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The BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA (Atmospheres Absolute).

The BARA-MED® and its predicate devices have the same intended use: as a prescription device intended for the whole-body administration of oxygen to a patient at pressures not exceeding 3 ATA. The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with purc oxygen, and the patient breathes the chamber atmosphere. Also, in cach of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time hold at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is sale and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance. The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of: ASME Boiler and Pressure Vessel Code, Section VIII, Rules For Construction . of Pressure Vessels, Division 1, 1998 Edition, ASME PVHO-1, Safety Standard For Pressure Vessets For Human . Occupancy, 1997 Edition NFPA 99, Standard For Health Care Facilities, Chapter 19, Hyperbaric . Facilities, 1999 Edition. In all respects, the BARA-MED" is substantially cquivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

The provided text describes a 510(k) premarket notification for a medical device, specifically the 'BARA-MED® Acrylic Monoplace Hyperbaric Chamber'. This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to previously marketed devices and allow commercialization.

Crucially, the provided text does NOT contain information about a study that proves the device meets specific acceptance criteria in the context of AI/ML performance evaluation. The document is focused on regulatory approval for a physical hyperbaric chamber, not a software or AI-driven medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML device. The document states that "Testing was indicated to demonstrate that the device meets the standards referenced above" (referring to ASME and NFPA standards for hyperbaric chambers), but it does not detail specific performance metrics, sample sizes, expert ground truth, or MRMC studies that would be relevant to an AI/ML system.

The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typically found in submissions for AI/ML-powered medical devices. This document describes a traditional medical device (a hyperbaric chamber) and its regulatory approval process, which relies on demonstrating compliance with engineering and safety standards, rather than clinical performance metrics typically associated with AI.

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