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The F&P Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician.

The Bubble CPAP System is for use in the hospital clinical environment such as the NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit).

The Fisher & Paykel Healthcare (F&P) Bubble CPAP (continuous positive airway pressure) System provides respiratory support to spontaneously breathing infants. The F&P Bubble CPAP System delivers heated and humidified respiratory gas through an inspiratory breathing circuit to the infant via a nasal interface. An expiratory circuit connects to a water column threshold resistor which pressurizes the circuit. The F&P Bubble CPAP System consists of an in-line pressure relief valve, a humidification chamber, a heated breathing circuit, patient nasal interface and CPAP generator (water column threshold resistor). The System is intended to be operated at input gas flows of 4 - 15 L/min with available CPAP levels of 3 - 10 cmH2O.

The Fisher & Paykel Healthcare (F&P) Bubble CPAP System provides respiratory support to spontaneously breathing infants.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of numerical "acceptance criteria" for the device's main function (CPAP delivery) or a direct comparison to specific threshold values. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Study Details Proving Acceptance Criteria:

The submission outlines a combination of bench testing and a summary of existing clinical literature to establish substantial equivalence.

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

• Bench Tests: The specific sample sizes for the various bench tests are not explicitly stated in the provided summary.
• Clinical Performance: "Eight peer reviewed and published reports using the F&P Bubble CPAP System, including three randomized controlled trials."
  • Data Provenance: "Used around the world" and "compared with other forms of respiratory support in a variety of settings." These are retrospective studies (already published). The countries of origin are not specified beyond "around the world."

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

• Bench Tests: The summary does not specify the number or qualifications of experts involved in establishing ground truth for the bench tests. Ground truth would likely be based on established engineering principles and measurement standards.
• Clinical Performance: For the eight peer-reviewed and published reports, the "ground truth" (i.e., clinical outcomes, efficacy, safety) would have been established by the clinicians and researchers involved in those studies. The number and specific qualifications of these experts are not detailed in this 510(k) summary. These would be implicit in the peer-reviewed publications.

4. Adjudication Method for the Test Set

• Bench Tests: No adjudication method is described. Bench tests typically rely on direct measurements against predefined standards.
• Clinical Performance: For the summarized clinical reports, the adjudication method would have been specific to each individual study and subject to the peer-review process of the journal in which they were published. This summary does not detail these methods (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed or referenced. The device is a medical device (CPAP system), not an imaging or diagnostic AI tool that would typically involve human readers interpreting cases. The comparison is between the F&P Bubble CPAP System and a predicate CPAP device, primarily through bench testing of physical performance and a review of existing clinical literature on the F&P system.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• The F&P Bubble CPAP System is a medical device that delivers a therapy, not an algorithm in the sense of a software-only tool. Its "standalone performance" is understood through its function of generating and delivering CPAP. The bench tests described (CPAP level delivered, work of breathing, compliance with ISO standards) directly assess its standalone physical performance.
• There isn't an "algorithm only" component in the context of typical AI/software medical devices. The device's operation is its standalone performance.

7. Type of Ground Truth Used

• Bench Tests: Engineering measurements, adherence to ISO standards, and comparison to the predicate device's measured performance.
• Clinical Performance: Clinical outcomes, safety data, and efficacy measures reported in peer-reviewed medical literature.

8. Sample Size for the Training Set

• The F&P Bubble CPAP System is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence or machine learning. The device's design is based on engineering principles and knowledge, validated through testing.

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

• As there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the device's development would be established engineering specifications, medical requirements for CPAP delivery, and safety standards, which are met through design and validation testing.

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