device Description

The ConforMIS, Inc., BiCompartmental Knee Repair System is a femorotibial semi-constrained total knee implant. The design of the product incorporates a bone preserving approach, with minimal bone resection, for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. It is intended for use in those patients whose condition cannot be appropriately and effectively addressed using a device that treats only a single knee compartment (i.e. a unicondylar or patellofemoral prosthesis), when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MRI scans), a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The device is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from data obtained from images of the patient's individual geometry obtained using either CT or MRI scans. The tibial and patellar components are manufactured from Ulta-High Molecular Weight Polyethylene ("UHMWP" ASTM-F-648) The ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface Subsequently, Solid Works OTS software is used to create the design. ConforMIS, Inc., Implant Engineering Drawing. The BiCompartmental Knee Repair System is intended for use in conjunction with the tibial components of the ConforMIS Unicondylar Knee Replacement System and the patellofemoral components of the ConforMIS Total Knee Repair System.

AI/ML Overview

The provided text is a 510(k) Summary for the ConforMIS, Inc. BiCompartmental Knee Repair System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets those criteria through performance metrics.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to performance testing against specific acceptance criteria, which is not the primary purpose of a 510(k) substantial equivalence submission for this type of device.

Here's a breakdown of what can and cannot be derived from the provided text:

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

Cannot be provided. The document states that the device is "substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics." It does not present specific acceptance criteria (e.g., in terms of biomechanical performance, wear rates, etc.) or report detailed performance data against such criteria. The "performance" assessment is based on comparison to predicate devices, not on a standalone performance study with defined acceptance metrics.

2. Sample size 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 or performance test set. It refers to patient imaging (CT or MRI scans) being used to design patient-specific implants, but this is part of the manufacturing process, not a test set for evaluating the device's overall performance against acceptance criteria.

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. There is no mention of a test set with ground truth established by experts.

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

Cannot be provided. No test set or adjudication method is described.

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 knee implant, not an AI diagnostic tool that assists human readers.

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

Not applicable. This device is a knee implant. While "ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface," this software is part of the design and manufacturing process, not a standalone diagnostic algorithm whose performance would be assessed in this manner.

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

Cannot be provided. There is no mention of ground truth as part of a performance study.

8. The sample size for the training set:

Cannot be provided. The document refers to "patient imaging (either CT or MRI scans)" being used to design the implant, suggesting individual patient data for custom manufacturing, not a "training set" in the context of an AI/ML algorithm development.

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

Cannot be provided. No training set or ground truth establishment is described.

Summary of what can be extracted related to the device:

The ConforMIS, Inc. BiCompartmental Knee Repair System is a Class II medical device (NPJ) intended for use in patients with severe knee joint pain and disability due to conditions like osteoarthritis, traumatic arthritis, or rheumatoid arthritis, where a single-compartment prosthesis is insufficient. It is a patient-specific implant designed using CT or MRI scans of the patient's knee. The device is manufactured from cobalt chromium molybdenum alloy, with tibial and patellar components from Ultra-High Molecular Weight Polyethylene and is intended for use with bone cement.

The 510(k) submission demonstrates substantial equivalence to predicate devices (listed in the table in section {1}) in terms of "indications for use and technological characteristics." The document states:

"The technological characteristics of the ConforMIS, Inc., BiCompartmental Knee Repair System are substantially equivalent to those of the cited predicate orthonedic devices."
"The image analysis is identical to that used for the Imaging Therapeutics Interpositional Device (iPD) and the ConforMIS Unicondylar Implant."
"This device is equivalent in terms of design process, materials, production process, and equipment."

The regulatory path chosen for this device (510(k) substantial equivalence) means that the testing and validation focus on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against a set of newly defined acceptance criteria. The FDA's letter (Section {4} and {5}) confirms the substantial equivalence determination, allowing the device to be marketed.

Summary

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MAR 9 2006

510(k) Summary

ConforMIS, Inc.

BiCompartmental Knee Repair System

510(k) Premarket Notification K_0 5-34 88

GENERAL INFORMATION

Manufacturer:

ConforMIS Inc. 323 C Vintage Park Drive Foster City, CA 94404 Phone 650-286-4151 FAX 650-286-4160

Contact Person:

Patrick Hess, PhD Chief Executive Officer ConforMIS, Inc.

Date Prepared: December 5, 2005

DEVICE INFORMATION

Trade/Proprietary Name: BiCompartmental Knee Repair System

Common/Classification Name: Knee joint femorotibial cemented prosthesis

Classification: 21 CFR 888.3530 – Knee joint femorotibial Classifications all polymer semi-constrained cemented prosthesis.

Device Class: Class II

Device Product Code: NPJ

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

PREDICATE DEVICES

The ConforMIS, Inc. BiCompartmental Knee Repair System is substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics. These predicate devices are:

Technological Characteristics	Indications for Use
• Imaging Therapeutics™ Knee InterpositionalDevice (K033242)• ConforMIS Unicondylar Knee (K043570)	• Smith & Nephew Hybrid Knee FemoralComponents (K042896)• ConforMIS Unicondylar Knee(K043570)• Natrual Knee® - Sulzer Orthopedics(K002356)

INTENDED USE

painful joint disease due to osteoarthritis, traumatic arthritis or . rheumatoid arthritis of the knee
post traumatic loss of joint function .
. failed osteotomies, hemiarthoplasties and unicondylar implants.

The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofcmoral areas have been affected by one or more of these conditions.

The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

PRODUCT DESCRIPTION

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

(i.e. a unicondylar or patellofemoral prosthesis), when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MRI scans), a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The device is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from data obtained from images of the patient's individual geometry obtained using either CT or MRI scans. The tibial and patellar components are manufactured from Ulta-High Molecular Weight Polyethylene ("UHMWP" ASTM-F-648) The ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface Subsequently, Solid Works OTS software is used to create the design. ConforMIS, Inc., Implant Engineering Drawing. The BiCompartmental Knee Repair System is intended for use in conjunction with the tibial components of the ConforMIS Unicondylar Knee Replacement System and the patellofemoral components of the ConforMIS Total Knee Repair System.

SUBSTANTIAL EQUIVALENCE

Use of the Term "Substantial Equivalence"

The term "Substantial Equivalence" is used in this submission within the confines of the statutory use of the term in the FDA's evaluation of a Pre-Market Notification Submission. Any statement regarding Substantial Equivalence used in this submission relates only to whether the device that is the subject of this submission may be lawfully marketed in the United States without pre-market approval or reclassification, and should not be interpreted as an admission, or any kind or type of evidence, in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office.

The present submission and statements therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in the submission, or its use, may be considered indistinct, from a patentability perspective, from any other device referred to in this submission.

Technological Characteristics

The technological characteristics of the ConforMIS, Inc., BiCompartmental Knee Repair System are substantially equivalent to those of the cited predicate orthonedic devices. The image analysis is identical to that used for the Imaging Therapeutics Interpositional Device (iPD) and the ConforMIS Unicondylar Implant. This device is equivalent in terms of design process, materials, production process, and equipment.

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

Indications for Use

Substantial equivalence is also supported for the ConforMIS, Inc., BiCompartmental Knee Repair System by the predicate devices previously cited and cleared in the treatment of osteoarthritic knees the use of such a device is warranted.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

ConforMIS, Inc c/o Patrick Hess, PhD Chief Executive Officer 323 Vintage Park Drive, Suite C Foster City, California 94404

Re: K053488

Trade/Device Name: ConforMIS BiCompartmental Knee Repair System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ Dated: December 13. 2006 Received: December 16, 2006

Dear Dr. Hess:

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. on 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). 11 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 docs 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 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

{5}------------------------------------------------

Page 2 - Patrick Hess, PhD

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) 276-0210. Also, please note the regulation emitled. "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 (300) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Herbert Lewis

Mark N. Melkerson Acting Director Division of General. Retorative and Neurological Devices Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

510(k) Number: K _____________________________________________________________________________________________________________________________________________________________

Device Name: ConforMIS, Inc., BiCompartmental Knee Repair System

Indications for Use:

The ConforMIS, Inc., BiCompartmental Knee Repair System is intended for The Conformils, Inc., Dicomparinent and disability whose conditions use in pattents with severe know form passes of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

painful joint disease due to osteoarthritis, traumatic arthritis or . rheumatoid arthritis of the knee
post traumatic loss of joint function .
post tradinatio 1005 01 Juliarthoplasties and unicondylar implants. .

The BiCompartmental Knee Repair System may be utilized when the medial The BROMIPATICAL TERS REPART COLLER COLLER COLLECT affected by one or more of these conditions.

The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use x__________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-

CONTINUE ON ANOTHER PAGE IF NEEDED)

Herbert Leunig

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

510(k) Number K053488

003

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.