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Intended use of our device is to correct tissue hypoxia for treatment of:

*Air or gas embolisms

*Decompression sickness

Carbon monoxide poisoning with or without cyanide complications

Smoke inhalation

Exceptional blood loss or anemia

Clostridial myonecrosis (gangrene)

Selected problem chronic wounds

Crush injury, compartment syndrome and acute traumatic ischemias

Compromised skin grafts

Osteomyelitis

Thermal burns

Osteoradionecrosis (radiation burns)

Necrotizing soft tissue infections

*In gas embolism and decompression sickness hyperbaric oxygenation van be used as a primary therapy. In the other indications hyperbaric oxygenation is an adjunctive treatment to further primary medical intervention.

Tampa Hyperbaric Monoplace Chamber

Stainless steel; supine patient position on gurney; eight acrylic viewports on 36" diameter chamber. All interior materials cleaned for oxygen service. Certified by the American Society of Mechanical Engineers - Pressure Vessel for Human occupancy.

The provided text is a 510(k) premarket notification letter and summary for a medical device, specifically a hyperbaric chamber. It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the provided text does not contain any information about acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed diagnostic performance metrics (e.g., sample size, provenance, expert qualifications, study types like MRMC or standalone performance, ground truth methods, or training set details).

The document is a regulatory submission for premarket notification, focusing on establishing substantial equivalence to an existing device based on physical characteristics and intended use, rather than a clinical performance study demonstrating diagnostic efficacy using specific acceptance criteria.

Therefore, I cannot provide the requested information.

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