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Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

The Autovent 1500 is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Flynn Genesis product - 510K # K913039/B except in the range of automatic settings of the device which have been extended and chosen to provide the output requirements of the latest AHA recommendations.

The document describes the Autovent 1500, an automatic time-cycled resuscitator, and its clearance based on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the international standard for these devices, ISO 8382-1988, which the predicate device's performance data addressed. The Autovent 1500's performance was then compared against the predicate device.

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

The document does not explicitly state a "test set" in the context of human data. The assessment of performance data relies on non-clinical test data.

• Sample Size: Not applicable. The testing was non-clinical.
• Data Provenance: The standard is "international standard for these devices - ISO 8382-1988." The testing was undertaken by the manufacturer, O-Two Systems International Inc. The document does not specify a country of origin for the test data itself, beyond the device manufacturer's location in Canada. The data is retrospective in the sense that it evaluates a completed device design against established standards.

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

Not applicable. The performance assessment was based on non-clinical testing against an international standard, not on expert-established ground truth from a human dataset.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation was based on non-clinical testing against a standard and comparison to a predicate device, not on expert adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device performance against a standard and equivalence to a predicate, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, a standalone study was done in the sense that the device's technical specifications and performance were evaluated independently as a piece of equipment ("algorithm only" in the context of device function, not AI). The "Assessment of Performance Data" section states that the predicate device submission incorporated significant non-clinical test data to support its claim of substantial equivalence, and this new device was verified against that performance. This testing would be considered standalone evaluation of the device's functional performance characteristics.

7. The Type of Ground Truth Used

The ground truth used was technical specifications and performance characteristics defined by the international standard ISO 8382-1988, as demonstrated by the legally marketed predicate device (Flynn® Genesis® II Adult/Child - 510K # K913039/B).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set in the typical sense. Its performance is based on its mechanical and pneumatic design.

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

Not applicable, as there is no "training set" for this device.

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