Search Results

Hyperbaric Oxygen Therapy (HBOT) is a painless procedure in which a person is exposed to increased pressure, thus allowing greater absorption of oxygen throughout body tissues. This increased pressure allows more oxygen to reach the cells within the body therefore contributing to the many healing and therapeutic benefits.

The expressed and intended use of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber is 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 U prescriptive device, it is further intended for physician involvement in their procurement and routine use.

The conditions listed as appropriate for the use of Hyperbaric Oxygen Treatment are:

• Air or gas embolism
• Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
• Clostridial myositis and myonecrosis
• Crush injury, compartment syndrome and other acute traumatic ischemias
• Decompression sickness
• Enhanced healing of selected problem wounds
• Exceptional blood loss anemia
• Necrotizing soft tissue infections
• Osteomyclitis (refractory)
• Delayed radiation injury (soft tissue and bony necrosis)
• Skin grafts and flaps (compromised)
• Thermal burns
• Intercranial abscess

The HyperOx Hyperbaric Oxygen Treatmcnt Chamber is a Class A multi-place hyperbaric chamber designed to treat up to 10 patients up to 32 psig. The device will use compressed, dried/chilled air as the pressurization gas and 100% medical oxygen as the treatment gas.

Specifications of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber are:
Design Code: ASME Section VIII, Div 1 and ASME-PVHO-
Operating Pressure: 32 psig
Operating Temperature: 65 to 95 degrees F
Design Pressure: 45 psig
Design Temperature: 65 to 95 degrees F
Design Life: 70,000 cycles (approx. 30 years)
Hydrostatic Pressure: 42.0 psig
Weight: 11,200 lbs. (5.6 tons)
Dimensions: 72" W X 88" H X 16' 6" L
Doorway Opening Size: 30" X 60" clear opening
Lighting: Four (4) external dimmable lights (1) 12" dia. clear view portlight in door (8) 9" dia. clear view portlights in shell
Capacity: Up to 11 occupants
Fire Suppression: IAW NFPA 99
Finish: SSPC-SP-10 shotblast, primed & painted
Controls: Manual electropneumatic pressurization Manual electropneumatic depressurization
Ventilation: Constant airflow
BIBBS with dump: Four
Oxygen Flow Manifold: Twelve feeds to O2 mask
Gas Analysis: Oxygen and carbon dioxide
Communications: Wireless PA
Entertainment (optional): Wireless internet connection External TV system w/remote & DVD player AM/FM tuner with CD player

The document describes a hyperbaric oxygen treatment chamber, not an AI/ML device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance is not applicable.

The document focuses on the substantial equivalence of the HyperOx 101 Hyperbaric Oxygen Treatment Chamber to existing predicate devices based on design, method of pressurization, and intended use.

Here's what can be extracted from the provided text regarding the device's specifications and comparison to predicates, which are analogous to acceptance criteria in this context for non-AI devices:

1. A table of acceptance criteria and the reported device performance:

For a non-AI medical device like a hyperbaric chamber, "acceptance criteria" are typically defined by compliance with established engineering and safety standards, and functional specifications meeting the intended use. The "reported device performance" is demonstrated by the device's design specifications meeting these standards and being substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a hardware device, not an AI/ML diagnostic or prognostic tool. Its performance is assessed through its engineering design, adherence to safety standards, and functional specifications, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device relates to its physical and functional integrity, and compliance with engineering standards (ASME, NFPA). These are evaluated by regulatory bodies and internal engineering teams against established codes, not by medical experts establishing diagnostic ground truth on a data set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the context of AI/ML evaluation. Compliance with standards and substantial equivalence is typically assessed through documentation review, inspection, and possibly performance testing of the physical chamber.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for a device like this is its compliance with recognized engineering codes and standards (e.g., ASME, NFPA) and its ability to achieve the specified operational parameters (pressure, temperature, gas delivery). The safety and efficacy are also supported by the well-established medical literature and guidelines for hyperbaric oxygen therapy (UHMS).

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device