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This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.

The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device.

The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).

This document is a 510(k) Summary for the Simple T Pediatric Nasal Mask (K151120). It details the substantial equivalence of the new device to previously cleared predicate devices. Unfortunately, the document does not contain specific acceptance criteria or study data in the format requested for AI/ML device testing.

The document discusses performance testing, but this refers to engineering tests on the physical mask (e.g., intentional leak, total mask leak, CO2 rebreathing, cleaning validation), not to the performance of an AI model. There is no mention of an algorithm or AI component in this device.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an algorithm.
2. Sample size for a test set, data provenance, number of experts, or adjudication method for an AI/ML model.
3. Multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance effect size.
4. Standalone (algorithm only) performance.
5. Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML model.
6. Sample size for the training set or how ground truth for the training set was established.

This document is for a physical medical device (a nasal mask) and outlines its substantial equivalence based on material, design, and non-clinical performance testing. It explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Simple T Pediatric Nasal Mask. Product functionality has been adequately assessed by non-clinical tests." This further confirms the absence of AI/ML or clinical efficacy studies as would be required for such devices.

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