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WIZARD 310/320 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.

The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion 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. WiZARD 310/320 series CPAP mask are 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 WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.

The provided text describes a CPAP mask and its FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device's performance against specific clinical acceptance criteria.

Therefore, I cannot create a table of acceptance criteria and reported device performance because the provided document does not contain this information in the context of a new study proving performance. The document primarily highlights:

• Comparison to a predicate device: The core of the submission is to show the WiZARD 310/320 series CPAP Mask is substantially equivalent to the WiZARD 210/220 Series CPAP Mask (K103174) and reference devices AirFit F20 (K170924) and AirFit N20 (K171212).
• Safety and Performance Testing: Non-clinical testing was performed to demonstrate equivalent performance to the predicate device, focusing on biocompatibility and reliability.

Here's a breakdown of the information that can be extracted based on the provided text, and what information is not available within this document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly provided as a set of clinical performance acceptance criteria with corresponding study results. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and non-clinical testing.
• Instead, the document lists "performance characteristics" that are deemed similar to the predicate device. These are not acceptance criteria in the sense of demonstrating a certain level of efficacy or diagnostic accuracy. They are design and functional specifications.

Summary of "Similar Performance Characteristics" to Predicate Device:

Note on Differences: While some differences are noted (Therapy Pressure Range, Noise, Biocompatibility Standards), the overall conclusion is that these "do not affect the substantial equivalence claim... because non-clinical testing demonstrated that the new device has equivalent performance to the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not provided. The document refers to "non-clinical testing" but does not detail sample sizes for any test sets or data provenance (e.g., country, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This information is typically relevant for studies involving human interpretation or clinical endpoints. The provided document details a 510(k) submission for a CPAP mask, relying on bench testing and comparison to a predicate device, not expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. As above, this is not relevant for the type of submission described.

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:

• No. This is not an AI/algorithm-based diagnostic device. The submission is for a medical device (CPAP mask).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. For this CPAP mask submission, "ground truth" would relate to engineering specifications, performance against standards, and biocompatibility, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy. The non-clinical tests (biocompatibility, reliability, risk assessment, usability) serve as the evidence base.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set is relevant here.

In summary, the provided FDA 510(k) clearance letter and summary detail a substantial equivalence submission for a CPAP mask. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering comparisons and non-clinical testing, rather than through clinical studies with acceptance criteria for diagnostic performance or outcomes data.

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