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

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

The FINK Hyperbaric Chamber is the rectangular pressure vessel that is identical in construction to the rectangular hyperbaric chambers covered by Fink's previously cleared K031649 which are all designed and built to meet the Safety Standard for Pressure Vessels for Human Occupancy ASME PVHO-1 and are certified accordingly. Chamber configurations vary depending upon the requirements set forth by the end user and supplied in the following configurations:

• Single Compartment - FESL
• Double Compartment - FEDL
• Triple Compartment FETL ●
  Patient capacities can range from four (4) to 28 twenty-eight (28) patients per chamber depending on the number of compartments required by the User. The pressure range for the individual compartments may also vary for the same reason with a minimum of 3.0 ATA to 6.0 ATA maximum allowable working pressures and design temperature range from 15℃ to 38℃ per compartment. The specific parameters for each chamber are defined by a User Design Specification which is approved by a Registered Professional Engineer in accordance with ASME PVHO-1. These chambers also comply with the National Fire Protection Agency (NFPA)
  The chambers include the following features:
• Fire Protection
• Compressed air system ●
• Oxygen Delivery ●
• Environmental control system ●
• Unintended power supply ●
• Control Console ●

Based on the provided text, the device in question is a Hyperbaric Chamber, and the submission is a 510(k) premarket notification for substantial equivalence. This type of submission relies on comparing the new device to a legally marketed predicate device rather than presenting detailed clinical study data proving efficacy or standalone performance against specific acceptance criteria for a novel AI/software function.

The document describes the acceptance criteria and study that proves the device meets the acceptance criteria in terms of substantial equivalence to a predicate device, rather than explicit performance metrics for a complex AI algorithm against a ground truth. Therefore, the "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence as required for a 510(k) clearance, and the "study" comprises the validation and verification testing conducted to support that claim.

Here's a breakdown based on the information provided, tailored to the context of a 510(k) submission for a hyperbaric chamber:

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

The "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented is primarily to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" primarily refers to the individual FINK Hyperbaric Chambers (models FESL, FEDL, and FETL) themselves and their components, which underwent a series of engineering and functional tests. There isn't a "test set" of patient data or images as would be seen for an AI diagnostic device.
• Data Provenance: The testing data originates from the manufacturer, Fink Engineering Pty Ltd, located in Queensland, Australia. The document does not specify if the testing itself was conducted in Australia or elsewhere, but it's generated by the manufacturer for regulatory submission. The data is implicitly "prospective" in the sense that it's data generated through testing specifically for this submission, not a retrospective analysis of existing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. For a device like a hyperbaric chamber, "ground truth" is established by adherence to engineering standards (e.g., ASME PVHO-1, NFPA 99), physical measurements, and functional verification. The "User Design Specification" is approved by a Registered Professional Engineer in accordance with ASME PVHO-1.
• Qualifications of Experts: A Registered Professional Engineer is mentioned as approving the User Design Specification according to ASME PVHO-1. Other "experts" involved would be qualified testing personnel and engineers performing the various physical and functional tests described.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Testing against physical and functional standards, as well as software verification and validation, does not involve a human adjudication process in the way a diagnostic algorithm's output would be adjudicated against ground truth labels. The "adjudication" is essentially the successful passing of pre-defined engineering tests and compliance with recognized standards.

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:

• MRMC Study: No. This is a medical device (hyperbaric chamber), not a diagnostic AI algorithm. An MRMC study is not relevant or required for this type of submission.

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

• Standalone Performance: Not applicable. This device is not an algorithm for standalone diagnosis or prediction. While it has a PLC control system, the "performance" is the safe and effective operation of the physical chamber as a whole, controlled by humans. Software verification and validation (often considered a form of standalone testing for the software component) was performed, and it was categorized as "Enhanced" in terms of risk, meaning a failure could lead to death or serious injury.

7. The type of ground truth used:

• Ground Truth: For this device, the "ground truth" is established by:
  • Regulatory Standards: Adherence to standards like ASME PVHO-1 (Safety Standard for Pressure Vessels for Human Occupancy) and NFPA 99 (National Fire Protection Agency).
  • Engineering Specifications: Successful operation within defined pressure ranges, temperatures, flow rates, and functional parameters.
  • Functional Verification: The ability of components (e.g., UPS, medical lock, communications, fire suppression) to operate as designed.
  • Biocompatibility Standards: Compliance with ISO 18562-1 and toxicological risk assessment.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for such a device is its design, manufacturing, and testing process according to established engineering and safety principles.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The accumulated knowledge and standards of engineering, pressure vessel design (ASME PVHO-1), and medical gas systems (NFPA 99) form the foundational "ground truth" for the device's design and manufacturing.

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The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.

The Portable Hyperbaric Chamber Revitalair® 430+ is a hyperbaric semi rigid chamber for low pressures (operating at pressures of no greater than 1.5 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).

Revitalair® 430+ consists of 2 parts, the cabin or chamber and the compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1).

The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves. The safety or relief valves are operated at pressures of 1.5 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the Revitalair® 430+ has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside. The Revitalair® 430+ can be operated from the exterior. After folding it up, the Revitalair® 430+ is placed in its transportation box or in the optional carrying case.

The provided text describes a 510(k) premarket notification for a medical device, the Revitalair 430+ Hyperbaric Chamber. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria for an AI/ML-driven diagnostic system.

The document does not contain information about:

• Acceptance criteria and reported performance of an AI/ML device.
• Sample sizes, data provenance, or ground truth establishment for a test set in the context of AI/ML validation.
• Number and qualifications of experts or adjudication methods for establishing ground truth for AI/ML.
• MRMC comparative effectiveness studies or standalone AI algorithm performance.
• Training set details for an AI/ML model.

This document is a regulatory submission for a physical medical device (a hyperbaric chamber) and relies on demonstrating substantial equivalence to existing predicate devices, rather than validating a novel AI/ML algorithm's analytical and clinical performance. Therefore, the requested information pertaining to acceptance criteria and performance study for an AI/ML device is not applicable and not present in the provided text.

The closest relevant information is the non-clinical performance data which focuses on safety and engineering standards for the physical device, not an AI/ML system. These include:

• Electrical safety testing (IEC 60601-1)
• Electromagnetic Disturbance (EMD) testing (IEC 60601-1-2)
• Biocompatibility testing (ISO 10993 and ISO 18562)
• Device Life Report (reliability analysis)
• Pressure Testing (ASME PVHO-1-2007)

The document states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device." This further confirms that it's not a study validating an AI/ML device.

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The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.

The Portable Hyperbaric Chamber Revitalair® 430F is a hyperbaric chamber for low pressures (operating at pressures of no greater than 1.4 atmospheres absolute (ATA)). The operational design pressure of a hyperbaric chamber that encloses a human within its pressure boundary falls within the scope of the American Society of Mechanical Engineers Pressure Vessels Human Occupancy 1 (ASME PVHO 1-2012).

Revitalair® 430F consists of 2 parts, the cabin or chamber and the compression system or compressor's cabinet. The chamber, weighing 62 pounds, is constructed of an airtight polyester-based plastic fabric joined by aluminum rings, forming a cylinder 900 mm in diameter and 1850 mm in length (Figure 1).

The chamber is inflated with atmospheric air through an electric compressor. Fittings allow the chamber to be connected to compressed air by means of manually controlled valves.

The safety or relief valves are operated at pressures above 1.3 ATM which ensures safe operations. The compressor has an additional safety valve for any obstruction of the supply hose from the compressor to the chamber.

The Revitalair® 430F has 10 transparent windows to let in light, 360º viewing and enable easy verification of the patient's comfort from the outside.

The Revitalair® 430F can be operated from the interior as well as from the exterior.

After folding it up, the Revitalair® 430F is placed in its transportation box or in the optional carrying case.

This document primarily concerns the 510(k) premarket notification for the Revitalair® 430F Portable Hyperbaric Chamber, seeking to establish substantial equivalence to an existing predicate device. It does not describe a study involving an AI/Machine Learning device, nor does it list acceptance criteria and performance data for such a device.

The information provided in the document is related to a traditional medical device (a hyperbaric chamber) and its non-clinical performance testing to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This document does not contain this information for an AI/ML device. It lists non-clinical performance tests for the hyperbaric chamber itself.
2. Sample sized used for the test set and the data provenance: Not applicable to an AI/ML study from this document.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable to an AI/ML study from this document.
4. Adjudication method: Not applicable to an AI/ML study from this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This indicates no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., pressure capabilities, material strength), verified through engineering tests, not expert consensus on medical images or patient outcomes.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, the provided text is a 510(k) submission for a non-AI/ML medical device (a hyperbaric chamber) and does not contain the information requested about AI device performance studies.

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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 intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.

Specific indication for use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations.

The thirteen indications are:

• Air or Gas embolism 1.
• 2. Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Complicated by Cyanide Poisoning

• 3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
• Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemia's 4.
• ನ. Decompression Sickness
• 6. Arterial Insufficiencies

Central Retinal Artery Occlusion

Enhancement of Healing In Selected Problem Wounds

• 7. Severe Anemia
• Intracranial Abscess 8.
• ರು Necrotizing Soft Tissue Infections
• 10. Osteomyelitis (Refractory)
• 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
• 12. Comprised Grafts and Flaps
• 13. Thermal Burns

A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.

The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.

These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes.

Each model is equipped with a clear anodized aluminum cover on one end and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device.

The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left.

The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device.

A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced.

A two-way intercommunication system is used to maintain contact between patient and attendant.

The provided document is a 510(k) Summary for Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers. It focuses on demonstrating substantial equivalence to a predicate device (Sechrist Model 4100H/HR) rather than presenting a standalone study with acceptance criteria and device performance results in the format typically seen for novel medical devices or AI algorithms.

However, I can extract the relevant information regarding design changes, their requirements, and validation methods, which serve as the "acceptance criteria" and "study" in the context of demonstrating substantial equivalence for these modifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes modifications to existing hyperbaric chambers and compares them to a predicate device. The "acceptance criteria" in this context are the device specifications and regulatory standards the modified devices must meet, and "reported device performance" refers to the validation that these specifications are met, often demonstrating equivalence to the predicate.

2. ASME Boiler & Pressure Vessels Code Section VIII Division 1.
3. PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy (Tested at 1.1 x MAWP). | 1. System Design Validation performed (Test Ref: 2009-0010).
4. ASME "U" Certificate of Authorization for ASME Boiler & Pressure Vessels Code Section VIII Division 1.
5. PVHO-1 testing (Appendix I, Enclosure 4) performed at 1.1 x MAWP.
   Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
   | Over-Pressure Relief Valve Pressure Change (Model 3300H/HR: 35 psig; Model 3600H/HR: 36 psig) | 1. Device Specification (35 psig ± 2 psig for 3300H/HR; 36 psig ± 2 psig for 3600H/HR).
6. Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
7. Activation pressure of valves tested and verified (Document 150156, Section 5).
   Outcome: "The data indicates that the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers activates the Relief Valves at the activation pressures as outlined in the product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
   | Gas Supply Flow Rate Change (Model 3300H/HR: 32 SCFM; Model 3600H/HR: 34 SCFM) | 1. Device Specification (32 SCFM for 3300H/HR; 34 SCFM for 3600H/HR).
8. Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
9. Device performs to specification after calibration (Document 150156). Each model is tested 100% using recommended supply pressure settings during manufacturing.
   Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |

Remaining Information (NotApplicable / Not Provided for this Device Type)

The provided document describes modifications to a hyperbaric chamber, which is a physical medical device. The questions related to sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness studies, standalone algorithm performance, ground truth type for test/training sets, and training set sample size are typically applicable to software as a medical device (SaMD) or AI/ML-based diagnostic/screening tools.

Since this submission is for a physical device (Hyperbaric Chamber) and demonstrates substantial equivalence based on engineering changes and performance specification verification, these specific metrics for data-driven algorithms are not applicable and therefore not provided in the document.

The "study" that proves the device meets the acceptance criteria consists of engineering validation and verification tests, compliance with specified industry standards (ASME, PVHO-1), and internal calibration procedures, all aimed at showing that the modified device performs to its specifications and equivalently to the predicate device in terms of safety and efficacy.

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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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Indications For Use:

The O.S.C.A.R. system is intended for use as an ancillary device for the support of whole-body oxygen administration to a patient at greater than ambient atmospheric pressure (hyperbaric oxygen) as prescribed by a physician. It is a device intended to provide control of Pressure Vessels for Human Occupancy without change to their established indications for use. The specific manufacturer's devices intended for use are Environmental Tectonics Corp.'s BARAMED 30" and XD monoplace models.

The FDA has cleared the use of hyperbaric chambers under 13 specific medical conditions that are based on the Undersea and Hyperbaric Medicine Society (UHMS)'s indications. These are:

• Air or Gas Embolism .
• Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning
• Clostridial Myositis and Myonecrosis (Gas Gangrene)
• Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias
• Decompression Sickness
• Enhancement of Healing in Selected Problem Wounds
• Exceptional Blood Loss (Anemia)
• Intracranial Abscess
• Necrotizing Soft Tissue Infections
• Osteomvelitis (Refractory)
• Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
• Skin Grafts and Flaps (Compromised)
• Thermal Burns

It is a prescription device that is intended for sale and use by or on the order and under the medical supervision of a physician.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a hyperbaric chamber system called O.S.C.A.R. It does not describe any acceptance criteria or studies related to device performance in the context of an AI/ML device as your prompt implies.

Therefore, I cannot extract the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.

The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 4 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523/1023 "oil-less, breathable air compressor" to pressurize the chamber and provide a suitable environment for the occupant. The Flexi-Lite construction utilizes a dual bag design with the inner the ooonpining the pressure and an exterior bag to provide structural support. All components are attached to the inner bag utilizing bulkhead connections. It is outfitted with two externally mounted metal relief valves (set at 4 psi), two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal), and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).

Here's an analysis of the provided text regarding the Flexi-Lite Hyperbaric Chamber (K101262), focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the device is a hyperbaric chamber, not an AI/ML-driven device, diagnostic algorithm, or medical imaging analysis tool. Therefore, many of the requested categories related to algorithm performance, expert review, and ground truth for AI studies are not applicable to this submission.

The document describes a traditional medical device submission for substantial equivalence to a predicate device. The "acceptance criteria" discussed are primarily related to the device's functional and safety characteristics compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: "SE" indicates Substantially Equivalent to the predicate device, K051759.

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

The document explicitly states: "Bench testing was performed as determined by the hazard analysis." This indicates physical testing on the device itself.

• Sample Size for Test Set: Not explicitly stated for each test, but it would typically involve one or more physical units of the Flexi-Lite hyperbaric chamber. The nature of bench testing implies testing of representative product units rather than a "data set" in the context of an algorithm.
• Data Provenance: The testing was non-clinical, meaning it focused on engineering performance and safety. It doesn't involve patient data, country of origin of data, or retrospective/prospective studies in the sense of clinical trials. The data would originate from the manufacturer's internal testing facilities or an accredited testing lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this type of device (a physical hyperbaric chamber) is its functional performance, safety features (e.g., relief valve settings), and material specifications, as validated by engineering tests against predetermined criteria or predicate device specifications. This doesn't involve "experts" establishing ground truth in the way a diagnostic algorithm requires clinical expert consensus.

4. Adjudication method for the test set

Not applicable. This is not a comparative clinical study requiring adjudication of interpretations. Bench testing results are typically objective measurements or pass/fail determinations based on engineering standards.

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 not an AI-assisted diagnostic tool. No MRMC study was performed as it is not relevant to 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.

7. The type of ground truth used

The "ground truth" for this device's substantial equivalence determination relies on:

• Engineering Specifications: Adherence to defined physical dimensions, material properties, pressure ranges, and component functionality (e.g., relief valve settings).
• Safety Standards: Compliance with recognized safety standards relevant to medical devices and pressure vessels.
• Predicate Device Equivalence: Direct comparison of features and performance parameters to a legally marketed predicate device (Flexi-Lite Hyperbaric Chamber K051759). The predicate device itself serves as the benchmark for acceptable performance and safety.
• Hazard Analysis: Identification and mitigation of potential hazards, with "bench testing" verifying that these mitigations are effective.

8. The sample size for the training set

Not applicable. This is a physical 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. There is no training set for this device.

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The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery, trauma surgery, thoracic surgery, otolaryngology, oral and maxillofacial surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vivo or in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for thirdparty reimbursement and most insurance carriers have established reimbursement policy based on the recommendations.

The thirteen indications are:

1. Air or Gas embolism
2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
5. Decompression Sickness
6. Arterial Insufficiencies Central Retinal Artery Occlusion 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. Compromise Grafts and Flaps
13. Thermal Burns

The Sechrist Model 4100H/HR Hyperbaric Chamber is a monoplace pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 ps) of pressure. The hyperbaric chamber is a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.

A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). Typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.

The Model 4100H/HR is constructed with a horizontal 41 inch internal diameter seamless acrylic cylinder. One end is equipped with a hard anodized aluminum cover and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device. The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. The Model 4100 comes in two configurations (4100H and 4100HR). In the Standard configuration-4100H-the control panel is located on the left of the chamber when facing the door. In the Reverse configuration-4100HR-the control panel is located on the right side of the chamber.

The Sechrist Model 4100H/HR Hyperbaric Chamber is a medical device. The provided text describes the device's technical specifications and how its performance was established, primarily through adherence to industry standards and a comparison to a predicate device for substantial equivalence.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/algorithm-based diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC as primary acceptance criteria. Instead, its acceptance criteria are based on its ability to meet engineering specifications and comply with established industry safety and performance standards for hyperbaric chambers.

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

This device is a hardware medical device, not a software algorithm that processes data. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) as seen in AI/diagnostic studies is not directly applicable.

The "testing" here refers to engineering and functional testing of the physical device and its control systems. The document states "Performance testing conducted confirms the device operates as designed." It also mentions "environmental testing, electrical safety/EMC testing." These tests would involve samples of the manufactured device itself, rather than a dataset of patient information. The number of devices tested is not specified, but typically this would involve a limited number of production or pre-production units to demonstrate compliance with specifications.

Data Provenance: Not applicable in the context of diagnostic data. The "data" here would be measurements from physical tests on the hyperbaric chamber.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a hardware device like a hyperbaric chamber, "ground truth" is established by engineering specifications, validated safety standards, and functional performance benchmarks (e.g., pressure achieved, oxygen concentration, integrity of seals). There isn't a "ground truth" established by human experts in the way that clinical images are adjudicated. The experts involved would be engineers, safety specialists, and regulatory affairs personnel who design, test, and approve the device against these objective criteria.

The "intended use" indications are established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This committee is described as being comprised of practitioners and scientific investigators in various medical fields. While they define the clinical indications for which the device can be used, they do not establish "ground truth" for the device's technical performance.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human readers establishing ground truth for diagnostic or prognostic studies. This device's performance is verified against objective physical and engineering standards.

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 or diagnostic tool designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable. This is a hardware medical device, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is its adherence to:

• Engineering Specifications: Designed parameters like internal diameter, pressure capabilities, material specifications.
• Industry Standards: Compliance with Section VIII, Division 1 of ASME Boiler and Pressure Vessel Code, ASME PVHO-1, and NFPA 99. These are highly detailed and rigorously defined safety and performance standards for pressure vessels and healthcare facilities.
• Predicate Device Equivalence: The performance of the new device is compared to a legally marketed predicate device (Sechrist Model 3200P/PR Hyperbaric Chamber) to demonstrate "substantial equivalence" in terms of safety and effectiveness.

The "ground truth" for the intended uses of hyperbaric chambers (the thirteen indications listed) is established by the clinical consensus and research findings accepted by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. This is based on:

• Sound physiologic rationale
• In vivo or in vitro studies
• Controlled animal studies
• Prospective controlled clinical studies
• Extensive clinical experience

8. The sample size for the training set

Not applicable. This is a hardware device, not an algorithm that requires a training set of data.

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

Not applicable. No training set is used for this type of device.

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