Search Results

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.

Ask a specific question about this device