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THIS DEVICE IS INTENDED FOR USE IN LONG-TERM RECORDING OF VOLT AGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH I II DIGITAL WORK - STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR A DIGITAL WORLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SPO2 PERCENT).

H2O receives signals from an EEG Amplifier, formats, and transmits them via a cable to a data collection and review workstation. The device can function either as a self-contained, battery-powered recorder or as an externally powered cable telemetry device. The "tethered option" which is the subject of this application is identical to the original H2O in every respect except that the battery pack is replaced with an isolating dc to dc converter power supply and a 115 kbaud optical isolator link for data communication. The function of this communication link is to replace the rotating wearable disk. Both the dc to dc converter and the optical isolator maintain a 4000 volt insulation barrier between the patient all external wire and cables. Power is supplied in the form of Svolts dc at one half ampere maximum current. This power is most commonly supplied through the keyboard adapter of a host computer, but when long communication distances are required may be supplied by a small local medical-grade 5 volt supply. The dc to dc converter operates at about 25 kHz and is of the resonant variety so that no measurable interference is produced by its switching action. To provide an added sensor modality useful in sleep recordings, the H2O incorporates a NONIN pulse oximeter board (NONIN OEM2 Pulse Oximeter Module), with a DB9 Female connector for one of the compatible NONIN finger probes. This option is retained in the tethered mode.

The provided text is a 510(k) summary and certification for a device modification, specifically the "H2O - Tethered Option" for an EEG recorder. It focuses on demonstrating substantial equivalence to a predicate device and safety, rather than providing a detailed study proving performance against acceptance criteria in the way a clinical trial for a new, innovative device might.

Therefore, many of the requested categories for a study proving device effectiveness are not directly addressed in this document. The document primarily highlights the safety and functional equivalence of the tethered option to the original H2O device.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for effectiveness in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on functional equivalence and safety standards. The primary "acceptance criteria" here relate to meeting established engineering and safety standards and maintaining the performance of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a test set of patient data to evaluate the diagnostic performance of the device in terms of accuracy, sensitivity, or specificity. The evaluation is primarily based on engineering specifications and comparison to the predicate device's established performance. Therefore, there is no sample size for a test set cited, nor is there data provenance (e.g., country of origin, retrospective/prospective).

The "study" refers to a technical assessment of the modified device's performance against the predicate and relevant standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no test set of patient data is described, there were no experts used to establish ground truth in the context of diagnostic performance for a study in this document.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done according to this document. The focus is on demonstrating substantial equivalence in technical performance and safety for a device modification, not on the comparative effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The H2O device is an EEG recorder, which captures physiological signals for human interpretation. It is not an AI algorithm or a standalone diagnostic tool that provides automated diagnoses. Therefore, a standalone performance study in the context of an algorithm's diagnostic output is not relevant or described. The "standalone" performance here would refer to the device's ability to accurately record EEG signals, which is addressed by verifying its recording performance is "identical to the original H2O."

7. The Type of Ground Truth Used

Given that no clinical study data is presented, the concept of "ground truth" for diagnostic accuracy is not directly applicable in this submission. The "ground truth" in this context is implicit in the technical specifications and established performance of the predicate device (Telefactor Corporation's "H2O" EEG-Recorder), against which the modified device's performance (e.g., noise levels, recording fidelity) is deemed "identical" or "adequate." Additionally, international safety standards (IEC 601, UL2601-1) serve as a form of "ground truth" for safety compliance.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (EEG recorder) and a modification to it, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is relevant to this device and its modification.

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