The ConforMIS Tri-compartmental Resurfacing Device (tCR)is a minimally invasive, bone preserving primary total knee system intended for use in patients with severe knee joint pain and disability. The indications for use include restoring joint function and relief of pain due to:

Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid . arthritis of the knee
Post traumatic loss of joint function .
Mild to moderate valgus or varus deformity of the knee .
The ConforMIS Tri-compartmental Resurfacing (tCR) Device is intended only for use with bone cement.

Device Description

The ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device is a tricompartmental semi-constrained total knee implant. The design of the product incorporates a bone preserving approach, with minimal bone resection of the tibia and femur, for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Using patient imaging (either MRI or CT 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 femoral component is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from specific design drawings created from data obtained from images of the patient's individual geometry obtained using either MRI or CT scans. 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 design. Subsequently, Solid Works OTS software is used to create the ConforMIS, Inc. Implant Engineering Drawing. The implant is manufactured using multiple SLA and standard casting techniques. The tibial component is manufactured from UHMWPE (ASTM-F-648) from a drawing produced in a similar manner to the femoral component. It is individualized on its footprint to match the patient's tibial anatomy. The articular surface is designed to be flat in the periphery and slightly concave in the femoral contact area. The all polyethelene (UHMWPE) component is designed for use with bone cement and central cement retention features will be incorporated on the undersurface of the implant. The circumferential size and shape of the tibial component are designed to be 1-3mm within the articulating surface borders of the tibia at the cut bone depth. The minimal polv thickness is 7mm and the component is designed to replace a bone cut of 2-6mm (measured distally from the lowest point of the bony surface of the affected condyle). The patellar component is also manufactured from UHMWPE.

AI/ML Overview

The provided 510(k) summary for the ConforMIS Tri-Compartmental Resurfacing (tCR) Device does not contain information about acceptance criteria or a specific study proving the device meets said criteria in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a defined ground truth).

The document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing process, equipment, and indications for use. The evaluation methodology described is primarily biomechanical testing rather than performance against a clinical ground truth.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices	- Technological Characteristics: The ConforMIS tCR Device is stated to be "substantially equivalent to those of the cited predicate orthopedic devices" (ConforMIS Knee Interpositional Device K033242, ConforMIS Unicompartmental K043570) in terms of design process, materials, production process, and equipment. The image analysis for patient-specific implant design is identical to that used for the predicate ConforMIS devices.
	- Indications for Use: Substantial equivalence is supported by the predicate devices (Biomet Anatomic Total Knee Prosthesis K000978, Advance® Total Knee system K974328, Alaron Surgical Active Knee® System K021740) for treating osteoarthritic knees where total knee replacement is warranted.
Device Design Evaluation	- Standardized Biomechanical Testing: "The device design was evaluated using standardized fatigue, constraint and contact area biomechanical testing."
Safety and Effectiveness	- "The ConforMIS, Inc. Tri-Compartmental Resurfacing (tCR) Device raises no new safety or effectiveness issues." (This is a conclusion based on the substantial equivalence argument and testing).

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable in the traditional sense for AI/ML. The document describes biomechanical testing and comparison to predicate devices, not an evaluation against a clinical test set of patient data with a defined ground truth for performance metrics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. Ground truth, in the context of clinical expert consensus for AI/ML device evaluation, is not mentioned as the evaluation method. The primary "ground truth" for the biomechanical testing would be established engineering standards and physical measurements.

4. Adjudication Method for the Test Set:

Not Applicable. No expert adjudication method is described, as the evaluation is based on biomechanical tests and comparison to predicate devices.

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, an MRMC study was not done. This type of study focuses on improving human reader performance with AI assistance, which is not the evaluation method described for this knee implant device.

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

Not Applicable in the context of clinical performance evaluation. The device itself is a physical implant. While there is "ConforMIS, Inc., implant Software" used to process imaging data for custom implant design, the document states "The image analysis is identical with that used for the ConforMIS interpositional device (iPD) and the ConforMIS unicondylar implant." This implies the software component was previously evaluated or deemed substantially equivalent based on its use in prior cleared devices, rather than a standalone clinical performance study specifically for this tCR device's software. The document focuses on the end-device's substantial equivalence.

7. The Type of Ground Truth Used:

For the biomechanical testing: Engineering standards and physical measurements (e.g., fatigue limits, constraint forces, contact area measurements).
For the overall substantial equivalence claim: Performance and safety of legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not Applicable in the context of AI/ML model training on clinical data. The "design" or "training" data refers to patient imaging (MRI or CT scans) used for individual patient-specific implant design. It's not a "training set" for a generalizable AI model in the typical sense. Each implant design uses data from a single patient.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. For the patient-specific implant design, the "ground truth" is the patient's own anatomy as captured by MRI or CT scans. The "ConforMIS, Inc., implant Software" processes this anatomical data, and "Off the Shelf (OTS) software is utilized to produce the surface design." The "ground truth" for the software's accuracy in capturing anatomy would likely have been established during the development and clearance of the earlier ConforMIS interpositional and unicondylar devices, but specific details are not provided in this document.

In summary: This 510(k) summary is for a physical medical device (knee implant) and demonstrates substantial equivalence through comparison to predicate devices and biomechanical testing, rather than through clinical performance studies against defined ground truth as would be typical for an AI/ML diagnostic or prognostic device. The software mentioned is for patient-specific design, and its performance is referenced by its prior use in predicate devices.

Summary

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510(k) Summary

AUG 3 1 2006

ConforMIS, Inc.

Total Knee Repair System

510(k) Notification K052687

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:

August 28, 2006 (revised)

DEVICE INFORMATION

Trade/Proprietary Name

Tri-Compartmental Resurfacing (tCR) Device

Common/Classification Name

Knee joint patellofemorotibial cemented prosthesis

21 CFR 888.3560 -- Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.

Class II

Device Product Code: JWH

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PREDICATE DEVICES

The ConforMIS, Inc. Tri-Compartmental Resurfacing (tCR) Device 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
• ConforMIS Knee InterpositionalDevice (K033242)• ConforMIS Unicompartmental(K043570)	• Biomet Anatomic Total KneeProsthesis(K000978)• Advance® Total Knee system (K974328)• Alaron Surgical Active Knee® System(K021740)

INTENDED USE

The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use in patients with severe knee joint pain and disability. The indication 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
valgus or varus deformity of the knee .

The ConforMIS Tri-Compartmental Resurfacing (tCR) Device is intended for use only with bone cement.

PRODUCT DESCRIPTION

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The implant is manufactured using multiple SLA and standard casting Drawing. techniques.

The tibial component is manufactured from UHMWPE (ASTM-F-648) from a drawing produced in a similar manner to the femoral component. It is individualized on its footprint to match the patient's tibial anatomy. The articular surface is designed to be flat in the periphery and slightly concave in the femoral contact area. The all polyethelene (UHMWPE) component is designed for use with bone cement and central cement retention features will be incorporated on the undersurface of the implant. The circumferential size and shape of the tibial component are designed to be 1-3mm within the articulating surface borders of the tibia at the cut bone depth. The minimal polv thickness is 7mm and the component is designed to replace a bone cut of 2-6mm (measured distally from the lowest point of the bony surface of the affected condyle).

The patellar component is also manufactured from UHMWPE.

SUBSTANTIAL EQUIVALENCE

Technological Characteristics

The technological characteristics of the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device are substantially equivalent to those of the cited predicate orthopedic devices. The image analysis is identical with that used for the ConforMIS interpositional device (iPD) and the ConforMIS unicondylar implant. This device is equivalent in terms of design process, materials, production process, and equipment.

Indications for Use

Substantial equivalence is also supported for the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device by the predicate devices previously cited and cleared in the treatment of osteoarthritic knees where total knee replacement is warranted.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

The device design was evaluated using standardized fatigue, constraint and contact area biomechanical testing. The results of this testing provide objective support for the claim of substantial equivalence.

SUMMARY

Based on the similarities in design, materials, function, and intended use, the ConforMIS, Inc., Tri-Compartmental Resurfacing (tCR) Device is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS, Inc. Tri-Compartmental Resurfacing (tCR) Device raises no new safety or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2006

Dr. Patrick Hess Chief Executive Officer ConforMIS, Inc. 323 C Vintage Park Drive Foster City, California 94404

Re: K052687

Trade/Device Name: ConforMIS Tri-compartmental Resurfacing Device Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 15, 2006 Received: August 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, 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. 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.

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Page 2 - Dr. Patrick Hess

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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Michum

Mark N. Melkerson 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): #K052687

ConforMIS Tri-compartmental Resurfacing Device Device Name:

Indications for Use:

Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid . arthritis of the knee
Post traumatic loss of joint function .
Mild to moderate valgus or varus deformity of the knee .

The ConforMIS Tri-compartmental Resurfacing (tCR) Device is intended only for use with bone cement.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Page 1 of 1

510(k) Number L052687

CONFIDENTIAL

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.