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The T-piece Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. * Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide. For professional use only, by trained clinicians. * As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.

The T-piece Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer. An optional air/oxygen blender including high-pressure yokes may be included with the system which allows the clinician to adjust FiO2 % from 21-100%. The airway pressure manometer allows a trained clinician to see pressure throughout the respiratory cycle. Peak Inspiratory Pressure (PIP) is adjusted using the PIP knob located on the front panel of the resuscitation system that allows the clinician to set the maximum pressure being delivered to the infant in order to facilitate adequate pressurization of the lungs. Positive End Expiratory Pressure (PEEP) can be set using the adjustable PEEP valve located on the T-piece patient circuit. The T-piece resuscitation system is intended for use only with GE Healthcare Tpiece resuscitation circuits.

The provided text describes the Giraffe and Panda T-piece Resuscitation System, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

Instead, the document states:

"Pulmonary resuscitation of infants includes well established clinical practices; animal or clinical testing to support safety and effectiveness is not necessary. The conformance of the Giraffe and Panda T-piece Resuscitation System to performance specifications and to multiple recognized performance standards is being established through bench testing."

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "performance specifications" and "recognized performance standards" but does not detail them or present a table of results.
2. Sample size used for the test set and the data provenance: No test set or clinical data is mentioned, as clinical testing was deemed (by the submitter) unnecessary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set or ground truth is described.
4. Adjudication method: Not applicable.
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 device is a resuscitation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document indicates that the device's conformance is established through bench testing against performance specifications and recognized standards. However, the details of these tests and results are not provided in this 510(k) summary.

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