(41 days)
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended for cemented application only.
The Repicci II® Onlay Tibial Component is an all-polyethylene unicondylar tibial component with four inferior fixation pegs. The inferior surfacy has macro grid (waffle) texture as well as four undercut pegs for cement fixation. Components in five profiles and four thicknesses are available.
This document describes the Biomet Repicci II® Onlay Unicompartmental Tibial Component. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through technological characteristics and mechanical testing.
The document explicitly states "Clinical Testing: None provided." This means that no studies demonstrating device performance, clinical efficacy, or safety in human subjects were conducted or submitted as part of this 510(k) Pre-market Notification.
Therefore, I cannot provide information on acceptance criteria based on human performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these were not part of the submission for this device.
Here's what can be inferred from the provided text regarding acceptance criteria and "study" (mechanical testing) for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Material composition equivalent to predicate devices. | The device is an all-polyethylene unicondylar tibial component. Its materials are "similar to or identical" to predicate devices. |
| Design equivalent to predicate devices (e.g., macro grid texture, undercut pegs). | Features four inferior fixation pegs, macro grid (waffle) texture, and four undercut pegs for cement fixation. Design characteristics are "similar to or identical" to predicate devices. |
| Sizing equivalent to predicate devices (e.g., range of profiles and thicknesses). | Components in five profiles and four thicknesses are available, "similar to or identical" to predicate devices. |
| Intended Use equivalent to predicate devices. | Intended for partial replacement of knee articulating surfaces for similar conditions to predicate devices (degenerative disease, fractures, deformity, revision). Intended for cemented application only, consistent with predicate devices. |
| Mechanical properties (e.g., strength, durability, fatigue resistance) demonstrated through non-clinical testing to be acceptable and comparable to predicate devices. | "Mechanical testing provided" (details not specified in this summary). The implication is that the mechanical testing demonstrated equivalence or acceptable performance for its intended use. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No human clinical test set was used. Mechanical testing was performed.
- Data Provenance: Not applicable for clinical data. For mechanical testing, the data would have been generated by Biomet Manufacturing Corp. in a laboratory setting. Its provenance would be internal Biomet testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No human clinical test set was used, therefore no experts were required to establish ground truth for clinical outcomes. For mechanical testing, engineers and technicians would be involved in setting up and interpreting the tests, but this is not "ground truth" in the clinical sense.
4. Adjudication method for the test set
- Not applicable. No human clinical test set was used.
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 a medical device (knee implant), not an AI diagnostic or assistive tool. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (knee implant), not an algorithm.
7. The type of ground truth used
- For demonstrating substantial equivalence: Comparison to the known characteristics (materials, design, sizing, intended use) and established mechanical performance of legally marketed predicate devices.
- For mechanical testing: Engineering standards and internal performance specifications. This is not "ground truth" in the clinical sense but rather acceptable engineering performance parameters.
8. The sample size for the training set
- Not applicable. No clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable. No clinical training set was used.
In summary, for this specific 510(k) submission, Biomet relied on the "Summary of Technologies" (comparison of materials, design, sizing, and indications to predicate devices) and "Non-Clinical Testing" (mechanical testing) to demonstrate substantial equivalence, rather than clinical studies.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.