(147 days)
The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.
The MS-IVB is a nerve stimulator with selectable stimulus output waveforms and adjustable output amplitude. The stimulus output is intended for monitoring the depth of patient muscle and nerve relaxation while
This document is a 510(k) summary for the MiniStim* Peripheral Nerve Stimulator – Model MS-IVB, indicating it is a premarket notification for a medical device. This type of document is not designed to contain acceptance criteria and detailed study results in the typical sense of a clinical trial or algorithm performance study.
Instead, the "acceptance criteria" here refer to the device meeting various standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" that proves the device meets these criteria is a series of non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Name) | Reported Device Performance |
|---|---|
| IEC 60601 Safety Testing (Electrostatic Discharge, Radiated Immunity, Conducted RD Immunity, Magnetic Field Immunity) | Pass |
| Software Verification | Pass |
| User Interface / Functionality | Pass |
| Waveform | Pass |
| Packaging and Labeling Verification | Pass |
2. Sample size used for the test set and the data provenance
The document discusses non-clinical testing of the device itself, not a test set of data from patients. Therefore, sample size and data provenance in the context of patient data are not applicable. The "sample" would refer to the physical device(s) tested. The provenance of the testing is internal to the manufacturer (Halyard Health, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical engineering and software verification tests for the device, not a study evaluating human interpretation or a machine learning algorithm's performance against expert-established ground truth.
4. Adjudication method for the test set
This is not applicable for the same reasons as points 2 and 3. The testing involves verifying device specifications and adherence to standards, not human expert adjudication of diagnostic outcomes.
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, an MRMC comparative effectiveness study was not done. This document describes a traditional medical device (peripheral nerve stimulator), not an AI/ML-driven diagnostic or assistive technology that would involve human readers.
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.)
For the non-clinical tests described, the "ground truth" would be established engineering specifications and international standards (e.g., IEC 60601 for safety, predefined waveforms for output verification, expected software behavior).
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).