(14 days)
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.
§ 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).