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The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are 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 healing 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 PAH-M10+2 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 12 patients at up to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch qauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas. The overall external length of the chamber is 7025mm (approx. 23 ft). Its internal diameter is 2500mm (approx. 8.2 ft). There are two compartments: main compartment and transfer compartment. Ten (10) seats and two (2) seats are installed in main compartment and transfer compartment respectively. Besides, there is one (1) additional seat installed in the main compartment for attendant. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirement of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as CD players, radios, etc. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The rectanqular door allows a normal size patient gurney to be used to transport nonambulatory patients into the chamber. This feature greatly improves patient handling safety.

This 510(k) Notification Summary describes a hyperbaric chamber system, not an AI/ML powered device. As such, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML or device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on:

• Device Description: A multiplace hyperbaric chamber system (PAH-M10+2) designed to treat up to 12 patients at specified pressures, using compressed air and 100% oxygen.
• Intended Use: To provide therapy for specific medical conditions that respond to hyperbaric oxygen, as outlined by the Undersea & Hyperbaric Medical Society (UHMS).
• Predicate Devices: A list of previously cleared hyperbaric chamber systems.
• Compliance with Standards: The device is designed and fabricated in accordance with ANSI/ASME codes and NFPA 99.
• FDA Clearance: A letter from the FDA stating substantial equivalence to predicate devices, thus allowing marketing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to AI/ML device performance. The type of device described here does not typically involve such metrics for its clearance.

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