(104 days)
The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee replacement include those with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous femoral condyle or tibial plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
- 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.
ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT scan. Disposable, patient-specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the software. Instead, it describes a process of "software verification and validation testing of proprietary software" to demonstrate substantial equivalence to a predicate device.
The "performance" reported is that the device, after software modifications, is substantially equivalent to the previous versions. This determination is based on the conducted non-clinical laboratory testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functions as intended and meets design specifications. | Detailed software description and software verification and validation testing of proprietary software SegSurf v3.0, iUniWorks v4.0, and iUni FemJigs v2.0 were performed. |
| Device maintains safety and effectiveness after software update. | Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use. Clinical data was not deemed necessary to demonstrate substantial equivalence. |
| Substantial Equivalence to Predicate Devices (K121974 & K111916). | "Based on the testing conducted it is concluded that the iUni Unicondylar Knee Replacement System with the use of SegSurf v3.0, iUniWorks v4.0, and iUni FemJigs v2.0 production software modules is substantially equivalent to the iUni Unicondylar Knee Replacement System" (predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of typical machine learning or algorithm validation. The testing described is "software verification and validation testing," which usually involves testing the software's functionality, compliance with requirements, and performance against defined specifications, rather than a clinical dataset.
The data provenance is not mentioned. Since this is a software update for a pre-existing medical device, the "data" being processed by the software would be patient imaging scans (MRI or CT) used to design the patient-specific implants. However, the origin and nature of any specific dataset used for the "verification and validation" of the software itself are not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the study is a "software verification and validation testing" for substantial equivalence, and not a clinical efficacy or performance study involving human interpretation of imaging, there is no mention of experts being used to establish ground truth for a test set in the traditional sense of medical image analysis (e.g., radiologists marking lesions). The "ground truth" for software validation would typically relate to the accuracy of the software's output compared to its specified design or known correct outputs (e.g., if a measurement is supposed to be X, the software calculates X). The document does not detail this aspect.
4. Adjudication Method for the Test Set
As there is no mention of a test set requiring expert interpretation or labeling, there is no adjudication method described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done or reported. The submission focuses on demonstrating substantial equivalence of the modified software to a predicate device through non-clinical software testing, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The testing performed was standalone software verification and validation of SegSurf v3.0, iUniWorks v4.0, and iUni FemJigs v2.0. These software modules are proprietary and are used for "analysis... of images obtained by MRI or CT scan" to design patient-specific implants. This constitutes standalone algorithm testing, as it doesn't involve human interpretation of the algorithm's output in a diagnostic setting, but rather the internal validation of the software's calculations and functionalities.
7. The Type of Ground Truth Used
The ground truth for the "software verification and validation testing" would be the expected and correct outputs/behaviors of the software modules based on their design specifications and computational requirements. This is typically established through:
- Design specifications: What the software is designed to calculate or segment.
- Reference data/models: Using known inputs with manually calculated or established correct outputs to compare against the software's results.
- Mathematical correctness: Ensuring algorithms perform calculations accurately.
The document does not elaborate on the specific type of ground truth beyond stating "software verification and validation testing."
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. The described software (SegSurf, iUniWorks, iUni FemJigs) is for custom implant design based on individual patient imaging data. While these systems are likely built on underlying algorithms that may have been developed and trained using various datasets, the submission focuses on the validation of an updated version of these proprietary software modules. The training details of the original or updated algorithms are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, the method for establishing its ground truth is also not mentioned.
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510(K) SUMMARY (PAGE 1 OF 4) 6.0
| Submitter's Name and Address: | ConforMIS Inc.28 Crosby DriveBedford, MA 01730 |
|---|---|
| Establishment Registration Number: | 3009844603 and 3004153240 |
| DEC 0 5 2013 | |
| Date of Summary: | August 21, 2013 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number: | (781) 345-9164 |
| Fax Number: | (781) 345-0104 |
| Name of the Device: | ConforMIS iUni Unicondylar Knee Replacement System (KRS) |
| Common Name: | Unicondylar Knee Replacement System |
| Regulatory Status and Regulation Number: | Class II21 CFR 888.3520 |
| Classification Name: | HSX - Prosthesis, knee, femorotibial, nonconstrained, cemented, metal/polymerOOG - Knee Arthroplasty Implantation System |
| Indications for Use: | The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. |
| Candidates for unicondylar knee replacement include those with: | |
| joint impairment due to osteoarthritis or traumatic arthritis of the kneeprevious femoral condyle or tibial plateau fracture, creating loss of functionvalgus or varus deformity of the kneerevision 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. | |
| Identification of the Legally Marketed Device (Predicate Device): | ConforMIS iUni Unicondylar Knee Replacement System (KRS)Device Class: IIProduct Code: HSX, OOGRegulation Number: 21 CFR 888.3520510(k) Number: K121974 and K111916 |
TradItional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0
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510(K) SUMMARY (PAGE 2 OF 4)
Device Description: ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT scan. Disposable, patient-specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System. Substantial The product subject of this premarket notification is substantially Equivalence: equivalent to the iUni Unicondylar Knee Replacement System (K121974 cleared September 06, 2012 and K111916 cleared September 29, 2011. The following testing was performed to establish substantial equivalence:
Software verification and validation testing of
proprietary software
Traditional 510(k) - Modification of the iUni Knee Replacement System - SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0
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23
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K132640 (3/4)
510(K) SUMMARY (PAGE 3 OF 4)
Device Comparison
| Characteristic | PredicateiUni Unicondylar Knee Replacement System(K121974 & K111916) | iUni Unicondylar Knee Replacement System(This submission) |
|---|---|---|
| Indication for Use | The ConforMIS Unicondylar KneeReplacement System (iUni) is intended foruse in one compartment of theosteoarthritic knee to replace the damagedarea of the articular surface in patients withevidence of adequate healthy bonesufficient for support of the implantedcomponents. | The ConforMIS Unicondylar KneeReplacement System (iUni) is intended foruse in one compartment of theosteoarthritic knee to replace the damagedarea of the articular surface in patients withevidence of adequate healthy bonesufficient for support of the implantedcomponents. |
| Candidates for unicondylar kneereplacement include those with:• joint impairment due to osteoarthritis ortraumatic arthritis of the knee• previous femoral condyle or tibialplateau fracture, creating loss offunction and• valgus or varus deformity of the knee• revision procedures provided thatanatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scansThis implant is intended for cemented useonly. | Candidates for unicondylar kneereplacement include those with:• joint impairment due to osteoarthritis ortraumatic arthritis of the knee• previous femoral condyle or tibialplateau fracture, creating loss offunction• valgus or varus deformity of the knee• revision procedures provided thatanatomic landmarks necessary foralignment and positioning of theimplant are identifiable on patientimaging scansThis implant is intended for cemented useonly. | |
| Cement Use Only | Yes | Yes |
| ProductClassification | 21 CFR 888.3520 (HSX) | 21 CFR 888.3520 (HSX) |
| Components andMaterials | • Femoral Implant: CoCrMo• Metal Backed Tibial Components:o Tibial tray: CoCrMoo Tibial Inserts: UHMWPE• All-Polyethylene Tibial Component:UHMWPE | • Femoral Implant: CoCrMo• Metal Backed Tibial Components:o Tibial tray: CoCrMoo Tibial Inserts: UHMWPE• All-Polyethylene Tibial Component:UHMWPE |
| Design | Prosthesis, knee, femorotibial,nonconstrained, cemented, metal/polymer | Prosthesis, knee, femorotibial,nonconstrained, cemented, metal/polymer |
| Patient Matched | Yes | Yes |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Characteristic | PredicateiUni Unicondylar Knee Replacement System.(K121974 & K111916) | iUni Unicondylar Knee Replacement System(This submission) |
| ProprietarySoftware forSegmenting andSurfacing | SegSurf version 2.0 | SegSurf version 3.0 |
| ProprietarySoftware forFemoralComponents | iUniWorks version 3.0 | iUniWorks version 4.0 |
| ProprietarySoftware for theFemoral Trial | iUni FemJigs version 1.3 | iUni FemJigs version 2.0 |
Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0
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510(K) SUMMARY (PAGE 4 OF 4)
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| Description andConclusion ofTesting: | Nonclinical Testing: The determination of substantialequivalence for this device was based on a detailed devicedescription. The following non-clinical laboratory testing wasperformed demonstrating that the device is safe and can beconsidered substantially equivalent to the predicate device forthe intended use:Detailed software description and software verificationand validation testing of proprietary software SegSurfDetailed software description and software verificationand validation testing of proprietary software iUniWorksDetailed software description and software verificationand validation testing of proprietary software iUniFemJigs |
|---|---|
| Safety andPerformance: | The determination of substantial equivalence for this device wasbased on a detailed device description. Non-clinical laboratorytesting was performed demonstrating that the device is safe andcan be considered substantially equivalent to the predicatedevice for the intended use. Clinical data is not necessary todemonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iUniUnicondylar Knee Replacement System with the use of SegSurfv3.0, iUniWorks v4.0, and iUni FemJigs v2.0 productionsoftware modules is substantially equivalent to the iUniUnicondylar Knee Replacement System (K121974 clearedSeptember 06, 2012 and K111916 cleared September 29, 2011. |
Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0
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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K132640
Trade/Device Name: ConforMIS" iUni Unicondylar Knee Replacement System (iUni) Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint fomorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II. Product Code: HSX, OOG Dated: September 5, 2013 Received: September 9, 2013
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 10 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: CDRFI docs not evaluate information related to contract liability warrantics. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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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Page 2 - Ms. Amita Shah
device-related adverse events) (21 CFR 803); good manufacturing practive 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/dcfault.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 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.
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): K132640
Device Name:
ConforMIS® iUni Unicondylar Knee Replacement System (iUni)
Indications for Use:
The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee replacement include those with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous femoral condyle or tibial plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
- 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.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopedic Devices |
Traditional 510(k) - Modification of the iUnl Knee Replacement System - SegSurf v3.0iUniWorks v4.0
§ 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.