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The Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs /30 kg.

The Kangaroo Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It 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 an adjustable headgear. It may be cleaned by the patient in the home (single patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).

The Kangaroo Nasal Mask consists of a frame with a gel cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. An elbow is connected to the cushion and includes integrated exhalation features. The elbow can rotate freely through 360 degrees and is connected to 15 mm tubing that includes an integrated 22 mm swivel connector. The mask is designed in such a way that it can be easily disassembled for cleaning or to replace several of the mask components.

The 22 mm swivel connector on the 15 mm tubing is used to connect the mask to a conventional 22 mm air delivery hose that is in turn connected to the positive airway pressure source. The swivel connector can rotate freely through 360 degrees.

The provided text describes a 510(k) submission for the "Kangaroo Nasal Mask." This submission does not include an AI-powered device or a study involving AI integration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate safety and effectiveness, and substantial equivalence to predicate devices, as typically required for medical devices.

Here's a breakdown of the requested information based on the provided text, focusing on the device's substantial equivalence through non-clinical testing, as no AI component, MRMC study, or standalone algorithm performance is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "extensive performance testing" and the execution of various standards, but does not provide specific sample sizes (e.g., number of masks tested per condition).
• Data Provenance: Not applicable in the traditional sense of patient data. The provenance relates to laboratory testing of the physical device and its materials, conducted by the manufacturer, Respironics, Inc. (USA). This testing is retrospective in the sense that it evaluates the manufactured product against predefined specifications and regulatory standards.

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

• This is not applicable as the "ground truth" for the non-clinical performance and safety testing is based on established engineering specifications, industry standards (e.g., AAMI TIR, ASTM, ISO 10993-1), and regulatory guidance from the FDA. The "experts" involved would be the testing engineers and scientists at Respironics, and potentially third-party labs if specialized testing was outsourced, whose qualifications would involve expertise in materials science, mechanical engineering, microbiology, and regulatory compliance, but they are not adjudicating clinical cases for ground truth.

4. Adjudication Method for the Test Set

• Not applicable in the context of clinical adjudication. The "adjudication" for this type of submission involves comparing test results against predefined thresholds and criteria outlined in the referenced standards and internal performance specifications. It's a binary outcome (pass/fail) based on objective measurements, not a consensus among clinical experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document explicitly states: "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Kangaroo Nasal Mask, as was the case with the predicate devices." This indicates that no clinical studies, including MRMC comparative effectiveness studies, were conducted or deemed necessary for this 510(k) submission.

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

• No. This product is a physical medical device (a nasal mask) and does not involve any algorithms or AI for performance. Therefore, no standalone algorithm performance testing was conducted.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering specifications, industry standards, and regulatory guidelines. For example:
  • Performance & Functionality: Meeting pre-defined operational parameters (e.g., airflow, pressure integrity, fitting) after various treatments.
  • Disinfection Efficacy: Achieving specified log reductions of microorganisms as per AAMI/ASTM standards.
  • Biocompatibility: Conforming to ISO 10993-1 requirements for biological safety.
  • Substantial Equivalence: Alignment with predicate devices in key technological characteristics and safety/effectiveness profiles.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

• Not applicable for the same reason as above.

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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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