(210 days)
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current The conditions instou as upprophato sic and Medical Society (UHMS)Hyperbaric Oxygen Therapy Committee Report (1998) are as follows: 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; Osteomyelitis (refractory); Delayed radiation injury ( soft tissue and bone necrosis); Skin grafts and flaps (compromised); Thermal burns; Intracranial abscess.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a hyperbaric chamber device, "Millennium 2000, 2001, 2002, 2003, 2004, 2005". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study with effect sizes for human readers.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document indicates that the device's indications for use are based on the "current Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998)". This implies that the device's efficacy for these conditions is established by existing medical consensus, rather than new clinical trials undertaken for this specific 510(k) submission.
In summary, this document is a regulatory approval letter based on substantial equivalence, and not a report of a study designed to prove the device meets specific performance acceptance criteria through the methods outlined in your request.
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).