(203 days)
The RMX is a physiological data recorder intended to collect and record data from multiple physiological channels and additional auxiliary inputs from undesignated channels. It is indicated for use by or on order of a physician. The RMX is intended for use in a supervised (hospital) or unsupervised (home) environment.
The RMX is an ambulatory unattended recording device intended for the recording of sleep physiological data. The RMX functions exclusively as a data-recording device and is not intended to monitor Apnea or other vital signs in an intensive care unit or any other real time application. It is used by or on the order of a physician.
The RMX data recording device offers a platform for collecting multiple channels of physiological signals such as pulse rate, ECG, EEG, airflow, thoracic and abdominal respiratory effort, sounds intensity (i.e. noise due to snoring), body position and movements, leg movement, pulse oximetry or similar physiological signals. The data collection box is normally attached over the clothes of the patient's chest using the chest inductive effort sensor band made of clothing-standard woven elastic laces. The device may use its internal sensors, standard wired physiological sensors or several wireless sensors (not covered in this application) to match the specific needs of the patient.
Data collected is transferred on an SD memory card from the recorder to a PC at the physician's clinic, where it is converted into industry standard EDF format, after which it is analyzed by standard scoring software to generate a detailed final report with recommendations.
The RMX data recording device includes 3 software elements; 1) the SETUP part that runs on a PC and uploads the recorder setup parameters to the SD (secure digital) card as determined by the physician, 2) The Firmware operating the main and auxiliary CPU hardware which control the A/D conversion and storage of the data, and 3) the Post-Study Software which runs on a PC, reads the raw data file from the SD card as a single file and converts it into the industry standard EDF format suitable for input to analytical systems (see section 16 for software description).
This document describes the RMX Physiological Data Recorder, but it does not contain a typical acceptance criteria table with performance metrics and a study comparing those metrics against predetermined thresholds. Instead, it focuses on functional testing to ensure accurate data recording.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or performance metrics in the way a diagnostic device might (e.g., sensitivity, specificity). The "acceptance criteria" can be inferred from the "FUNCTIONAL TEST" section, which describes the device's ability to accurately record signals.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accurately generate an output replica in EDF format from known simulated signals injected to its inputs. | "The results of this test confirm that the RMX can accurately record multiple physiological signals, at a sufficient quality for later analysis by trained experts." (Page 3) |
| Confirm that the original patient details and the loaded setup data are correct. | "The test also confirms that the original patient details and the loaded set-up data are correct." (Page 3) |
| Match accepted non-formal industry standards (sampling rates, sampling depths, sensor types, attachment location, overall operation protocol). | "The technical specifications of the RMX were selected to match accepted non-formal standards in the industry, including sampling rates, sampling depths (# of bits per sample), sensor types and attachment location, as well as methods and overall operation protocol." (Page 3) The functional test confirmed its ability to generate an accurate output replica, implicitly meeting these standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The description of the "FUNCTIONAL TEST" implies a single setup (a single device or system under test) where simulated signals were injected. It does not mention a "test set" of patient data or a specific number of tests.
- Data Provenance (country of origin, retrospective/prospective): Not applicable. The test involved "known simulated signals injected to its inputs," not real patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the functional test was the "known simulated signals" that were injected into the device. The output was then compared to these known signals.
- Qualifications of Experts: Not applicable for establishing ground truth. The document mentions that the recorded signals are of "sufficient quality for later analysis by trained experts," but these experts are for downstream analysis, not for establishing the ground truth of the recording capability itself.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The functional test involved comparing the device's output to the "known simulated signals" (the ground truth). There's no mention of human adjudication in this technical verification process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Performed? No. The RMX is described as a "physiological data recorder," not an AI-powered diagnostic tool. The document focuses on its ability to accurately record data, not on the interpretation of that data by humans or AI. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's functional validation as presented.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Performed? Not applicable in the context of an "algorithm only" study for diagnostic performance. The device's primary function is recording, not automated interpretation or diagnosis. The "FUNCTIONAL TEST" describes the standalone performance of the recording system (hardware and firmware) in replicating input signals.
- If "standalone performance" refers to the device's accuracy in recording data without human intervention, then the "FUNCTIONAL TEST" could be considered a form of standalone performance assessment. It confirms the device's ability to capture and store data correctly on its own.
7. Type of Ground Truth Used
- Type of Ground Truth: Known simulated signals. For the functional test described, the ground truth was the precisely known electrical signals injected into the RMX device's inputs.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The RMX is a physiological data recorder, not a machine learning model that requires a training set. Its functionality is based on hardware design and firmware logic, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there is no training set for this type of device.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).