(210 days)
A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.
The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.
The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
I am sorry, but based on the provided FDA 510(k) Clearance Letter and the accompanying 510(k) Summary, there is no information provided regarding acceptance criteria for an AI/ML powered medical device, nor any study details that would prove such a device meets these criteria.
The document describes the clearance of a physical medical device, the F&P Nova Nasal Mask, which is a non-invasive positive airway pressure (PAP) therapy nasal mask. The performance data section lists standard engineering and biocompatibility tests typically performed on such devices (e.g., cleaning validation, leak, CO2 rebreathing, resistance to flow, vibration and noise, dead space analysis, human factors, mechanical integrity, shelf-life, and various ISO standards related to masks and biological evaluation).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study for an AI-powered device using this document. The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are specifically relevant to the validation of AI/ML algorithms in medical devices, which this document does not cover.
§ 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).