(105 days)
The Image3 SE Disposable Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The mask is disposable and for single patient use. It is intended for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
The Image3 SE Disposable Full Face Mask is an externally placed mask covering the nose and mouth (full face) of a patient. It is intended to provide a seal so that positive pressure from a positive pressure source is directed to the patient's nose and mouth. The device consists of a faceplate, standard elbow, cushion, and headgear. The faceplate has one pressure pick off/oxygen enrichment port with port cap, a slot at the top of the faceplate to attach a headgear strap, and two integrated headgear quick release clips (one each side of the faceplate) for fast and easy removal of the mask.
The provided document is a 510(k) premarket notification for a medical device (Image3 SE Disposable Full Face Mask). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed study information, acceptance criteria, or performance data in the format requested.
Specifically, the document states: "Design verification tests were performed on the Respironics Image3 SE Disposable Full Face Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This confirms that tests were done and met criteria, but it does not provide the specific acceptance criteria, the reported device performance, information about sample sizes, ground truth establishment, or details of a comparative effectiveness study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study detailed.
- Adjudication method for the test set: Not applicable.
- 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, as this is a physical medical device (face mask), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission focused on substantial equivalence for a physical product, not a clinical study report for an AI/diagnostic device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).