(110 days)
The OptiGen™ Total Knee System is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis
- Failed osteotomies, unicompartmental replacement, or total knee replacement
- Moderate varus, valgus, or flexion deformities
This device is indicated for cemented use only.
OptiGen™ Total Knee System consists of femoral components(PS, CR), tibial components, tibial bearings(PS, CR), patellar components and accessories(locking bars, tibial cement plug). Components are available in a variety of designs and size ranges intended for primary application with bone cement. Implant components are made from materials meeting the requirements of various widely recognized standards including ISO, ASTM.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets them, based on the provided text. The document refers to the OptiGen™ Total Knee System and describes its materials, intended use, and claims substantial equivalence to predicate devices based on "bench testing." However, the text does not explicitly state the acceptance criteria for these tests, nor does it detail the specific numerical results or how these results "prove" that the device meets them.
The document only states that the testing "met all acceptance criteria and verifies that performance of the OptiGen™ Total Knee System is substantially equivalent to the predicate devices." It does not provide the specifics of these criteria or the test outcomes.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The acceptance criteria and specific performance results are not provided.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document only mentions "non clinical setting (bench testing)." There's no information on sample size or data provenance.
- 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): This type of information is not relevant or included in the provided text for a bench testing study of a knee implant.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned for bench testing.
- 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, as this is a bench testing study for a physical device, not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For bench testing of a physical device, the "ground truth" would be the engineering specifications and performance metrics of established predicate devices, which are not detailed here.
- The sample size for the training set: Not applicable, as this is bench testing, not an AI model.
- 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.