(10 days)
The indications for the Ascent™ Anterior Stabilized Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is to be used with bone cement.
The Ascent™ Anterior Stabilized Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The anterior stabilized tibial bearings are available in varying thicknesses and widths. The Ascent™ Anterior Stabilized Tibial Bearings are used in conjunction with the Ascent™ Primary Femoral Components.
This document states that no clinical testing was provided as a basis for substantial equivalence for the Ascent™ Anterior Stabilized Tibial Bearings.
Therefore, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from the given text:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "Non-Clinical Testing: Engineering Justifications determined that the Ascent™ Anterior Stabilized Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device. Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."
§ 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.