Search Results

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.

Ask a specific question about this device