(60 days)
The Genesis II Constrained System is indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
The Genesis II Constrained System is designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Genesis II Constrained System is indicated for use with cement and is a single use device.
The Genesis II Constrained System consists of a femoral component and a tibial insert. The femoral component is manufactured from cobalt-chromium-molybdenum and the tibial insert is manufactured from ultra-high-molecular-weight polyethylene. The femoral component has a boxlike design that mates with a post on the tibial insert to constrain motion.
This document, K962137, "Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Genesis II Constrained System," is a 510(k) premarket notification for a medical device. It does not describe a study related to AI or a software algorithm, but rather a traditional mechanical medical device (a knee replacement system).
Therefore, I cannot provide information for most of your requested points, as they are specific to AI/software device evaluation studies.
Here's what can be extracted and addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Capability of withstanding in vivo loading without failure | All of the test results indicate that the Genesis II Constrained System is capable of withstanding in vivo loading without failure. |
Explanation: The document states that "Mechanical testing was performed according to the requirements in the knee draft guidance document." The reported performance is a general statement that the device meets the criteria. Specific numerical values for the acceptance criteria and the test results are not provided in this summary document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the document describes a mechanical medical device (a knee replacement system), not an algorithm or AI system.
The remaining requested information cannot be provided from the input document as it pertains to AI/software performance studies:
- 2. Sample sized used for the test set and the data provenance: Not applicable.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 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.