(90 days)
The SSR3201 Ambulatory EEG/Sleep Recorder is Intended for medical purposes to record electrical activity of the brain (EEG) and to record physiological data required for sleep studies (Polysomnography or PSG). These studies Including EEG, eye movement (EOG), respiratory signals such as air flow or air pressure and thoraco-abdominal movement, chin and armleg movement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor.
This device is intended to record up to 24 hours of continuous patient data for freely-moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system to assist in diagnosing EEG related conditions such as epilepsy and sleep related conditions such as sleep related breathing disorders.
The SSR3201 is intended for medical purposes to record electively of the brain (EEG) and other blo-potential signals and to record physiological data required for sleep studies (Polysomnography or PSG) including EEG, eye movement (EOG), respiratory signals such as also (Polysomnography of PSG) Molding LCC, oyo nevent, chinand amovement (EMG), body position, EKG and blood oxygen saturation. The device does not provide alarms and can not be used as an automated apnea monitor.
This device is intended to record up to 24 hours of continuous patient data for freely moving or sleeping patients both inside and outside of a medical facility. The SSR3201 is intended to of sleeping patients Don miside and Outsier of a medical reciments of legally marketed digital EEG/PSG system.
The SSR3201 is a battery-powered device with no voltage inside the unit greater than 9 volts DC. An isolated junction box connects electrodes and/or sensors to the patient.
The provided text is a 510(k) summary for the NIHON KOHDEN AMERICA, INC. SSR3201 Ambulatory EEG/Sleep Recorder. It mainly focuses on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and general characteristics.
Crucially, the document does NOT contain specific acceptance criteria, detailed study designs, or performance data that would allow for a comprehensive description of how the device meets such criteria. It mentions "environmental, safety and performance testing procedures" and "Software validation is performed for the device software" to "verify the operation and confirm that the device performs within specifications," but these specifications and the results are not provided.
Therefore, I cannot populate most of the requested table and study information. However, I can extract what is available and indicate where information is missing.
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria for EEG/PSG recording accuracy, signal quality, etc. | Not specified in the provided document. The document states "These tests verify the operation and confirm that the device performs within specifications," but the specifications themselves are not detailed. |
| Compliance with environmental, safety, and performance testing procedures. | "The SSR3201 is subjected to environmental, safety and performance testing procedures." |
| Software validation. | "Software validation is performed for the device software." |
| Non-contacting material components (for good laboratory practice studies). | "The device material components were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58." |
| Low voltage and isolated junction box (for patient safety). | "The SSR3201 is a battery-powered device with no voltage inside the unit greater than 9 volts DC. An isolated junction box connects electrodes and/or sensors to the patient." |
| Ability to record up to 24 hours of continuous patient data. | "This device is intended to record up to 24 hours of continuous patient data for freely-moving or sleeping patients both inside and outside of a medical facility." |
| Compatibility with legally marketed digital EEG/PSG systems for review. | "The SSR3201 is intended to record patient data for later review by a medical professional using a legally marketed digital EEG/PSG system." |
Study Information (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document mentions "environmental, safety and performance testing procedures" but does not detail the nature of these tests in terms of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document focuses on regulatory compliance and the device's technical specifications, not a clinical validation study involving expert ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or comparative effectiveness study is mentioned. This device, being an ambulatory recorder from 1998, predates widespread AI integration in such devices. It is an EEG/PSG recording device, not an interpretation device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone performance study is explicitly described. The device is a data acquisition device, and its output is intended "for later review by a medical professional."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of the device as a recorder, its "ground truth" would likely relate to the accuracy and fidelity of the physiological signal acquisition compared to established measurement techniques, rather than diagnostic "ground truth" for disease states. However, details of such validation are not provided.
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The sample size for the training set:
- Not applicable/Not specified. As a 1998 device and a recorder, it is highly unlikely it utilized machine learning models requiring a "training set" in the modern sense.
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How the ground truth for the training set was established:
- Not applicable/Not specified.
Summary of Missing Information:
The provided 510(k) summary (from 1998) primarily focuses on demonstrating substantial equivalence to predicate devices and outlining the device's intended use and general system characteristics. It mentions that performance testing was conducted and software was validated, implying that there are internal specifications and acceptance criteria that were met. However, the document does not provide details on:
- Specific quantitative acceptance criteria (e.g., signal-to-noise ratio, frequency response, accuracy of parameter measurements).
- Any details of clinical studies or performance studies involving patient data, including sample sizes, ground truth establishment, expert involvement, or adjudication methods.
- Any information related to artificial intelligence or machine learning components, which would require training and test sets as per modern standards.
This level of detail on performance data is not typically a requirement for 510(k) summaries, especially for devices from 1998 that are primarily data acquisition systems rather than diagnostic algorithms.
§ 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).