(243 days)
The F&P Brevida™ Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Therapy. The F&P Brevida™ Nasal Pillows Mask is intended for single patient adult (> 66 los (30kgs)) use in the home and multiple patient adult use in the clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Brevida™ Nasal Pillows Mask is a non-invasive patient interface with a silicone seal that encloses the nasal airway entrance. The mask is held on the face with a headgear.
The mask connects to a single breathing tube by a 22mm swivel adaptor to receive pressurized gases from a continuous airway pressure device (CPAP or Bi-Level). The exhaust holes on the elbow of the mask allow exhaled gases to be flushed out while the system is in operation.
The F&P Brevida™ Nasal Pillows Mask is a prescription only device, provided in a nonsterile state.
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found for complex AI/ML devices in regulatory documents. Instead, it describes a medical device, the F&P Brevida™ Nasal Pillows Mask, and its substantial equivalence to a predicate device (F&P Pilairo™ Nasal Pillows Mask) based on non-clinical performance data.
Therefore, for your request, I must state that the information asked is largely absent from the document. The document focuses on establishing "substantial equivalence" to a predicate device, a pathway that often relies on demonstrating similar technical characteristics and performance without requiring new, extensive clinical trials or specific acceptance criteria studies in the AI/ML sense.
However, I can extract the following based on the provided text's approach to "performance" and "equivalence," which are proxies for meeting certain expectations for a medical device:
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A table of acceptance criteria and the reported device performance
- The document does not list explicit acceptance criteria with numerical targets for performance metrics in the way a study for a novel AI/ML diagnostic device might.
- Instead, for most characteristics, the "performance" is reported as being "Identical" to the predicate device, or in cases of differences, it is stated that the difference "does not introduce any additional risk to the user" or that it "does not introduce any new risk to the patient."
- For Dynamic Dead Space, the document provides specific values: "29.27cc (XS-S)" and "33.14cc (M-L)" for the F&P Brevida™. It states that "Both seal sizes are in conformance with ISO 17510-2 (2007)." This ISO standard would implicitly define the "acceptance criteria" for dead space, but the specific numerical limit from the standard is not provided in the text.
- For High Level Disinfection Methods, the "performance" refers to the parameters used: "Thermal Disinfection (80°C for 10 mins and 75°C for 30 mins)" and states that "The parameters used for the thermal disinfection are identical" to the predicate for thermal disinfection. It also notes "Please see Section 14 for testing of both sets of parameters," implying that testing confirmed efficacy at these parameters.
- For Seal sizes, it states that "Both seal sizes have undergone product verification and meet all product requirements." This indicates an internal set of acceptance criteria, but they are not detailed.
- For Material changes, it states that "The new materials have been assessed for biocompatibility and no additional risk to the patient was found to have been introduced due to the new materials." This implies acceptance based on passing biocompatibility assessments per ISO standards.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states: "Substantial equivalence was not based on an assessment of clinical performance data."
- It lists non-clinical performance data which refers to bench testing against various ISO standards.
- No sample sizes for test sets are mentioned, as this is not a study assessing clinical performance on patient data.
- Data provenance is not applicable, as the "data" consists of engineering test results (e.g., dead space measurements, material biocompatibility tests, disinfection efficacy).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This device is a physical nasal pillows mask, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication method described because there's no diagnostic or interpretive data requiring expert consensus or review.
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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. This is a physical medical device (nasal mask), not an AI system, so no MRMC study with human readers or AI assistance would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm; it's a physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense. For the technical characteristics described, "ground truth" would be established by physical measurements, chemical analyses, and adherence to engineering standards (e.g., ISO 17510-2 for dead space, ISO 10993 for biocompatibility).
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The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set with established ground truth.
In summary, the provided document describes a regulatory submission for a physical medical device, not an AI/ML product. The "acceptance criteria" are implied by adherence to ISO standards and demonstrating "substantial equivalence" to a predicate device through non-clinical bench testing. The information requested, particularly concerning expert ground truth, sample sizes for test/training sets, and AI performance metrics, is not present because it's not relevant to the type of device and regulatory pathway described.
§ 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).