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510(k) Data Aggregation
(104 days)
The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interface; and is intended for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).
The Somnera System is a positive airway pressure system comprised of an airflow generator and a patient interface. The patient interface has a SmartValve™ seated in either a nasal mask or nasal pillow mask. A hose connects the valve to the generator. The mask is held in place with adjustable headgear straps. The patient interface is supplied non-sterile and intended for single patient reuse in the home environment. The Somnera System is a prescription device.
The Somnera System is intended to treat Obstructive Sleep Apnea (OSA) by delivering therapeutic breathing pressure to a patient. The provided text details the performance data, including a clinical study, to support the substantial equivalence of the Somnera System to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds for clinical performance. Instead, it describes a "primary effectiveness endpoint" and the results of a non-inferiority study designed to demonstrate that the subject device (Somnera System) is not worse than the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness (Non-inferiority to Predicate Device for AHI Reduction) | The difference in mean Apnea-Hypopnea Index (AHI) between the predicate and subject device was 1.7/h. A 95% confidence interval of (-0.2 - 3.6) was reported. The non-inferiority p-value was 0.002, which demonstrates that the subject device is non-inferior to the predicate device in the treatment of OSA. (The non-inferiority margin is not explicitly stated in the provided text, but the p-value indicates the criterion was met.) |
| Safety | The study reported 8 subjects with a total of 20 adverse events during one or both randomization nights. One adverse event was reported as related to the predicate device, one to the subject device, and the remaining device-related events were associated with the patient interface. All events resolved by the end of the sleep night. Adverse event types were similar on both sleep nights and included primarily skin and nose irritation and difficulty breathing. |
| Biocompatibility | Evaluation conducted in accordance with FDA Guidance ISO 10993-1 and ISO 18562-1. Tests included Cytotoxicity, Irritation, Sensitization, Volatile Organic Compound (VOC) Analysis of Gas Pathway, Emitted Particulate Gas Analysis, Ozone Gas Analysis, Carbon Monoxide (CO) and Carbon Dioxide (CO2) Gas Analysis, and Extractables. (Presumably met acceptance criteria since the device was cleared). |
| Electrical Safety and EMC | Testing conducted according to IEC 60601-1, IEC 60601-1-2, and IEC60601-1-11. (Presumably met acceptance criteria since the device was cleared). |
| Software Verification and Validation | Conducted and documented as recommended by FDA guidance for software in medical devices. Designated as "moderate" level of concern. (Presumably met acceptance criteria since the device was cleared). |
| Performance Testing (Non-clinical) | Included sound power level, CO2 rebreathing, component cycling, pressure regulation, waveform testing, maximal output temperature testing, and device integrity testing. (Presumably met acceptance criteria since the device was cleared). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): The study enrolled 52 subjects. Of these, 42 were available for primary endpoint analysis.
- Data Provenance: The study was a multi-center study conducted at six U.S. sites. It was a prospective, open-label, randomized crossover assignment study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated how many individual experts; however, the sleep nights were scored by "an independent, central scorer." The text implies a single entity or group providing the central scoring, rather than a panel of multiple individual experts.
- Qualifications of Experts: Not explicitly stated beyond "independent, central scorer blinded to the sequence assignment." Typical qualifications for such a role would be a Registered Polysomnographic Technologist (RPSGT) or a board-certified sleep physician, but this is not detailed in the provided text.
4. Adjudication Method for the Test Set
- The ground truth for the AHI endpoint was established by an "independent, central scorer blinded to the sequence assignment." There is no mention of an adjudication method (e.g., 2+1, 3+1) involving multiple human readers for conflicting interpretations, as the scoring was performed by a single central entity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This study was a clinical trial comparing the performance of two different Positive Airway Pressure (PAP) devices (Somnera System vs. Predicate Device) on human subjects to treat OSA, specifically measuring AHI. It was not an AI-assisted diagnostic device study involving human readers and a comparison of their performance with and without AI assistance. The Somnera System is a PAP delivery system, not an AI diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. The Somnera System is a medical device, a positive airway pressure delivery system, and not a standalone AI algorithm for diagnosis or interpretation. The clinical study assessed the device's therapeutic effect (reduction in AHI) in patients.
7. The Type of Ground Truth Used
- The primary ground truth for the effectiveness endpoint was the Apnea-Hypopnea Index (AHI) measurements derived from in-lab sleep studies, which were scored by an independent, central scorer. This can be categorized as expert consensus/measurement-based ground truth (as opposed to pathology or long-term outcomes data, though AHI is an objective measure of a physiological outcome). Safety ground truth was based on reported adverse events.
8. The Sample Size for the Training Set
- Not applicable for this document. The document describes a clinical study to evaluate the performance of a medical device (Somnera System) for treatment. It does not describe the development or training of an AI algorithm, so there is no "training set" in that context. The device's internal algorithms (e.g., for auto-adjusting pressure) would have been developed and validated internally, but the document does not provide details on data used for that process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained in point 8, this document does not describe the training of an AI algorithm or the establishment of ground truth for such a training set.
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