(30 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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
- · Post traumatic loss of joint function.
- · Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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 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, traumatoid 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® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.
Using patient imaging 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 single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, 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 KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile and for single-use only. The purpose of this submission to propose the alternative option to provide these single-use, disposable iTotal iJig instruments non-sterile to be steam sterilized by the end-user. 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 K142161 and K142404.
The provided text is a 510(k) summary for the ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, specifically regarding a change in how ancillary instruments are supplied (non-sterile for steam sterilization by the end-user).
This is not a study that provides performance metrics like sensitivity, specificity, accuracy, or effect sizes for a diagnostic or AI-driven device. Instead, it details a regulatory submission for a physical medical device (knee implants and surgical instruments) and the testing conducted to support its safety and effectiveness relative to existing devices. Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide acceptance criteria and reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity). Instead, it refers to equivalence testing of the sterilization process and product integrity after sterilization.
| Acceptance Criteria (Implied for sterilization) | Reported Device Performance |
|---|---|
| Achieve a Sterility Assurance Level (SAL) of 1x10-6 | Steam Sterilization Validation to an SAL of 1x10-6 (Passed) |
| Maintain product integrity post-steam sterilization | Product Integrity Testing Post-Steam Sterilization (Passed) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for test set: Not explicitly stated regarding the number of devices or sterilization cycles. However, regulatory testing for sterilization validation typically involves multiple samples to demonstrate consistency.
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer (ConforMIS, Inc.) in the USA, as per the submission details.
- Retrospective or prospective: This would be prospective laboratory testing of the sterilization process and material integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic outcome. The "ground truth" here is the validation of the sterilization process and physical integrity of the instruments, which is typically assessed through standardized laboratory methods and microbial challenges, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving human interpretation or adjudication of diagnostic outputs.
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 a study assessing human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (knee implants and instruments), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this type of submission is the successful demonstration of sterilization to a defined SAL (Sterility Assurance Level) and the maintenance of product integrity under validated test conditions. This is established through microbiology testing (for SAL) and mechanical/material testing (for product integrity), rather than medical expert consensus or patient outcomes.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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.