(71 days)
The Weinmann Silentflow 2 Exhalation System is intended for prescription use to be used with nasal masks which are used in CPAP or bi-level pressure therapy for adult patients (> 30 kg) and do not have a built-in exhalation device.
The Weinmann Silentflow 2 Exhalation System consists of two components assembled together. It allows for a patient to exhale during CPAP or bi-level pressure therapy.
The provided text describes a 510(k) premarket notification for the Weinmann Silentflow 2 Exhalation System. It does not contain information about acceptance criteria, device performance metrics, or a study that evaluates a device based on such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and environmental testing.
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The text states "Functional and environmental testing was conducted to ensure that the device would perform as described in its specifications," but no specific criteria or performance numbers are given.
- Sample size used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
- 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: This is not applicable. The device is an exhalation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable as it's not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided. The testing mentioned is "functional and environmental," implying engineering or physical performance standards, rather than medical ground truth as typically understood in diagnostic studies.
- The sample size for the training set: This is not applicable as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: This is not applicable as there is no mention of a training set for an algorithm.
Summary of available information related to testing:
The device underwent:
- Functional testing: To ensure it performs as described in its specifications.
- Environmental testing: To ensure it performs as described in its specifications.
The conclusion drawn from this testing was that the device is "substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use." However, specific acceptance criteria and reported numerical performance data are not detailed in this document.
§ 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).