(177 days)
The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.
The EnduraVent-5 Ventilator is a self-contained, portable ventilator, consisting totally of non-magnetic components which include: (10 a gas inlet connector, (2) a gas inlet filter, (3) two timing valves, (4) a pilot actuator valve, (5) a flow metering valve, and, (6) a pressure-relief valve. During the inspiratory time phase of the system, a small portion of the gas flowing through the system is diverted to the exhalation valve diaphragm, inflating the diaphragm in sequence with the inspiratory time, thereby allowing the main gas flow from the Device to flow to the patient. During the expiratory phase, all ventilator gas flow ceases, the exhalation valve opens and the patients's exhaled gases flow to atmosphere.
The provided 510(k) summary for the EnduraVent-5 Ventilator describes its substantial equivalence to a predicate device, the Magellan Ventilator. It does not detail a study involving specific acceptance criteria or performance metrics for the EnduraVent-5 beyond confirming it operates as designed and functions as intended, with a focus on manufacturing process verification.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in a table format. It broadly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device operates as designed. | "In all instances, the EnduraVent-5 Ventilator functioned as intended." |
| Delivery of gas volumes. | "delivery of the gas volumes... was verified." |
| Delivery of frequencies. | "delivery of the... frequencies... was verified." |
| Function of safety devices. | "delivery of the... safety devices was verified." |
| Manufacturing process consistent with predicate. | "Bench testing... was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" but does not specify the sample size for the tests conducted.
The data provenance is not explicitly stated, but the testing was conducted by Providence Global Medical, Inc. in the context of a US 510(k) submission. It appears to be prospective testing for the EnduraVent-5 against the predicate.
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/Not mentioned. This type of information is typically relevant for AI/software-based devices assessing medical images or complex data, where human expert review establishes ground truth. For a mechanical ventilator, the "ground truth" is typically defined by engineering specifications and physical measurements, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. Adjudication methods are typically used when multiple human readers interpret data, and their disagreements need resolution to establish ground truth. This is not described for the ventilator's performance testing.
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
No. The document describes a comparison between the EnduraVent-5 Ventilator and its predicate, the Magellan Ventilator, based on "exactly duplicated technological characteristics and components, and exactly the same principles of operations." It is a substantial equivalence claim for a physical medical device, not an AI or software-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The EnduraVent-5 is a physical ventilator; the concept of a "standalone algorithm" is not relevant here. The performance testing was of the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of the EnduraVent-5 Ventilator appears to have been established by:
- Engineering specifications and design intent: "confirms that the device operates as designed."
- Comparison to the predicate device: "Bench testing with the Endura-Vent-5 and the predicate Magellan Ventilator was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories." This implies the predicate's known and accepted performance served as a benchmark.
- Physical measurements: Verification of "delivery of the gas volumes, frequencies, and safety devices."
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this device.
In summary: The 510(k) submission for the EnduraVent-5 Ventilator relies on demonstrating substantial equivalence to a legally marketed predicate device (Magellan Ventilator). The "study" described is primarily bench testing to confirm that the new device replicates the predicate's design and performs as intended, using the same testing protocols. The focus is on verifying manufacturing consistency and functional operation rather than specific quantitative performance metrics against a defined "ground truth" that would be typical for a diagnostic or AI-driven device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).