(191 days)
WiZARD 210/220 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
WiZARD series mask consists of a frame with a cushion seal on the face. Different height forehead support pad are offer to user allow fitting forehead better. Series of vents are feature on the elbow that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. WiZARD serous mask is connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly
The provided 510(k) summary for the WiZARD 210/220 Series CPAP Mask is for a medical device that does not involve AI. Therefore, many of the requested categories related to AI models and their evaluation (such as sample sizes for test/training sets, ground truth establishment methods, number/qualifications of experts, adjudication, MRMC studies, and standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through compliance with established international standards for non-continuous ventilators.
Here's a breakdown of the available information based on your request:
1. Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials used in the construction of the mask shall be compliant with ISO 10993-1. | PASS |
| Performance | Overall performance shall be compliant to ISO 17510-2. (Specifically for Exhaust Flow, Resistance to Flow, Anti-asphyxia Valve Pressure, Inspiration Resistance, Expiration Resistance, Noise) | PASS |
| Safety | Overall safety shall be compliant to ISO 17510-2. (Including cleaning/disinfection and CO2 rebreathing under normal and single fault conditions) | PASS |
| Shelf Life | Should be compliant to product specification. | PASS (5 years) |
2. Sample size used for the test set and the data provenance
Not applicable. The "test set" in this context refers to physical testing performed on the device to ensure compliance with specified standards, not a data-based test set for an algorithm. The 510(k) summary does not specify the number of units tested for each criterion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device does not involve expert-labeled ground truth as it is a physical medical device, not an AI/ML system. The "ground truth" for the performance and safety criteria is defined by the requirements of the ISO standards themselves.
4. Adjudication method for the test set
Not applicable. As this is not an AI/ML system, there is no adjudication process for conflicting interpretations of data. Compliance is assessed against objective engineering and safety standards.
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 medical device (CPAP mask) and does not involve AI or human "readers" interacting with an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not include an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance and safety is defined by compliance with international standards: ISO 10993-1 for biocompatibility and ISO 17510-2 for performance and safety. These standards specify objective measurement methods and acceptable limits.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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).