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The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.

This document describes a 510(k) premarket notification for the "Epimed RF Introduction Cannula," and as such, it does not detail acceptance criteria and a study proving device performance in the way a clinical trial or AI device study would. Instead, it demonstrates substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a bench testing comparison to predicate devices, not a clinical study with a "test set" in the context of AI or clinical efficacy. The "test set" here refers to the Epimed RF Introduction Cannula itself, which was subjected to bench tests.
• Data Provenance: The data comes from "Bench Testing performed on the Epimed RF Introduction cannula." No information on country of origin or retrospective/prospective nature is given beyond being bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth in the context of expert consensus or clinical outcomes is not relevant for this type of regulatory submission, which relies on bench testing comparisons for substantial equivalence. The "ground truth" for the bench testing would be the measured physical and technical characteristics of the device and its predicate.

4. Adjudication method for the test set

• Not Applicable. No explicit adjudication method is mentioned. The comparison seems to be direct measurements of physical/technical characteristics against those of predicate devices.

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

• No, not done. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device (cannula), not an algorithm or AI system.

7. The type of ground truth used

• For the non-clinical data, the ground truth was the measured physical and technical characteristics of the Epimed RF Introduction Cannula and the referenced predicate devices, assessed through bench testing.

8. The sample size for the training set

• Not Applicable. This is not an AI device with a training set.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI device with a training set.

Summary of the Study (Bench Testing):

The study performed was Non-Clinical Bench Testing. This testing aimed to compare the performance characteristics of the Epimed RF Introduction Cannula to its predicate devices. The conclusion from this bench testing was that the performance of the Epimed RF Introduction Cannula is "similar to the predicate device(s)," leading to the determination of substantial equivalence in terms of safety and effectiveness. The specific parameters measured during these bench tests are not detailed in this summary.

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