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It is the expressed, intended use of the Oxyheal 1000 Monoplace Hyperbaric Chamber series 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 the procurement and routine use.

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee report (2003) 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 of healing in selected problem wounds
7. Exceptional blood loss (anemia)
8. Intracranial abscess
9. Necrotizing soft tissue infections
10. Osteomyelitis (refractory)
11. Delayed radiation injury (soft tissue and bony necrosis)
12. Skin Grafts and flaps (compromised)
13. Thermal burns

The OxyHeal 1000 series is a Class B monoplace hyperbaric chamber system designed to treat 1 patient to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 30 pounds per square inch gauge (psig). The chamber uses compressed 100% oxygen as the pressurization gas as well as the hyperbaric treatment gas. The overall external length of the chamber is 105" inches. Its internal diameter is 33.5" inches. Pressurization and ventilation is continuously provided by compressed 100% oxygen. The patient breathes the chamber atmosphere directly. An air-break assembly using a regulated medical air source and mask is available. A low-voltage patient intercommunication system provides communications between the patient in the chamber and the outside chamber operator. Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic, manually operated control system is provided for double control redundancy. A series of penetrators are provided in the vessel end caps wall to allow user supplied intravenous lines, suction, medical monitoring leads, etc., to be used as required.

This is a 510(k) premarket notification for a medical device, the OxyHeal 1000 Monoplace Hyperbaric Chamber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a study.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It describes the device's intended use, its design, and its substantial equivalence to existing predicate devices based on principles of operation and intended use.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance acceptance criteria (e.g., a certain pressure accuracy, oxygen concentration range, or safety feature reliability threshold) nor does it report the results of a study against such criteria. The "performance" described relates to the design and features (e.g., maximum operating pressure, internal diameter, communication system).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or studies are referenced in this document for the OxyHeal 1000 chamber itself. The mention of "extensive data collection" refers to the UHMS's process for validating indications for hyperbaric oxygen therapy, not a study performed on this specific device.

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): As no test set or ground truth establishment relevant to this device's performance is described, this information is not present. The UHMS is cited as the authority for indications, but this is a medical society, not a panel establishing ground truth for a device's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process for device performance is mentioned.

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 device is a hyperbaric chamber, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for device performance. The "ground truth" mentioned in the context of hyperbaric oxygen indications comes from scientific validation and verification through extensive data collection by the UHMS.

8. The sample size for the training set: Not applicable, as this is not a machine learning device and no training set is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided document is a 510(k) summary for a hyperbaric chamber, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

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