(42 days)
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
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with UL2601-1 and IEC601-1 standards | "Carried out with careful attention to compliance with these standards." |
| Isolation from mains voltages preventing harmful shock/burns | "Equipment will pass a breakdown test from mains to patient electrodes." Patient ground floating with 4000V isolation. Inadvertent contact with mains will not produce current > 50 microamperes. | |
| Prevention of electrolytic lesions from low voltage circuits (Failure Mode 2) | Telefactor CTE amplifier uses capacitors to block direct current. System is single fault tolerant; two capacitor failures required for harmful currents. | |
| Prevention of serious lesions from implanted electrodes (Failure Mode 3) | CTE amplifiers are safe from Mode 3 failures in a hospital environment due to features protecting against Mode 2. | |
| Functional Equivalence | Recording performance equivalent to BEEHIVE | "DEEG-LITE system has recording performance with the supplemental SZAC software package... recognized performance exactly equivalent to that of Telefactor SZAC systems." Uses the same recognition algorithm. |
| Ability to handle specific recording montages (e.g., "Nice Liat") | "As with Beehive, the DEEG-LITE may be set up with a specific recording montage... (referred to as 'Nice Liat')." | |
| Intended Use | Primary use for long-term monitoring of suspected seizure and sleep disorders. | Stated intended use matches this description. |
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.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).