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The Zest™ Petite Nasal Mask is intended to be used by individuals greater than 66lbs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The Zest™ Petite Nasal Mask is intended for Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The Zest™ Petite Nasal Mask is a respiratory mask which is non invasive, the Silicone Seal is positioned over the nose, and it seals on the area around the nose, and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor, to receive pressurized gases. On the mask base are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The silicone seal is contoured for comfort and to reduce leakage.

The provided text describes a 510(K) summary for the Zest™ Petite Nasal Mask. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study to prove that a device meets specific performance metrics in the way a clinical trial or a validation study for an AI/ML device would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, sample size for training set, how ground truth for training set was established) are not applicable in this context. The 510(k) submission for the Zest™ Petite Nasal Mask primarily relies on non-clinical testing and comparison to predicate devices, not on a study with human readers or AI algorithms.

Here's a breakdown of the information that can be extracted from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a medical device in a 510(k) submission like this are generally aligned with demonstrating substantial equivalence to a predicate device. This means the new device must perform comparably to the predicate device in relevant non-clinical tests. The text indicates the device met these criteria through testing.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text. The text mentions "Testing of the Zest™ Petite Nasal Mask was compared to the predicate..." but does not detail the number of units tested.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) and performed by Fisher & Paykel Healthcare. The country of origin for the data (where the tests were conducted) is not explicitly stated but is likely New Zealand, given the company's location. The testing is prospective in the sense that it was conducted specifically for this submission, but it's not a clinical trial on patients.

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

• Not applicable. This device submission relies on non-clinical performance and biocompatibility testing, not expert-adjudicated "ground truth" in the context of diagnostic accuracy or similar metrics.

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

• Not applicable. As above, no expert adjudication was involved.

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 (nasal mask), not an AI/ML diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" in this context is the performance and biocompatibility characteristics of the predicate devices and industrial standards for such masks, against which the new device was compared. The testing involved measuring physical properties and material responses (e.g., performance, biocompatibility).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. No training set was used.

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