(266 days)
A-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home.
SLA-Model: The F&P Nova Micro Pillows Mask is intended to be used by adults weighing ≥ 66 lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bi-level by a physician. The F&P Nova Micro Pillows Mask is intended for single-patient use in the home and for multiple-patient use in the hospital or other clinical settings where proper disinfection of the device can occur between patient uses.
The F&P Nova Micro Pillows Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal pillows mask with a silicone seal that seals the nasal airway entrance of the Nova Micro Pillows Mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The Nova Micro Pillows Mask features a pillows cushion with prongs that extrance of the patient's nasal nares, held in place by adjustable headgear straps. The Nova Micro Pillows Mask is a prescription-only device, provided in a non- sterile state. The F&P Nova Micro Pillows Maskrange is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-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.
This document is a 510(k) Premarket Notification from the FDA regarding the F&P Nova Micro Pillows Mask. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technological characteristics, and non-clinical performance data.
However, the provided text does not contain the specific information requested about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. This document describes a medical device (a CPAP mask) that is not an AI/ML device according to the information provided. Therefore, there is no discussion of performance metrics like accuracy, specificity, sensitivity, or the methodology of an AI/ML study (e.g., sample size for AI training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment).
The "Performance Data" section (Section VII) lists various non-clinical tests performed on the mask, such as Cleaning Validation, Leak, Dead Space Analysis, CO2 Rebreathing, Pressure-Flow Curve, Resistance to Flow, Vibration and Noise, Human Factors/Usability Engineering, Mechanical Integrity, and Shelf-Life. These are standard engineering and safety tests for a physical medical device, not performance evaluations for an AI/ML algorithm.
Therefore, I cannot provide the requested table or details about an AI/ML study from the given text. The information is simply not present because the device described is not an AI/ML device.
§ 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).