(43 days)
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
The VORTRAN Automatic Resuscitator (Model VAR-Plus) provides constant flow pressure cycled ventilatory support. The primary working mechanism of the VAR-PLUS is the Modulator which is an exhalation valve that opens at a set PIP (Peak Inspiratory Pressure) pressure and closes at a lower PEEP (Positive End Expiratory Pressure) pressure. During inhalation, exhalation will not start until the peak pressure is reached. During exhalation, inhalation will not begin until the pressure drops to PEEP. The rest of the VAR-PLUS consists of the Patient Connector Tee used to supply a flow of gas, entrain additional air, and provide a redundant pop-off valve
The provided document is a 510(k) summary for the VORTRAN Automatic Resuscitator (VAR-Plus), a Class II medical device. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain information about clinical studies measuring specific performance metrics against acceptance criteria.
The document explicitly states "Clinical Tests: None" and "Adverse S & E: None." Instead, the submission relies on in vitro testing and comparison to existing standards and predicate devices to demonstrate substantial equivalence.
Therefore, many of the requested items cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding device performance metrics. It refers to two standards/guidances that define performance and safety requirements:
- "FDA Draft Emergency Resuscitator Equivalency Guidance" 14 April 1993 868.5925 Powered Emergency Ventilator (Resuscitator) BTL
- "Standard Specification for Minimum Performance and Safety requirements for Resuscitators Intended for Use with Humans", ASTM Designation: F 920 - 93 (Reapproved 1999) An American National Standard.
However, the specific acceptance criteria from these documents and the VAR-Plus's reported performance against them are not detailed in this 510(k) summary. It only states that the device "meets" these standards. The device's operational characteristics are described qualitatively:
| Operational Characteristic | Reported Device Performance (Qualitative) |
|---|---|
| Gas Flow Input | Up to 40 L/min |
| Automatic Delivery (50 PSIG source) | 40 L/min (667 mL/second) |
| Peak Pressure (PIP) | Adjustable from 10 to 45 cm H2O |
| PEEP | Typically 1/5th of PIP |
| Inspiratory Time | Adjustable over a wide range |
| Rate | Adjustable over a wide range |
| Air Entrainment Valve | Allows patient to entrain additional air and respond to demand (pressure support) |
| Redundant Pop-off Valve | Relieves pressure at 60 cm H2O |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical tests were performed. The "in vitro testing" mentioned is not detailed in terms of sample size or methodology.
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)
Not applicable, as no clinical tests requiring expert-established ground truth were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests requiring adjudication were performed.
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 mechanical resuscitator, not an AI or diagnostic imaging device that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mechanical resuscitator. However, "standalone performance" in the context of typical AI/diagnostic device evaluation refers to the algorithm's performance without human intervention, which is not relevant here. The device's performance, as a mechanical product, was evaluated through in vitro testing against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical studies. The "ground truth" for the in vitro testing would be the specifications and requirements outlined in the referenced FDA Guidance and ASTM Standard. Compliance was likely verified through physical measurements and observations during bench testing.
8. The sample size for the training set
Not applicable, as this is a mechanical device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a mechanical device, not an AI/machine learning algorithm.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).