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Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Babi.Plus Infant Nasal Cannula System:

The information provided describes a 510(k) premarket notification for a medical device (Babi.Plus Infant Nasal Cannula System), emphasizing its substantial equivalence to a predicate device. The core of the "study" proving acceptance criteria here is a bench testing and dimensional analysis comparison to a legally marketed predicate device, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent performance" to the predicate device. The performance characteristics compared are "Resistance to gas flow in the inspiratory circuit" and "Resistance to gas flow in the expiratory circuit."

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria is met by demonstrating that the "Proposed Device" (Babi.Plus Nasal Cannula) has "substantially equivalent performance" to the "Predicate" device based on the measured resistance to gas flow values. Visually, the reported values for the proposed device are consistently close to, or slightly lower than, the predicate device's values, especially for the inspiratory circuit, indicating comparable or even slightly reduced resistance.

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

• Sample Size: Not explicitly stated in terms of number of devices tested. The data presented is a series of measurements across different gas flow rates (1 to 12 L/min). It implies measurements were taken for at least one unit of each device type (Proposed and Predicate).
• Data Provenance: The data is generated from bench testing conducted by A Plus Medical. There is no mention of country of origin of the data, nor is it clinical (retrospective or prospective) data. It's engineering performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the study is a bench test comparing physical performance characteristics (gas flow resistance) of medical devices, not an evaluation requiring expert interpretation of medical images or patient outcomes. The "ground truth" is derived from metrology/measurement techniques, not expert consensus.

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

• None. This concept is not applicable to a bench testing study comparing physical specifications. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretation of qualitative data.

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:

• No. An MRMC comparative effectiveness study was not done. This study is a bench comparison of physical device characteristics, not an AI-assisted diagnostic tool.

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

• Not applicable. This study does not involve an algorithm or AI. It's a physical device.

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

• The "ground truth" for this study is the measured physical properties (resistance to gas flow) of the predicate device. The proposed device's performance is then compared directly against these established measurements. This is based on objective measurements from a bench test setup, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This study does not involve a training set as it is a bench test comparison of physical devices, not a machine learning model.

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

• Not applicable. As there is no training set, this question is irrelevant to the described study.

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