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The Stimuplex®-DIG-RC Nerve Stimulator is intended for use with B. Braun Medical Inc. Stimuplex and Contiplex® insulated needle sets for use in regional anesthesia and regional pain therapy. Peripheral nerves are stimulated and located via electrical current impulses flowing through an insulated needle.

The modified Stimuplex®-DIG-RC Nerve Stimulator consists of a hand held remote control unit with separate finger rings for the remote control. The STIM-DIG RC consists of a closed circuit led, a current regulator, an internal connection for electrode cable, a frequency switch, and a battery led. The digital display indicates the current settings.

This submission is for a modification to a Stimuplex®-DIG-RC Nerve Stimulator, not a new device requiring a full clinical study with acceptance criteria and a test set. Therefore, much of the requested information regarding performance, sample sizes, expert involvement, and ground truth is not applicable.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or report device performance data. The submission is for a modification to an existing device, and the primary demonstration is substantial equivalence to the predicate device. The "Substantial Equivalence" section states: "The modifications that were made to the STIM-DG-RC do not affect the indication for use and does not alter the fundamental technology of the device. The operation and function of the unit remains the same. The risk analysis method used to access the impact of the modifications was a Failure Modes and Effects Analysis." This implies that the acceptance criteria for the modifications were likely related to ensuring the modified device met the same functional and safety requirements as the predicate, possibly through engineering verification tests, but these specific criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. Since this is a modification to an existing device and not a de novo submission requiring efficacy testing, there is no mention of a test set or clinical data of this nature. The evaluation appears to be based on engineering analysis rather than human subject data.

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. No ground truth establishment by experts is described for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or related adjudication method is mentioned.

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 nerve stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth of this nature was established, as the submission focuses on modifications to an existing device and substantial equivalence based on engineering and risk analysis.

8. The sample size for the training set

Not applicable. No training set is mentioned or relevant for this submission type.

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

Not applicable. No training set or ground truth for it was established.

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