(38 days)
The XLTek PSG-40 may be used for sleep recordings (polysomnography) in research or clinical environments for:
- Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional . polygraphic recorders, signal transducers or amplifiers
- Selection of recorded signal sections for on-screen review, annotation annotation of sleep stages .
- Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals
- Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and . frequency and simple statistical measures of marked events)
The PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.
The PSG-40 requires competent user input, and its oulput must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information.
The PSG-40 does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.
Not Found
This document is a 510(k) premarket notification for the XLTEK PSG-40 Polysomnography Headbox. It primarily focuses on the device's substantial equivalence to predicate devices and provides its intended use. However, it does not contain the detailed information necessary to describe acceptance criteria and a study proving those criteria are met.
The document outlines the indications for use, stating the device is for sleep recordings (polysomnography) in research or clinical environments to:
- Digitally record high-level output signals (EEG, respiratory, oximetry).
- Allow selection of recorded signal sections for on-screen review and annotation of sleep stages.
- Provide computer-assisted event marking and quantitative analysis of EEG, respiratory, and oximetry signals.
- Generate computer-assisted reporting of simple measures from recorded signals.
It explicitly states that the PSG-40 is not intended to replace conventional devices in critical care or intraoperative settings, requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists, and does not make diagnostic judgments.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain this data.
Here's a breakdown of why this information is missing based on your request:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory approval based on substantial equivalence, not performance metrics.
- Sample size used for the test set and the data provenance: Not present. No specific test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. "Ground truth" for device performance is not discussed.
- Adjudication method: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. This type of study is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware headbox, not an AI algorithm.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present. This is not an AI/machine learning device that would typically have a "training set" in that context.
- How the ground truth for the training set was established: Not present.
§ 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).