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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:

1. Air or Gas Embolism
2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Enhancement of Healing in Selected Problem Wounds
7. Exception Blood Loss (Anemia)
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
10. Osteomyelitis (Refractory)
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Skin Grafts and Flaps (Compromised)
13. 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:

1. 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
2. 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.
3. Windows: The chamber windows are positioned and sized to provide a feeling of comfort and spaciousness to
4. 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:

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.

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The RSI GSP1 Gas Selection Panel is intended for use with hyperbaric oxygen (HBO) treatment gas systems whenever there is a need to select between two available gases. This typically includes support for monoplace chamber pressurization/ventilation systems and patient breathing gas systems supporting masks and hoods.

The RSI gas selection panels (GSP1) are gas manifolds designed to accept two breathing gases. {Usually, air and oxygen will be specified; however, the device will work with any breathing gas.) Depending on the options selected, it will then supply one to four other devices. These other devices may be hyperbaric monoplace chambers (up to two) or patient breathing stations such as the RSI ODS1 Hood Driver (up to four). The GSP1 allows each device supplied to receive either qas.

The GSP1 incorporates a "block and bleed" gas circuit (like those used to supply mask breathing systems on larger multiplace hyperbaric chambers) that insures that the device supplied receives only the gas selected even if there is a leak in any of the other piping components. A positive means, such as the "block and bleed" design, is required to prevent contamination of one gas with another and is a safety requirement of the ASME PVHO-1 code.

The GSPI is designed to be surface mounted on a wall. It also has two service shut-off valves, one for each gas supply, and gauges to indicate supply pressures.

This K962869 submission for the REIMERS SYSTEMS, INC. GSP1 Gas Selection Panel describes a medical device, but it does not include any acceptance criteria or a study demonstrating device performance in the way typically expected for clinical or diagnostic devices.

The submission focuses primarily on demonstrating substantial equivalence to a predicate device (RSI T-Class air/oxygen switch-over circuit) based on design, materials, and intended use. This is a common approach for 510(k) clearances when a new device is very similar to an already marketed one.

Therefore, I cannot populate the requested table and information as there isn't a study proving the device meets performance criteria in the usual sense (e.g., sensitivity, specificity, accuracy against a clinical gold standard).

Here's a breakdown of why and what information can be extracted:

Why the requested information is not available in this 510(k) summary:

• Device Type: The GSP1 is a gas manifold, essentially a mechanical system for routing breathing gases. It's not a diagnostic tool or a treatment device where typical performance metrics like sensitivity, specificity, or outcomes are relevant.
• Regulatory Pathway: The 510(k) pathway relies on demonstrating substantial equivalence to a predicate device. This often involves comparing design specifications, materials, and intended use, rather than conducting new clinical performance studies.
• Focus on Safety and Equivalence: The key "proof" in this submission is that the GSP1 uses the same "block-and-bleed" gas isolation method as the predicate, which is a safety requirement of the ASME PVHO-1 code to prevent gas contamination. Its effectiveness is thus presumed by its adherence to this established, safe design principle already used in a legally marketed device.

Information that can be inferred or directly stated from the document, but does not fit the requested format for acceptance criteria/performance study:

• "Acceptance Criteria" (Implicit): The implicit acceptance criteria are that the device:

  • Accepts two breathing gases.
  • Employs a "block-and-bleed" gas isolation method.
  • Is intended for breathing gases (air, oxygen).
  • Uses specified wetted materials (Copper, Brass, Stainless-steel).
  • Uses 100% oxygen compatible soft goods.
  • Can be manually operated.
  • Adheres to ASME PVHO-1 code for gas isolation.
  • Is substantially equivalent to the predicate in function and safety.

• "Device Performance" (Implicit): The device is reported to perform "the same" as the predicate device's air/oxygen switch-over circuit in terms of gas selection and isolation. The "block-and-bleed" design "insures that the device supplied receives only the gas selected even if there is a leak in any of the other piping components," which is the core performance claim related to safety.

Therefore, the table and subsequent questions cannot be populated meaningfully as a clinical performance study was not conducted or reported.

Explanation for missing fields:

1. A table of acceptance criteria and the reported device performance: Not applicable as performance is demonstrated by substantial equivalence to an existing device and adherence to a safety standard (ASME PVHO-1) for its safety mechanism. There are no measurable performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. No test set in the conventional sense was used for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in a clinical sense was established.
4. Adjudication method for the test set: Not applicable.
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 mechanical gas manifold, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" here is the established safety and functional equivalence of the "block-and-bleed" design, as validated by ASME PVHO-1 code and its prior use in a legally marketed device.
8. The sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) focuses on demonstrating safety and functional equivalence through design comparison rather than presenting results from a performance study with specific acceptance criteria.

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Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.

The Model ODS1 - Hood Driver is intended for use with monoplace hyperbaric chambers. It is normally used to permit the patient to breath oxygen while the chamber is pressurized on air. However, it can be used to supply the patient with any physiologically appropriate gas which may or may not be the same as the gas used to pressurize the chamber. The ODSI circuit is designed to supply a steady flow of breathing gas to the breathing apparatus used in the chamber. The breathing apparatus can be either a "Sea-Long" hood or a free-flow mask arrangement.

The provided text is a 510(k) summary for a hyperbaric chamber breathing station (ODS1 Hood Driver). It does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details that would be found in a study proving a device meets acceptance criteria.

This document describes the device's function, its intended use, and compares it to a similar, already legally marketed device (Lifeforce Hyperbaric Chamber System) to demonstrate substantial equivalence. This is a regulatory submission, not a clinical study report.

Therefore, I cannot provide the requested information from the given text as it is not present.

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