(68 days)
The Fisher & Paykel Healthcare Flexifit™ Series HC431 Full Face Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR §868.5905.
The Flexifit™ Series HC431 Full Face Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a noncontinuous ventilator system. The device administers positive airway pressure via a mask which covers the nose and mouth. The HC431 Full Face Mask is a multi-patient reusable device for use on the prescription of a suitably qualified physician.
The Flexifit™ Series HC431 Fuill Face Mask is an accessory to a Noncontinuous ventilator (IPPB) according to 21 CFR §868.5905. It constitutes the patient to ventilator interface in a noncontinuous ventilator system.
The Flexifit™ Series HC431 Full Face Mask is a respiratory mask which covers the mouth and nose. The mask is connected to the output breathing tube of the ventilator. The ventilator supplies air at CPAP or Bilevel pressures (typically in the range 3 - 25 cm H₂O) which is available at the mask.
The mask is positioned over the patient's nose and mouth during CPAP or Bilevel treatment. The HC431 Full Face Mask is designed to ensure the desired positive airway pressure is delivered to the patient with minimal leakage and that the mask is held securely over the nose and mouth while asleep.
The non-rebreathing valve prevents CO2 re-breathing in the event of pressure loss due to power outage or ventilator machine failure. The elbow on the front of the mask facilitates freedom of movement while maintaining circuit integrity. Bias slots on the mask provide a means to purge exhaled gases from the breathing circuit.
The provided text, K040506, describes the Fisher & Paykel Healthcare Flexifit™ Series HC431 Full Face Mask, an accessory to a noncontinuous ventilator. It details the device's function, design, intended use, and its claim of substantial equivalence to predicate devices. However, this document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, or specific study results for demonstrating performance beyond a general statement of "effective performance."
The document focuses on the technical characteristics and the regulatory submission process for a 510(k) premarket notification. It asserts that "Non-clinical tests have demonstrated effective performance in terms of strength, durability, pressure and flow characteristics, and conformance of connections to industry standards," but it does not provide the quantitative acceptance criteria or the reported device performance from these tests.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as that data is not present in the provided text.
Based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document states that "Non-clinical tests have demonstrated effective performance in terms of strength, durability, pressure and flow characteristics, and conformance of connections to industry standards." However, it does not specify the quantitative acceptance criteria for these characteristics (e.g., specific pressure ranges, leakage rates, durability cycles) nor the numerical results obtained from the tests. | Not provided. The document makes a general claim of "effective performance" but does not offer specific numerical results, comparisons to predicate devices, or any data points that would quantify the device's performance against defined criteria. |
2. Sample size used for the test set and the data provenance: Not provided. The document mentions "Non-clinical tests" but does not specify the number of units tested or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document describes non-clinical engineering tests (strength, durability, pressure, flow), not a study requiring expert clinical assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a medical mask, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Provided. For non-clinical tests, "ground truth" would typically be derived from engineering specifications, industry standards, and predicate device performance benchmarks. The document states "conformance of connections to industry standards" but doesn't detail the method of establishing "ground truth" for the non-clinical tests.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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).