(457 days)
The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.
The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi rigid chamber for low pressures (operating at pressures of no greater than 1.5 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® 430+ consists of 2 parts, the cabin or chamber and the 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 of 1.5 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the Revitalair® 430+ has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside. The Revitalair® 430+ can be operated from the exterior. After folding it up, the Revitalair® 430+ is placed in its transportation box or in the optional carrying case.
The provided text describes a 510(k) premarket notification for a medical device, the Revitalair 430+ Hyperbaric Chamber. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria for an AI/ML-driven diagnostic system.
The document does not contain information about:
- Acceptance criteria and reported performance of an AI/ML device.
- Sample sizes, data provenance, or ground truth establishment for a test set in the context of AI/ML validation.
- Number and qualifications of experts or adjudication methods for establishing ground truth for AI/ML.
- MRMC comparative effectiveness studies or standalone AI algorithm performance.
- Training set details for an AI/ML model.
This document is a regulatory submission for a physical medical device (a hyperbaric chamber) and relies on demonstrating substantial equivalence to existing predicate devices, rather than validating a novel AI/ML algorithm's analytical and clinical performance. Therefore, the requested information pertaining to acceptance criteria and performance study for an AI/ML device is not applicable and not present in the provided text.
The closest relevant information is the non-clinical performance data which focuses on safety and engineering standards for the physical device, not an AI/ML system. These include:
- Electrical safety testing (IEC 60601-1)
- Electromagnetic Disturbance (EMD) testing (IEC 60601-1-2)
- Biocompatibility testing (ISO 10993 and ISO 18562)
- Device Life Report (reliability analysis)
- Pressure Testing (ASME PVHO-1-2007)
The document states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device." This further confirms that it's not a study validating an AI/ML device.
§ 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).