(140 days)
The Neptune Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwise require mechanically supported ventilation during hyperbaric therapy.
The Neptune Hyperbaric Ventilator consists of two main components: (1) a Control Module and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators and timing valves for control of inspiratory time, expiratory time, and inspiratory flow, as well as pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber and includes an exhalation valve, a pressure relief valye, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber door. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Neptune Hyperbaric Ventilator that are supplied with the device.
Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
The provided text describes a 510(k) premarket notification for the Neptune Hyperbaric Ventilator. It does not contain information about a clinical study involving human patients or complex performance metrics typically associated with AI/ML device evaluations. Instead, the performance testing described is focused on verifying the device's functional operation and safety features.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Functional Operation | Device operates as designed. | "In all instances, the Neptune Hyperbaric Ventilator functioned as intended." |
| Gas Delivery | Delivery of specified gas volumes. | "delivery of the gas volumes...was verified." |
| Timing/Frequency | Delivery of specified frequencies (e.g., inspiratory/expiratory time). | "delivery of the...frequencies...was verified." |
| Safety Devices | Functionality of safety features (e.g., patient airway pressure gauge, adjustable pressure relief valve, hand-operated oxygen flush valve). | "safety devices was verified." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an algorithm. It describes performance testing of the physical ventilator device itself. The sample size for this physical device testing is not explicitly stated, but it implies testing would have been conducted on one or more units of the Neptune Hyperbaric Ventilator. The data provenance is not applicable as this refers to a physical device performance test, not a data-driven algorithm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical ventilator, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for a test set. The performance testing would have involved engineering and technical personnel assessing the device's functionality against its design specifications.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This document does not mention any MRMC comparative effectiveness study. This type of study is typically used for AI-assisted diagnostic or prognostic devices where human readers (e.g., radiologists) are involved. The Neptune Hyperbaric Ventilator is a mechanical ventilator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone mechanical ventilator. Its "performance" is its ability to deliver gases and manage ventilation parameters, which would be tested directly. There is no separate "algorithm only" performance reported in the context of AI.
7. The type of ground truth used
The "ground truth" for the performance testing was the design specifications and intended operation of the Neptune Hyperbaric Ventilator. The device's output (gas volumes, frequencies) and the function of its safety mechanisms were compared against these pre-defined engineering and medical requirements.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
§ 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).