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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 OxyHeal 2000 series is a Class A multiplace hyperbaric chamber system designed to treat up to 12 patients to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch gauge (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 can range from 12 feet to 20 feet. Its internal diameter can range from 72 inches to 180 inches. Large circular windows create a more open atmosphere and help reduce patient claustrophobia. Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oro-nasal masks or head tents. A low-voltage patient intercommunication system provides communications between the patients 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 and manually operated control system is provided for triple control redundancy. A penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. The large rectangular door allows a normal size patient gurney or wheelchair to be used to transport nonambulatory patients without having to transfer the patient to a smaller transport device.

The provided text, a 510(k) Notification Summary for the OxyHeal 2000 Hyperbaric Chamber Series (K011866), describes a medical device rather than an AI algorithm or software. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested for an AI/software device performance evaluation are not directly applicable in the same manner.

This document describes the device's technical specifications, intended use, and claims substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. The "study" here refers to the comparison of the device's design and performance against established standards and predicate devices, rather than a clinical trial validating an algorithm's diagnostic accuracy.

However, I can extract information relevant to the intent of your request by describing the device's compliance with established standards and its equivalence to predicate devices, which served as the basis for its market acceptance.

Acceptance Criteria and Device Performance for OxyHeal 2000 Hyperbaric Chamber Series (K011866)

For this type of device (a hyperbaric chamber), the concept of "acceptance criteria" is largely defined by adherence to recognized engineering standards and clinical practice guidelines, and demonstration of substantial equivalence to already approved devices. Device performance is typically evaluated against these standards and the capabilities of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification itself, which substantiates substantial equivalence to legally marketed predicate devices and compliance with relevant standards. No separate, formal clinical trial or AI performance study is described in this document for the OxyHeal 2000.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable in the context of an AI/software device. This device is a physical hyperbaric chamber. The "test set" for its acceptance is primarily its design documents, manufacturing processes, and comparison to predicate devices, and adherence to engineering and safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not directly applicable in the terms for AI/software. However, the ground truth for the medical indications for use is established by the Undersea and Hyperbaric Medical Society (UHMS). The UHMS is a professional medical organization that produces a list of medical conditions for which hyperbaric oxygen therapy is appropriate, based on scientific validation and extensive data collection. While specific numbers of individual experts are not named, the UHMS represents a consensus of medical professionals specializing in hyperbaric medicine.

4. Adjudication Method for the Test Set:

Not applicable as an adjudication method for a "test set" as understood for AI/software. The regulatory assessment involves the FDA's review of the submitted documentation, including design specifications, manufacturing controls, and the comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI diagnostic or assistance tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device (hyperbaric chamber), not an algorithm.

7. The Type of Ground Truth Used:

The primary ground truth for the clinical indications and safety standards for hyperbaric oxygen therapy is:

• Expert Consensus / Clinical Guidelines: The listed medical conditions for hyperbaric oxygen therapy are based on the Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999). The UHMS scientifically validates and verifies these indications through extensive data collection.
• Engineering and Safety Standards: Compliance with ANSI/ASME Boiler and Pressure Vessel Code, ANSI/ASME-PVHO-1, and NFPA 99 for the physical design and operation of the chamber serves as a "ground truth" for safe and effective device construction.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device. The "training" for this device would refer to its design and manufacturing informed by existing engineering principles and predicate devices.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as for an AI/machine learning algorithm. For a physical device, its "ground truth" or foundational knowledge comes from established engineering principles, material science, safety regulations, and the design and operational history of predicate devices. The substantial equivalence argument relies on demonstrating that the new device meets or exceeds the safety and efficacy profiles of these established products.

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