(25 days)
The iTotal® CR 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, patello-femoral or bi-compartmental 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 in which the ligamentous structures can be returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.
The iTotal CR KRS is intended for cemented use only.
The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet 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 either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments 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 marking of bone before cutting. The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510k i.e. K094050, K103117 and K112780.
The provided text describes the KonforMIS iTotal CR Knee Replacement System, but it is a Knee Replacement System, not an AI/ML powered medical device. As such, the standard acceptance criteria and study methodologies for AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment methods) are not applicable.
The document pertains to a 510(k) premarket notification for a traditional medical device, specifically a modified version of an existing knee replacement system. The focus of the submission and the FDA's review is on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific AI/ML metrics.
Therefore, many of the requested fields cannot be filled as they are not relevant to this type of device and submission.
Here's a breakdown of the available information regarding its 'acceptance criteria' (which in this context means demonstrating substantial equivalence) and the 'study' (which is non-clinical testing):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Components: Identical to predicate device | Identical (Femoral, Tibial, Metal Backed Tibial, Patellar components) |
| Materials: Identical to predicate device | Identical (CoCrMo for femoral/tibial tray, UHMWPE for tibial/patellar inserts) |
| Design: Identical to predicate device | Identical (Knee joint patellofemorotibial semi-constrained cemented prosthesis) |
| Principle of Operation: Identical to predicate device | Identical (Cemented Use fixed Bearing Design) |
| Patient Matched: Identical to predicate device | Identical (Yes) |
| Patellar Design/Dimensions: Identical to predicate device | Identical (Symmetrical, offered in various sizes) |
| Minimum Thickness Tibial Insert (UHMWPE): Identical to predicate device | Identical (6 mm) |
| Posterior Cruciate Ligament (PCL) Sparing: Identical to predicate device | Identical (Yes) |
| Instrumentation: Patient specific Nylon jigs | Patient specific Nylon jigs (similar to predicate, but new proprietary software for femoral iJig). |
| Proprietary Software for femoral iJig instrumentation: (New element) Demonstrated functionality and safety through software verification and validation testing. | iTotal FemJigs version 1.0 - Software verification and validation testing performed. |
Note: The "acceptance criteria" here are implicitly about demonstrating that the modified device is as safe and effective as the predicate device(s) through a comparison of physical and functional characteristics, and specifically for the new software component, through verification and validation.
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device, not an AI/ML model for diagnostic or prognostic purposes with a 'test set' of patient data in the conventional sense. The "test set" refers to the proprietary software verification and validation, which would involve software testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth established by experts is mentioned for this type of device. The determination of substantial equivalence relies on device comparison and non-clinical testing data.
4. Adjudication method for the test set
Not applicable. Not an AI/ML device with a human-adjudicated test set.
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 or prognostic device, and no human reader study was conducted for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The proprietary software is part of the instrumentation for the surgeon as a human-in-the-loop tool, it is not a standalone algorithm performing a diagnostic task. The software itself underwent "software verification and validation testing," which is a standalone assessment of the software's functionality and correctness, but not in the context of diagnostic performance metrics.
7. The type of ground truth used
Not applicable. The "ground truth" concept as applied to AI/ML to validate diagnostic accuracy is not relevant here. The device's safety and effectiveness are established through comparison to a predicate device and engineering testing.
8. The sample size for the training set
Not applicable. The software described is for patient-specific implant and instrumentation design, not an AI/ML model that is 'trained' on a dataset in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there's no 'training set' for an AI/ML model as described in the conventional sense.
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FEB - 3 2012
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5.0 510(K) SUMMARY
| Submitter's Name and Address | ConforMIS Inc.11 North Ave.Burlington, MA 01803 |
|---|---|
| Establishment Registration Number | 3004153240 |
| Date of Summary | January 4, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and Regulatory Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0104 |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or Usual Name | Cruciate Retaining Total Knee Replacement System |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Indications for Use | The iTotal® CR 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, patello-femoral or bi-compartmental 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 in which the ligamentous structures can be returned to adequate function and stability.Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal CR KRS is intended for cemented use only. |
| Identification of the Legally Marketed Device (Predicate Device) | ConforMIS iTotal CR Knee Replacement System (KRS)Device Class: IIProduct Code: JWH, OOGRegulation Number: 21 CFR 888.3560510(k) number: K094050, K103117 and K112780 |
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510(k) Summary continued
| Device Description | The iTotal CR Knee Replacement System (hereafter referred to asthe "iTotal CR KRS") is a patient specific tricompartmental facetedposterior cruciate ligament (PCL) retaining knee replacementsystem. The iTotal CR KRS is a semi-constrained cemented kneeimplant which consists of a femoral, tibial and patellar component.The product design incorporates a bone preserving approach withminimal bone resection of the tibia and femur for the treatment ofsevere pain and/or disability of a knee damaged by osteoarthritis ortrauma. |
|---|---|
| Using patient imaging (either CT or MR scans) and a combinationof proprietary and off the shelf software a patient-specific implantand related instrumentation are designed, that best meet thegeometric and anatomic requirements of the specific patient. Thefemoral component is manufactured from cobalt chromiummolybdenum ("CoCrMo") alloy. The tibial component includes ametal tray manufactured from CoCrMo alloy and either one or twopolyethylene inserts manufactured from UHMWPE of identicalconfiguration. The patellar component is manufactured fromUHMWPE. | |
| For user convenience, and similar to the predicate iTotal CR KRS,accessory orthopedic manual surgical instruments designed foruse with the modified iTotal CR KRS are provided to assist withimplantation. The ancillary instruments are provided sterile and forsingle-use only. These patient specific instruments are providedto assist in the positioning of total knee replacement componentsintra-operatively and in guiding the marking of bone before cutting.The function and general design features of the patient specificancillary instruments remain similar to those described in thepredicate 510k i.e. K094050, K103117 and K112780. | |
| SubstantialEquivalence: | The product subject of this premarket notification is substantiallyequivalent to the iTotal Cruciate Retaining Knee ReplacementSystem (K094050 cleared September 16, 2010, K103117 clearedJanuary 7, 2011, K112780 cleared December 15, 2011). Thefollowing testing was performed to establish substantialequivalence:Software verification and validation testing of proprietarysoftware |
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K1200681314
510(k) Summary continued
Device Comparison
| PredicateiTotal CR Knee ReplacementSystem(K112780) | Modified DeviceiTotal CR Knee ReplacementSystem(This submission) | |
|---|---|---|
| Components | • Femoral Component• Tibial Implant• Metal Backed TibialComponent• Patellar component | • Femoral Component• Tibial Implant• Metal BackedTibial Component• Patellar component |
| Materials | • Femoral Implant: CoCrMo• Metal Backed TibialComponents:o Tibial tray: CoCrMoo Tibial Inserts:UHMWPE• All Polymer PatellarComponent: UHMWPE | • Femoral Implant: CoCrMo• Metal Backed TibialComponents:o Tibial tray: CoCrMoo Tibial Inserts:UHMWPE• All Polymer PatellarComponent: UHMWPE |
| Design | Knee joint patellofemorotibialsemi-constrained cementedprosthesis | Knee joint patellofemorotibialsemi-constrained cementedprosthesis |
| Principle of Operation | Cemented Use fixed BearingDesign | Cemented Use fixed BearingDesign |
| Patient Matched | Yes | Yes |
| Patellar Design/Dimensions | Symmetrical, offered in varioussizes | Symmetrical, offered in varioussizes |
| Minimum ThicknessTibial Insert(UHMWPE) | 6 mm | 6 mm |
| Posterior CruciateLigament (PCL)Sparing | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| Proprietary Softwarefor femoral iJiginstrumentation | N/A -manual process | iTotal FemJigs version 1.0 |
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510(k) Summary continued
| Description andConclusion ofTesting | Nonclinical Testing: The determination of substantial equivalencefor this device was based on a detailed device description. Thefollowing non-clinical laboratory testing was performeddemonstrating that the device is safe and can be consideredsubstantially equivalent to the predicate device for the intendeduse:• Detailed software description and software verification andvalidation testing of proprietary software |
|---|---|
| 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 predicate devicefor the intended use. Clinical data is not necessary to demonstratesubstantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iTotalCruciate Retaining Knee Replacement System with the use of theiTotal FemJigs manufacturing software is substantially equivalentto the iTotal Cruciate Retaining Knee Replacement System(K094050 cleared September 16, 2010, K103117 cleared January7, 2011 and K112780 cleared Dec 15, 2011. |
:
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS. Incorporated % Ms. Amita S. Shah Vice President, Quality Assurance and Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803
FEB - 3 2012
Re: K120068
Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JWH, OOG Dated: January 4, 2012 Received: January 9, 2012
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
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Page 2 - Ms. Amita Shah
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.
Erich Keith
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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Indications for Use
510(k) Number (if known): K120068
Device Name: iTotal CR Knee Replacement System
Indications for Use:
The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee ioint 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, patello-femoral or bi-compartmental 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 in which the ligamentous structures can be . returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (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 Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
CR Knee Replacement System - iTotal FemJigs
§ 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.