(163 days)
The Scorpio® NRG™ Knee System components are for use in total knee arthroplasty for painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in with the ligamentous structures can be returned to adequate function and stability; revision of previous unsuccessful knee replacement or other procedure. Additional indications for posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament.
The device includes femoral components and tibial insert components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided document describes the Scorpio® NRG™ Knee System, but it is a premarket notification (510(k)) for a medical device and does not contain the information requested in the prompt regarding acceptance criteria and a study proving those criteria were met for an AI/ML device.
The document states that the proposed modification is to "Redesign the femoral and tibial insert component dimensions to provide for increased range of motion." The "Summary of Data" section (labeled as {1} in the input) briefly details the testing conducted for this knee system.
Here's an analysis of what is available and why it doesn't fit the request for AI/ML device study information:
Analysis of Provided Information:
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Acceptance Criteria and Reported Device Performance:
- The document mentions "risk analysis and Research and Development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices."
- Specific tests included "range of constraint testing, finite element analysis of contact stress/area and finite element analysis of femoral fatigue."
- The reported performance is simply: "The results demonstrate equivalence."
- This is not specific acceptance criteria in the format requested (e.g., sensitivity, specificity, AUC, or other quantitative metrics typically used for AI/ML performance), nor does it provide the detailed quantitative results of these tests.
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Sample Size and Data Provenance:
- Not applicable for AI/ML testing. The testing mentioned (range of constraint, finite element analysis) are mechanical engineering tests, not data-driven performance evaluations. No "test set" in the AI/ML sense is described.
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Number of Experts and Qualifications:
- Not applicable. No expert review for ground truth establishment is mentioned as this is not an AI/ML diagnostic or prognostic device.
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Adjudication Method:
- Not applicable. No adjudication process is relevant to the mechanical tests described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance is compared with and without AI assistance. The Scorpio® NRG™ Knee System is a physical joint replacement, not a diagnostic AI/ML tool.
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Standalone (Algorithm Only) Performance:
- No, this was not done. The device itself is a physical implant. The "finite element analysis" mentioned is a computational simulation (an "algorithm" in a very broad sense) used to design and verify the mechanical properties, not to perform a diagnostic or prognostic task in a standalone manner like an AI/ML algorithm.
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Type of Ground Truth:
- Not applicable. The "ground truth" for mechanical equivalence would be the physical properties and performance of the predicate device under specific mechanical loads and conditions. It's not "expert consensus," "pathology," or "outcomes data" in the context of an AI/ML evaluation.
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Sample Size for Training Set:
- Not applicable. There is no AI model or "training set" for physical knee implants.
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How Ground Truth for Training Set was Established:
- Not applicable.
In conclusion, the provided document K042343 describes a traditional medical device (a knee implant) and its regulatory submission. It does not contain any information relevant to the acceptance criteria or studies typically performed for AI/ML-driven medical 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.