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The SleepWeaver Advance Pediatric Nasal Mask is intended to provide an interface for noninvasive Positive Airway Pressure (PAP) ventilation therapy. This mask is intended for single-patient use in the home and single-patient use in the hospital / institutional environment. This mask is to be used on patients between 2 and 7 years of age.

The SleepWeaver Advance Pediatric Nasal CPAP Mask serves as a mechanism for connecting a pediatric patient between 2 and 7 years of age for whom PAP therapy has been prescribed to maintain an open airway. The nasal mask is placed over a patient's nose and held in place by use of an adjustable elastic headgear. A cloth cushion contacts the patient's face. The mask assembly has a tubing swivel connector which is compatible with the industry standard 22 mm air tubing. Air is supplied to the mask by a therapy device. The patient inhales air from the mask and exhales into the mask where continuous airflow from the therapy device purges the exhaled carbon dioxide from the mask through the mask exhalation holes. The SleepWeaver Advance Pediatric Nasal CPAP Mask can be used in the home environment (single-patient use) or the hospital/institutional environment (single-patient use). The mask features a cloth cushion made of a blue polyester fabric with a polyester / nylon / lycra / polyurethane interface material. The mask exhalation feature is incorporated into the cloth cushion. Attached to the cushion is a 22-mm tubing swivel connector that can rotate 360°. The tubing connector can be removed by unwrapping the white medical tape for cleaning and cushion replacement. The cloth headgear is connected to the mask through slots in the cushion wings. The headgear is removable for cleaning and replacement. The SleepWeaver Advance Pediatric Nasal CPAP Mask product also offers an optional accessory: the Feather Weight tube. The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757. The Feather Weight tube is an 18" plastic extension tube compliant to ISO 5356-1 and ISO 5367 that connects between the SleepWeaver Advance Pediatric Nasal CPAP Mask and standard CPAP tubing.

The provided document is a 510(k) premarket notification for a medical device called the "SleepWeaver Advance Pediatric Nasal CPAP Mask." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where an AI-driven device's performance is compared against human readers or specific acceptance criteria for AI output.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, stand-alone performance, training set sample size, how ground truth for training set was established) are not applicable to this type of submission. The device described is a physical medical device (a CPAP mask), not an AI/ML-driven software device.

However, I can extract the acceptance criteria and reported device performance from the "Non-Clinical Testing Summary" and "Technological Characteristics" sections, as these effectively serve as the performance evaluation for this type of device.

Acceptance Criteria and Reported Device Performance

Device: SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683)
Predicate Device: ResMed Ltd., Pixi Pediatric Mask (K102224)

Study Details (as applicable to a physical medical device submission)

1. Sample size used for the test set and the data provenance:

   • Specific human subject sample sizes for each test are not explicitly stated. The "Fit evaluation and anthropometric analysis" implies human subjects were used, but the number is not provided.
   • The "CO2 rebreathing testing per ISO 17510-2" and "Fixed leak rate per ISO 17510-2" were likely conducted in a lab setting using test lungs or simulated breathing circuits rather than human subjects for the core performance metrics.
   • Data provenance: Primarily bench-top testing, not clinical trial data from specific countries.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is a physical device, and the "ground truth" is established by compliance with engineering standards (like ISO 17510-2) and direct measurements from bench-top tests, rather than expert interpretation.

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

   • Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical data, which is not the primary basis of this submission.

4. 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 not an AI-driven device.

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

   • Not applicable. This is not an AI-driven device. The "standalone" performance is the device's measured physical characteristics on a test bench.

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

   • The "ground truth" for this medical device consists of established engineering standards (e.g., ISO 17510-2 for CO2 rebreathing), physical measurements (e.g., dead space, resistance, leak rate), and biocompatibility testing results.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable. As there is no training set.

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