(209 days)
The indications for the Patient-Specific Vanguard™ Femoral Components are as follows:
- l . Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity. 2.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These devices are single-use implants intended for cemented applications.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Patient-Specific Vanguard™ Femoral Components are comprised of a series of CoCrMo femoral components with each size offering an envelope of acceptable dimensions to allow for a fit that is specific to each patient, while still maintaining the Vanguard" design. These components are intended for primary knee arthroplasty.
This document is a 510(k) premarket notification for a medical device called "Patient-Specific Vanguard™ Femoral Components." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Specifically:
- No acceptance criteria or device performance table: The document does not provide a table outlining specific acceptance criteria (e.g., performance metrics, thresholds) for the device.
- No study proving acceptance criteria are met: The document explicitly states under "Clinical Testing" that "None provided as a basis for substantial equivalence." Non-clinical testing was performed, and the results indicated the device is "functional within its intended use," but this is a general statement and not a detailed study proving specific acceptance criteria are met.
- No information on test set sample size, data provenance, ground truth establishment, or adjudication method: Since no clinical study or formal test set evaluation is presented in the document, these details are not available.
- No MRMC comparative effectiveness study: The document does not describe any study involving human readers and AI assistance.
- No standalone (algorithm only) performance study: The device is a physical femoral component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
- Type of ground truth: Not applicable as no clinical study or performance evaluation with ground truth is described.
- Training set sample size: Not applicable as this is a physical device, not an AI/algorithm-based product requiring a training set in the conventional sense.
- How ground truth for training set was established: Not applicable for the same reason mentioned above.
In summary, this document is a regulatory submission for a physical medical device and does not contain the type of information requested regarding acceptance criteria and performance studies typically associated with AI/algorithmic 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.