The ConforMIS iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 unicondylar or patellofemoral prosthesis. The indications for use including 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, hemiarthroplasties and unicondylar implants
The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.

Device Description

The iDuo KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component (patellar component packaged separately). The product design 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 or effectively addressed using a device that treats only a single knee compartment (i.e. a unicompartmental or patellofemoral prosthesis) when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. Two tibial components are offered: a single-piece all polyethylene tibial component manufactured from ultra-high molecular weight polyethylene ("UHMWPE") or a two-piece metal-backed tibial component which includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert manufactured from UHMWPE. The patellar component is manufactured from UHMWPE.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the ConforMIS® iDuo® Bicompartmental Knee Repair System (iDuo® KRS). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria through device performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document.

Here's a breakdown of the information that can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not Available	Not Available
(Specific performance metrics, e.g., range of motion, wear rates, load bearing capacity, durability, etc., for the modified device are not
explicitly stated as acceptance criteria or results of a specific performance study in this summary.)	The submission states that "Nonclinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use." This implies performance was comparable but doesn't specify criteria or results.

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

Sample Size for Test Set: Not applicable. No clinical or standalone performance test set is described. The submission focuses on non-clinical laboratory testing for substantial equivalence.
Data Provenance: Not applicable. The "nonclinical laboratory testing" details are not provided.

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. No clinical test set with human-established ground truth is described.

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

Not applicable. No clinical test set 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 repair system (implant), not an AI diagnostic tool. No MRMC study or AI component is mentioned.

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

Not applicable. This is an implantable medical device, not a standalone algorithm. The submission mentions "patient imaging (either CT or MR scans)" being used to design the patient-specific implant, but this is part of the manufacturing process, not an algorithm's standalone performance evaluation in the context of diagnostic accuracy.

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

Not applicable. No ground truth for device performance in a clinical or diagnostic context is detailed in this 510(k) summary. The basis for substantial equivalence was "a detailed device description" and "nonclinical laboratory testing."

8. The sample size for the training set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI for this device. The device itself is patient-specific, designed using patient imaging, but this is a design input, not a "training set" for an algorithm being evaluated.

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

Not applicable. As above, no training set is described in the context of this device's submission.

Summary

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K093513

6.0 510(k) SUMMARY

Page 1 of 3

This 510(k) Summary for the modified ConforMIS® iDuo Bicompartmental Knee Repair System (iDuo® KRS) is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name and Address:	ConforMIS Inc.2 Fourth Ave.Burlington, MA 01804
	DEC 1 6 2009
Contact Person:	Amita S. ShahDirector, Quality Assurance & Regulatory Affairs
Date:	November 12, 2009
Name of Medical Device:	Device Regulation: 21 CFR 888.3560,
	Product Code: NPJ
	Common/Usual Name: Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis.
	Proprietary Name: ConforMIS iDuo BicompartmentalKnee Repair System
Device Classification:	In accordance with per 21 CFR 888.3560, a knee jointpatellofemorotibial polymer/metal/polymer non-constrained cemented prosthesis is classified by the FDAas a Class II Medical Device.

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510(k) SUMMARY Page 2 of 3

Indications for Use:

painful joint disease due to osteoarthritis, 0 traumatic arthritis or rheumatoid arthritis of the knee.
o post traumatic loss of joint function
failed osteotomies, hemiarthroplasties and . unicondylar implants

The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.

Using patient imaging (either CT or MR scans), a patientspecific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. Two tibial components are

Device Description:

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510(k) SUMMARY Page 3 of 3

offered: a single-piece all polyethylene tibial component manufactured from ultra-high molecular weight polyethylene ("UHMWPE") or a two-piece metal-backed tibial component which includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert manufactured from UHMWPE. The patellar component is manufactured from UHMWPE.

Substantial Equivalence:

Safety and Performance:

The product subject of this premarket notification is substantially equivalent to the currently marketed iDuo Bicompartmental Knee Repair System (reference K053488 cleared March 9, 2006) and other currently marketed devices.

The determination of substantial equivalence for this device was based on a detailed device description. Nonclinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use. Clinical data are not necessary to demonstrate substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Conformis, Inc. % Ms. Amita Shah, RAC Director, Quality Assurance & Regulatory Affairs 2 Fourth Ave Burlington, Massachusetts 01803

DEC 1 6 2009

Re: K093513

Trade/Device Name: iDuo Bicompartmental Knee Repair System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ Dated: November 12, 2009 Received: November 17, 2009

Dear Ms. Shah:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Ms. Amita Shah

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucn11115800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (211CFR Pratt 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its colloffree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jonita Bs

(g) Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name: ConforMIS® iDuo® Bicompartmental Knee Repair System (iDuo KRS)

Indications for Use:

The ConforMIS iDuo Bicompartmental Knee Repair System (iDuo KRS) is intended for use in patients with severe knee internal ritics Nipul KRS) is intended for use in
by the use of a prosthational disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofen as no the trouts only a single Kneed compartment, such as
function and rollef of nein due to function and relief of pain due to:

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

The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions.

The iDuo KRS is intended for cemented use only.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smeter
(Division Sign-Off) for MXM

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K0935/3

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.