(57 days)
The iTotal Identity Posterior Stabilized 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 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.
Conformis knee replacement systems are patient-specific semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.
For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity Posterior Stabilized Knee Replacement System are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This FDA document is a 510(k) summary for a medical device called the "iTotal Identity Posterior Stabilized Knee Replacement System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
However, the document does not contain the kind of information typically found in a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy. This is a notification of intent to market, and its primary purpose is to demonstrate "substantial equivalence" to existing cleared devices, not to present a de novo clinical or algorithm performance study.
Therefore, for the information requested in your prompt, I can only provide what is explicitly stated or can be reasonably inferred from the document. Many of your requested points, especially those related to AI/algorithm performance studies, ground truth establishment, expert adjudication, and detailed statistical metrics, are not present in this type of FDA submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in the typical sense of numerical performance targets (e.g., sensitivity > X%, specificity > Y%). Instead, the "performance" is assessed through non-clinical confirmatory testing to ensure safety and functionality.
| Acceptance Criteria (Implied by testing standards) | Reported Device Performance (Conclusion) |
|---|---|
| Meets ASTM F1814 and ASTM F2083 for insert interlock/modularity | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
| Meets ASTM F1800 and ASTM F2083 for tibial tray fatigue | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
| Meets criteria for simulated use | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies satisfactory performance. |
| Meets ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07 for MR Compatibility | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document refers to "confirmatory testing" but does not detail the number of units or conditions tested for each non-clinical performance evaluation.
- Data provenance: Not applicable in the sense of patient data. The testing mentioned is non-clinical/bench testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not present in the document. The "ground truth" for non-clinical testing typically involves engineering specifications and compliance with standardized test methods, not expert clinical interpretation.
4. Adjudication method for the test set
- Not applicable and not present. Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation or consensus is needed for a "ground truth." This document describes non-clinical engineering tests.
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. This document describes a new knee replacement system, which is a physical implant, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a knee implant, not an algorithm. While its design involves "patient-specific implant [design] that best meets the geometric and anatomic requirements of the specific patient" using "patient imaging (either CT or MR scans)", the document focuses on the implant and its physical performance, not on the performance of a standalone algorithm for diagnosis or image interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance evaluations, the "ground truth" is established by the engineering specifications and the requirements of the ASTM (American Society for Testing and Materials) standards referenced (e.g., F1814, F2083, F1800, F2052-14). These standards define acceptable performance metrics for various aspects of orthopaedic implants.
8. The sample size for the training set
- Not applicable/not specified. Since this is a physical medical device (knee implant) and not an AI algorithm being "trained," there is no concept of a training set in the context of device performance as requested in your prompt. The patient imaging data mentioned is used for individual patient-specific design rather than training a general algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.