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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:

1. 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.

2. 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).

3. 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.

4. 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.

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: This is not applicable. The device is a manual resuscitator with a pressure manometer, not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. The sample size for the training set: This is not applicable as it's not an AI/machine learning device.

9. How the ground truth for the training set was established: This is not applicable.

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Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. The operating clinician controls peak pressure and monitors several respiratory parameters by use of a built-in manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve.

Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve

The provided text describes a 510(k) premarket notification for a medical device called the "Ventlab Hyperinflation Bag System with Built-In Pressure Monitor and Optional Pop-Off Valve." This document is a clearance letter from the FDA, and as such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.

FDA 510(k) clearance letters primarily state that a device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. They generally do not include the underlying performance study results, acceptance criteria, sample sizes, ground truth methodologies, or details about expert involvement.

To answer your questions, one would typically need access to the original 510(k) submission document itself, which contains the summary of safety and effectiveness, including performance data and the study design.

Therefore, based solely on the provided text, I can state the following:

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

• Cannot be provided. The text does not contain any specific acceptance criteria or detailed performance metrics. It only states that the device is "substantially equivalent" to predicate devices.

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

• Cannot be provided. The text does not describe any specific test set, its sample size, or its provenance.

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

• Cannot be provided. The text does not mention any experts or ground truth establishment relevant to a performance study.

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

• Cannot be provided. The text does not describe any adjudication method.

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:

• Cannot be provided. This device is a mechanical hyperinflation bag system, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance would not be applicable or expected.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• Cannot be provided. The text does not detail any ground truth methodologies. For a mechanical device like this, performance testing would typically involve engineering and bench testing against established standards for flow, pressure, etc., rather than clinical "ground truth" as you might see for diagnostic AI.

8. The sample size for the training set:

• Not applicable / Cannot be provided. There's no indication of a "training set" as this is not an algorithm requiring machine learning. Performance testing for a mechanical device would not involve a training set in this context.

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

• Not applicable / Cannot be provided. As above, no training set is mentioned or implied for this type of device.

In summary, the provided FDA clearance letter is a regulatory document affirming substantial equivalence, not a scientific publication detailing performance studies. The information requested typically resides in the 510(k) Summary or other accompanying technical reports submitted to the FDA, which are not part of this document.

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Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

This document is a 510(k) clearance letter for the Ventlab Hyperinflation Bag System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed devices. It outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot provide the requested information about acceptance criteria and the study based on the provided text.

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Ask a specific question about this device

The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffering from respiratory insufficiency. Typical treatment consists of hyperinflating the patient's lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.

The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis.

This looks like a 510(k) clearance letter for the SIMS Hyperinflation Bag System. Unfortunately, the provided text does not contain the acceptance criteria or details of a study used to prove the device meets such criteria.

The document is purely administrative, confirming the substantial equivalence of the SIMS Hyperinflation Bag System to legally marketed predicate devices. It discusses regulatory product codes, general controls, and other administrative information related to market authorization.

To answer your request, I would need a different document, such as:

• A summary of safety and effectiveness (SSE), which often accompanies 510(k) submissions and details the studies conducted.
• The 510(k) submission itself, which would contain the full details of performance testing and acceptance criteria.
• Clinical study reports or bench testing reports for the device.

Without that specific information, I cannot provide the details you've requested about acceptance criteria and the supporting study.

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