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The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The Puffin Lite Infant Resuscitation System underwent bench testing to demonstrate conformance to performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual bench test. The testing was described as "bench testing," which typically involves laboratory-controlled environments and simulated conditions rather than real patient data. The data provenance is from this bench testing, not from human subjects or real-world clinical data. Therefore, there is no information on country of origin or whether the data was retrospective or prospective.

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. The study involved bench testing of a medical device, where acceptance criteria were based on engineering and performance specifications (e.g., pressure, flow, FIO2 accuracy) rather than expert interpretation of medical images or data. Ground truth was established by measuring the physical performance parameters of the device against predefined technical requirements.

4. Adjudication method for the test set:

Not applicable. As the study was bench testing against predefined technical specifications, there was no need for an adjudication method by human experts for the "ground truth." The "passing" or "failing" of a test was determined by whether the device's measured performance fell within the specified limits.

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:

Not applicable. This is a 510(k) submission for a physical medical device (infant resuscitator) and not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical medical device (infant resuscitator) that is intended for use by trained medical professionals.

7. The type of ground truth used:

The ground truth used for this study was the engineering and performance specifications outlined in the acceptance criteria. The device's performance was measured against these objective, predefined technical requirements. There was no reliance on expert consensus, pathology, or outcomes data in the context of this bench testing.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning system that requires a "training set" of data.

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

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

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The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).

The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).

It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.

The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.

The provided document describes the Mercury T-Piece Resuscitator and its substantial equivalence to predicate devices, focusing on non-clinical testing for performance. This is a 510(k) premarket notification summary, which means the device is being compared to an already legally marketed device (predicate device) and does not involve AI or complex analytical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories in the prompt are not applicable to this document. I will focus on the information that can be extracted directly from the provided text.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally aligned with the performance requirements outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators. The "Reported Device Performance" column reflects the specifications of the proposed Mercury Medical T-Piece Resuscitator as presented in comparison tables with its predicate devices.

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The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).

Here's a breakdown of the acceptance criteria and study information for the LifeBorne Infant Resuscitator, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated as a separate "test set" sample size. The document refers to "bench testing" as the method for performance evaluation. The tests themselves are functional evaluations of the device's components and overall system.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or simulated environment. The country of origin of the data is not specified, but the submission is from International Biomedical, located in Austin, TX, U.S.A. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

• Not applicable. This device's performance was evaluated through bench testing against predefined technical specifications, not by expert interpretation of data. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method for the test set:

• Not applicable. As described above, the evaluation was based on meeting objective technical requirements through bench testing, not on human interpretation requiring 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. This is a medical device (resuscitator) that does not involve "human readers" interpreting medical cases or utilizing AI. Its effectiveness is determined by its mechanical and functional performance.

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

• Yes, in a way. The device itself operates "standalone" in performing its functions (e.g., delivering precise FIO2, controlling PIP/PEEP). The "bench testing" represents the performance of the algorithm/device without human intervention during the test itself (though humans operate the test setup). There is no "algorithm" in the sense of AI or image analysis involved.

7. The type of ground truth used:

• The ground truth for the device's performance was based on predefined technical specifications and engineering standards. Each test had a specific, measurable requirement (e.g., FIO2 within 5%, dead space less than 7 mL) which served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

• Not applicable. This device is a mechanical/electronic system, not one that uses machine learning or AI that would require a "training set" of data.

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

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

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