The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee repair Systems, in patients with:

joint impairment due to osteoarthritis or traumatic arthritis of the knee .
previous tibial condyle or plateau fracture, creating loss of function .
. valgus or varus deformity of the knee

The ConforMIS metal backed tibial component is intended only for use with bone cement.

Device Description

The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar Knee Repair System or the BiCompartmental Knee Repair ConforMIS System to provide the surgeon with an alternative tibial component in the event that prefers to use a metal backed he/she component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint"). are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee. It is available with UHMEPE inserts with minimal thickness from 6 to 14 mm.

AI/ML Overview

The provided text is a 510(k) summary for the ConforMIS Metal Backed Tibial Component ("mBT"). It describes a device intended for knee repair and seeks to establish substantial equivalence to predicate devices, rather than proving specific performance against acceptance criteria through a clinical study.

Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, and ground truth establishment cannot be found in this document. This document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. This document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that "Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices," implying that it met internal design verification standards, but no specific metrics are given.

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. The document states, "Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices. further confirming substantial equivalence." This refers to non-clinical (likely bench or mechanical) testing, not a clinical test set with patient data. No details on sample size or data provenance for any "test set" are present.
The document explicitly states, "Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

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. No clinical test set or ground truth establishment by experts is mentioned, as the submission relies on non-clinical performance and equivalence to predicates.

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

Cannot be provided. No clinical test set or adjudication method is mentioned.

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

Cannot be provided. This document describes a medical device (a knee implant component), not an AI algorithm or a diagnostic tool that would typically involve human readers or MRMC studies.

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

Cannot be provided. This document is for a medical device (implant component), not an algorithm.

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

Cannot be provided. No clinical ground truth is mentioned, as the submission focuses on non-clinical performance and substantial equivalence.

8. The sample size for the training set

Cannot be provided. This document is for a physical medical device. It does not mention any "training set" in the context of an algorithm. The device design is customized "based on images (MRI or CT scan) of the patient's knee," but this refers to patient-specific design, not an algorithmic training process.

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

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

Summary

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K072368

SECTION 2

SEP 2 0 2007

1/3

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of the 510(k) premarket notification for the ConforMIS, Inc. Unicondylar Knee Repair System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Summary of Safety and Effectiveness

Submitted By:	ConforMIS, Inc.2 Fourth AvenueBurlington, MA 01803
Contact Person:	S. Michael Sharp, PhDSr. Vice President, Regulatory/Clinical & Quality
Date:	August 22, 2007
Trade/Proprietary Name	Metal Backed Tibial Component ("mBT")
Common Name	Metal-backed tibial component
Reference/Classification Name	21 CFR 888.3520 - Knee joint femorotibialmetal/polymer non-constrained cemented

prosthesis

Predicate Devices

TechnologicalCharacteristics	Design & InsertThickness	Indications for Use
ConforMIS UniCondylarKnee Repair System(K043570)	DePuy PreservationUnicondylar Knee(K040268)	ConforMIS UniCondylarKnee Repair System(K043570)
ConforMISBiCompartmentalKnee Repair System(K053488)	ConforMIS Metal-backedTibial Component("mBT")(K063432)	ConforMISBiCompartmentalKnee Repair System(K053488)
	DePuy PreservationUnicondylar Knee(K040268)	DePuy PreservationUnicondylar Knee(K040268)
	Encore Uni Knee(K022437)
	Whiteside BiomechanicsUnicompartmental KneeSystem (K01280)

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Image /page/1/Picture/1 description: The image shows a white square with a black border. Inside the square, the fraction "2/3" is written in black ink. The number 2 is above the fraction line, and the number 3 is below the fraction line.

Intended Use:

The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee Repair Systems, in patients with:

joint impairment due to osteoarthritis or traumatic arthritis of the knee .
previous tibial condyle or plateau fracture, creating loss of function .
valgus or varus deformity of the knee .

The ConforMIS metal backed tibial component is intended only for use with bone cement

Device Description

Comparison to Predicates

The ConforMIS Metal Backed Tibial Component the tibial substantially equivalent to is components cleared for the ConforMIS Unicondylar and BiCompartmental Knee Repair Systems in is use of imaging data to design a patient-matched implant geometry, as well in terms of design and production process, as well as materials and indications. It is substantially equivalent to the cited predicate devices in terms of design, materials, mechanical safety All are intended for and intended use. cemented use only.

Non-clinical Performance and Conclusions:

Testing completed as part of the design verification procedure for the ConforMIS Metal

510(K) Submission: ConforMIS mBT Extended Thickness Range August 23, 2007: CONFIDENTIAL

Performance Data

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Backed Tibial Component found this device to be as safe and effective as the predicate devices. further confirming substantial equivalence.

Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence.

SUMMARY

Based on the similarities in design, materials, function, and intended use the ConforMIS - Metal Backed Tibial Component is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the ConforMIS Metal Backed Tibial Component raises no new safety or effectiveness issues.

USE OF THE TERM "SUBSTANTIAL EQUIVALENCE"

The term "Substantial Equivalence" is used in this submission within the confines of the statutory use 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 sub mission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConforMIS, Inc. % S. Michael Sharp, Ph.D. Sr. VP, Regulatory and Clinical 2 Fourth Avenue Burlington, Massachusetts 01803

SEP 2 0 2007

K072368 Re: Trade/Device Name: Metal Backed Tibial Component Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX

Dated: August 22, 2007 Received: August 23, 2007

Dear Dr. Sharp:

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

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Page 2 - S. Michael Sharp, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buehrig

Mark N. Me 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): K K072368

ConforMIS Metal Backed Tibial Component (mBT) Device Name:

Indications For Use:

The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee repair Systems, in patients with:

joint impairment due to osteoarthritis or traumatic arthritis of the knee .
previous tibial condyle or plateau fracture, creating loss of function .
. valgus or varus deformity of the knee

The ConforMIS metal backed tibial component is intended only for use with bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

harbare friedm

(Division Sign of General, Restorative, Division ---------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number K072368

Page 1 of

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.