(60 days)
Medium and Large Size: The AF531 Oro-Nasal SE 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 ventilation 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 for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE 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 ventilation 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 for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
The document describes a medical device, the AF531 Oro-Nasal SE Face Mask, and its substantial equivalence to predicate devices, rather than a study on an AI/ML powered device. Therefore, it does not contain the information required to answer your query regarding acceptance criteria and performance studies for an AI/ML device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes used for a test set (in the context of AI/ML).
- Data provenance (country of origin, retrospective/prospective) for AI/ML data.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication method for AI/ML ground truth.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for a training set in an AI/ML context.
- How ground truth for a training set was established for an AI/ML model.
The document is a 510(k) summary for a physical medical device (a face mask for ventilation) and focuses on demonstrating substantial equivalence based on intended use, design, materials, and performance specifications relevant to a physical component. The "Non-Clinical Data Submitted" section lists engineering and biological performance tests (e.g., total mask leak, pressure drop, sound testing, biocompatibility), not AI/ML model performance metrics.
§ 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).