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The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

VPAP ST-A System (VPAP ST-A with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is similar to the S9 VPAP ST (K102513) 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. The system comprises the flow generator, patient tubing, mask (patient interface), alarm functions and integrated humidifier. Therapy modes contained in the VPAP ST-A are CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Therapy modes come from the S9 VPAP ST (K102513) and Stellar 150 (K103167). The functional characteristics of the VPAP ST-A system includes all the clinician and user friendly features of the predicate devices.

The provided document is a 510(k) summary for the ResMed VPAP ST-A. It discusses the device's substantial equivalence to predicate devices and outlines non-clinical testing. However, it does not contain information about a study that used a test set with established ground truth, MRMC studies, or training sets.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a study with a test set, nor can I answer questions related to sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, or MRMC studies, as this information is not present in the document.

Based on the provided text, here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided directly. The document states: "All bench tests confirmed the product met the predetermined acceptance criteria, this included Pressure. Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices." However, the specific acceptance criteria values and the quantitative reported device performance for these criteria are not detailed in the summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document describes "bench tests" and "validated patient simulation models" but does not detail a "test set" in the context of patient data with a specific sample size or provenance. It explicitly states: "Clinical data for the VPAP ST-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 phases."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Cannot be provided. As there is no mention of a clinical test set requiring expert ground truth establishment for patient outcomes, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Cannot be provided. Similar to point 3, without a clinical test set subject to human interpretation, adjudication methods are not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. The document explicitly states: "Clinical data for the VPAP ST-A is not required". The device described is a medical device (ventilator) and not an AI or imaging diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, in essence, standalone testing was done. The "bench tests" and testing "against the predicate devices using common protocols" along with the use of "validated patient simulation models" can be considered a form of standalone performance assessment against engineering and functional specifications, rather than human-in-the-loop performance. However, this is for the device's core functions, not an 'algorithm' in the typical AI sense.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Objective engineering/functional specifications and predicate device performance. For the bench tests, the "ground truth" would be the pre-defined engineering design specifications for parameters like pressure, flow, trigger, cycling, and apnea/hypopnea detection, as well as the performance characteristics of the predicate devices. These are objective, measurable parameters rather than clinical outcomes or pathology.

8. The sample size for the training set

• Not applicable/Cannot be provided. The device is a ventilator, not an AI model that undergoes "training" in the machine learning sense from a dataset.

9. How the ground truth for the training set was established

• Not applicable/Cannot be provided. As there is no training set for an AI model, this question is not relevant.

Summary of what the document does state regarding testing:

• Type of Testing: Non-clinical bench tests and simulation models.
• Confirmation: "All bench tests confirmed the product met the predetermined acceptance criteria."
• Criteria Areas: Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests.
• Comparison Basis: Against predicate devices.
• Protocols: Common protocols for both devices (new and predicate).
• Clinical Data: "Clinical data for the VPAP ST-A is not required."
• Standards: Tested to appropriate FDA consensus standards and other applicable requirements, including IEC 60601-1-2:2007, IEC 60601-1:2005, and IEC 60601-1-8:2006.

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