(29 days)
The iTotal® PS Knee Replacement System 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, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- 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 Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is 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 PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
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 K160025 & K153217.
This document describes the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System (iTotal PS) and its substantial equivalence determination. However, it does not contain information about acceptance criteria for device performance or a study demonstrating the device meets specific performance criteria in the way typical for AI/ML device evaluations.
The "study" referenced in this document concerns software verification and validation, aimed at demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical performance study with acceptance criteria and ground truth.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here is a breakdown of what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics with thresholds in this document. The "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, particularly regarding software verification and validation.
- Reported Device Performance: The document states that "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use." The specific performance metrics for the device itself (e.g., accuracy of cuts, implant fit) are not reported in this summary, nor are quantitative acceptance criteria for such metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The "tests" mentioned are software verification and validation, not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this document focuses on software validation and substantial equivalence, not a clinical study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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/ML diagnostic or assistive device in the context of human reader improvement. The software generates patient-specific surgical guides, not interpretations for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the "iTotal FemJigs PS v1.0" and "iTotal TibJigs PS v1.0" software modules automate the generation of iJigs. The "software verification and validation testing" performed on these proprietary software modules could be considered a form of standalone testing for the algorithm's output (i.e., the iJigs design). However, specific performance metrics for this standalone algorithm are not presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software verification and validation, the ground truth would likely involve established engineering specifications, design requirements, and comparisons against outputs generated by the previous manual process or predicate software versions. It is not clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- This information is not provided. The document describes software that "automates the generation of the iTotal PS iJigs" using "proprietary software modules iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0". It doesn't explicitly state that these modules comprise a machine learning model that requires a "training set" in the conventional sense. It's possible the software uses rule-based systems or sophisticated algorithms developed through engineering rather than machine learning on a large dataset.
9. How the ground truth for the training set was established:
- Not applicable, as a training set is not explicitly mentioned or implied to be used for machine learning in the conventional sense. If the software involves AI/ML, this information is not disclosed.
Summary from the document:
The ConforMIS iTotal® PS Knee Replacement System (iTotal PS) received a 510(k) clearance based on its substantial equivalence to predicate devices (K160025 and K153217). The primary focus of this submission was on modifications involving the automation of the generation of iTotal PS iJigs (surgical guides) using new proprietary software modules (iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0).
The study that "proves the device meets the acceptance criteria" in this context is the software verification and validation testing performed on these new proprietary software modules. The "acceptance criteria" were met by demonstrating that the modifications did not alter the fundamental technological characteristics, materials, design, manufacturing, packaging, or sterilization of the device and that the new automated process was equivalent to the previous methods (manual or older software).
The document states: "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use. The following non-clinical laboratory testing was performed: Detailed software description and software verification and validation testing of proprietary software iTotal FemJigs PS v1.0. Detailed software description and software verification and validation testing of proprietary software iTotal TibJigs PS v1.0."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with the heads of the figures forming the top part of the symbol.
July 15, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conformis, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K161668 Trade/Device Name: ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System (iTotal PS) 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, OOG, OIY Dated: June 13, 2016 Received: June 16, 2016
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. Please note: CDRH does not evaluate information related to contract liability 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Amita Shah
the quality systems (OS) 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" (21 CFR 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.
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) K161668
Device Name
ConforMIS iTotal® PS Knee Replacement System (iTotal PS)
Indications for Use (Describe)
The iTotal® PS Knee Replacement System 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, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
-
Post traumatic loss of joint function.
-
Moderate varus, valgus or flexion deformity.
-
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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8.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name andAddress: | ConforMIS, Inc.28 Crosby DriveBedford, MA 01730 |
|---|---|
| Establishment RegistrationNumber: | 3009844603 and 3004153240 |
| Date of Summary: | June 13, 2016 |
| Contact Person:Telephone Number:Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs(781) 345-9164(781) 345-0147 |
| Name of the Device(s): | ConforMIS iTotal® PS Knee Replacement System (iTotal PS) |
| Common Name(s): | Total Knee Replacement System |
| Regulatory Status andRegulation Number: | Class II21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis |
| Device Classification: | Product Codes:JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis. |
| OOG: Knee Arthroplasty Implantation System.Intended to be used to assist in the implantation of a specific knee arthroplastydevice or a set of specific knee arthroplasty devices. Indicated to includeguiding 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 deviceincludes prostheses that have a femoral component made of alloys, such ascobalt-chromium-molybdenum, and a tibial component(s) and/or a retropatellarresurfacing component made of ultra-high molecular weight polyethylene plusan additive, such as α-tocopherol. |
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510(K) SUMMARY (PAGE 2 OF 5)
Indications for Use: The iTotal® Posterior Stabilized (PS) 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, polyarthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity.
- 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(s) (Predicate Device(s)):
ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS) Device Class: . Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) Number: K160025 & K153217
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510(K) SUMMARY (PAGE 3 OF 5)
Device Description: The iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is 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 PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
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 K160025 & K153217.
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510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The proposed iTotal PS KRS and predicate iTotal PS KRS have the same technological characteristics. There have been no changes to the proposed iTotal PS KRS device with respect to design, materials and methods of manufacture, packaging, or sterilization. The designs of the device remains similar to that cleared in K160025 and K153217.
Modifications which represent improving manufacturing efficiencies are primarily focused on adding the option of automating the generation of the iTotal PS iJigs using the proprietary software modules iTotal FemJigs PS v1.0 and iTotal TibJigs PS v1.0.
| Characteristic | PredicateiTotal PS KRS(K160025 andK153217) | ProposediTotal PS KRS(This submission) |
|---|---|---|
| Generation ofiTotal PSFemoral iJigs | iTotal FemJigs v3.0and Manual process | iTotal FemJigs PSv1.0 orManual process |
| Generation ofiTotal PS TibialiJigs | Manual process | iTotal TibJigs PSv1.0 orManual process |
Table 8.0-1: Comparison Between the Proposed and Predicate Device
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510(K) SUMMARY (PAGE 5 OF 5)
| Substantial Equivalence: | The determination of substantial equivalence for this device was based on adetailed device description. Non-clinical laboratory testing was performeddemonstrating that the device can be considered substantially equivalent to thepredicate device for the intended use. The following non-clinical laboratorytesting was performed:Detailed software description and software verification and validationtesting of proprietary software iTotal FemJigs PS v1.0. Detailed software description and software verification and validationtesting of proprietary software iTotal TibJigs PS v1.0. |
|---|---|
| Conclusion: | Based on the testing conducted, it is concluded that the proposed iTotalPosterior Stabilized Knee Replacement System is substantially equivalent to thepredicate iTotal Posterior Stabilized Knee Replacement System (K160025,cleared March 07, 2016, and K153217, cleared January 07, 2016). |
§ 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.