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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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