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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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The Bag and Mask 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 Bag and Mask Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; an optional air/oxygen blender including high-pressure yokes that allows the clinician to adjust FiO2 % from 21-100%; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer. 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. The Giraffe and Panda Bag and Mask Resuscitation System, like the Ohmeda Medical Infant Resuscitation System, does not include the manual resuscitator. The patient circuit is to be supplied by the user.

Here's an analysis of the acceptance criteria and supporting study based on the provided text, recognizing that it's for a traditional medical device and not AI software, so some requested fields may not be applicable.

Acceptance Criteria and Device Performance

The provided document (K070247) describes a traditional medical device, the "Giraffe and Panda Bag and Mask Resuscitation System," which is a manual emergency ventilator. The acceptance criteria and performance are not presented in a quantitative table as typically seen for AI/software devices with metrics like sensitivity, specificity, etc. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and conformance to performance specifications and recognized standards through bench testing.

There is no table of acceptance criteria and reported device performance in the provided document. The document states that the device is substantially equivalent to the predicate devices listed.

Study Details

Given that this is a traditional medical device (manual emergency ventilator) intended for a specific clinical practice with well-established guidelines, the nature of the "study" to prove it meets acceptance criteria differs significantly from a study for an AI-powered diagnostic device.

Here's a breakdown of the requested information, with explanations where a direct match isn't present due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

   • N/A. As mentioned above, a quantitative table of performance metrics (like sensitivity, specificity, accuracy) is not provided or typically required for this type of traditional device. Acceptance is based on substantial equivalence to predicate devices and conformance to recognized performance standards through bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. The document explicitly states: "Pulmonary resuscitation of infants includes well established clinical practices; animal or clinical testing to support safety and effectiveness is not necessary." This means there was no clinical "test set" involving patients or actual clinical data. The testing was limited to bench testing.
   • Therefore, there is no "sample size" of patients/data, nor "data provenance" in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. As no clinical "test set" was used, there was no need for experts to establish ground truth in the context of clinical outcomes or diagnoses. The "ground truth" for this device's performance is compliance with engineering specifications and recognized performance standards for manual emergency ventilators.

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

   • N/A. No clinical test set. Adjudication methods are not applicable here.

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:

   • N/A. This device is a manual emergency ventilator, not an AI assistance tool for human readers. Therefore, an MRMC study or AI assistance comparison is not relevant.

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

   • N/A. This device does not contain an "algorithm" in the sense of AI or software processing data. It is a mechanical medical device operated by a "trained clinician." Its performance is inherently coupled with human operation, but not in an AI-assisted manner.

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

   • The "ground truth" for this device's acceptance is based on its conformance to performance specifications and multiple recognized performance standards as established through bench testing. This aligns with engineering and regulatory standards for mechanical medical devices, rather than clinical ground truth from patient data. The "Intended Use Statement" also references "collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation," which represent the established standard of care that the device supports.

8. The sample size for the training set:

   • N/A. As there was no clinical data and no AI/machine learning model involved, there is no "training set."

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

   • N/A. No training set was used.

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