(91 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 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 manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
Here's a summary of the acceptance criteria and study information for the ConforMIS iTotal® CR Knee Replacement System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Software Verification and Validation | Software verification and validation testing of proprietary software (SegSurf(T) version 2.0) was performed. |
| Substantial Equivalence to Predicate Device | The device was found to be substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 and K103117) based on non-clinical laboratory testing and a detailed device description. |
Study Details
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document states "Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following 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: Detailed software description and software verification and validation testing of proprietary software". This implies the "test set" primarily refers to the software itself rather than a patient cohort.
- Data Provenance: Not specified. The tests were "non-clinical laboratory testing" and focused on software and device characteristics.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The determination of substantial equivalence was based on software verification and validation and a detailed device description, not on expert-adjudicated patient data.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there was no expert adjudication of patient data for this submission.
-
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 submission concerns a physical knee replacement system and its associated software for patient-specific design, not an AI-assisted diagnostic or interpretative tool for human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in essence, a standalone evaluation of the algorithm (software) was performed through "Software verification and validation testing of proprietary software." The software (SegSurf(T) version 2.0) is described as 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." This indicates the software operates independently to design the implant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the software's performance would internally be defined by the accuracy and precision of its design functions against predetermined anatomical and mechanical specifications, likely derived from engineering principles and clinical requirements for knee implants. No external ground truth from patient pathology or outcomes data is mentioned for this specific submission's verification and validation process.
-
The sample size for the training set: Not specified. The document refers to "proprietary and off the shelf software" for designing patient-specific implants using imaging data, but does not detail the training set used for any machine learning components within this software.
-
How the ground truth for the training set was established: Not specified.
{0}------------------------------------------------
K 113378 PAGE 1 OF 5
FEB 1 5 2012
8.0 510(K) SUMMARY
. : -- --
| Submitter's Name andAddress | ConforMIS Inc.11 North Ave.Burlington, MA 01803 |
|---|---|
| EstablishmentRegistration Number | 3004153240 |
| Date of Summary | November 14, 2011 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance andRegulatory Affairs(781) 345-9164(781) 345-0104 |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or UsualName | Cruciate Retaining Total Knee ReplacementSystem |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Indications for Use | The iTotal® CR Knee Replacement System (KRS) is intendedfor use as a total knee replacement in patients with knee jointpain and disability whose conditions cannot be solelyaddressed by the use of a prosthetic device that treats onlyone or two of the three knee compartments, such as aunicondylar, patello-femoral or bi-compartmental prosthesis.The indications for use include :• Painful joint disease due to osteoarthritis, traumaticarthritis, rheumatoid arthritis or osteonecrosis of the knee.• Post traumatic loss of joint function.• Moderate varus, valgus or flexion deformity in which theligamentous structures can be returned to adequatefunction 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 theLegally MarketedDevice(Predicate Device) | ConforMIS iTotal CR Knee Replacement System (KRS)Device Class: IIProduct Code: JWHRegulation Number: 21 CFR 888.3560510(k) number: K094050, K103117 |
| DeviceDescription | 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 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 insertsmanufactured from UHMWPE of identical configuration. Thepatellar component is manufactured from UHMWPE. | |
| SubstantialEquivalence: | The product subject of this premarket notification is substantiallyequivalent to the iTotal Cruciate Retaining Knee ReplacementSystem (K094050 cleared September 16, 2010 and K103117cleared January 7, 2011). The following testing was performed toestablish substantial equivalence:Software verification and validation testing of proprietarysoftware |
{1}------------------------------------------------
KII3378 PAGE 2 OF 5
510(k) Summary continued
.
·
:
{2}------------------------------------------------
510(k) Summary continued
Device Comparison
| PredicateiTotal CR KneeReplacement SystemK103117 | PredicateiTotal CR KneeReplacement SystemK094050 | Modified DeviceiTotal CR KneeReplacement System | |
|---|---|---|---|
| Components | FemoralComponent Tibial Implant Metal Backed TibialComponent Patellar component | FemoralComponent Tibial Implant Metal BackedTibial Component Patellar component | FemoralComponent Tibial Implant Metal BackedTibial Component Patellar component |
| Materials | Femoral Implant:CoCrMo Metal Backed TibialComponents: Tibial tray:CoCrMo TibialInserts:UHMWPE All Polymer PatellarComponent:UHMWPE | Femoral Implant:CoCrMo Metal Backed TibialComponents: Tibial tray:CoCrMo TibialInserts:UHMWPE All Polymer PatellarComponent:UHMWPE | Femoral Implant:CoCrMo Metal Backed TibialComponents: Tibial tray:CoCrMo TibialInserts:UHMWPE All Polymer PatellarComponent:UHMWPE |
| Design | Knee jointpatellofemorotibialsemi-constrainedcemented prosthesis | Knee jointpatellofemorotibialsemi-constrainedcemented prosthesis | Knee jointpatellofemorotibialsemi-constrainedcemented prosthesis |
| Principle ofOperation | Cemented Use fixedBearing Design | Cemented Use fixedBearing Design | Cemented Use fixedBearing Design |
| PatientMatched | Yes | Yes | Yes |
| PatellarDesign/Dimensions | Symmetrical, offered invarious sizes | Symmetrical, offered invarious sizes | Symmetrical, offered invarious sizes |
| MinimumThickness ofTibial Insert(UHMWPE) | 6 mm | 6 mm | 6 mm |
| PosteriorCruciateLigament(PCL) Sparing | Yes | Yes | Yes |
| PredicateiTotal CR KneeReplacement SystemK103117 | PredicateiTotal CR KneeReplacement SystemK094050 | Modified DeviceiTotal CR KneeReplacement System | |
| Instrumentationn | Patient specific Nylonjigs | Patient specific Nylonjigs | Patient specific Nylonjigs |
| Software | SegSurf(T) version 1.1 | SegSurf(T) version 1.1 | SegSurf(T) version 2.0 |
{3}------------------------------------------------
K113378
PAGE 4 OF 5
.
:
s
.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the text "KII3378 PAGE 5 OF 5" in a handwritten style. The text is black and the background is white. The text appears to be part of a document or page numbering system.
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 modifieddevice is substantially equivalent to the iTotal Cruciate RetainingKnee Replacement System (K094050 cleared September 16, 2010and K103117 cleared January 7, 2011). |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS, Incorporated % Ms. Amita Shah, RAC Vice President, Quality Assurance and Regulatory Affairs l l North Avenue Burlington, Massachusetts 01803
FEB 15 2012
Re: K113378
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 prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 14, 2011 Received: November 16, 2011
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
{6}------------------------------------------------
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 vours.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): _if(33388
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, 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. o
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be t returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bio compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Katherin V. Cheney
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113378
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)
§ 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.