(78 days)
HydroPrep and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.
HydroPrep is a skin preparation solution similar to NuPrep. It is different in that is has more water and more salt that the current formulation. It used the same preservatives and gritty media.
This document describes a medical device, the Physiometrix Model 1700, HydroPrep, which is a skin preparation solution. The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
The text is a 510(k) Premarket Notification summary from 1997 for a Class II medical device (Electroconductive media). It focuses on:
- Identification of the device: Physiometrix Model 1700, HydroPrep.
- Comparison to a predicate device: K885306, NuPrep (Weaver & Co.).
- Description of the device: A skin preparation solution, similar to NuPrep but with more water and salt, using the same preservatives and gritty media.
- Intended Use: To reduce skin impedance and increase signal quality for EEG electrodes, applied with a cotton swab. It explicitly states it's not for use with stimulating electrodes.
- Regulatory Classification: 882.1275 Electroconductive media.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided input does not contain any of this information or any indication of an AI/ML component.
The information requested, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc., are standard components of evaluating AI/ML-driven medical devices. The HydroPrep, as described, is a chemical solution and not an AI/ML device.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).