(112 days)
The GoLife Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.
The GoLife Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bilevel systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home using warm water and a mild liquid dish washing detergent (single patient use) or cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process (multi-patient use).
The design consists of a silicone nasal pillows cushion designed to fit in the patients' nostrils. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion is connected to a nasal cushion support (frame) that rests along the patient's cheeks and supports the cushion. Areas of the frame that contact the patient's cheeks are covered in a fabric material for comfort purposes. A polycarbonate elbow is connected at the frame. The elbow is capable of rotating freely through 360 degrees. The fabric headgear is connected to the mask through slots in the frame. The nasal pillows cushion is designed in such a way that it can be easily removed, from the frame for cleaning or replacement purposes.
The elbow connects to 15mm EVA tubing that is fitted at the end with a 22mm polycarbonate swivel connector. This fitting is used to connect conventional air delivery hose between the mask and the positive airway pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.
The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.
The provided text describes the GoLife Nasal Mask, a medical device intended for use with positive airway pressure devices. The document is a 510(k) summary submitted to the FDA for market clearance, rather than a study report detailing specific acceptance criteria and performance of a device. Therefore, it does not contain the detailed information requested regarding acceptance criteria, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies in the format of AI/ML device evaluations.
However, based on the information provided, here's a breakdown of what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
The document states that "Results from this testing concluded that the verification testing performed verified that the GoLife Nasal Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates."
The specific acceptance criteria and detailed quantitative performance results are not provided in this summary. The categories of testing performed are listed, implying that the acceptance criteria would be related to these performance aspects:
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Intentional Leak | Meets performance specifications |
| Unintentional Leak | Meets performance specifications |
| Pressure Drop | Meets performance specifications |
| CO2 Rebreathing | Meets performance specifications |
| Deadspace | Meets performance specifications |
| Flow Triggering | Meets performance specifications |
| Cleaning Efficacy (6 log reduction for high-level disinfection) | Meets performance specifications |
| Biocompatibility (irritation, sensitization, cytotoxicity) | Meets performance specifications |
2. Sample size used for the test set and the data provenance:
- Test Set: The document does not specify a "test set" in the context of a machine learning study. All testing mentioned is non-clinical bench testing and cleaning efficacy testing. The sample sizes for these engineering tests (e.g., number of masks tested for leak, CO2 rebreathing, or cleaning) are not provided.
- Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Respironics, Inc. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer's location (Murrysville, PA, USA). The testing is prospective in the sense that it was performed to support the 510(k) submission for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical medical mask, not an AI/ML diagnostic or prognostic system that requires expert-established ground truth from patient data. The "ground truth" for this device would be established by engineering specifications and laboratory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above.
5. 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 information is not applicable. This is a physical nasal mask, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For performance aspects (leak, pressure drop, etc.): The ground truth would be established by engineering specifications, relevant industry standards (e.g., for positive airway pressure devices), and regulatory requirements.
- For cleaning efficacy: The ground truth was established through adherence to standards like AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and FDA CDRH guidance for sterilants/disinfectants, which specify criteria for log reductions of microorganisms.
- For biocompatibility: The ground truth was established through adherence to ISO 10993-1, with specific tests for irritation, sensitization (ISO 1093-10), and cytotoxicity (ISO 10993-5).
8. The sample size for the training set:
This information is not applicable as this is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
In summary, the document describes a traditional medical device (nasal mask) and its non-clinical testing for safety and effectiveness to demonstrate substantial equivalence to predicate devices, rather than an AI/ML-driven device with associated acceptance criteria, test sets, or expert ground truths as typically discussed in AI/ML regulatory submissions. The closest analogy to "acceptance criteria" are the performance specifications and regulatory standards the device was tested against.
§ 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).