(190 days)
Biopotential skin electrodes will be used by the Bio Medical community in both clinical and research applications of the acquisition of all surface biopotentials, standards, and reference, i.e. Electroencephalograph (EEG), Electrocardiograph (ECG), Electromyography (EMG), Electrooculograph (EOG).
This specific device is comprised of a sintered Ag-AgCl electrode with a 99.99% Silver wire. Some of the electrodes are to be sold as bare electrodes. Some are set and sealed in an epoxy or silicone housing with a PVC, Silicone or other TPE insulated, tinseled copper lead wire attached. The device is then sealed with either silicone or Epoxy. They have a smooth, non-porous finish on all surfaces with no cracks, seams, or bubbles. It is then considered waterproof and cold sterilizable. There is a recess in the underside of the housing surrounding the exposed electrode surface to allow for the placement of an electroconductive gel. The gel establishes contact between the Ag-AgCl electrode and the subject surface to be measured. The gel improves electro conductivity between the subject surface and the Ag-AgCl electrode surface for a more sensitive and accurate reading of the Biopotential. The lead wires are either unterminated or terminate with a 1.5 DIN safety socket, snap, or pinch connector.
The provided text is a 510(k) summary for "Cutaneous Electrodes" from DocXS, LLC. This document focuses on the regulatory clearance process for a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation or performance studies.
Instead, it's a submission for a "substantial equivalence" determination to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as another device already on the market, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based solely on the provided text. The document does not contain the information required for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The text describes the device (Ag-AgCl electrodes), its intended use ("acquisition of all surface biopotentials"), and the regulatory process (510(k) submission, substantial equivalence to a predicate device). It explicitly states that the FDA's "issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
In summary, the provided document does not contain the information requested regarding a study or acceptance criteria for device performance.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).