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The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

The Geo is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lbs (30 kg). The Geo mask system delivers airflow noninvasively to a user from the integrated CPAP device. The Geo system is intended for single-patient re-use in the home environment and while traveling.

The provided text describes a Special 510(k) submission for the ResMed Geo device, which is a non-continuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA). The submission is for a device modification, and it states that the modified device has similarities to the previously cleared Tasman device in terms of intended use, operating principle, technologies, and manufacturing process.

The document indicates that design and verification activities were performed on the modified device, and these tests confirmed the product met predetermined acceptance criteria.

Here's an breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The document states that the tests met the acceptance criteria, but it does not explicitly list the specific numerical/quantitative acceptance criteria themselves (e.g., "pressure stability must be within +/- X units"). It only lists the parameters that were evaluated.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Design and Verification activities" and "All tests," but does not provide details on the number of units or patients included in these tests.
• Data Provenance: Not explicitly stated. The document indicates the submitter is ResMed, with an official contact in San Diego, CA, USA. However, it does not specify the country of origin for the data generated from the testing. The study appears to be prospective in nature, as it describes "Design and Verification activities were performed on the modified device."

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

This information is not provided in the document. The tests performed (pressure stability, jitter, swings, ISO 17510-1 pressure performance, functional dead space) are primarily engineering and performance-based, rather than relying on human expert assessment for "ground truth" in clinical interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The nature of the tests described (device performance metrics) does not typically involve an adjudication method in the way clinical diagnostic studies do.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC study is not mentioned and is not relevant to the type of device performance testing described. This is a ventilation device, and the focus of the submission is on engineering performance compared to a predicate device, not on diagnostic accuracy with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable/provided. The Geo device is a physical medical device (a ventilator), not an AI algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here. The "standalone" performance in this context would refer to the device's inherent performance characteristics, which are implicitly what the "pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests" measured.

7. Type of Ground Truth Used

The "ground truth" for the tests performed was based on engineering specifications and established performance standards (specifically ISO 17510-1 for pressure performance) and comparison against the "previously cleared device using common protocols."

8. Sample Size for the Training Set

This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."

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

This is not applicable as the Geo device is a hardware product, not an AI algorithm that requires a "training set."

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