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WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bilevel system) has been prescribed.

The WiZARD 510 Nasal Mask provides an interface to direct airflow from a positive pressure source to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face. The elbow connector is designed with a series of vent holes to exhale air from the mask. WiZARD 510 nasal mask is connected to a CPAP or bi-level system via a standard 22 mm breathing tube. A quick release mechanism allows users to quickly remove the mask from the face. WiZARD 510 Nasal Mask is safe when used under the conditions and purposes as indicated in the labeling provided with the product. WiZARD 510 Nasal Mask is a prescription device supplied in non-sterile condition.

The provided text is a 510(k) Summary for the WiZARD 510 Nasal Mask. This document largely focuses on demonstrating substantial equivalence to a predicate device through comparison of features and non-clinical testing. It does not contain information about a study involving expert readers and AI for diagnostic purposes as requested in the prompt. Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for the test set
• MRMC comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The document describes non-clinical performance and a comparison to a predicate device, as seen in the "Non-clinical data" section and the "Comparison of subject device to predicate device" table.

The device in question, the WiZARD 510 Nasal Mask, is a medical device (CPAP mask), not an AI/ML-driven diagnostic tool. The acceptance criteria and study described in the document relate to the mask's physical, mechanical, and biocompatibility properties to ensure it functions safely and effectively as an interface for CPAP/bi-level therapy.

Here's an overview of the acceptance criteria and proof provided, based on the document's content:

Acceptance Criteria and Device Performance (as related to the physical mask):

The acceptance criteria are generally established by meeting the requirements of relevant ISO standards and demonstrating equivalence to a legally marketed predicate device. The document states that "Non-clinical verification and validation testing completed for the subjected device demonstrated that the WiZARD 510 Nasal Mask met all intended performance requirements."

Although not presented in a single table, the acceptance criteria are implicitly met by:

• Biocompatibility: Meeting ISO 10993 series and ISO 18562 series standards for biological evaluation of medical devices and breathing gas pathways.
• Reliability: Meeting ISO 17510:2015 for Medical devices – Sleep apnoea breathing therapy – Masks and application accessories. This includes mechanical integrity performance following various exposures (home cleaning, transportation, storage, operational temperature/humidity, drop test, sit test, shelf life).
• Risk Assessment: Adhering to ISO 14971:2007 for risk management.
• Reprocessing: Validation of cleaning and disinfection efficacy, and mechanical integrity after reprocessing.

The "Comparison of subject device to predicate device" and "Comparison of subject device to reference device" tables (found on pages 4-7) serve as the primary "proof" of meeting performance and equivalence criteria by demonstrating that key specifications and features of the WiZARD 510 Nasal Mask are "Same as predicate" or "Same as reference devices" or otherwise comparable within acceptable limits.

Example Comparison Data (from "Comparison of subject device to predicate device" table):

Data Provenance and Sample Size:

The document does not detail specific sample sizes for each non-clinical test (e.g., how many masks were tested for biocompatibility or reliability). The tests are described as "Non-clinical verification and validation testing," indicating they were conducted to a standard deemed sufficient for regulatory approval. Data provenance is implied to be from Apex Medical Corp. and certified testing laboratories. These are typically controlled, prospective tests designed to specifications.

Experts, Ground Truth, MRMC Studies, Standalone Performance:

As this is a physical medical device and not a diagnostic AI/ML tool, the concepts of "experts," "ground truth" (in the diagnostic sense of disease presence), "MRMC studies," and "standalone algorithm performance" are not applicable. The "ground truth" for this device would be its physical specifications, material properties, and functional performance under simulated conditions, all validated by engineering and biocompatibility testing against defined standards.

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