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The Hamilton Medical ARABELLA® NCPAP Masks (single patient use only) are intended for use with the Hamilton ARABELLA® infant nasal CPAP system which consists of (a.) the tubing and support set and (b.) the monitoring oxygen/air mixer. This system is intended to provide CPAP therapy with a nasal mask or nasal prongs in hospitals or other clinical settings to treat newborns and infants.

The ARABELLA® NCPAP Masks are single-patient use only infant nasal CPAP masks which can be used with the Hamilton ARABELLA tubing and support set (K945740) as an alternative to the NCPAP prongs. The tubing and support set has been designed to work with the ARABELLA Monitoring Oxygen/Air Mixer (K990293 and K960359). The items covered by K945740 and K990293/K960359 together form the Hamilton Medical ARABELLA infant NCPAP system.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The provided document is a 510(k) summary for the Hamilton Medical ARABELLA® NCPAP Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing direct clinical effectiveness through a complex study with standalone performance metrics or controlled human reader studies.

Therefore, many of the requested criteria related to AI/algorithm performance, ground truth establishment with experts, MRMC studies, and detailed statistical power are not applicable or not explicitly provided in this type of regulatory document. The "acceptance criteria" here are primarily about demonstrating that the new device performs comparably to the predicate and meets its own stated specifications.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Among the information and data presented in the 510(k) submission to support the equivalency of the ARABELLA® NCPAP Masks to the predicate device are: (a.) device description, (b.) comparison to the legally marketed predicate device, (c.) human factors information, (d.) laboratory verification and validation testing of the device specifications, and (e.) comparison testing of NCPAP mask performance to NCPAP prong performance within the ARABELLA infant NCPAP system. The testing demonstrated compliance with the mask specifications and showed no difference in the performance, safety or effectiveness between the nasal masks and the nasal prongs."

This paragraph describes the "study" (or rather, a collection of tests and comparisons) that supports the claim of substantial equivalence. The primary mechanism for meeting "acceptance criteria" here is demonstrating substantial equivalence to a predicate device through these various tests and comparisons.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated for specific tests. The comparison table lists mask sizes (Small, Medium, Large) for the ARABELLA masks and corresponding sizes for the predicate, implying that tests were conducted across these sizes.
• Data Provenance: Not specified, but given the nature of laboratory verification and validation, it would be laboratory-generated data rather than patient data from a specific country. It is retrospective in the sense that the data was collected for the purpose of the 510(k) submission after device development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable/Not provided. This type of information is typically found in studies involving diagnostic accuracy or clinical interpretation. The evaluation here is for a medical device accessory's performance characteristics (e.g., dead space, pressure range, material biocompatibility) and functional equivalence, not for diagnostic accuracy where expert ground truth is critical. Biocompatibility testing was done at a "nationally recognized biological testing laboratory," implying expert oversight in that specific area.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are for determining ground truth in cases of disagreement among interpreters, which is not relevant for the type of device performance testing 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

• Not applicable. This device is an infant nasal CPAP mask, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on the specifications of the device, established engineering principles, and comparison to the predicate device's known performance.
  • For performance metrics (e.g., dead space, treatment range), the "ground truth" would be measurements obtained through laboratory testing according to validated methods.
  • For biocompatibility, the ground truth would be established through adherence to biocompatibility testing standards at a specialized laboratory.
  • For functional equivalence, the ground truth is the performance and characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This refers to machine learning models. This document describes a physical medical device accessory. Design and testing would involve prototypes and production samples, not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As above, there is no "training set" in the machine learning context for this device.

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