(250 days)
The Somté PSG is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or sleep related respiratory or cardiac disorders. The Somté PSG is designed for ambulatory and mobile operation and can be used in either the patient's home, the hospital or other environments, thus enabling patients to be investigated under as realistic conditions as possible. The Somté PSG is only to be used under the direction of a physician.
The Somté PSG System comprises hardware and software which provides up to 27 separate parameters for recording, review and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The Somté PSG device consists of two components permanently connected by a cable: the Patient Input Box (PIB) and the Recorder. The Somté PSG device is powered by 2 AA Batteries - Alkaline or NiMh.
Acceptance Criteria and Device Performance for SOMTÉ PSG SYSTEM (K072201)
The provided 510(k) summary for the Compumedics SOMTÉ PSG SYSTEM primarily focuses on demonstrating substantial equivalence to predicate devices through a detailed comparison of technological characteristics and successful completion of various tests. It does not explicitly state specific quantifiable acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity for a particular sleep disorder). Instead, the performance validation relies on demonstrating the device's ability to accurately record and process physiological signals comparable to the predicate devices and conform to relevant safety and electromagnetic compatibility standards.
Therefore, the "acceptance criteria" can be inferred from the nature of the tests conducted and the general objective of demonstrating substantial equivalence for a medical device that aids in diagnosis.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: Device meets international safety standards to prevent harm to users and environment. (IEC 60601-1) | Successfully completed Safety Tests to conform to IEC 60601-1. |
| Electromagnetic Compatibility: Device does not introduce intolerable magnetic disturbances and operates reliably within its electromagnetic environment. (IEC 60601-1-2) | Successfully completed Electromagnetic Compatibility Tests to IEC 60601-1-2. |
| Functional Performance Validation: Device accurately captures and processes physiological parameters as intended for sleep disorder diagnosis, comparable to predicate devices. | "Performance Validation was conducted, results were recorded and an internal and external Sleep authority generated a Somté PSG Performance Validation Report." Specific reports cited: AC550-01 Woody Clinical Validation Report, AD052-01 Vampire Heart Rate Verification Report and AC551-01 Report to EN60601-1-4 for Woody-Somte PSG. |
| Hardware, Software, and Firmware Compliance: Device components conform to design requirements. | Compliance tested to hardware, software, and firmware test specifications. |
| Substantial Equivalence: Device's technological characteristics and intended use are comparable to legally marketed predicate devices, posing no new safety or effectiveness concerns. | Demonstrated through a comprehensive comparative table and discussion with predicate devices (Compumedics Sleep Monitoring System K955841, Compumedics Somté Recording System K021176). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the performance validation. It refers to a "Performance Validation Report" which would contain this information.
The data provenance is implicitly from "an internal and external Sleep authority" who generated the validation report. There is no mention of country of origin or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document states, "an internal and external Sleep authority generated a Somté PSG Performance Validation Report."
- Number of Experts: Not explicitly stated, but it implies at least two ("internal and external Sleep authority").
- Qualifications of Experts: The term "Sleep authority" suggests expertise in sleep medicine, likely physicians qualified in sleep disorder diagnosis. No specific details like years of experience or board certifications are provided in this summary.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the performance validation. It simply mentions that a "Sleep authority" generated the validation report, implying their expert opinion served as the reference.
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 explicitly mentioned or performed in the context of comparing human readers with and without AI assistance. The device in question is a physiological signal recording system, not an AI-powered diagnostic algorithm designed to assist human readers. Its purpose is to collect data for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Somté PSG System is a data acquisition system, not a standalone diagnostic algorithm. While it collects data for analysis (which can be computer-assisted or manual), its primary function is accurate signal recording. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop directly assisting diagnosis does not apply in the typical sense for this device. Its performance validation is focused on the accuracy of data acquisition and signal processing.
7. The Type of Ground Truth Used
The ground truth for the performance validation was established by "an internal and external Sleep authority" as part of a "Clinical Validation Report." This indicates that the ground truth was based on expert consensus/clinical judgment from sleep experts, likely comparing the device's recorded signals and derived parameters against established clinical standards or other validated PSG systems. The "Vampire Heart Rate Verification Report" suggests physiological signal accuracy verification, which would use known physiological measurements as a reference.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning components for which a training set would be required. The Somté PSG System is a medical device for acquiring physiological signals, not an AI/ML diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.
§ 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).