(56 days)
The ConforMIS Unicondylar Knee System is intended for use 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 Unicondylar Knee System is intended for use with cement.
The ConforMIS Unicondylar Knee System ("iUni") is a device developed from patient CT scans or MR images to replace one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and allows internal/external rotation between the femoral and tibial components. Movement is limited by the ligaments and other soft tissues surrounding the device. The device is designed to match the patient's unique normal anatomy.
The provided document describes the ConforMIS Unicondylar Knee System ("iUni"), a device developed from patient CT scans or MR images to replace one compartment of the knee condyles. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly a version of the implant designed based on CT scan data.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implants designed using MRI data for the ConfoRMIS Unicondylar Knee System ("iUni") must have the same physical parameters as those for the same patient designed from CT scan data. | The design verification procedure found that implants designed using MRI data have the same physical parameters as those for the same patient designed from CT scan data. |
| Implants designed from MR images must be as safe and effective as the predicate device (the previously cleared version designed based on CT scan data). | It was concluded that implants designed from MR images would be as safe and effective as the predicate device, given the identical materials and manufacturing methods. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/ML device. Instead, it refers to a "design verification procedure" where implants designed using MRI data were compared to those designed from CT scan data for "the same patient." The exact number of patients or imaging sets (sample size) used in this comparison is not provided.
The provenance of this data (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not describe the use of human experts to establish "ground truth" for evaluating the performance of the device in the way it would for an AI/ML imaging device. The comparison is based on the physical parameters of the implants themselves.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned, as the evaluation did not involve expert interpretation or subjective assessment of the device's output in the typical sense of an AI/ML study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The study described is a design verification comparing physical parameters of implants derived from different imaging modalities, not a study of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The core of the described study (design verification comparing implants derived from MRI vs. CT) is effectively a standalone (algorithm-only) performance assessment in that it evaluates the output of the design process, which is driven by algorithms interpreting imaging data to create the implant. However, it's not a "standalone" performance evaluation in the context of an AI-driven diagnostic system producing a specific output (like disease detection) for human review. It assesses the consistency of the physical implant parameters based on different input imaging.
7. The Type of Ground Truth Used
The ground truth used in this context is the physical parameters of the produced implants. The acceptance criteria are that implants designed from MRI data must have the "same physical parameters" as those designed from CT scan data for the same patient. This implies a comparison of quantitative measurements of the implant's design.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. The device is described as being "developed from patient CT scans or MR images," suggesting that these images are used in the design process, but it does not detail a separate "training set" in the machine learning sense. The focus is on the development of the device from these images, rather than the training of an AI model.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the AI/ML context is not explicitly described, neither is the method for establishing its ground truth. The design process presumably involves established engineering principles and anatomical measurements derived from imaging.
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K 072586 # '1/3
Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc.2 Fourth AvenueBurlington, MA 01803 | NOV 0 8 2007 |
|---|---|---|
| Contact Person: | S. Michael Sharp, PhDSr. VP, Regulatory and Clinical Affairs | |
| Phone | 781.860.5111 | |
| FAX | 781.860.5108 | |
| Date: | September 14, 2007 | |
| Trade/Proprietary Name | Unicondylar Knee Repair System/ConforMIS™ UCD | |
| Common Name | Unicondylar Knee System | |
| Reference/Classification Name | 21 CFR 888.3520 - Knee joint femorotibialmetal/polymer non-constrained cemented prosthesis |
Predicate Devices:
| Technological Characteristics | Indications for Use |
|---|---|
| • ConforMIS Bicompartmental Knee(K053488)• ConforMIS Total Knee (K0526876) | • ConforMIS Unicondylar Knee(K 043570) |
Intended Use:
The ConforMIS Unicondylar Knee System is intended for use 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 Unicondylar Knee System is intended for use with cement.
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Use of the Term "Substantial Equivalence"
The term "Substantial Equivalence" is used in this submission within the confines of its 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 or 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.
| Device Description | The ConforMIS Unicondylar Knee System ("iUni")is a device developed from patient CT scans or MRimages to replace one compartment of the kneecondyles. It is unconstrained in the anteroposteriorand mediolateral directions and allowsinternal/external rotation between the femoral andtibial components. Movement is limited by theligaments and other soft tissues surrounding thedevice. The device is designed to match thepatient's unique normal anatomy. |
|---|---|
| Comparison to Predicates: | The ConforMIS Unicondylar Knee System ("iUni")designed from MR images is substantially equivalentto the ConforMIS Unicondylar Knee Systemdesigned from CT Scan data, in technologicalcharacteristics in terms of design method, designcharacteristics and production process, as well asmaterials and indications. It is substantiallyequivalent to the ConforMIS Bi-Condylar KneeSystem and the ConforMIS total knee system interms of design method, materials and manufacturingmethods. All are intended for cemented use only. |
| Performance Data | Non-clinical Performance and Conclusions:The design verification procedure for the ConforMISUnicondylar Knee System ("iUni") found thatimplants designed using MRI data to have the samephysical parameters as those for the same patientdesigned from CT scan data. As all implants aremade of the same materials, using identicalmanufacturing methods, it was concluded that |
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K072586 # 3/3
implants designed from MR images would be aas safe and effective as the predicate device, the previously cleared version of the implant designed based on CT scan data. 1
Clinical Performance:
Clinical data and conclusions are not necessary to demonstrate substantial equivalence
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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 features a stylized eagle with three overlapping wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2007
NOV 0 8 2007
ConforMIS, Inc. % S. Michael Sharp, Ph.D. Sr. Vice President, Regulatory and Clinical 2 Fourth Avenue Burlington, Massachusetts 01803
K072586 Re: Trade/Device Name: ConforMIS Uni-Condylar Knee System 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: September 12, 2007 Received: September 13, 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 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 – S. Michael Sharp, Ph.D.
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 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,
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): K072586
Device Name: ConforMISTM, Inc. Uni-condylar Knee Repair System
Indications for Use:
The ConforMIS unicondylar implant is intended for use 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 unicondylar implant is for use with bone cement
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K072546
(Posted November 13, 2003)
§ 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.