(258 days)
Joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities; .
- treatment of fractures that are unmanageable using other techniques. .
This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.
The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.
The provided document is a 510(k) summary for a medical device modification, specifically adding a Titanium Nitride (TiNbN) coating to existing femoral components of the Foundation® Knee System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing, rather than establishing efficacy or accuracy through clinical studies.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC effectiveness studies is not applicable to this document.
Here's why and a summary of what the document does provide:
- Device Type: This is a knee joint prosthesis, a mechanical implant. The evaluation for such devices often relies heavily on biomechanical testing, material characterization, and manufacturing process validation rather than AI performance metrics.
- 510(k) Purpose: The 510(k) submission seeks to clear a modification (adding a coating) to already cleared devices. The primary goal is to show that the modified device is "substantially equivalent" to predicate devices, meaning it is as safe and effective. This is typically achieved through non-clinical bench testing rather than clinical trials involving human subjects, especially for material changes.
- "Clinical Testing: None provided": The document explicitly states "Clinical Testing: None provided," confirming that no human clinical trials were conducted to evaluate this specific modification.
Summary of Information from the Document (Addressing the spirit of the request where applicable):
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not present acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, or specificity, as it's not a diagnostic AI device. Instead, it lists non-clinical tests performed to demonstrate safety and performance of the material modification.
- Non-Clinical Tests Performed:
- Accute System Toxicity Study
- Bone Implantation Study
- Cytotoxicity Study
- GC/MS Fingerprint Study
- Irritation Study
- 28 Day Muscle Implantation Study
- 90 Day Muscle Implantation Study
- Sensitisation Study
- Coating Chemical Composition
- Coating Thickness
- Coating Hardness
- Adhesion Strength
- Roughness
- Wear Resistance
- The document implies that these non-clinical tests were successful in demonstrating substantial equivalence, but specific pass/fail criteria or quantitative results are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No human test sets or patient data were used for this 510(k) submission, as "Clinical Testing: None provided." The sample sizes for the non-clinical tests (e.g., number of test specimens for wear, number of animals for toxicity/implantation) are not specified in this summary.
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. No clinical test set or ground truth in the context of diagnostic performance was established for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication was performed.
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 a mechanical implant, not an AI software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's safety and performance comes from the established scientific understanding of biomaterials and biomechanics, as validated by the non-clinical tests listed.
8. The sample size for the training set
- Not Applicable. No training set was used, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth was established.
In summary: The provided document is a regulatory submission for a material modification to existing knee prostheses. Its focus is on non-clinical substantiation of equivalent safety and performance, not on clinical performance metrics typically associated with AI or diagnostic devices.
§ 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.