(324 days)
Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific indications are:
- Air or Gas Embolism
- Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning
- Clostridial Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
- Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds
- Exception Blood Loss (Anemia)
- Intracranial Abscess
- Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
- Osteomyelitis (Refractory)
- Radiation Tissue Damage (Osteoradionecrosis)
- Skin Grafts and Flaps (Compromised)
- Thermal Burns
The model RST*200(™) hyperbaric chamber is a monoplace (one person) pressure chamber designed to be pressurized with air while is a monoplace (one person) presure chamber designed atmospheres absolute, ATA). atmospheres absolute, ATA).
The chamber comes with fixed tray system with comfortable custom mattress. The patient tray system is designed to accommodate a lying or sitting patient during a hyperbaric tray chamber is designed to accommodate a lying or sitting patient treatment. The chamber is designed to administer all of the standard treatment protocols for 3 ATA or less. The or less. The chamber includes the following sub systems:
- Pressurization, Depressurization and Ventilation: This system includes pneumatically controlled valves and components. These valves and controls are used to control the pressurization rate and components. These valves and control and
- Communications and Entertainment: The chamber is equipped with a system to facilitate clear and easy communication between the patient and changer operator. The communication system also permist the use of an auxiliary audion input for patient entertainment. Patient entertainment is anternational in input for patient entertainment Patient entertainment is automatically muted when withing audion the hand set from its cradle.
- Windows: The chamber windows are positioned and sized to provide a feeling of comfort and spaciousness to
- Oxygen Breathing System: The chamber is equipped with the necessary controls to administer oxygen to the patient whereby the patient wears a standard medical oxygen hood or mask.
This document is a 510(k) premarket notification for the RSI 4200 (TM) MONOPLACE Hyperbaric Chamber. It describes the device, its indications for use, and a summary of substantial equivalence to predicate devices. However, this document does not contain any information about a study proving the device meets acceptance criteria in the way you've described for an AI/CAD diagnostic device.
Here's why and what information is missing:
This document describes a physical medical device (a hyperbaric chamber), not a diagnostic AI or software device. The concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as it applies to an AI/CAD system (e.g., performance metrics like sensitivity, specificity, F1-score, sample size of test sets, ground truth establishment by experts, MRMC studies) is not applicable to this type of submission.
Instead, for a physical device like a hyperbaric chamber, "acceptance criteria" are generally related to:
- Compliance with recognized industry standards: As listed in the document (ASME Boiler and Pressure Vessel Code, ASME PVHO-1, NFPA 99).
- Performance specifications: Such as maximum operating pressure, pressurization/depressurization rates, communication system functionality, oxygen delivery capability, safety features, and material integrity. These are typically verified through engineering tests, material certifications, and functional checks during manufacturing and quality control.
- Substantial equivalence to predicate devices: The primary method for FDA clearance for Class II devices like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy from scratch.
Therefore, many of the specific questions you've asked are not addressed (and wouldn't typically be expected to be addressed) in this type of 510(k) submission for a physical medical device.
However, I can extract the relevant information that is present, framed as closely as possible to your request, and explicitly state what is not available due to the nature of the device and document.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Compliance with Standards/Requirements) | Reported Device Performance/Compliance |
|---|---|
| Industry Standards: | |
| 1. ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 | Designed and manufactured in accordance with this standard. Vessel construction is similar to predicate devices (Millennium series) and is in accordance with this code. |
| 2. ASME PVHO-1 Pressure Vessels for Human Occupancy Standard | Designed and manufactured in accordance with this standard. Windows are designed to meet the applicable sections of PVHO. |
| 3. NFPA 99 Safety Standard for Health Care Facilities, Chapter 20 | Designed and manufactured in accordance with this standard. Communication system designed to meet requirements of NFPA 99 Chapter 20 for hyperbaric facilities. |
| Functional/Design Requirements (Implicit in Substantial Equivalence): | |
| 1. Ability to be pressurized with air to 3 ATA or less | Device description states it is designed to be pressurized to atmospheres absolute (ATA) and administer standard treatment protocols for 3 ATA or less. |
| 2. Accommodate a lying or sitting patient | Patient tray system designed for this purpose. |
| 3. Control pressurization, depressurization, and ventilation rates | System includes pneumatically controlled valves and components for this purpose. |
| 4. Facilitate clear patient-operator communication | Equipped with a communication system for this purpose; operation similar to Sechrist 2500B predicate device. Automatically mutes entertainment when handset taken off-cradle. |
| 5. Provide patient comfort and spaciousness (windows) | Windows positioned and sized to achieve this. |
| 6. Administer oxygen to the patient (via hood/mask) | Equipped with necessary controls for this. |
| 7. Substantial equivalence to predicate device pressure controls, communication system, and vessel construction | Pressure controls are "very similar" to predicate devices (Sechrist 2500B, Millennium series). Communication system "similar" to Sechrist 2500B. Vessel construction "similar" to Millennium series predicate devices and in accordance with ASME code. RSI accepts it is substantially equivalent to predicate devices and safe and effective. |
For the following points, the information is not applicable or not present in the provided document, as it pertains to AI/CAD diagnostic studies, not physical medical devices cleared via substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document describes a physical hyperbaric chamber, not a diagnostic algorithm. There is no "test set" of data in the context of an AI/CAD study. Performance is demonstrated through compliance with engineering standards and comparison to predicate devices.
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. No ground truth establishment for a diagnostic test set is mentioned or required for this type of device. The "ground truth" for a hyperbaric chamber's safety and effectiveness is its adherence to recognized engineering and safety standards, and its proven performance in predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No diagnostic test set or adjudication process 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 is a physical medical device. MRMC studies are for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the context of AI/CAD). For this device, "ground truth" for safety and performance relies on engineering principles, compliance with established industry standards (ASME, NFPA, PVHO), and successful track records of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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).