(155 days)
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:
- 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 bony necrosis)
- Skin grafts and flaps (compromised)
- Thermal burns
- Intracranial abscess
The PAH-S1 Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses 100% oxygen as the pressurization gas and patient breathes the oxygen contained inside the chamber as the hyperbaric treatment das. The overall external length of the chamber is 2200mm (approx, 7.22 ft). Its internal diameter is 813mm (approx. 32 inches). The chamber is constructed by half-steel and half-acrylic tube. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 and provides communications between the patients in the chamber and the outside chamber operator. The system consists of an operator control panel that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. Spare penetrators are provided to allow user supplied medical monitoring leads, etc., to be used as required. Patient is loaded and unloaded by a retractable qurnev. The chamber is also equipped with for pressurization. There is no gas supply for pressurization before the chamber's door is closed and secured thoroughly.
This is a 510(k) premarket notification for a hyperbaric chamber system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.
The document focuses on demonstrating substantial equivalence to predicate hyperbaric chambers by adhering to established safety and performance standards for such medical devices.
Here's a breakdown of what can be extracted, though it doesn't fit the AI/ML framework:
1. Acceptance Criteria and Reported Device Performance (Non-AI Context):
While not framed as "acceptance criteria" for an AI model, the submission implies adherence to specific engineering and safety standards, which serve as performance benchmarks for a hyperbaric chamber.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Maximum Operating Pressure | Up to 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig) |
| Pressurization Gas | 100% oxygen |
| Construction Standards | Designed and fabricated in accordance with: |
- ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels
- ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy)
- NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2002 Edition |
| Intercommunication System | Low-voltage system designed and installed in accordance with NFPA 99, Chapter 19
Maximum power to speaker: 250 mW at 1.4 volts (NFPA 99, Chapter 20 limit is 500 mW and 28 volts) |
| Operator Control | Single operator chamber pressure control achieved via a simple manual pneumatic control. |
| Safety Features | No gas supply for pressurization before the chamber's door is closed and secured thoroughly. |
| Intended Use | Therapy for selected medical conditions determined to respond to hyperbaric oxygen, as per UHMS guidelines (e.g., air/gas embolism, CO poisoning, decompression sickness, problem wounds, etc.) |
| Installation and Operation Environment | Designed to be installed and operated in medical facilities as defined by NFPA 99, Chapter 20.
Intended to be operated only by medical personnel specifically trained in HBO use and safe operation. |
The following points are not applicable/found in the document for this type of device:
- Sample size used for the test set and the data provenance: Not applicable. This is a hardware device; testing involves engineering and safety validation, not a "test set" of data in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a hyperbaric chamber involves engineering specifications and safety standards, not expert consensus on medical image interpretation or similar AI tasks.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and performance is adherence to recognized engineering and medical standards (ASME, NFPA 99, UHMS guidelines for indications).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).