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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 (Gas Gangrene)
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 Makai Marine Industries Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber system designed to treat up to 20 patients to a maximum treatment 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 11 feet to 40 feet. Its internal diameter can range from 42 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 oral-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 simple adjustable control valves providing infinite control. Multiple penetrators and/or penetrator plate is provided in the vessel wall to allow user supplied intravenous lines, medical monitoring leads, etc., to be used as required. Where applicable a large rectangular door(s) 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.

This document describes a 510(k) premarket notification for the Makai Marine Industries, Inc. (MMI) Hyperbaric Chamber System.

Based on the provided text, there is no acceptance criteria or study demonstrating device performance in the typical sense of a clinical trial with specific metrics like sensitivity, specificity, or reader improvement. This document is a regulatory submission to the FDA seeking substantial equivalence to existing predicate devices, not a report on a clinical performance study.

Here's an analysis based on the structure of your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criteria for this 510(k) submission are regulatory in nature, focusing on meeting design standards and demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: Not reported in clinical performance metrics. The document describes the device's technical capabilities (e.g., maximum pressure, patient capacity, pressurization gas) and its intended use, which aligns with the indications of existing hyperbaric chambers.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable: This document does not describe a performance study with a test set. This is a regulatory submission for premarket clearance.

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: As there is no performance study described, there is no ground truth establishment for a test set. The "ground truth" for the device's intended use is established by the medical community, specifically the Undersea and Hyperbaric Medical Society (UHMS), which publishes a list of approved medical conditions (indications for use). This is a consensus-based approach from a medical professional body, not specific experts for a performance study.
  • Qualifications of Experts for UHMS lists: The UHMS is a professional medical society. While not explicitly stated in this document, their lists are typically based on extensive scientific data reviewed by committees of hyperbaric medicine specialists (physicians, researchers, etc.) with significant experience in the field.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable: No test set or performance study is described.

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: No MRMC study was done, as this is not an AI-assisted diagnostic device. It is a hyperbaric chamber.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the indications for use (the medical conditions the device is intended to treat) is based on expert consensus and scientifically validated data collection by the Undersea and Hyperbaric Medical Society (UHMS). The document states: "The disorders on the list have been scientifically validated and verified through extensive data collection." This is not ground truth for a device performance study, but for the medical efficacy of the treatment itself.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not a machine learning device or a clinical study evaluating its performance against a specific dataset.

9. How the ground truth for the training set was established

• Not Applicable: No training set.

Summary:

The provided document is a 510(k) premarket notification for a hyperbaric chamber. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a clinical performance study with defined acceptance criteria for metrics like sensitivity or specificity. The "performance" of the device is described in terms of its technical specifications (e.g., pressure, capacity, construction materials meeting standards) and its intended use, which aligns with established medical indications for hyperbaric oxygen therapy as defined by the UHMS.

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