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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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The DEEG-LITE-OXY is intended for use in long-term recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device. An integrated pulse oximeter provides supplemental diagnostic data in the form of blood oxygen saturation (SpO2 percent).

The DEEG-LITE-OXY system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists of State) Signa components such as: a mgil resolution Analog to Digital converter, a DSP (Digital Signal processor a safe low voltage includes supply and (d) a wearable, 32 channel EEG amplifier/recorder, and (e) an internal pulse ossimeter module supplied by Neilcor(model Mr 205). The DDLG De De oximeter module, all of the foregoing power supply. With the exception of the pulse oximeter modules income DEEC I ITE power supply. With the excopiton of unded in the predicate device DEEG-LITE.

The provided document is a 510(k) summary for the DEEG-LITE-OXY device, which is a portable EEG recorder with an integrated pulse oximeter. The document focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) and does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically described for AI/ML devices.

Instead, the submission relies on the following:

1. Acceptance Criteria and Device Performance (Implicit - based on Substantial Equivalence):

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, DEEG-LITE (K972202), and that the addition of the pulse oximeter does not alter its safety or effectiveness. The device performance is affirmed by claiming identity of components and performance where relevant.

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

• Sample Size: Not applicable in the context of a clinical test set. The evaluation was primarily based on nonclinical (bench tests). The pulse oximeter module itself references Nellcor's 510(k) #K962424, implying that its performance was established separately by Nellcor.
• Data Provenance: The bench tests were conducted by Telefactor Corporation. The country of origin for this data is implicitly the United States, where Telefactor Corporation is located. The tests were likely prospective in nature, performed specifically for this 510(k) submission.

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

• Not applicable. No clinical expert-driven ground truth establishment is described for the "test set" because no clinical trials or reader studies were performed for this submission. The "ground truth" for the EEG aspect is the established performance of the predicate DEEG-LITE, and for the oximeter, it's Nellcor's specifications documented in their respective 510(k).

4. Adjudication Method for the Test Set:

• Not applicable. No human readers or adjudication processes are described for evaluating the device's performance in a clinical setting.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Because of the identical performance confirmed by the Bench Tests, clinical performance tests are deemed unnecessary." This indicates reliance on non-clinical testing and substantial equivalence rather than human performance studies.

6. Standalone (Algorithm Only) Performance:

• Yes, the evaluation conducted was primarily a standalone (algorithm/device only) performance assessment through nonclinical bench tests. The device's electrical characteristics, noise performance, and adherence to established standards (for both EEG and the pulse oximeter module) were tested independently. There is no "human-in-the-loop" component to the described testing.

7. Type of Ground Truth Used:

• The "ground truth" for this submission is based on:
  • Predicate Device Performance: The established performance and safety of the legally marketed predicate device, DEEG-LITE (K972202).
  • Manufacturer Specifications/Standards: For the integrated Nellcor pulse oximeter, its performance is compared against Nellcor's own documented specifications and its previously cleared 510(k) (K962424).
  • Industry Standards: Electrical safety compliance is measured against UL2601-1 and IEC601-1 standards.

8. Sample Size for the Training Set:

• Not applicable. This device is a hardware system for signal acquisition and recording, not an AI/ML algorithm that undergoes "training." Therefore, there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

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THIS DEVICE IS INTENDED FOR USE IN LONG-TERN RECORDING OF VOLTAGES PRODUCED BY THE BRAIN AND MEASURED ON THE SCALP (EEG) FOR SUBSEQUENT DIAGNOSTIC REVIEW WITH A DIGITAL WORK-STATION SUPPLIED BY THE MANUFACTURER (TELEFACTOR BEEKEEPER) OR SIMILAR COMPATIBLE DEVICE. AN INTEGRATED PULSE OXIMETER PROVIDES SUPPLEMENTAL DIAGNOSTIC DATA IN THE FORM OF BLOOD OXYGEN SATURATION (SpO2 percent).

The H2O system is battery powered, wearable, 32 channel EEG amplifies/recorder. The H2O system operates on a pack of eight Alkaline batteries for twelve hours or a pack of two lithium batteries for 24 hours. Unlike DEEG-LITE, the H2O recorder never operates from mains power, but only from batteries. Like DEEG-LITE, a binary, optically isolated output data stream is utilized by a notebook or desktop computer for initial setup. Unlike DEEG-LITE, all data recording in H2O is performed internally in the wearable device in a Flash-RAM for short recordings, or on an internal rotating disk for long recordings. The DEEG-LITE utilizes DSPs (Digital Signal Processors) for data manipulation and preparation. It uses a Intel-486 or Pentium processor in a notebook computer for data recording and display. H2O uses a single internal INTEL 186 processor for data manipulation and recording and an external notebook or desktop computer only for initial setup and electrode application to verify good EEG waveform at the beginning of the data recording session. 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.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The provided text, a 510(k) summary for the H2O device, focuses on demonstrating substantial equivalence to a predicate device (DEEG-LITE) rather than outlining specific, quantifiable acceptance criteria and a detailed study against them. This is typical for a 510(k) submission where the primary goal is to show the new device is as safe and effective as a legally marketed device.

Therefore, the "acceptance criteria" are implied through the comparison to the predicate device's performance, and the "study" is largely a non-clinical (bench) test demonstrating identical or better performance.

Here's the breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified, as only non-clinical (bench) tests were deemed necessary. No patient data or clinical sample size is mentioned for testing.
• Data Provenance: Not applicable, as there are no clinical studies or human data mentioned for the H2O device's performance evaluation against the predicate. The "Bench Tests" would typically involve laboratory measurements on the device itself.

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

• Not applicable. There are no clinical studies or expert-driven ground truth establishment mentioned for the performance evaluation.

4. Adjudication Method for the Test Set

• Not applicable. There are no clinical studies or expert adjudication processes described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Because of the identical performance confirmed by Bench Tests, clinical performance tests are deemed unnecessary." This indicates no human reader comparison was performed or considered necessary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This question isn't directly applicable in the context of this device. The H2O is an EEG recorder/amplifier, a hardware medical device that generates data for a clinician to review, not an algorithm that autonomously interprets data. The performance evaluation focuses on the fidelity of the recording itself, rather than an AI's interpretation of it. The "Bench Tests" would serve as the standalone performance assessment of the hardware's electrical characteristics.

7. The Type of Ground Truth Used

• The "ground truth" for the device's performance appears to be established through engineering specifications and direct measurements against the predicate device's known performance characteristics. The document highlights "equivalent noise performance," "equal or better signal to noise ratio," "equal digital resolution," and "identical sample rates" verified through bench tests. The predicate device (DEEG-LITE) itself, having been previously cleared, serves as the de facto performance standard.

8. The Sample Size for the Training Set

• Not applicable. The H2O device is a hardware EEG recorder and amplifier, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" to prove the H2O device meets its acceptance criteria (which are defined by its equivalence to the predicate DEEG-LITE) consists solely of Nonclinical (Bench Tests). These tests are described as documenting "equivalent noise performance" and verifying that the H2O's wearable amplifiers have "equal or better signal to noise ratio, equal digital resolution, and identical sample rates" compared to the DEEG-LITE system. The H2O also incorporated electrical safety design in accordance with UL2601-1 and IEC601-1 standards. The conclusion drawn from these bench tests is that "the nonclinical (Bench Tests) demonstrate that the device is safe, effective and performs as well as the predicate device." No clinical studies or human performance evaluations were conducted or deemed necessary.

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this device is intended for use in rong-term digital recording of voltages produced by the brain and measured on the scalp (EEG) for subsequent diagnostic review with a digital workstation supplied by the manufacturer (Telefactor Beekeeper) or similar compatible device.

The DEEG-LITE system consists of (a) a laptop computer with liquid crystal display, (b) a MicroCoder which consists on as: a high resolution Analog to Digital converter, a DSP (Digital Signal Processor) and programmable logic devices, (c) a power supply and (d) a weatable, 32 chamel EEG amplifier/recorder identical to that used with the current Telefactor BEEHIVE system (510(k) #884937). The DEEG-LITE system operates on a safe low voltage power supply, as does the BEEHIVE system which is based on a standard desk-top personal computer.

Here's an analysis of the provided text regarding the DEEG-LITE device, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) summary and FDA clearance letter. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than detailing extensive independent performance studies with quantitative acceptance criteria. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number of experts for ground truth, MRMC studies, etc.) is not explicitly available within these documents. The provided text emphasizes electrical safety and functional equivalence.

Acceptance Criteria and Study to Demonstrate Device Meets Criteria: DEEG-LITE

Based on the provided K972202 510(k) summary for the DEEG-LITE, the primary "acceptance criteria" discussed relate to electrical safety and functional equivalence to its predicate device, the Telefactor BEEHIVE EEG Recorder (K884937). The study described is a demonstration of adherence to safety standards and a statement of functional similarity.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document primarily discusses electrical engineering compliance tests and functional comparisons. It does not mention a clinical "test set" in the context of patient data for performance evaluation.
• Data Provenance: Not applicable, as there's no clinical test set described in terms of patient data. The "testing" appears to be engineering validation of safety and functional characteristics.

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

• Not applicable. The document does not describe a clinical study requiring expert-established ground truth for a test set. Ground truth, in this context, would be engineering standards and the functional performance of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There's no described clinical test set requiring an adjudication method.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described. The focus is on the device's inherent functional and safety properties, and its equivalence to a predicate, not on how human readers perform with or without the device's assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The document implies a "standalone" functional comparison in terms of its digital signal processing capabilities. It states the DEEG-LITE with the MicroSZAC software has "recognition performance exactly equivalent" to the Telefactor SZAC systems because "same recognition algorithm is used in the software for both systems." This implies that the algorithm's performance is being considered, but it's relative to the predicate's algorithm, not a novel standalone performance evaluation. No specific metrics for the algorithm's standalone performance (e.g., sensitivity, specificity for seizure detection) are provided.

7. The Type of Ground Truth Used

• For electrical safety: International and national safety standards (UL2601-1 and IEC601-1).
• For functional equivalence: The performance characteristics and software algorithm of the predicate device, the Telefactor BEEHIVE-EEG-Recorder (K884937) and its associated SZAC software.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning model where a specific training set size would be disclosed. The "training" for the device's design and software algorithm would be considered part of the development process that led to the predicate device.

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

• Not applicable. There is no training set described in the context of this 510(k) summary. The "ground truth" for the device's design is based on established engineering principles and the performance of the predicate device.

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