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It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use.

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) is as follows:

1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myositis and myonecrosis
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhanced of selected problem wounds
7. Exceptional blood loss anemia
8. Necrotizing soft tissue infections
9. Osteomyelitis (refractory)
10. Delayed radiation injury (soft tissue and bony necrosis)
11. Skin grafts and flaps (compromised)
12. Thermal burns
13. Intracranial abscess

The Gulf Coast Hyperbarics rectangular multiplace hyperbaric chambers are designed and manufactured in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel code, Section VIII, Division 1, Pressure Vessels ANSVASME-PVHO-1 (American Society of Mechanical Engineers- Pressure Vessels for Human Occupancy. and NFPA 99, Health Care Facilities; Chapter 20, Hyperbaric Facilities, 2005 Edition. The new Gulf Coast Hyperbaric multiplace rectangular chambers (K082455) are designed and manufactured using the same major components as in the cleared Gulf Coast Hyperbarics multiplace cylindrical chamber (K950957). The rectangular multiplace chamber includes as a key component, a new and user friendly rectangular design which is simple and simulates as closely as possible the clinical conditions found elsewhere in their working environment.

The rectangular chamber(s) place major emphasis on patient and operator safety, and user-friendly operator controls and includes several unique features including:

• A large, comfortable rectangular hyperbaric chamber that has been outfitted to appear like any other clinical room in a hospital to reduce patient anxiety
• Large walk-through rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over the doorjamb.
• A large and easy to use control console designed to display all functions of the chamber
• An oxygen hood supply and exhaust system designed for easy use and eliminates over or under pressurization of the hood and eliminates the possibility of "shrink wrapping" the patient hood.
• Air conditioning system providing controllable cooling and heating of the chamber interior. The temperature and humidity is monitored at the control console.

The provided text is a 510(k) summary for a hyperbaric chamber (K082455). It describes the device, its intended use, and its substantial equivalence to existing devices. However, it does not contain information about any studies conducted to prove the device meets acceptance criteria.

The document lists the specifications of the device, which could be considered design acceptance criteria, but there is no mention of testing or studies performed to demonstrate adherence to these specifications beyond the statement that the device is "designed and manufactured in accordance with the requirements".

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information on:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is purely a premarket notification for substantial equivalence, which primarily relies on comparing the new device to existing legally marketed predicate devices, rather than conducting new performance studies for the new device as would be required for a novel device or a PMA submission.

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