(90 days)
The Fisher & Paykel Healthcare Acute Care Single Use Face Mask is a nasal-oral patient interface for use as an accessory to ventilators providing noninvasive bi-level and constant positive airway pressure ventilation. The ventilator must have adequate alarms and safety systems for ventilator failure. The mask is for single patient use with spontaneously breathing patients with respiratory insufficiency or respiratory failure, who are suitable for noninvasive pressure support ventilation in the hospital/institutional environments only.
The Acute Care Face Mask is a nasal-oral non invasive patient interface. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a double swivel adaptor, to receive pressurized gases. On the body, or base, of the mask is an exhalation vent located above the bridge of the nose that allows exhaled gases to be continually flushed and removed to room air. The base is contoured and has a soft facial seal for comfort and to reduce leakage. Oxygen and pressure ports in the base can be used for pressure monitoring and supplemental oxygen tube connection.
The provided text describes a 510(k) summary for the Fisher & Paykel Healthcare Acute Care Face Mask. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing the acceptance criteria and a rigorous study for device performance in the way requested for an AI/software-as-a-medical-device (SaMD) context.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of traditional medical device submission.
Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance demonstrated to be substantially equivalent to predicate device (Flexifit mask). | Testing showed substantial equivalence to the Flexifit mask for performance. |
| Biocompatibility demonstrated to be substantially equivalent to predicate device (Flexifit mask). | Testing showed substantial equivalence to the Flexifit mask for biocompatibility. |
| Suitable for use with ventilators having alarms and safety systems for ventilator failure. | Device is for use with ventilators that have alarms and safety systems for ventilator failure. |
| Facilitate non-invasive ventilation (CPAP or bi-level). | Device is a nasal-oral non-invasive patient interface for respiratory support. |
| Allow continuous flushing and removal of exhaled gases. | Exhalation vent allows exhaled gases to be continually flushed and removed. |
| Comfortable and reduce leakage. | Contoured base and soft facial seal for comfort and to reduce leakage. |
| Allow for pressure monitoring and supplemental oxygen. | Oxygen and pressure ports in the base can be used for pressure monitoring and supplemental oxygen. |
Explanation of "Acceptance Criteria"
For this type of device, explicit numerical "acceptance criteria" are not detailed in the same way they would be for an AI algorithm. Instead, the primary acceptance criterion for regulatory approval (510(k)) is demonstrating substantial equivalence to an already legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially that it met this overarching criterion through comparative testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "testing" but does not quantify the number of masks or subjects involved in these tests.
- Data Provenance: Not specified. The type of testing (e.g., bench, animal, human) is not detailed, nor is the country of origin of any test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a physical medical device (face mask), not an AI/SaMD requiring expert-labeled ground truth for algorithm training or validation in the typical sense. Performance was likely assessed through engineering tests and potentially clinical observation without a formal "ground truth" establishment by experts.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
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 is a physical face mask, not an AI-based diagnostic or assistive technology. No human reader improvement with AI assistance is relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical face mask, not an algorithm.
7. The Type of Ground Truth Used
- For a device like this, "ground truth" would relate to measurable physical properties and user acceptability.
- Performance: Likely assessed through objective measures such as airflow resistance, dead space, CO2 washout, leak rates, and compatibility with ventilators according to relevant standards. The "ground truth" would be the measured values meeting engineering specifications and being comparable to the predicate device.
- Biocompatibility: Assessed through standard biocompatibility tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 series. The "ground truth" would be the pass/fail results against specified limits.
- User Comfort/Fit (Implied): While not explicitly detailed, comfort and fit are mentioned. This would be subjective user feedback, compared against the predicate.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).