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The VPAP S-A is indicated to provide noninvasive ventilation for patients weighing more than 30 lbs (13 kg) with respiratory insufficiency such as that associated with hypercapnic Chronic Obstructive Pulmonary Disease (COPD) or obstructive sleep apnea (OSA). The VPAP S-A is intended for home and hospital use.

VPAP S-A System (VPAP S-A with H5i) is similar to the predicate device, using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is the Same as the S9 VPAP ST-A (K113288) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure (CPAP) between 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmHzO for the treatment respiratory insufficiency caused by COPD. The system comprises the flow generator, patient interface), alarm functions and integrated humidifier. Therapy modes contained in the VPAP S-A are CPAP and Spontaneous. Therapy modes come from the S9 VPAP ST-A (K113288) and remain unchanged.

The provided document for K122324, the VPAP S-A, is a 510(k) summary for a non-life-supporting continuous ventilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than reporting on a clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI component.

Therefore, many of the requested sections below cannot be fully completed based on the provided text, as the submission relies on bench testing and similarity to a predicate device, not a novel AI/algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All bench tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table with specific acceptance criteria values and corresponding reported device performance values. It lists the types of tests conducted.

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

The document explicitly states: "Clinical data for the VPAP S-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing activities."

Therefore, there isn't a "test set" in the sense of a patient dataset for evaluating an algorithm's performance. The testing involved bench tests with patient simulation models. The sample size for these simulation models is not specified, nor is the provenance directly applicable.

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

Not applicable. As no clinical test set using human data was employed, there was no need for experts to establish ground truth in the context of diagnostic accuracy. The "ground truth" for the bench tests would be the known, controlled parameters of the simulation models.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

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

No MRMC study was performed or reported. This submission focused on substantial equivalence through bench testing to a predicate device, not on improving human reader performance with AI assistance.

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

The device is a medical device (ventilator), not a diagnostic algorithm. Its performance is evaluated through its functional capabilities, and those were assessed via bench testing in a standalone manner (device performance alone) against predetermined engineering criteria and compliance with standards. It does not involve "algorithm only" performance in the context of an AI/ML diagnostic tool.

7. The Type of Ground Truth Used

The ground truth used for the bench testing was the known, controlled parameters of the validated patient simulation models and the specifications outlined in the relevant IEC standards (e.g., IEC 60601-1-2, IEC 60601-1, IEC 60601-1-8). The device's outputs (Pressure, Flow, etc.) were compared against these known simulation parameters and standard requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its functionality is based on established engineering principles and control systems.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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