(879 days)
The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
The Portable Hyperbaric Chamber Revitalair® 430F is a hyperbaric chamber for low pressures (operating at pressures of no greater than 1.4 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).
Revitalair® 430F consists of 2 parts, the cabin or chamber and the compression system or compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1).
The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves.
The safety or relief valves are operated at pressures above 1.3 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the chamber.
The Revitalair® 430F has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside.
The Revitalair® 430F can be operated from the interior as well as from the exterior.
After folding it up, the Revitalair® 430F is placed in its transportation box or in the optional carrying case.
This document primarily concerns the 510(k) premarket notification for the Revitalair® 430F Portable Hyperbaric Chamber, seeking to establish substantial equivalence to an existing predicate device. It does not describe a study involving an AI/Machine Learning device, nor does it list acceptance criteria and performance data for such a device.
The information provided in the document is related to a traditional medical device (a hyperbaric chamber) and its non-clinical performance testing to demonstrate safety and effectiveness.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This document does not contain this information for an AI/ML device. It lists non-clinical performance tests for the hyperbaric chamber itself.
- Sample sized used for the test set and the data provenance: Not applicable to an AI/ML study from this document.
- Number of experts used to establish the ground truth... and qualifications: Not applicable to an AI/ML study from this document.
- Adjudication method: Not applicable to an AI/ML study from this document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This indicates no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., pressure capabilities, material strength), verified through engineering tests, not expert consensus on medical images or patient outcomes.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the provided text is a 510(k) submission for a non-AI/ML medical device (a hyperbaric chamber) and does not contain the information requested about AI device performance studies.
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).