(324 days)
The PERFECTA® Revision Hip System is intended to be used in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
The PERFECTA® Revision Hip System is a monolithic design femoral component. The device is manufactured from titanium alloy (ASTM F-136) with a titanium alloy wire arc spray coating. The stem is available in two configurations: straight and bowed. All configurations have a calcar platform, from 2.0cm to 3.75cm. All sizes, except for 12mm x 190mm, have a coronal slot. The stem is designed to be press-fit or can be used with bone cement.
This document is a 510(k) summary for a medical device (PERFECTA® Revision Hip System), not a study report on device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.
However, I can extract the limited information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it makes general statements about testing results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable fatigue strength | The PERFECTA® Revision Hip System demonstrates acceptable fatigue strength. |
| Coating durability/wear | The titanium wire arc spray coating demonstrates less weight loss as compared to the sintered bead control specimen through a comparable range of loads. |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). This document describes pre-market testing, which would typically be conducted in a controlled lab environment rather than using clinical patient data at this stage.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The testing described appears to be mechanical and material testing, not human-read clinical data.
4. Adjudication method
- Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC study was not done. This document describes mechanical and material testing, not clinical studies involving human readers and AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for the mechanical testing would be the physical properties and performance metrics measured in a laboratory setting (e.g., actual fatigue cycles to failure, actual weight loss during wear simulation).
8. The sample size for the training set
- Not applicable/Not specified. This document is about a physical device undergoing mechanical testing, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented 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 component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.