(77 days)
The ADVANCE® Total Knee System components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
These products are for use with cement only.
The ADVANCE® knee system components consists of femoral and modular tibial inserts intended to be used only with bone cement.
The ADVANCE® femoral component is manufactured from cobalt chrome alloy. The tibial components are manufactured from ultra high molecular weight polyethylene.
The provided text describes a 510(k) summary for the ADVANCE® knee system components, which are total knee replacement implants. It details the device's description, intended use, materials, and a testing summary. However, it does not contain the specific information required to adequately complete the table and answer the questions as it pertains to a study proving acceptance criteria for an AI/device. The document focuses on mechanical testing of the physical implant components and comparability to a predicate device, not on AI-driven performance or studies involving human readers or ground truth.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance Table: The document lists types of mechanical tests and states the device is "comparable to the predicate device" or "demonstrates" certain properties, but it does not quantify acceptance criteria (e.g., specific thresholds for contact area, shear resistance) or precise performance metrics.
- Sample size for the test set and data provenance: Not applicable as no AI/device performance study is documented.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document's "Testing Summary" refers to bench testing of the physical components of the knee system, confirming their mechanical properties and comparability to a predicate device (Axiom Total Knee System). This is a different type of validation than what is requested, which seems to pertain to a diagnostic or AI-powered medical device.
§ 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.