(139 days)
The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The constrained liner is first snapped into the shell and a ridge or lip around the outside of the liner engages a groove on the inside of the shell to provide a positive lock. The femoral head is inserted into the constrained liner and the locking ring secures the head into the liner.
The Constrained Liner consists of an UHMWPE insert conforming to ASTM F648 and a titanium alloy locking ring conforming to ASTM F620. The ID of the liners is 28 mm and the minimum thickness of the insert is 6 mm. The constrained liner is to be used in conjunction with the acetabular shells previously cleared in K973199, K974093, and K974095.
The provided document describes the acceptance criteria and the methods used to demonstrate that the FMP Constrained Liner meets these criteria. However, it does not detail a study in the context of an AI/ML device, as the document is for a physical medical device (hip prosthesis). Therefore, several requested points, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and data provenance, are not applicable.
Here's a summary based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Identified Risk | Acceptance Criteria | Results of Mitigation | Acceptance Criteria Met |
|---|---|---|---|
| Infection | Must provide a SAL of 10-6 | Verified by dose validation per ANSI/AAMI/ISO11137-94 and EN552. | YES |
| Adverse Tissue Reaction | Must meet the following standards: | ||
| ASTM F136-98 | |||
| ASTM F620-00 | |||
| ASTM F648-00 | Performance characteristics for all materials meet these standards. | YES | |
| Pain and/or loss of function | Must meet the following standards: | ||
| ASTM F136-98 | |||
| ASTM F620-00 | |||
| ASTM F648-00 | Performance characteristics for all materials meet these standards. | YES | |
| Revision | Must include the precautions and intended use provided in the guidance document. Must meet the following standards: | ||
| ASTM F136-98 | |||
| ASTM F620-00 | |||
| ASTM F648-00 | Precautions and intended use are provided in labeling. Material standards met. | YES | |
| Device disassembly | Must meet or exceed the lever-out forces for Encore bipolar acetabulum | Testing was performed to show lever out mode exceeds those of the bipolar. | YES |
| Precautions and intended use (part of Revision risk mitigation) | Must include the precautions and intended use provided in the guidance document. | Precaution statement, intended use, and precautions recommended in the guidance document are provided in the labeling, package insert, and surgical technique. | YES |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This document pertains to a physical medical device (hip prosthesis), not a data-driven AI/ML device. Performance is demonstrated through compliance with material and sterilization standards, and mechanical testing.
- Data Provenance: Not applicable.
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 device's performance is established through adherence to recognized engineering standards and physical testing, not expert consensus on data interpretation.
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. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering and medical standards (e.g., ASTM F136-98, ASTM F620-00, ASTM F648-00, ANSI/AAMI/ISO11137-94, EN552) for material properties and sterilization, and physical mechanical testing (lever-out testing).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”