(85 days)
The ADVANCE™ Tibial Component is intended for tricompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis: 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques.
The ADVANCE™ Tibial Component is part of the ADVANCE™ Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE™ Tibial Component is a modular two-piece component consisting of a metal tibial base and a plastic insert. The ADVANCE™ Tibial Component is intended to be used only with bone coment.
The provided text describes a medical device, the ADVANCE™ Tibial Component, and summarizes safety and effectiveness information for a 510(k) submission. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML powered device.
The document focuses on the mechanical and material testing of a knee implant. Therefore, I cannot generate the requested table and study details as they pertain to AI/ML device performance and evaluation.
Here's a breakdown of why the requested information cannot be extracted from the given text:
- Acceptance Criteria & Reported Device Performance (Table): The text describes various mechanical tests (fatigue, contact area, locking detail, constraint, UHMWPE properties) and states that the device "demonstrates" it meets certain conditions (e.g., "was able to withstand test loading," "is more conforming," "is comparable," "is expected to remain stable," "should perform adequately"). These are general statements of performance relative to predicate devices or simulated conditions, not specific, quantifiable "acceptance criteria" with precise numerical targets often seen in AI/ML device evaluations (e.g., "sensitivity > 90%", "specificity > 85%"). There are no numerical results reported for these tests that could be placed in a table alongside an acceptance criterion.
- Sample Size (Test Set & Data Provenance): The document refers to "submitted" testing but does not specify sample sizes for any of the tests conducted. There's no mention of a "test set" in the context of data for an algorithm, nor is there any information about data provenance (country, retrospective/prospective).
- Number of Experts & Qualifications: This is relevant for establishing ground truth in AI/ML studies, but entirely irrelevant for the mechanical testing of a knee implant. No experts were used in this capacity.
- Adjudication Method: Not applicable for mechanical testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is specific to AI/ML devices involving human readers. Not applicable here.
- Standalone Performance: While the "device" (implant) has standalone performance, this term typically refers to an algorithm's performance without human intervention. Not applicable in the AI/ML sense.
- Type of Ground Truth: The "ground truth" for the mechanical tests would be the physical properties and performance measured under controlled laboratory conditions, not expert consensus, pathology, or outcomes data in the AI/ML context.
- Sample Size for Training Set: Not applicable, as there's no AI/ML algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical implant (knee component) and describes mechanical testing, not the evaluation of an AI/ML powered medical device. Therefore, the requested information, which is specific to AI/ML device evaluation, cannot be extracted from this text.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.