(98 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, 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 in which the ligamentous structures can be returned to adequate function and stability.
- · 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.
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.
Using patient imaging (either CT or MR scans) 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 either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
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 cutting of bone.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K131467 and K131019.
Here's an analysis of the acceptance criteria and study information for the ConforMIS iTotal® CR Knee Replacement System (K140423), based on the provided text:
Acceptance Criteria and Device Performance for ConforMIS iTotal® CR Knee Replacement System (K140423)
It's important to note that this 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific numerical performance acceptance criteria in the way one might see for a diagnostic AI device. The "performance" here is demonstrating that the modified device is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a 510(k) for a modified knee replacement system), the acceptance criteria are largely qualitative, centered around demonstrating equivalence and safety. The performance is assessed through verification and validation of changes.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Substantial Equivalence | Comparison of Indications for Use, Principle of Operation, Product Classification, Components & Materials, Design, Patient Matched status, and Instrumentation with Predicate Device. | The modified iTotal CR KRS (this submission) shares identical Indications for Use, Principle of Operation, Product Classification, Components & Materials, Design, Patient Matched status, and Instrumentation with the predicate iTotal CR KRS. Minor software version updates are the primary difference. |
| Software Functionality | Software verification and validation testing for proprietary software: iTotalWorks (v5.0), iTotal FemJigs (v2.0), iTotalTib (v2.0), iTotal TibJigs (v1.0), iTotal iView (v2.0). | Detailed software description and software verification and validation testing were performed for all proprietary software, demonstrating its functionality and safety. |
| Device Design & Function | Design validation via cadaveric testing. | Cadaveric testing was performed, demonstrating the safety and effectiveness of the device's design. |
| Overall Safety & Performance | Demonstration that the device is safe and can be considered substantially equivalent to the predicate device for its intended use. | Non-clinical laboratory testing (software V&V, cadaveric testing) demonstrated the device is safe and substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" in the context of typical AI/ML model evaluation with granular sample sizes.
- Software Verification and Validation: Performed for specific software versions (iTotalWorks v5.0, iTotal FemJigs v2.0, iTotalTib v2.0, iTotal TibJigs v1.0, iTotal iView v2.0). The sample size for these tests is not explicitly stated in terms of patient cases or specific data points, but rather implies a thorough testing regimen for the software itself.
- Cadaveric Testing: This typically involves a very small number of specimens. The exact number of cadavers used is not specified, but this is a common method for validating surgical instrument fit and implant placement.
- Data Provenance: Not applicable in the context of patient data for model training/testing as this is a medical device (knee replacement system) and associated software for design and implantation, not a diagnostic AI algorithm analyzing patient data. The "data" here relates to the software itself and the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this submission. The ground truth for this device revolves around established engineering principles, biomechanical performance, and surgical accuracy. The "ground truth" for cadaveric testing would be the precise fit and alignment of the implant components as assessed by experts (e.g., orthopedic surgeons, biomedical engineers), but the specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of multiple readers reviewing outputs that would require an adjudication method. Verification and validation are typically performed against pre-defined specifications and expected outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for a knee replacement system and its associated planning software, not a diagnostic AI.
6. Standalone (Algorithm Only) Performance Study
Yes, in a sense, standalone performance was assessed through the "Software verification and validation testing of proprietary software" for each component of the iTotal CR KRS system (iTotalWorks, iTotal FemJigs, iTotalTib, iTotal TibJigs, iTotal iView). This means the algorithms within these software packages were tested for their intended function (e.g., design generation, jig creation, surgical planning) independent of human intervention in the evaluation process. The cadaveric testing also validates the output of these algorithms in a realistic, non-human patient setting prior to clinical use.
7. Type of Ground Truth Used
- Software Verification and Validation: The "ground truth" is defined by the software's functional requirements, design specifications, and expected outputs. This includes accuracy of calculations, proper generation of designs, and adherence to engineering principles.
- Cadaveric Testing: The "ground truth" is the optimal anatomical fit and alignment of the implant components, typically measured against surgical goals and expected outcomes derived from anatomical studies and surgical best practices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that "learns" from a training set in the typical sense. The software involved in designing patient-specific implants is based on algorithms and models derived from extensive anatomical data and biomechanical principles, but there is no explicitly defined "training set" of patient data in the context of machine learning. The software uses patient-specific imaging (CT or MR scans) to design the implant, rather than being "trained" on a large dataset of patient images to develop its core functionality.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there wasn't a "training set" in the machine learning sense. The underlying principles for the software's algorithms would have been established through biomechanical research, anatomical studies, engineering design principles, and clinical experience, not through a labeled dataset for AI model training.
{0}------------------------------------------------
K140423 (page 1/6)
MAY 2 7 2014
| 6.0 510(K) SUMMARY (PAGE 1 OF 6) | MAY 27 20 |
|---|---|
| ---------------------------------- | ----------- |
| Submitter's Name and Address: | ConforMIS Inc.28 Crosby DriveBedford, MA 01730 |
|---|---|
| Establishment Registration Number: | 3009844603 and 3004153240 |
| Date of Summary: | February 11, 2014 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number: | (781) 345-9164 |
| Fax Number: | (781) 345-0147 |
| Name of the Device: | ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) |
| Common Name: | Cruciate Retaining Knee Replacement System |
| Regulatory Status and Regulation Number: | Class II21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 knee arthroplasty device or a set of specific knee arthroplasty devices.Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. | |
| OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented polymer + additive/metal/polymer + additive. This generic type of device includes prosthesis that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellar resurfacing component made of ultra-high molecular weight polyethylene plus an additive, such as a-tocopherol. |
:
1 of 6
{1}------------------------------------------------
510(K) SUMMARY (PAGE 2 OF 6)
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, 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 in which the ligamentous structures can be returned to adequate function and stability.
- · 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.
ldentification of the Legally Marketed Device (Predicate Device):
ConforMIS iTotal CR Knee Replacement System (ITOTAL CR KRS) Device Class: = JWH, OOG, OIY Product Code: Regulation Number: 21 CFR 888.3560 510(k) Number: K131467, K131019, K122991, K122033, and K120068
{2}------------------------------------------------
510(K) SUMMARY (PAGE 3 OF 6)
| 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.Using patient imaging (either CT or MR scans) and a combinationof proprietary and off the shelf software a patient specific implant isdesigned, that best meets the geometric and anatomicrequirements of the specific patient. The femoral component ismanufactured from cobalt chromium molybdenum ("CoCrMo")alloy. The tibial component includes a metal tray manufacturedfrom CoCrMo alloy and either one or two polyethylene inserts. Thepolyethylene inserts may be manufactured from either UHMWPE ora highly cross-linked Vitamin E infused polyethylene (iPoly XE™)The patellar component is also manufactured from either UHMWPEor from a highly cross-linked Vitamin E infused polyethylene (iPolyXE™).For user convenience, and similar to the predicate iTotal CR KRS,accessory orthopedic manual surgical instruments designed for usewith 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 provided toassist in the positioning of total knee replacement componentsintra-operatively and in guiding the cutting of bone.The function and general design features of the patient specificimplants and ancillary instruments remain similar to thosedescribed in the predicate 510(k)'s K131467 and K131019. |
|---|---|
| SubstantialEquivalence: | The product subject of this premarket notification is substantiallyequivalent to the iTotal CR KRS (K131467, cleared July 18, 2013;K131019, cleared May 24, 2013; K122991, cleared December 20,2012; K122033, cleared September 27, 2012 and K120068,cleared February 3, 2012). The following testing was performed toestablish substantial equivalence:Software verification and validation testing of proprietary |
-
Software verification and validation testing of proprietary software
. -
Design validation via cadaveric testing .
•
45
.
3 of 6
.
.
{3}------------------------------------------------
510(K) SUMMARY (PAGE 4 OF 6)
Device Comparison
| Characteristic | PredicateiTotal Cruciate Retaining KneeReplacement System(K131467, K131019, K122991, K122033 &K120068) | iTotal Cruciate Retaining KneeReplacement System(This submission) |
|---|---|---|
| Indication for Use | The iTotal CR Knee Replacement System(KRS) is intended for use as a total kneereplacement in patients with knee joint painand disability whose conditions cannot besolely addressed by the use of a prostheticdevice that treats only one or two of the threeknee compartments, such as a unicondylar,patellofemoral or bicompartmental prosthesis.The Indications for Use include:• Painful joint disease due to osteoarthritis,traumatic arthritis, rheumatoid arthritis orosteonecrosis of the knee.• Post traumatic loss of joint function.• Moderate varus, valgus or flexiondeformity in which the ligamentousstructures can be returned to adequatefunction and stability.• Failed osteotomies, hemiarthroplasties,and unicondylar, patellofemoral orbicompartmental implants.• Revision procedures provided thatanatomic landmarks necessary foralignment and positioning of the implantare identifiable on patient imaging scans.This implant is intended for cemented useonly. | The iTotal CR Knee Replacement System(KRS) is intended for use as a total kneereplacement in patients with knee joint painand disability whose conditions cannot besolely addressed by the use of a prostheticdevice that treats only one or two of the threeknee compartments, such as a unicondylar,patellofemoral or bicompartmental prosthesis.The Indications for Use include:• Painful joint disease due to osteoarthritis,traumatic arthritis, rheumatoid arthritis orosteonecrosis of the knee.• Post traumatic loss of joint function.• Moderate varus, valgus or flexiondeformity in which the ligamentousstructures can be returned to adequatefunction and stability.• Failed osteotomies, hemiarthroplasties,and unicondylar, patellofemoral orbicompartmental implants.• Revision procedures provided thatanatomic landmarks necessary foralignment and positioning of the implantare identifiable on patient imaging scans.This implant is intended for cemented useonly. |
| Principle ofOperation | Cemented Use Fixed Bearing Design | Cemented Use Fixed Bearing Design |
| ProductClassification | 21 CFR 888.3560 (JWH, OOG, OIY) | 21 CFR 888.3560 (JWH, OOG, OIY) |
| Components andMaterials | • Femoral Implant: CoCrMo• Metal Backed Tibial Components:o Tibial tray: CoCrMoo Tibial dual or single pieceinserts: UHMWPE or iPoly XE• All Polymer Patellar Component:UHMWPE or iPoly XE | • Femoral Implant: CoCrMo• Metal Backed Tibial Components:o Tibial tray: CoCrMoo Tibial dual or single pieceinserts: UHMWPE or iPoly XE• All Polymer Patellar Component:UHMWPE or iPoly XE |
| Characteristic | PredicateiTotal Cruciate Retaining KneeReplacement System(K131467, K131019, K122991, K122033 &K120068) | iTotal Cruciate Retaining KneeReplacement System(This submission) |
| Design | Knee joint patellofemorotibial semi-constrained cemented prosthesis | Knee joint patellofemorotibial semi-constrained cemented prosthesis |
| Patient Matched | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| ProprietarySoftware forFemoralComponents | iTotalWorks version 4.0 or Manual Process | iTotalWorks version 5.0 or Manual Process |
| ProprietarySoftware for theFemoral iJigs | iTotal FemJigs version 1.5 or Manual Process | iTotal FemJigs version 2.0 or Manual Process |
| ProprietarySoftware for TibialComponents | iTotalTib version 1.0 or Manual Process | iTotalTib version 2.0 or Manual Process |
| ProprietarySoftware for TibialiJigs | N/A - Manual Process | iTotal TibJigs version 1.0 or Manual Process |
| ProprietarySoftware forPatient-SpecificSurgical Plan | iTotal iView version 1.0 or Manual Process | iTotal iView version 2.0 or Manual Process |
1
.
{4}------------------------------------------------
510(K) SUMMARY (PAGE 5 OF 6)
Device Comparison
{5}------------------------------------------------
510(K) SUMMARY (PAGE 6 OF 6)
| 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 iTotalWorks Detailed software description and software verification andvalidation testing of proprietary software iTotal FemJigs Detailed software description and software verification andvalidation testing of proprietary software iTotalTib Detailed software description and software verification andvalidation testing of proprietary software iTotal TibJigs Detailed software description and software verification andvalidation testing of proprietary software iTotal iView Design validation via cadaveric testing |
|---|---|
| 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 modifiediTotal CR KRS is substantially equivalent to the predicate iTotal CRKRS (K131467 cleared July 18, 2013, K131019 cleared May 24,2013, K122991 cleared December 20, 2012, K122033 clearedSeptember 27, 2012, and K120068 cleared February 03, 2012) |
.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2014
ConforMIS. Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford. Massachusetts 01730
Re: K140423
Trade/Device Name: iTotal Cruciate Retaining (CR) Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OOG, OIY Dated: April 23, 2014 Received: April 24, 2014
Dear Ms. Shalı:
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 tiability 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
{7}------------------------------------------------
Page 2 - Ms. Amita Shah
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/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/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, Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
K140423 510(k) Number (if known): _
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 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 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, 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.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices
§ 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.