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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 PAH-M3+1 Hyperbaric Chamber System is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea & Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and smoke inhalation; clostridial myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds: exceptional blood loss anemia: necrotizing soft tissue infections: osteomyelitis (refractory); radiation tissue damage (osteoradionecrosis); compromised skin flaps and grafts; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.

It is the expressed, intended use of the Pan-America Hyperbarics' PAH-M3+1 Hyperbaric Chamber System 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 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
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 PAH-M3+1 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 4 patients at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.

The PAH-M3+1 Hyperbaric Chamber System is 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); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). The overall external length of the chamber is 4500mm (approx. 14.76 ft). Its internal diameter is 1016mm (approx. 40 inches). There are two compartments: main compartment and transfer compartment. Three (3) removable seats and one fixed (1) seat are installed in main compartment and transfer compartment respectively. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirements of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A lowvoltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The patients are loaded and unloaded by a retractable gurney, which is equipped with a sliding transport chair. When supine position is needed, a sliding bunk will be used instead. The chamber is also equipped with safety switch for pressurization. There is no gas supply before the chamber's door is closed and secured thoroughly.

This 510(k) summary describes a hyperbaric chamber system, not an AI/ML device. Therefore, the specific criteria for AI/ML device evaluation such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies are not applicable to this document. The provided text does not contain information about the performance evaluation of an AI-powered diagnostic or therapeutic device.

The acceptance criteria for the PAH-M3+1 Hyperbaric Chamber System are based on compliance with established engineering and medical standards for such devices. The "study" that proves the device meets these criteria is the design and manufacturing process adhering to these standards, as well as the 510(k) submission and FDA's substantial equivalence determination.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and 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)

Not applicable. This is a hyperbaric chamber, not an AI/ML device that uses a test set of data. The "testing" involves engineering and functional validation against established safety and performance standards for mechanical and medical 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. Ground truth, in the context of AI/ML, refers to validated diagnostic labels or outcomes for data. For a hyperbaric chamber, the "ground truth" is defined by the technical specifications and clinical indications established by regulatory bodies and medical societies (like UHMS).

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

Not applicable. Adjudication methods are used to resolve disagreements in expert labeling of data, which is not relevant for this device.

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 medical apparatus, not an AI-assisted diagnostic tool for human readers.

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 concensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the device's acceptable performance is its demonstrated compliance with design and manufacturing standards (ANSI/ASME, NFPA 99) and its intended use for specific medical conditions as recognized by organizations like the Undersea & Hyperbaric Medical Society (UHMS). The FDA's substantial equivalence determination implies that its safety and effectiveness are comparable to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

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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
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 PAH-S1 Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber 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 das. The overall external length of the chamber is 2200mm (approx, 7.22 ft). Its internal diameter is 813mm (approx. 32 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 19 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 qurnev. 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.

This is a 510(k) premarket notification for a hyperbaric chamber system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to predicate hyperbaric chambers by adhering to established safety and performance standards for such medical devices.

Here's a breakdown of what can be extracted, though it doesn't fit the AI/ML framework:

1. Acceptance Criteria and Reported Device Performance (Non-AI Context):

While not framed as "acceptance criteria" for an AI model, the submission implies adherence to specific engineering and safety standards, which serve as performance benchmarks for a hyperbaric chamber.

• 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)
• NFPA 99, Health Care Facilities, Chapter 20, Hyperbaric Facilities, 2002 Edition |
  | Intercommunication System | Low-voltage system designed and installed in accordance with NFPA 99, Chapter 19
  Maximum power to speaker: 250 mW at 1.4 volts (NFPA 99, Chapter 20 limit is 500 mW and 28 volts) |
  | Operator Control | Single operator chamber pressure control achieved via a simple manual pneumatic control. |
  | Safety Features | No gas supply for pressurization before the chamber's door is closed and secured thoroughly. |
  | Intended Use | Therapy for selected medical conditions determined to respond to hyperbaric oxygen, as per UHMS guidelines (e.g., air/gas embolism, CO poisoning, decompression sickness, problem wounds, etc.) |
  | Installation and Operation Environment | Designed to be installed and operated in medical facilities as defined by NFPA 99, Chapter 20.
  Intended to be operated only by medical personnel specifically trained in HBO use and safe operation. |

The following points are not applicable/found in the document for this type of device:

2. Sample size used for the test set and the data provenance: Not applicable. This is a hardware device; testing involves engineering and safety validation, not a "test set" of data in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a hyperbaric chamber involves engineering specifications and safety standards, not expert consensus on medical image interpretation or similar AI tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and performance is adherence to recognized engineering and medical standards (ASME, NFPA 99, UHMS guidelines for indications).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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
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 PAH-M10+2 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 12 patients at up to a maximum operating pressure of 6 Atmospheres Absolute (ATA) or 73.5 pounds per square inch qauge (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 is 7025mm (approx. 23 ft). Its internal diameter is 2500mm (approx. 8.2 ft). There are two compartments: main compartment and transfer compartment. Ten (10) seats and two (2) seats are installed in main compartment and transfer compartment respectively. Besides, there is one (1) additional seat installed in the main compartment for attendant. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirement of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A low-voltage patient intercommunication system designed and installed in accordance with NFPA 99, Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. It also provides patients with audio program content from external sources such as CD players, radios, etc. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The rectanqular door allows a normal size patient gurney to be used to transport nonambulatory patients into the chamber. This feature greatly improves patient handling safety.

This 510(k) Notification Summary describes a hyperbaric chamber system, not an AI/ML powered device. As such, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML or device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on:

• Device Description: A multiplace hyperbaric chamber system (PAH-M10+2) designed to treat up to 12 patients at specified pressures, using compressed air and 100% oxygen.
• Intended Use: To provide therapy for specific medical conditions that respond to hyperbaric oxygen, as outlined by the Undersea & Hyperbaric Medical Society (UHMS).
• Predicate Devices: A list of previously cleared hyperbaric chamber systems.
• Compliance with Standards: The device is designed and fabricated in accordance with ANSI/ASME codes and NFPA 99.
• FDA Clearance: A letter from the FDA stating substantial equivalence to predicate devices, thus allowing marketing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to AI/ML device performance. The type of device described here does not typically involve such metrics for its clearance.

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