(63 days)
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.
The iTotal Posterior Stabilized Retaining 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 cobalt chromium molybdenum 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 modified 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 K152704, K142404 and K142161.
The provided text is a 510(k) summary for the ConforMIS iTotal® Posterior Stabilized Knee Replacement System (iTotal PS KRS). The purpose of this summary is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for an AI/device performance study is not present in this document.
The document discusses a modification to an existing device, specifically "adding the option of automating the generation of the iTotal PS iView using the proprietary software module iTotal PS iView v1.0." The relevant "study" for this modification is primarily software verification and validation.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria for device performance in the typical sense of accuracy, precision, sensitivity, specificity, etc., as it is a 510(k) summary focused on demonstrating substantial equivalence of a modified manufacturing process of a medical device, not a new AI diagnostic or prognostic device's performance.
The "performance" criteria for the software modification are related to its functionality and reliability in automating the generation of the iTotal PS iView, which would be assessed through software verification and validation. No quantitative performance metrics are reported in this summary.
| Acceptance Criteria (Implied for software) | Reported Device Performance (Implied from substantial equivalence) |
|---|---|
| Software functions as intended for iTotal PS iView generation | Software verification and validation testing completed; demonstrated substantial equivalence to predicate device where iView generation was manual. |
| Automation of iView generation maintains design, materials, and methods of manufacture equivalency | No changes to design, materials, methods of manufacture, packaging, or sterilization of the iTotal PS KRS itself. |
| The modified process does not impact the safety and effectiveness of the device compared to the predicate | The device is considered substantially equivalent to the predicate device for the intended use. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI performance study. The testing performed was "Detailed software description and software verification and validation testing of proprietary software iTotal PS iView v1.0." The number of test cases or data points used during this software testing is not specified.
- Data Provenance: Not applicable in the context of an AI performance study. The document refers to patient imaging (CT scans) being used to design the patient-specific implant, but this is part of the original design process, not a test set for the "iView v1.0" software. The source or nature of data used for software testing is not detailed (e.g., synthetic, real patient scans, number of scans).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe a study involving expert-established ground truth for a test set. The modification is about software automation in the manufacturing process, not expert interpretation of outputs.
4. Adjudication method for the test set
Not applicable. As there is no described test set involving expert ground truth, no adjudication method is mentioned.
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
No. An MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a manufacturing process modification (software automation), not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes "Software verification and validation testing of proprietary software iTotal PS iView v1.0." This testing would inherently be assessing the algorithm's performance in generating the iView, so it can be considered a standalone assessment of the software module. However, specific performance metrics are not provided. The entire ConforMIS iTotal PS KRS system requires human-in-the-loop (surgeon) for implantation, but the iView generation itself is an automated step.
7. The type of ground truth used
For the software verification and validation of the iTotal PS iView v1.0, the ground truth would likely be established by comparing the automatically generated iViews to manually generated iViews (the predicate process) or to predefined specifications/requirements for the iView output. The document doesn't explicitly state the type of ground truth, but for software testing, it would involve functional correctness and adherence to design specifications.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning model that requires a training set in the conventional sense. The "iTotal PS iView v1.0" is described as a "proprietary software module" for automating a process, implying it's a rule-based or algorithmic system rather than a deep learning model trained on a large dataset.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is mentioned.
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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 features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope. The logo is simple, using a single color, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2016
ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K153217
Trade/Device Name: ConforMIS iTotal® Posterior Stabilized Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibal polymer/metal/polymer semi-contrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: November 3, 2015 Received: November 5, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 500(k) Number (if known7733317 | |
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6.0 510(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: | November 3, 2015 |
| 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: | ConforMIS iTotal® Posterior Stabilized Knee Replacement System(iTotal PS KRS) |
| Common Name: | Total Posterior Stabilized 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 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 kneearthroplasty device or a set of specific knee arthroplasty devices.Indicated to include guiding alignment, making or establishing cuts,selecting, sizing, attaching, positioning or orienting implantcomponents.OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,polymer + additive/metal/polymer + additive.This generic type of device includes prosthesis that have a femoralcomponent made of alloys, such as cobalt-chromium-molybdenum, anda tibial component(s) and/or a retropatellar resurfacing componentmade of ultra-high molecular weight polyethylene plus an additive, suchas a-tocopherol. |
| 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. | |
| Identification of the LegallyMarketed Device (PredicateDevice): | ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS)Device Class: IIProduct Code: JWH, OOG, OIYRegulation Number: 21 CFR 888.3560510(k) Number: K152704, K142404, K142161 |
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510(K) SUMMARY (PAGE 2 OF 5)
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510(K) SUMMARY (PAGE 3 OF 5)
The iTotal Posterior Stabilized Retaining Knee Replacement System Device Description: (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 modified 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 K152704, K142404 and K142161.
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510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The modified iTotal PS KRS and predicate iTotal PS KRS have the same technological characteristics. There have been no changes to the modified 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 K152704, K142404 and K142161.
Modifications which represent improving manufacturing efficiencies are primarily focused on adding the option of automating the generation of the iTotal PS iView using the proprietary software module iTotal PS iView v1.0.
Table 6.0-1: Comparison between the Modified and Predicate Device
| Characteristic | PredicateiTotal PS KRS(K152704, K142404and K142161) | Modified iTotal PSKRS(This submission) |
|---|---|---|
| Generation ofiView | Manual process | iTotal PS iView v1.0or Manual process |
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 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 iTotal PS iView v1.0.
Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal PS KRS (K152704, cleared October 21, 2015, K142404, cleared December 11, 2014 and K142161, cleared November 14, 2014). The following testing was performed to establish substantial equivalence: -
. Software verification and validation testing of proprietary software iTotal PS iView v1.0.
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510(K) SUMMARY (PAGE 5 OF 5)
Conclusion: The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use. Clinical data is not necessary to demonstrate substantial equivalence.
Based on the testing conducted, it is concluded that the modified iTotal PS KRS is substantially equivalent to the predicate iTotal PS KRS (K152704, cleared October 21, 2015, K142404, cleared December 11, 2014 and K142161, cleared November 14, 2014).
§ 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.