(89 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 plasma 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 the 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® PS Revision Hip Stem) and describes testing performed to demonstrate substantial equivalence to predicate devices, not an AI/ML study with acceptance criteria. Therefore, most of the requested information regarding AI/ML study design is not applicable.
However, I can extract the relevant information about the "acceptance criteria" in the context of device testing as presented and the "study" that proves the device meets them.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Abrasion Resistance | Comparable to sintered bead coating | Meets: Plasma spray porous coating is comparable to sintered bead coating. |
| Fatigue Strength | Able to withstand simulated in vivo loading | Meets: The PERFECTA® PS Revision Hip Stem was able to withstand test loading designed to simulate in vivo loading. |
Explanation: In the context of medical device regulatory submissions like a 510(k), "acceptance criteria" for demonstrating substantial equivalence often relate to performance characteristics of the new device being equivalent or non-inferior to predicate devices, or meeting established engineering standards for safety and effectiveness. Here, the criteria are implicitly defined by comparison to existing technologies or by successfully passing simulated use conditions.
Non-Applicable AI/ML Study Information:
The following information is not present in the provided document as it pertains to an AI/ML study, which this document is not. This 510(k) summary describes a traditional physical medical device and its mechanical testing.
- Sample size used for the test set and the data provenance: Not relevant for mechanical testing of a hip stem.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant as ground truth is based on physical measurements and engineering standards.
- Adjudication method for the test set: Not relevant.
- 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 relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant; ground truth is based on mechanical properties and simulated stress.
- The sample size for the training set: Not relevant.
- How the ground truth for the training set was established: Not relevant.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.