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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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The VersalVent Model V1 Hyperbaric Chamber Ventilator is intended and indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

The VersalVent Model V1 Hyperbaric Chamber Ventilator provides ventilatory support for pediatric and adult patients who require mechanical ventilator support while undergoing hyperbaric chamber therapy under the direction of a physician. The Device is completely pneumatically operated by pressurized oxygen sources from the hospital main oxygen source or by oxygen cylinders. The Device provides controlled ventilation and imv ventilatory modes with operator-set inspiratory pressure relief capabilities as further described in Technical Characteristics on page S2.

The VersalVent Model V1 Hyperbaric Chamber Ventilator was submitted for 510(k) clearance (K122560) based on substantial equivalence to the Providence Global Medical, Inc.'s Atlantis Hyperbaric Ventilator (K092264). The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a quantitative, pass/fail manner with specific thresholds. Instead, it demonstrates substantial equivalence by comparing the VersalVent Model V1 to the predicate device across various parameters. The reported device performance is presented as being "the same" or having "insignificant differences" compared to the predicate, implying the predicate's performance serves as the de-facto acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The submission mentions "extensive individual, or side-by side bench and actual hyperbaric chamber testing (comparing the device to the predicate)" for verification, validation, and design safety. However, no specific sample sizes (e.g., number of test runs, number of devices tested) are provided for the non-clinical testing.

The "data provenance" is derived from these bench and hyperbaric chamber tests, implying a controlled laboratory environment rather than patient data. No country of origin for the data is specified, but the submitter's address is in Kaosiung City, Taiwan, R.O.C. The studies are prospective in nature, as they involve testing the subject device, often alongside the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, clinical outcomes) is not directly applicable here. This submission relates to a mechanical ventilator where performance is measured against established engineering specifications and comparison to a predicate device.

The "ground truth" for the performance of the device and predicate would be established by the engineering specifications and measurements generated during the testing procedures themselves. There is no mention of experts establishing a separate "ground truth" for the test set in the same way one would for image interpretation tasks. The testing was likely conducted by engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 typically refer to processes for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For a mechanical device performance test, the "adjudication" would be based on whether the measured parameters fall within acceptable ranges or match the predicate's performance, as determined by direct measurement and comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a mechanical ventilator, and there is no human-in-the-loop performance being evaluated in this manner.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense. The non-clinical testing described is essentially a standalone performance evaluation of the device itself (and side-by-side with the predicate) without direct human patient interaction or human interpretation of results as part of the primary evaluation. The device's output (pressure, volume, flow) speaks for itself.

7. Type of Ground Truth Used

The "ground truth" for this ventilator's performance is based on direct physical measurements and engineering specifications. The ultimate "ground truth" for regulatory purposes is demonstrating that these measurements align with acceptable safety and performance standards for ventilators and are substantially equivalent to the legally marketed predicate device. This involves:

• Measured physical parameters: Pressure, volume, flow waveforms, minute volume, tidal volume, breaths per minute, inspiratory/expiratory times, I:E ratio, inspiratory flow, airway pressure, inspiratory pressure limit, etc.
• Comparison to predicate device: Establishing that the VersalVent V1's measurements are "the same" or have "insignificant differences" compared to the predicate's known performance.
• Compliance with general safety standards: Ensuring features like pressure relief and exhalation valve function correctly.

8. Sample Size for the Training Set

Not applicable. This is a purely mechanical device submission, not an AI/ML device where a "training set" of data would be used to develop an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved.

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The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.

The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device. Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.

This document is a 510(k) summary for the Atlantis Hyperbaric Ventilator. It is a premarket notification for a medical device seeking substantial equivalence to a predicate device. This type of document generally describes the device, its intended use, and argues for its equivalence to a device already on the market, rather than detailing a clinical study with acceptance criteria and performance data in the way one might expect for a novel device requiring extensive clinical trials.

Based on the provided text, there is no detailed clinical study described that specifically outlines acceptance criteria and then presents study results to prove the device meets those criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through a comparison of intended use, technological characteristics, and principles of operation.

Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted because such a study is not presented in this document.

Here's an analysis based on the available information:

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

• Acceptance Criteria: No specific numerical acceptance criteria are stated in this document. The "acceptance criteria" here is implicitly that the device is "as safe and effective" as the predicate and exhibits "no new issues of safety or effectiveness." This is a regulatory standard for substantial equivalence, not a performance metric.
• Reported Device Performance: No specific performance metrics (e.g., flow rate accuracy, pressure control precision, response time) are reported. The document states that the Atlantis Hyperbaric Ventilator is an "exact duplicate" of the predicate and has "exactly the same technological characteristics" and "exactly the same principles of operations."

2. Sample size used for the test set and the data provenance

• Not applicable. No "test set" in the context of a clinical performance study is described. The comparison is based on design and technical specifications against a predicate device.

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" or expert review of a test set is described.

4. Adjudication method for the test set

• Not applicable. No "test set" and thus no adjudication method 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. This is a ventilator, not an imaging device requiring human reader interpretation or AI assistance.

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

• Not applicable. This is a ventilator, not an algorithm.

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

• Not applicable. The "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" for an algorithm or a clinical trial.

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

• Not applicable.

Summary of Relevant Information from the Document (Reinterpreted for Context):

This 510(k) submission seeks to establish substantial equivalence for the Atlantis Hyperbaric Ventilator (K092264) to the predicate device, the Level-S, Inc.'s Neptune Hyperbaric Ventilator (K082351).

The core of the "proof" that the Atlantis device meets "acceptance criteria" (which in this context means being substantially equivalent to the predicate) is the assertion that:

• "The Atlantis Hyperbaric Ventilator is as safe and effective and is an exact duplicate of the predicate, designed and built by the same person as the predicate Neptune Hyperbaric Ventilator, who is now Vice-President of the Company."
• "The Atlantis Hyperbaric Ventilator has the same intended uses, exactly the same technological characteristics, and exactly the same principles of operations as its predicate device."
• "Any minor technological differences between the Atlantis and its predicated device raise no new issues of safety or effectiveness."

Essentially, the "study" or justification here is a direct comparison of design and specifications to an already approved device, rather than an independent clinical performance study. The FDA's acceptance of the 510(k) implies that they agreed with this assessment of substantial equivalence based on the provided technical documentation and comparisons, rather than requiring a separate clinical trial to establish new performance benchmarks.

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It is the expressed, intended use of the Gulf Coast Hyperbaric rectangular hyperbaric chamber to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in their procurement and routine use.

The UHMS is the professional medical organization chartered with setting the standards of care defining the appropriate use of hyperbaric oxygen. More specifically, the UHMS publishes a listing of medical conditions that have been clearly established as appropriate primary or adjunctive use of hyperbaric oxygen (HBO). The disorders on the list have been scientifically validated and verified through extensive data collection. It should be noted that the list is dynamic. Based on the strength of the scientific data, disorders are both added and removed from the list, depending on the outcomes of scientific pursuit.

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) is as follows:

1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myositis and myonecrosis
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhanced 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 Gulf Coast Hyperbarics rectangular multiplace hyperbaric chambers are designed and manufactured in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel code, Section VIII, Division 1, Pressure Vessels ANSVASME-PVHO-1 (American Society of Mechanical Engineers- Pressure Vessels for Human Occupancy. and NFPA 99, Health Care Facilities; Chapter 20, Hyperbaric Facilities, 2005 Edition. The new Gulf Coast Hyperbaric multiplace rectangular chambers (K082455) are designed and manufactured using the same major components as in the cleared Gulf Coast Hyperbarics multiplace cylindrical chamber (K950957). The rectangular multiplace chamber includes as a key component, a new and user friendly rectangular design which is simple and simulates as closely as possible the clinical conditions found elsewhere in their working environment.

The rectangular chamber(s) place major emphasis on patient and operator safety, and user-friendly operator controls and includes several unique features including:

• A large, comfortable rectangular hyperbaric chamber that has been outfitted to appear like any other clinical room in a hospital to reduce patient anxiety
• Large walk-through rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over the doorjamb.
• A large and easy to use control console designed to display all functions of the chamber
• An oxygen hood supply and exhaust system designed for easy use and eliminates over or under pressurization of the hood and eliminates the possibility of "shrink wrapping" the patient hood.
• Air conditioning system providing controllable cooling and heating of the chamber interior. The temperature and humidity is monitored at the control console.

The provided text is a 510(k) summary for a hyperbaric chamber (K082455). It describes the device, its intended use, and its substantial equivalence to existing devices. However, it does not contain information about any studies conducted to prove the device meets acceptance criteria.

The document lists the specifications of the device, which could be considered design acceptance criteria, but there is no mention of testing or studies performed to demonstrate adherence to these specifications beyond the statement that the device is "designed and manufactured in accordance with the requirements".

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information on:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is purely a premarket notification for substantial equivalence, which primarily relies on comparing the new device to existing legally marketed predicate devices, rather than conducting new performance studies for the new device as would be required for a novel device or a PMA submission.

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It is the expressed, intended use of the Hyperbaric America, LLC, Presidential Hyperbaric Chamber Systems to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.

The conditions listed as appropriate for the use of HBO by the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003) are as follows:

• 1. Air or gas embolism
• Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide 2. poisoning
• Clostridial myositis and myonecrosis
• 4. Crush injury, compartment syndrome, and other acute traumatic ischemias
• Decompression sickness
• Enhanced healing of selected problem wounds 6.
• 7. Exceptional blood loss anemia
• Necrotizing soft tissue infections 8.
• Osteomyelitis (refractory)
• 10. Delayed radiation injury (soft tissue and bony necrosis)
• 11. Skin grafts and flaps (compromised)
• 12. Thermal burns
• 13. Intracranial abscess

The Hyperbaric America Presidential Monoplace Hyperbaric Chamber Systems (Model HA-34 and HA-38) are Class B monoplace hyperbaric chambers 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 gas. Air pressurization with oxygen delivery by mask is optional

The Presidential Hyperbaric Oxygen Systems are designed and fabricated in accordance with the requirements of the 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, 2007 Edition); and, NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2005 Edition. The overall external length of both models is 92 inches. The internal diameter of Model HA-34 is 33.5 inches and of Model HA-38 is 38 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 20 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 qurney. When loading, patient lies down on the fire retardant foamed bunk, aligned to the rails of the chamber and fixes four wheels of the gurney, then push the bunk into the chamber. Unloading the patient with an opposite procedure. 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.

The provided text is a 510(k) Notification Summary for a medical device: the Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber Systems. This document is a regulatory submission for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study report proving device performance against acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information elements related to the acceptance criteria, study data, ground truth establishment, sample sizes, and expert reviews for such a study are not applicable to this type of document and device. This document describes the device, its intended use, and its adherence to established engineering and safety standards, rather than clinical performance metrics.

Here is a summary of the requested information, noting its applicability to the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and engineering standards for market clearance. It does not present clinical performance data in terms of accuracy, sensitivity, or specificity as would be expected for a diagnostic or AI-driven device.

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 is a regulatory submission for a medical device (hyperbaric chamber) and does not involve a "test set" of data in the context of diagnostic performance evaluation or AI model validation. The "study" mentioned here refers to the engineering design and manufacturing process adhering to established standards, rather than a clinical trial with a test set of patient data.

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. "Ground truth" in the context of expert consensus on diagnostic images or outcomes data is not relevant to the approval of a hyperbaric chamber. The "truth" in this context is adherence to engineering codes and safety standards, and the recognized indications for hyperbaric oxygen therapy as established by medical societies.

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

• Not Applicable. There is no "test set" or adjudication process described as this is not a diagnostic device study.

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 device is a hyperbaric chamber, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a hyperbaric chamber, not an algorithm.

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

• The "ground truth" for this device's approval is primarily based on:
  • Adherence to recognized engineering and safety standards: ANSI/ASME Boiler and Pressure Vessel Code, ANSI/ASME-PVHO-1, and NFPA 99.
  • Established medical literature and society recommendations: The conditions suitable for HBO therapy are those listed by "the Undersea & Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee Report (2003)."

8. The sample size for the training set

• Not Applicable. This document pertains to a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

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The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism; Carbon Monoxide / Smoke Inhalation; Compromised Skin Grafts and Flaps; Crush Injuries / Acute Traumatic Ischemia; Decompression Sickness; Enhanced Healing in Selected Problem Wounds; Exceptional Blood Loss (Anemia); Gas Gangrene (Clostridia Myonecrosis); Intracranial Abscess; Necrotizing Soft Tissue Infections; Radiation Tissue Damage (Osteoradionecrosis); Refractory Osteomyelitis; Thermal Burns.

The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have the same intended use; as a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA. The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is safe and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The provided text is for a 510(k) submission for a hyperbaric chamber, which is a medical device, and does not involve AI or algorithms that would have a "reported device performance" in the typical sense of diagnostic metrics like sensitivity or specificity.

Therefore, the specific information requested in the prompt, such as "reported device performance," "sample size," "ground truth," "MRMC study," and "training set," is not applicable to this type of device submission.

Instead, the acceptance criteria for this device are demonstrated by its compliance with recognized industry standards for design, manufacturing, and safety. The "study" that proves the device meets these criteria is a series of engineering and safety tests to ensure it adheres to these standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the difference in device type:

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

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

This information is not applicable and therefore not provided in the document. As a physical medical device (hyperbaric chamber), the "test set" would refer to the chambers themselves undergoing engineering and safety testing, not a dataset of patient information or images. The "provenance" would be the manufacturing location and standard compliance testing, not data collection.

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 to the submission for a hyperbaric chamber. The "ground truth" for this device is compliance with engineering and safety standards, validated through testing by qualified engineers and technicians, not by medical experts interpreting results from the device.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review for diagnostic performance. For a hyperbaric chamber, it's about meeting quantifiable engineering and safety standards through documented testing, not subjective assessment.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a physical medical device (hyperbaric chamber) and does not involve AI or human readers in the context of diagnostic interpretation.

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

This is not applicable. The device is a hyperbaric chamber, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness relies on adherence to established engineering, safety, and medical device standards (ASME, NFPA, CAN/CSA, EN standards). These standards themselves represent a form of "ground truth" in terms of what constitutes a safe and functional hyperbaric chamber, based on collective expert consensus in engineering and healthcare safety fields.

8. The sample size for the training set

This is not applicable. There is no "training set" for a hyperbaric chamber in the context of an algorithm or AI.

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

This is not applicable, as there is no "training set" for this type of device.

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It is the expressed, intended use of the Oxyheal 1000 Monoplace Hyperbaric Chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in the procurement and routine use.

The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee report (2003) 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
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness.
6. Enhanced of healing in selected problem wounds
7. Exceptional blood loss (anemia)
8. Intracranial abscess
9. Necrotizing soft tissue infections
10. Osteomyelitis (refractory)
11. Delayed radiation injury (soft tissue and bony necrosis)
12. Skin Grafts and flaps (compromised)
13. Thermal burns

The OxyHeal 1000 series is a Class B monoplace hyperbaric chamber system designed to treat 1 patient to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 30 pounds per square inch gauge (psig). The chamber uses compressed 100% oxygen as the pressurization gas as well as the hyperbaric treatment gas. The overall external length of the chamber is 105" inches. Its internal diameter is 33.5" inches. Pressurization and ventilation is continuously provided by compressed 100% oxygen. The patient breathes the chamber atmosphere directly. An air-break assembly using a regulated medical air source and mask is available. A low-voltage patient intercommunication system provides communications between the patient in the chamber and the outside chamber operator. Single operator chamber pressure control is achieved via a simple industrial adjustable controller with output and input feedback. A pneumatic, manually operated control system is provided for double control redundancy. A series of penetrators are provided in the vessel end caps wall to allow user supplied intravenous lines, suction, medical monitoring leads, etc., to be used as required.

This is a 510(k) premarket notification for a medical device, the OxyHeal 1000 Monoplace Hyperbaric Chamber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a study.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It describes the device's intended use, its design, and its substantial equivalence to existing predicate devices based on principles of operation and intended use.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define specific performance acceptance criteria (e.g., a certain pressure accuracy, oxygen concentration range, or safety feature reliability threshold) nor does it report the results of a study against such criteria. The "performance" described relates to the design and features (e.g., maximum operating pressure, internal diameter, communication system).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or studies are referenced in this document for the OxyHeal 1000 chamber itself. The mention of "extensive data collection" refers to the UHMS's process for validating indications for hyperbaric oxygen therapy, not a study performed on this specific device.

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): As no test set or ground truth establishment relevant to this device's performance is described, this information is not present. The UHMS is cited as the authority for indications, but this is a medical society, not a panel establishing ground truth for a device's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process for device performance 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 device is a hyperbaric chamber, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for device performance. The "ground truth" mentioned in the context of hyperbaric oxygen indications comes from scientific validation and verification through extensive data collection by the UHMS.

8. The sample size for the training set: Not applicable, as this is not a machine learning device and no training set is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided document is a 510(k) summary for a hyperbaric chamber, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

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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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• 1 Air or Gas Embolism
• 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
• 3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
• Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias
• 5 Decompression Sickness
• Enhancement of Healing in Selected Problem Wounds
• 7 Exceptional Blood Loss (Anemia)
• 8 Intracranial Abscess
• 9 Necrotizing Soft Tissue Infections
• 10 Osteomyelitis (Refractory)
• 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis
• 12 Skin Grafts & Flaps (Compromised)
• 13 Thermal Burns
  These are the indicated uses by the Undersea & Hyperbaric Medical Society.
  The device is designed to be used for the indicated uses only.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "MSI i2010 Dual Place Hyperbaric Chamber." This type of document declares a device substantially equivalent to a legally marketed predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not available in this document.

The document primarily focuses on:

• Device Name: MSI i2010 Dual Place Hyperbaric Chamber
• Regulation Number: 868.5470
• Regulation Name: Hyperbaric Chamber
• Regulatory Class: II
• Product Code: CBF
• Indications for Use: A list of 13 specific conditions for which the hyperbaric chamber is indicated, as outlined by the Undersea & Hyperbaric Medical Society (e.g., Air or Gas Embolism, Carbon Monoxide Poisoning, Clostridal Myositis and Myonecrosis, Decompression Sickness, etc.).
• Substantial Equivalence: The core finding is that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This means it did not require a new clinical study to prove its safety and effectiveness, but rather demonstrated similarity in design, intended use, and technological characteristics to an already approved device.

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