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The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.

The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.

The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.

The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.

The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.

The provided text describes a medical device, the Spiritus™ Respiratory System, a patient interface accessory for positive airway pressure treatment. However, the document is a 510(k) summary and approval letter, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria in the manner typically seen for novel AI/ML devices.

Therefore, much of the requested information (like sample size for test/training set, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods) is not available in this document. The document describes traditional engineering performance testing, not studies of diagnostic accuracy that would involve expert readers or AI algorithms.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the way that would be expected for a diagnostic AI device. Instead, it lists the types of performance tests conducted and asserts that these tests confirmed the device's performance. The implied acceptance criterion for these tests is "meets performance expectations for a substantially equivalent device."

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

• Test Set Sample Size: Not specified. Standard engineering-style performance testing was performed, not studies on patient data.
• Data Provenance: Not applicable in the context of device performance testing described. These are likely bench or laboratory tests.

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

• Number of Experts: Not applicable. These were engineering performance tests, not human-read diagnostic studies.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. The device is a patient interface accessory, not a diagnostic imaging device or an AI algorithm that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering standards, specifications, and comparison to the predicate device's known performance for flow resistance, enclosed volume, and intentional leak rate.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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