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Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Babi.Plus™ Pressure Limitation Manifold. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria or a study proving the device meets them in the context of diagnostic performance or clinical efficacy.

Instead, the document details non-clinical bench testing to demonstrate the device's functional performance against its design claims. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the way it would be for a diagnostic or therapeutic device that has a "performance" in terms of accuracy, sensitivity, or specificity.

However, I can extract information related to the device's functional claims and the tests performed.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

General performance claims for the Babi.Plus™ Pressure Limitation Manifold:

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

• Test Set Sample Size: Not explicitly stated. The described tests are bench tests performed on device units. For "accuracy of pressure relief" and "service life testing," multiple units would typically be tested, but the exact number isn't provided.
• Data Provenance: Not applicable in terms of country of origin of patient data, as these are non-clinical bench tests. The tests were performed by "A Plus Medical." Retrospective or prospective classification is also not applicable for these types of engineering/bench tests.

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

• Not applicable. Ground truth as typically understood for clinical/diagnostic devices (e.g., expert consensus on medical images) is not relevant for these non-clinical functional performance tests. The "ground truth" here would be established by validated test equipment and engineering specifications.

4. Adjudication method for the test set

• Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.

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, a MRMC comparative effectiveness study was not done. This device is a mechanical pressure limitation manifold, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's inherent mechanical function. The described bench tests assess this standalone performance.

7. The type of ground truth used

• For the functional bench tests (e.g., pressure relief accuracy), the ground truth is established by engineering specifications and measurements from calibrated testing equipment. For example, a calibrated pressure sensor would measure the actual pressure at which the device relieves, and this would be compared against the intended relief pressure.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI models, so there is no "training set."

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

• Not applicable, as there is no training set for this device.

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The Wet Nose Technologies (WNT) Pressure Release Valve is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow Nasal Cannula or Bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up to, and including 15 L/min. The device is intended for use when a disposable, low pressure (20 cm H20 +/- 4 cm H2O activation), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.

The Pressure Release Valve (PRV) is a custom valve designed specifically for pediatric/infant use within a Continuous Positive Airway Pressure (CPAP), High/Heated Flow Nasal Cannual (HFNC) and other pressure systems. This valve is a safety feature designed to limit the system pressure of the circuit to pressures below the PRV relief pressure range. The device is intended for use with flow rates greater than 0 L/min up to, and including, 15 L/min. The device is placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Thus, this device may be used to regulate the maximum pressure achievable within a pressure system. Opening the PRV will activate an audible sound to alert Healthcare professionals over pressurization and the possible need for corrective action. The activation pressure 20 cm H2O +/- 4 cm H2O is based on the relief pressure at 8 L/min is 16 is 20 cm H2O and at 15 L/min is 24 cm H2O. The valve reacts instantaneously to an occlusion and automatically resets upon release of the occlusion. The device is disposable, single-patient use and is prescription only.

The Pressure Release Valve connects with the pressure tubing by way of a Wet Nose Technologies 'T6' Adapter.

The Pressure Release Valve and the 'T6' Adapter are sterilized by gamma irradiation and supplied sterile in bag pouch. Fifty bag pouches are packaged in a dispenser box. Each bag pouch and dispenser box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

The Wet Nose Technologies Pressure Release Valve is designed as a safety feature for pediatric/infant breathing gas delivery systems to prevent excessive inspiratory pressure. The acceptance criteria and performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or clinical trials. Instead, performance testing was conducted on the device itself.

• Sample Size: Not explicitly stated as a number of devices, but implies testing of the manufactured product.
• Data Provenance: The testing was nonclinical and conducted by the manufacturer, Wet Nose Technologies, LLC. The studies are prospective in nature, as they involve testing the device against its specifications. There is no indication of country of origin of patient data, as no clinical data was used.

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

Not applicable. Ground truth for this device's performance was established through engineering specifications and objective measurements against those specifications, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies or diagnostic accuracy assessments involving human interpretation. For this device, performance was measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. The device is a mechanical safety valve, and its performance is evaluated against engineering specifications, not human diagnostic performance. Therefore, there is no effect size of human readers improving with or without AI assistance.

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

Yes, in a sense. The performance testing conducted (e.g., change in relief pressure with flow rate, leak testing, response time) assessed the device's functional characteristics independently. This is analogous to a "standalone" evaluation of the device's mechanical and operational performance.

7. The Type of Ground Truth Used

The ground truth used was the engineering specifications and established physical principles for a pressure relief valve. Performance was measured against these predefined thresholds (e.g., activation pressure, response time).

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical safety valve, not an AI or machine learning algorithm requiring a "training set."

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

Not applicable, as there is no training set for this device.

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