(70 days)
The Weinmann SOMNOmask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 KG).
The Weinmann SOMNOmask comes in three sizes, small, medium and large. It has a removable mask seal. Because the Weinmann SOMNOmask does not contain any ports or vents for removing the CO2 buildup, an external exhalation device must be used. The SOMNOmask is secured to the patient's head with a 4-point headgear called the SOMNOstrap.
This document (K013738) describes a 510(k) premarket notification for the Weinmann SOMNOmask, a nasal mask intended for use during CPAP or Bi-level Positive Pressure therapy. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria through clinical studies.
Based on the provided information, the following answers are generated:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not specify quantifiable acceptance criteria for clinical performance in a table format. The study described focuses on technical characteristics and safety, rather than effectiveness metrics against pre-defined thresholds.
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Summary) |
|---|---|
| Clinical effectiveness for CPAP/Bi-level Positive Pressure therapy | Substantially equivalent to legally marketed predicate devices (Respironics Reusable Contour II Nasal Mask and Puritan-Bennett Breeze SleepGear with DreamSeal). Concluded to be "safe and effective for its intended use" based on technical testing and comparison to predicates. |
| Technical Specifications: | |
| Drop Test | Performed, results indicate device met specifications. |
| Operating Temperature | Performed, results indicate device met specifications. |
| Storage Temperature | Performed, results indicate device met specifications. |
| Flow Resistance | Performed, results indicate device met specifications. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance test set with human subjects or a dataset for algorithm evaluation. The "testing" referred to is laboratory-based technical testing of the physical mask.
- Data Provenance: Not applicable. The "testing" mentioned is technical testing of the device itself (drop test, temperature, flow resistance) rather than data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is mentioned as part of this 510(k) submission, as it focuses on technical equivalence and laboratory testing, not clinical performance or diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. No adjudication method is mentioned as part of this 510(k) submission, as it does not involve a clinical performance test set or data requiring expert review.
5. 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. This device is a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable. The relevant "truth" in this submission relates to the device meeting its technical specifications and being substantially equivalent to predicate devices, rather than ground truth for diagnostic accuracy or clinical outcomes.
8. The sample size for the training set:
Not applicable. This submission does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
Not applicable. This submission does not describe a machine learning algorithm or a training set.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).