(69 days)
The MSA-21 intended use is for the measurement of Galvanic Skin Respons
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The provided document, K993824, is a 510(k) premarket notification for the BioMeridian MSA-21 device. This document primarily focuses on establishing the device's substantial equivalence to previously marketed devices and its compliance with safety standards. It does not contain information related to the clinical performance of the device against specific acceptance criteria in the manner typically described for AI/ML devices in a study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be extracted from this document, as they are not present.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the device's intended use (Galvanic Skin Response measurement). Instead, it focuses on safety and substantial equivalence to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document describes safety tests (UL, CSA, EN, IEC standards) and electromagnetic compatibility tests. These are engineering/safety compliance tests, not clinical performance studies with a "test set" of patient data. Therefore, there is no information on sample size or data provenance for a clinical 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)
- Cannot be provided. As there is no clinical test set in the context of device performance, there are no experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable as there is no clinical test set.
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
- Cannot be provided. The MSA-21 is a Galvanic Skin Response device, not an AI-based diagnostic imaging or analysis tool. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's function or the information presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The MSA-21 is a physical device for measuring Galvanic Skin Response. It is not an algorithm in the AI/ML sense, and there's no discussion of standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. Not applicable as there is no performance study against a clinical ground truth described. The "ground truth" here relates to compliance with safety standards and the device's ability to measure GSR, which is intrinsically what the device does.
8. The sample size for the training set
- Cannot be provided. Since this is not an AI/ML device, there is no concept of a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
- Cannot be provided. See point 8.
Summary of Information Present in the Text:
The document focuses on:
- Device Identity: BioMeridian MSA-21, a Galvanic Skin Response Device.
- Regulatory Classification: Class II, Product Code GZO (Galvanic Skin Response Device), under 21 CFR 82.1540.
- Intended Use: "for the measurement of Galvanic Skin Response."
- Substantial Equivalence: Claimed to be substantially equivalent to the J&J G-25a GSR and Global Corp.'s C-29 devices.
- Safety Compliance: The device passed tests by Intertek Testing Services, confirming compliance with:
- UL 2601-1
- CSA C22.2 No 601.1
- EN60601-1
- IEC 601-1
- EN60601-1-2:1993 (Emissions and Immunity Testing)
- The document emphasizes design features for safety, such as distinct connectors for electrodes and probes.
- CE Mark: The MSA-21 has received a registered CE mark.
This document serves as a regulatory submission demonstrating safety and substantial equivalence rather than a report on clinical performance outcomes against specific acceptance criteria.
§ 882.1540 Galvanic skin response measurement device.
(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.