(63 days)
The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.
The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.
The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:
- Manufactured from Cobalt Chrome Alloy .
- 11 Sizes in 2mm increments .
The provided text describes a 510(k) summary for the CONSERVE® Femoral Resurfacing Component but does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The document is for a medical device (a prosthetic hip component) and uses "substantial equivalence" to a predicate device as its basis for clearance, not performance metrics from a study against predefined acceptance criteria for an AI/ML algorithm.
Therefore, most of the requested information cannot be extracted from this document, as it outlines a different type of regulatory submission.
Here's what can be stated based on the provided text:
Acceptance Criteria and Device Performance for the CONSERVE® Femoral Resurfacing Component:
This document is a 510(k) summary for a physical medical device (CONSERVE® Femoral Resurfacing Component), not an AI/ML-driven device. As such, it does not detail specific quantitative acceptance criteria or a study proving the device meets these criteria in the manner typically described for AI/ML performance. Instead, its acceptance is based on substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: Indications for use, design, and materials are substantially equivalent to the Orthomet Resurfacing Femoral Component. The fundamental scientific technology has not changed. | The CONSERVE® Femoral Resurfacing Component's indications for use and design are identical to the Orthomet Resurfacing Femoral Component. The materials are substantially equivalent. This supports the safety and effectiveness of the component. |
| Intended Use: For hemi resurfacing to reduce or relieve pain and/or improve hip function in skeletally mature patients with non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, painful hip dysplasia). For cemented use only. | The device's stated indications for use match the criteria for intended use, and are identical to the predicate device. |
Regarding the specific points for an AI/ML study, the information is not present in the provided text:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML algorithm evaluated on data sets.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical hip implant is not established in this manner.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML ground truth. The "truth" for this device relates to its material properties, design specifications, and clinical performance (which is inferred from historical data of the predicate device).
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.