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The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is:

• to be used by adult patients (>66lb / 30 kg); (1)
• to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment.
• (3) to be used in the following environments: home, hospital, and sub-acute institutions.
• intended for prescription use. (4)

The 3B Flex-Lite™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

The 3B Flex-Lite™ is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The 3B Flex-Lite™ is a prescription device supplied non-sterile.

The provided document describes the 3B Flex-Lite Nasal Mask, a device intended to channel airflow noninvasively to a patient from a positive airway pressure (PAP) device. The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria. Therefore, the information provided does not directly outline "acceptance criteria" as distinct performance thresholds that the device must meet for a specific clinical task. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through comparable technological characteristics and performance.

Here's an analysis based on the provided text, focusing on how the device meets the implicit acceptance criteria of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will frame the "acceptance criteria" as comparability to predicate devices for key performance and safety characteristics.

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

The document refers to "Performance bench testing of both the 3B Flex-Lite™ and the Nasal Aire II were conducted" and explicitly mentions a "Piper Medical" test report dated March 23, 2011, annexed at Appendix A. However, the specific sample size for these bench tests (e.g., number of units tested) and the country of origin of the data are not detailed in the provided text. The testing appears to be retrospective in the sense that it evaluates the manufactured device against established performance benchmarks and comparisons to existing devices, rather than a prospective clinical trial with human subjects.

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

This information is not provided in the document. The "ground truth" for the bench tests would typically be defined by engineering specifications, regulatory standards, and the performance characteristics of the predicate devices. The individuals conducting and reporting the tests (e.g., Piper Medical) would be engineers or technicians with expertise in medical device testing, but their specific qualifications or the number involved are not stated.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests are bench tests, an adjudication method in the clinical sense (e.g., 2+1 physician consensus) is not directly applicable. The "adjudication" would be based on comparison of test results to predefined criteria or to the predicate device's measured performance.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. The 3B Flex-Lite™ Nasal Mask is a physical medical device (mask interface), not an AI-powered diagnostic or assistive technology for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study of an algorithm is not applicable to this device, as it is a physical device, not an algorithm or AI system. The performance tests ("Non-clinical Tests") evaluated the physical mask's characteristics.

7. The Type of Ground Truth Used

The ground truth used for evaluating the 3B Flex-Lite™ appears to be based on:

• Engineering specifications and regulatory standards for medical devices (implicitly, concerning safety, materials, and performance parameters like dead space, CO2 rebreathing, flow vs. leak pressure).
• Performance characteristics of legally marketed predicate devices (InnoMed Nasal-Aire II and Resmed Swift FX) as established through their own testing and marketing. The goal was to demonstrate that the new device is "substantially equivalent" in terms of performance to these predicates.

8. The Sample Size for the Training Set

This is not applicable. The 3B Flex-Lite™ Nasal Mask is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI.

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

This is not applicable for the same reasons as #8.

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