(176 days)
The RABEATM Cement Restrictor Device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries.
The RABEATM Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1 mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
This document is a 510(k) summary for the RABEA™ Cement Restrictor Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and detailed study parameters for device performance is not applicable in this context.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The provided document is a 510(k) summary, which demonstrates substantial equivalence to predicate devices. It does not present specific quantitative performance metrics against pre-defined acceptance criteria from a clinical trial or performance study. The "performance" described is in terms of functional and safety testing, which are qualitative in nature here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned as this is a 510(k) submission based on substantial equivalence and functional/safety testing, not a clinical trial. The testing performed was "examination of the function of the device under conditions similar to those found in normal usage." This would typically involve bench testing or engineering verification rather than a human subject test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert ground truth establishment. The evaluation centered on functional and safety testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 device is a cement restrictor, not an AI-powered diagnostic device. No MRMC study was performed.
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 an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The evaluation was based on functional and safety testing of the physical device to ensure conformance to product specifications.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm requiring a training set.
Summary of Device Performance and Equivalence (as described in the document):
The document states:
- Acceptance Criteria/Performance Goal: "Functional and safety testing of the RABEA™ Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications."
- Reported Device Performance: "The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device."
The primary conclusion is that the RABEA™ Cement Restrictor Device is substantially equivalent to two predicate devices:
This substantial equivalence is based on "the devices' similarities in functional design, materials and indications for use." The FDA's clearance letter confirms this substantial equivalence, with an added WARNING regarding its use for spinal indications, indicating that safety and effectiveness for such use have not been established.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.