(77 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 for use with cement.
The ConforMIS Unicondylar Knee System is a device developed from patient CT scans 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 conform to the patient's anatomy as closely as possible based on the CT scans.
The provided document describes the ConforMIS™ Unicondylar Knee Repair System, a custom-designed knee implant. However, it does not contain specific acceptance criteria, performance data from a clinical study, or details about the methodology of such a study.
Here's an breakdown of the information that is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not reported in the document. The document states: "Performance Data: Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System 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."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data is 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 data is provided, and therefore no ground truth establishment based on expert review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set data is provided.
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 physical knee implant, not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical study involving ground truth establishment is described.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. It is "developed from patient CT scans to replace one compartment of the knee condyles" and "designed to conform to the patient's anatomy as closely as possible based on the CT scans." While patient CT scans are used for designing the individualized implant, this is not a "training set" in the context of an AI algorithm, and no sample size for such a set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no "training set" in the AI sense for which ground truth would be established. The "ground truth" for the device design is the individual patient's anatomy derived from their CT scans.
Summary of the Study (as described in the document):
The document explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence." Instead, the submission relies on:
- Non-clinical Performance and Conclusions: "Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence." This refers to non-clinical (e.g., bench, mechanical) testing, but no specific results or acceptance criteria for this testing are provided.
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through a comparison to legally marketed predicate devices (K033242, K033363, K033769). The ConforMIS™ Unicondylar Knee System is deemed substantially equivalent in terms of technological characteristics (design, production process, materials) and intended use.
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K04357-0
SECTION 2
1
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.
MAR 1 4 2005
CONFIDENTIAL
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Summary of Safety and Effectiveness
| Submitted By: | ConforMIS, Inc.323 C Vintage Park DriveFoster City, CA 94404Phone 650-286-4151 |
|---|---|
| Contact Person:PhoneFAX | Lyndall Erb, PhDDirector, Regulatory/Clinical & Quality Assurance650-286-4166650-286-4160 |
| Date: | December 22, 2004 |
| Trade/Proprietary Name | Unicondylar Knee Repair System/ConforMISTM 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 |
|---|---|
| • ConforMIST™ IPD Knee Interpositional(K033242) | • Zimmer Unicompartmental Knee System(K033363)• EIUS Unicompartmental Knee System(K033769) |
The ConforMIS™ Unicondylar Knee System is intended Intended Use: 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 for use with cement.
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| Device Description | The ConforMIS Unicondylar Knee System is a devicedeveloped from patient CT scans to replace onecompartment of the knee condyles. It is unconstrainedin the anteroposterior and mediolateral directions andallows internal/external rotation between the femoraland tibial components. Movement is limited by theligaments and other soft tissues surrounding the device.The device is designed to conform to the patient'sanatomy as closely as possible based on the CT scans. |
|---|---|
| Comparison to Predicate Devices: | The ConforMIS Unicondylar Knee System issubstantially equivalent to the ConforMIS IPD intechnological characteristics in terms of design andproduction process, as well as materials and indications.It is substantially equivalent to the ZimmerUnicompartmental Knee System and the Repicci IIUnicondylar Knee in that all have similar indications,design, materials and mechanical safety. All areintended for cemented use only. |
| Performance Data | Non-clinical Performance and Conclusions:Testing completed as part of the design verificationprocedure for the ConforMIS Unicondylar Knee Systemfound this device to be as safe and effective as thepredicate devices, further confirming substantialequivalence.Clinical Performance:Clinical data and conclusions are not necessary todemonstrate substantial equivalence. |
·
CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAR 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lyndall Erb, Ph.D. Director, Regulatory/Clinical Affairs & Quality Assurance ConforMIS., Inc. 323 C Vintage Park Drive Foster City, California 94404
Re: K043570
Trade/Device Name: ConforMIS™ Unicondylar Knee Repair System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 18, 2005 Received: February 22, 2005
Dear Dr. Erb:
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 – Lyndall Erb, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I fills letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification. The I Dri mang of baction for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad rios for your (240) 276-__. Also, please note the regulation entitled, Colliation of Compliance at (210) 210-210-2007 (21CFR Part 807.97). You may obtain Misoranung of Telerence to premainters inibilities under the Act from the Division of Small other general information on Jour respenses Assistance at its toll-free number (800) 638-2041 or jvaliulacturers, International und Constal.http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
O mark X Millican
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K043570
Device Name: ConforMIS™ Unicondylar Knee Repair System
Indications for Use:
The ConforMIS™ unicondylar implant is intendcd for use in patients with:
- ontoriVIS™ unicondyial implant is incentration anthritis of the knee
joint impairment due to osteoarthritis or traver ation loca of function o - joint impairment due to osteourings of cacture, creating loss of function .
- valgus or varus deformity of the knee e
The ConforMIS™ unicondylar implant is for use with bone cement.
Mark n Millican
Vegarotive Division of and Neurological De Carlis
510(k) Number K043570
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
()ver-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
) (PLEASE DO NOT WRITEDED) OF NEEDED)
CONFIDENTIAL
§ 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.