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The intended use of the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is to administer hyperbaric oxygen therapy (HBOT) to treat patients with any of the below listed indications.

The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org.are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.

• 1. Air or Gas Embolism
• 2. Carbon Monoxide Poisoning
• a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
• 3. Clostridial Myositis and Myonecrosis (Gas Gangrene)
• 4. Crush Injury, Compartment Syndrome and Other Acute Ischemias
• 5. Decompression Sickness
• 6. Arterial Insufficiencies
• a. Central Retinal Artery Occlusion
• b. Enhancement of Healing in Selected Problem Wounds
• 7. Severe Anemia
• 8. Intracranial Abscess
• 9. Necrotizing Soft Tissue Infections
• 10. Osteomyelitis (Refractory)
• 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
• 12. Compromised Grafts and Flaps
• 13. Acute Thermal Burn Injury

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is comprised of a multiplace hyperbaric chamber of major subsystems that support the overall system operation, control, and monitoring.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber is a pressure vessel for human occupancy (PVHO) that is designed in a horizontally orientated cylindrical geometry. Chamber configurations vary based on the needs of the end user, and may be designed and manufactured in one (1), two (2), or three (3), compartment configurations. Patient capacities may range anywhere from four (4) to twenty-four (24) dependent on chamber size, number of compartments, or the direction provided by the customer to meet their needs. Lastly, maximum operating pressures range from 3ATA (~30psi) to 6ATA (~73.5psi), with each of the compartments designed to operate independently.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System design also complies with the hyperbaric facilities requirements specified in the FDA recognized consensus standard NFPA 99 and satisfies the requirements for protection against electrical, explosive, and fire hazards and associated facilities used for medical procedures at gauge pressures within the ranges: 0psi to 100psi.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chambers consists of the hyperbaric chamber itself and the major subsystems briefly described below. Each substantially equivalent to that which is contained in the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family predicate device (K152223).

The provided document is a 510(k) premarket notification for a hyperbaric chamber system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a new, AI-based device meets acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML medical device cannot be extracted from this document.

This document describes a change in the shape of a hyperbaric chamber (from rectangular to cylindrical) and demonstrates that it adheres to existing safety and manufacturing standards, mirroring the predicate device. It is a traditional medical device submission, not one pertaining to AI/ML.

No information regarding AI-specific acceptance criteria or a study proving an AI device meets them is present in the provided text.

The document details:

• Device: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family
• Predicate Device: OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223)
• Key Modification: Change from rectangular to cylindrical geometry.
• Demonstration of Equivalence: Through adherence to recognized industry standards (ASME PVHO-1, NFPA 99, ISO 14971), non-clinical testing (Non-destructive Testing, Hydrostatic Testing, Fire Suppression System Testing, First Operational System Test, Software Validation Testing - note: "software validation" in this context refers to confirming the chamber's control software functions as intended, not AI/ML inference), and factory acceptance testing.

The document explicitly states: "The fundamental technology for this minor modification consists of a change in dimensional specifications; i.e. the predicate device (K152223) is a multiplace hyperbaric chamber with a rectangular geometry. The modified device is a multiplace hyperbaric chamber with a cylindrical geometry. This modification does not change the intended use, indications for use, and product labeling." It also says, "The validation / verification efforts performed for the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family are identical to those performed for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223) predicate device."

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The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.

1. Air or Gas Embolism
2. Carbon Monoxide Poisoning
   a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3. Clostridial Myositis and Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Ischemias
5. Decompression Sickness
6. Arterial Insufficiencies
   a. Central Retinal Artery Occlusion
   b. Enhancement of Healing in Selected Problem Wounds
7. Severe Anemia
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections
10. Osteomyelitis (Refractory)
11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
12. Compromised Grafts and Flaps
13. Acute Thermal Burn Injury

The OxyHeal® 5000, Rectangular Multiplace Hyperbaric Chamber System is comprised of a multiplace hyperbaric chamber and a number of major subsystems that support the overall system operation, control, and monitoring. An OxyHeal® 5000 multiplace hyperbaric chamber is a pressure vessel for human occupancy that is designed in a rectangular geometry. Configurations vary based on the needs of the end user and may consist of two (2), three (3), or more compartments. Capacities may range anywhere from six (6) to twenty-four (24) patients or more, dependent on chamber of compartments, or the direction of the customer to meet their needs. Lastly, maximum operating pressures range from 3ATA (~30psi) to 6ATA (~73.5psi), with each of the compartments designed to operate independently. Each OxyHeal® 5000 multiplace hyperbaric chamber is designed, inspected, tested, marked and stamped to meet the standards defined in the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1). These chambers comply with the National Fire Protection Agency (NFPA) 99, Health Care Facilities. The OxyHeal 5000, Rectangular Multiplace Hyperbaric Chamber System consists of the hyperbaric chamber itself and the major subsystems briefly described below: Compressed Air System, Fire Suppression System, Bulk Oxygen System, Built-in Breathing System, HP Gas System, Environmental Control System (ECS), Control Console.

The provided text details the 510(k) summary for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a "study" in the typical sense of a clinical trial or performance study comparing it against a predefined metric.

Instead, the "study" mentioned here refers to a comparison of the new device's technological characteristics, design, and operational parameters against those of legally marketed predicate devices. The acceptance criteria are implicit in meeting or exceeding the standards and performance of these predicate devices, as well as adherence to relevant industry standards like ASME and NFPA.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are the characteristics of the predicate devices and relevant standards (ASME, NFPA). The "reported device performance" is the OxyHeal® 5000's characteristics in comparison to these.

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

This document describes engineering tests and a comparison to predicate devices, not a clinical study on a patient test set in the conventional sense. The "test set" for the non-clinical testing comprises the physical components and integrated system of the OxyHeal® 5000 chamber itself.

• Sample Size: The sample size is essentially one (the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, representing its design). The testing applies to the specific device models being submitted. The document evaluates the design and performance characteristics of new models within this product family against established standards and predicate devices.
• Data Provenance: The testing details suggest that tests were conducted by the manufacturer (OxyHeal Medical Systems, Inc.) or by independent bodies (like ASME authorized inspectors) as part of the manufacturing and verification process. This is prospective testing for the submitted device design. The origin would be the manufacturing site or testing facilities. No country of origin for specific testing data is explicitly mentioned, but the manufacturer is based in National City, CA, USA.

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)

This is not applicable as this is a device engineering and performance validation against standards and predicate devices, not an AI or diagnostic device requiring expert interpretation for "ground truth" establishment in a clinical imaging context. The "ground truth" for compliance to standards comes from the ASME and NFPA codes themselves, and expert judgment is inherent in the design, engineering, and inspection processes by qualified engineers and ASME authorized inspectors.

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

Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving multiple readers interpreting data where a consensus or tie-breaking mechanism is needed to establish ground truth.

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 not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device. The device itself is the hyperbaric chamber system.

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

The "ground truth" in this context refers to established engineering standards, safety requirements, and the validated performance of predicate devices. Specifically:

• Engineering Standards: ASME/PVHO-1 for pressure vessels, NFPA 99 for health care facilities (including fire suppression, electrical design, etc.).
• Performance Specifications: User Design Specifications for the OxyHeal® 5000, which are verified through various tests (structural, fire suppression, operational, software validation, factory acceptance).
• Predicate Device Characteristics: The established and legally marketed performance and design features of the Fink Engineering PTY LTD SL8, DL8, and TL20 Hyperbaric Oxygen Facility (K031649) and the OxyHeal Health Group®, Inc. OxyHeal® 2000 Hyperbaric Chamber Series (K011866).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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