The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
Post traumatic loss of joint function.
Moderate varus, valgus or flexion deformity.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only.

Device Description

The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate, ancillary orthopedic manual surqical instruments designed for use with the iTotal PS KRS are provided to assist with implantation. The ancillary instruments are made from biocompatible nylon, and similar to the implants, are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510(k)s (K140833).

AI/ML Overview

This document describes a 510(k) premarket notification for the ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (KRS). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial or AI performance study would.

Therefore, many of the requested categories for AI/medical device performance evaluation are not applicable or cannot be extracted from this document, as it concerns a medical implant that has undergone non-clinical laboratory testing for substantial equivalence, not a diagnostic AI algorithm.

Here's an attempt to address your request based on the provided text, noting where information is not applicable:

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

The document does not present explicit "acceptance criteria" in terms of clinical performance metrics with target values. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical laboratory testing. The "performance" reported are the results of these tests, which support the claim of substantial equivalence.

Acceptance Criteria Category (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (via Non-Clinical Tests)
Mechanical Strength/Durability:
Femoral Component Fatigue	Testing demonstrated substantial equivalence. (Specific numerical criteria not provided, but implies meeting predicate's performance or relevant standards.)
Tibial Insert Spine-Femoral Cam Fatigue	Testing demonstrated substantial equivalence. (Specific numerical criteria not provided, but implies meeting predicate's performance or relevant standards.)
Functional/Biomechanical:
Range of Motion	Analysis demonstrated substantial equivalence. (Specific methods or numerical results not detailed, but implies similar range of motion to predicate.)
Cadaveric Evaluation	Evaluation demonstrated substantial equivalence. (Specific outcomes not detailed, but implies similar fit, function, and surgical approach to predicate.)
Overall Safety and Effectiveness	The determination of substantial equivalence was based on a detailed device description and non-clinical laboratory testing, demonstrating the device is safe for its intended use and substantially equivalent to the predicate devices. Clinical data was deemed not necessary.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable in the context of human data or a "test set" for an AI algorithm. The "test set" here refers to the physical devices and materials used in the non-clinical laboratory tests. The document does not specify the number of components or constructs tested for each non-clinical test (e.g., how many femoral components were fatigued).
Data provenance: Not applicable. The "data" comes from physical laboratory testing of the device components, not from patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no human "ground truth" establishment in this context, as it's mechanical and functional testing of an implant rather than diagnostic assessment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among experts for ground truth in diagnostic cases. This document describes non-clinical laboratory tests, which would follow established testing protocols and standards, not expert adjudication.

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 is not an AI-assisted diagnostic device, and therefore no MRMC study with human readers was conducted or is relevant.

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

Not applicable. This is not an algorithm, but a physical knee implant.

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

Not applicable. For the non-clinical tests, the "ground truth" would be established engineering standards, material properties, and biomechanical principles against which the device's performance is measured or compared to the predicate's known performance.

8. The sample size for the training set

Not applicable. This device is a physical knee implant, not an AI model requiring a training set. The design of the implant is patient-specific based on imaging, but this is a manufacturing process, not a machine learning training process.

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

Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

December 11, 2014

ConforMIS Incorporated Ms. Amita Shah Senior Vice President Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730

Re: K142404

Trade/Device Name: iTotal Posterior Stabilized (PS) Knee Replacement 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: JWH Dated: November 12, 2014 Received: November 13, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K142404

Device Name:

ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (iTotal PS KRS)

Indications for Use:

The Indications for Use include:

Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis 0 or osteonecrosis of the knee.
Post traumatic loss of joint function. ●
Moderate varus, valgus or flexion deformity.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental o implants.
Revision procedures provided that anatomic landmarks necessary for alignment and o positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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8.0 510(K) SUMMARY (PAGE 1 OF 4)

Submitter's Name andAddress:	ConforMIS, Inc.28 Crosby DriveBedford, MA 01730
Establishment RegistrationNumber:	3009844603 and 3004153240
Date of Summary:	August 25, 2014
Contact Person:Telephone Number:Fax Number:	Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs(781) 345-9164(781) 345-0147
Name of the Device:	ConforMIS iTotal® Posterior Stabilized Knee Replacement System(iTotal PS KRS)
Common Name:	Posterior Stabilized Total Knee Replacement System
Regulatory Status andRegulation Number:	Class II21 CFR 888.3560
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis
Device Classification:	Product Code:JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
	OOG: Knee Arthroplasty Implantation System.Intended to be used to assist in the implantation of a specific kneearthroplasty device or a set of specific knee arthroplasty devices.Indicated to include guiding alignment, making or establishing cuts,selecting, sizing, attaching, positioning or orienting implantcomponents.
	OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer + additive/metal/polymer + additive.This generic type of device includes prosthesis that have a femoralcomponent made of alloys, such as cobalt-chromium-molybdenum, anda tibial component(s) and/or a retropatellar resurfacing componentmade of ultra-high molecular weight polyethylene plus an additive, suchas a-tocopherol.

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510(K) SUMMARY (PAGE 2 OF 4)

Indications for Use: The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: Painful joint disease due to osteoarthritis, traumatic arthritis, . rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. Post traumatic loss of joint function. .

o Moderate varus, valgus or flexion deformity.
Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
o Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only.

ldentification of the Legally Marketed Device (Predicate Device):

ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS) Device Class: ll Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K140833

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510(K) SUMMARY (PAGE 3 OF 4)

Device Description: The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510(k)s (K140833).

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510(K) SUMMARY (PAGE 4 OF 4)

Substantial Equivalence: The proposed iTotal Posterior Stabilized Knee Replacement System, which consists of minor modifications to the posterior stabilizing features of the femoral implant, is substantially equivalent in design and functionality to the iTotal Posterior Stabilized Knee Replacement System (K140833, cleared June 30, 2014). The following non-clinical laboratory tests were performed to determine substantial equivalence: . Femoral Component Fatique Testing Tibial Insert Spine-Femoral Cam Fatique Testing . Range of Motion Analysis ● Cadaveric Evaluation ● All testing has demonstrated that the device is substantially equivalent to the predicate devices. Description and Nonclinical Testing: The determination of substantial equivalence for Conclusion of Testing: this device was based on a detailed device description and non-clinical laboratory testing. The following non-clinical laboratory tests were performed to determine substantial equivalence: Femoral Component Fatigue Testing . Tibial Insert Spine-Femoral Cam Fatique Testing . Range of Motion Analysis ● Cadaveric Evaluation . Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate devices for the intended use. The determination of substantial equivalence for this device was based Safety and Performance: on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices. Clinical data is not necessary to demonstrate substantial equivalence. Conclusion: Based on the testing conducted, it is concluded that the iTotal Posterior Stabilized Knee Replacement System is substantially equivalent to the predicate device: the iTotal Posterior Stabilized Knee Replacement System (K140833, cleared June 30, 2014).

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.