(206 days)
The ABR-2000 intended use is for the meas orement of galvanic skin response.
Not Found
The provided text describes a 510(k) premarket notification for the ABR-2000, a Galvanic Skin Response Measurement device. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety standards. It does not contain information about a study proving the device meets specific acceptance criteria related to its performance in measuring galvanic skin response, nor does it detail a study that would include the specific elements requested (e.g., sample size for test set, ground truth methods, MRMC studies, standalone performance).
Therefore, based on the provided text, I cannot complete a table of acceptance criteria versus reported device performance relevant to the measurement of galvanic skin response, nor can I provide information on sample sizes, ground truth establishment, or multi-reader studies.
The document indicates:
- Substantial Equivalence: The ABR-2000 is considered substantially equivalent to the MERIDIAN-II and MERIDIAN-Plus devices. This is the primary "acceptance criterion" in the context of a 510(k) submission where direct performance data might be deferred if equivalence to a legally marketed device is established for the same intended use.
- Electrical Safety: The device meets electrical safety requirements as per EN 60601-1 (IEC 601-1) and EN 60601-1-2. This is a safety-related acceptance criterion.
Based on the provided text, the specific information requested about a performance study is not available. The document focuses on regulatory compliance for electrical safety and substantial equivalence for its intended use, rather than a detailed performance study proving specific clinical or technical acceptance criteria for galvanic skin response measurement.
§ 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.