(261 days)
Onera STS measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders.
Onera STS is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders.
The device is intended to be used for adults.
Onera STS is a wearable system for measuring (physiological) signals during a sleep study. The device can be used in home (Home Healthcare Environment) as well as Professional Healthcare Facilities, to perform the sleep study.
Onera STS consists of four sensors applied on the forehead, upper chest area, abdominal and lower leg area.
The sensors measure EEG, EOG, EMG, ECG, bioimpedance based respiratory effort, bioimpedance based respiratory flow, cannula based respiratory flow, oxygen saturation, activity, position, and sound pressure level.
The study preparation and data retrieval are done in a professional/clinical environment by the trained operator. The device is provided to the user by the trained operator.
The device is not a life supporting physiological monitor.
The provided text is a 510(k) summary for the Onera Sleep Test System (Onera STS). It details the device, its intended use, and a comparison to a previously cleared predicate device (K210593). The primary change in this submission (K223573) is an extension of the device's use time from 8 hours to 16 hours.
It's crucial to understand that this document is a premarket notification asserting substantial equivalence, not a detailed clinical study report proving performance against specific acceptance criteria for diagnostic accuracy. The FDA's review for a 510(k) focuses on safety and effectiveness in comparison to a predicate device, rather than requiring new, full-scale clinical trials for every parameter.
Therefore, the information regarding acceptance criteria and performance studies within this document is limited to demonstrating that the change (extended wear time) does not introduce new safety or effectiveness concerns, and that the device still meets regulatory standards. There is no information provided about a study that assesses the device's diagnostic accuracy or performance against specific, quantifiable "acceptance criteria" for detecting sleep disorders. The device is described as measuring and recording parameters for clinicians to use, not as an automated diagnostic tool itself.
Given this context, I will address your points based on the available information in the provided text.
Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)
The FDA 510(k) summary primarily focuses on demonstrating that the modified device (Onera STS with 16-hour wear time) is substantially equivalent to its predicate device (Onera STS with 8-hour wear time) and that the change does not introduce new safety or effectiveness concerns. There are no explicit "acceptance criteria" for diagnostic accuracy or performance of the device in the context of detecting sleep disorders presented in this document. The "performance testing" mentioned is related to meeting general safety and performance standards, and verifying that the extended wear time does not degrade existing performance or safety.
Table of Comparison (Not "Acceptance Criteria" for Diagnostic Performance):
The table below summarizes the comparison between the proposed device and the predicate, highlighting the only stated difference: extended use time. This is a demonstration of substantial equivalence rather than meeting specific diagnostic acceptance criteria.
| Characteristic | Proposed device Onera STS | Currently cleared Onera STS (Predicate) | Result | Implication for "Acceptance" |
|---|---|---|---|---|
| Recording time | 16 hours | 8 hours | Extended use time | The primary change, supported by "new skin irritation testing and 16-hour wear time testing as part of design verification and validation activities" to ensure continued safety and performance at extended duration. This is the core "acceptance" point for this 510(k). |
| Regulation Number | 21 CFR 868.2375 | 21 CFR 868.2375 | Identical | Regulatory classification is the same. |
| Product Code | MNR | MNR | Identical | Product code is the same. |
| Indications General | Measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders. Intended for patients prescribed a sleep study; applied by layperson under direction of physician/trained technician. Recorded data assists healthcare professional. | Measures and records multiple physiological parameters from a patient during a sleep study which are used by clinicians to make a decision on the diagnosis of sleep disorders. Intended for patients prescribed a sleep study; applied by layperson under direction of physician/trained technician. Recorded data assists healthcare professional. | Identical | Intended use remains the same. |
| Indications – Patient population | Adults | Adults | Identical | Target population remains the same. |
| Indications – Environment | Home and professional environments. | Home and professional environments. | Identical | Usage environment remains the same. |
| Indications - Limitations | Not intended to monitor or diagnose the patient and does not issue alarms. | Not intended to monitor or diagnose the patient and does not issue alarms. | Identical | Device limitations remain the same. |
| Operating principle | Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. Recording of the data. Making the data available for display on a suitable platform. | Measuring of electrophysiological and other (sound, flow, position) signals via a range of sensors. Recording of the data. Making the data available for display on a suitable platform. | Identical | Core technology and function are unchanged. |
| Energy | Battery powered devices. | Battery powered devices. | Identical | Power source unchanged. |
| Materials | Patches are included with the device and found biocompatible. | Patches are included with the device and found biocompatible. | Identical | Materials remain the same, biocompatibility verified. |
| Measured parameters (EEG, EOG, EMG head, EMG leg, SpO2, ECG, Respiratory effort via bioimpedance, Respiratory flow via nasal cannula, Sound pressure) | All listed as identical. ECG listed as "Similar" for proposed device vs predicate but this appears to be a formatting error in the FDA document as it is then listed as "Identical" across the line. Assuming it is identical. | All listed as identical. | Identical (or similar as noted for ECG, likely formatting error) | The parameters measured are unchanged. |
| Derived parameters (Position, Activity) | Identical | Identical | Identical | Derived parameters are unchanged. |
| Operating temperature | 10°C - 40°C | 10°C - 40°C | Identical | Operating range unchanged. |
| Operating relative humidity | 10% - 90% | 10% - 90% | Identical | Operating range unchanged. |
Study Details (Based on provided 510(k) Summary)
The provided document describes a 510(k) "premarket notification" which asserts substantial equivalence, not a dedicated clinical study for diagnostic accuracy. Therefore, information related to diagnostic performance studies, AI algorithms, human readers, or specific "acceptance criteria" for disease diagnosis is largely absent.
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A table of acceptance criteria and the reported device performance:
- As explained above, the "acceptance criteria" discussed are for substantial equivalence and compliance with general safety and performance standards for a medical device (e.g., biocompatibility for extended wear, electrical safety, EMC).
- The reported performance for the primary change (extended wear time) is implied by the statement: "The extension is supported by new skin irritation testing and 16-hour wear time testing as part of design verification and validation activities." This testing demonstrated that the device performs safely and effectively for the increased duration. No quantitative performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for detecting specific sleep disorders) are provided, as the device records data for clinicians to use for diagnosis, it does not autonomously diagnose.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states: "No clinical data was required to support equivalence." This means a dedicated clinical test set for diagnostic accuracy was not part of this 510(k) submission.
- The extended wear time and skin irritation testing would have involved engineering and biocompatibility testing, likely using a limited number of human subjects or in-vitro/in-vivo models. Specific sample sizes and provenance for these verification/validation activities are not detailed in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Since "No clinical data was required," there was no clinical test set for which ground truth needed to be established by experts for diagnostic performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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:
- Not applicable. The document does not describe the device as incorporating AI for automated diagnosis or interpretation to assist human readers. The device records physiological parameters for clinicians to interpret.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device's stated function is to "measure and record multiple physiological parameters... which are used by clinicians to make a decision on the diagnosis of sleep disorders." It is not presented as a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" for this 510(k) was the predicate device's cleared performance and safety standards, combined with verification and validation of the extended wear time not introducing new risks.
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The sample size for the training set:
- Not applicable. This device is not described as involving machine learning or AI that would require a "training set" for diagnostic functions.
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How the ground truth for the training set was established:
- Not applicable.
§ 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).