(83 days)
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
The provided text describes the Venti.Plus Hyperinflation Bag System with Pressure Manometer. While it mentions performance characteristics and equivalence to a predicate device, it does not detail specific acceptance criteria or a dedicated study in the format requested (i.e., a table of acceptance criteria and reported device performance). It primarily focuses on demonstrating substantial equivalence based on indications for use, environment of use, patient population, materials, and overall function, referencing bench testing and adherence to an ISO standard for connectors.
Here's a breakdown of the information that is available in relation to your questions, and what is missing:
Information Provided in the Document:
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A table of acceptance criteria and the reported device performance: This is not explicitly provided in a table format. The document states:
- "Bench testing confirmed that the A Plus Medical Venti.Plus Hyperinflation System with Pressure Manometer and predicate device have similar performance characteristics and the accuracy of the integrated pressure manometer in the Venti.Plus Hyperinflation System with Pressure Manometer is equivalent to the predicate device when used with its associated pressure manometer."
- It also states that both the device and predicate meet "the requirements set forth ISO 5356- 1:2004 entitled 'Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets'." This ISO standard likely contains specific acceptance criteria for conical connectors, but the document doesn't extract or list them.
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Sample size used for the test set and the data provenance: This information is not mentioned. The document refers to "bench testing" but provides no details on the sample size of devices tested or the origin of any data (e.g., retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not mentioned. The "bench testing" does not involve human readers or experts establishing ground truth in the context of diagnostic performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as there is no mention of a test set requiring adjudication in this context.
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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: This is not applicable. The device is a manual resuscitator with a pressure manometer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "accuracy of the integrated pressure manometer," the ground truth would presumably be a calibrated reference pressure measurement device. For the "similar performance characteristics," it would involve comparing the Ventin.Plus to the predicate device under various testing conditions, with the predicate serving as a benchmark. For the ISO standard, the ground truth would be the specifications outlined in the standard. However, the document does not explicitly state the type of ground truth or reference standards used for the performance comparisons.
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The sample size for the training set: This is not applicable as it's not an AI/machine learning device.
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How the ground truth for the training set was established: This is not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).