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This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.

Trending Option is a software and hardware modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.

Although the provided text describes a medical device, the "Trending Option for the Infrasonics Adult Star Ventilator," it does not contain information related to acceptance criteria for diagnostic performance. The 510(k) summary focuses entirely on hardware and software modifications, intended use, similarities to predicate devices, and environmental and system-level functional testing.

Therefore, the following information, typically found when describing the acceptance criteria and a study proving device performance (especially for AI/diagnostic devices), cannot be extracted from this document, as it doesn't pertain to diagnostic performance:

1. A table of acceptance criteria and the reported device performance: No performance criteria (e.g., sensitivity, specificity, accuracy) are mentioned, nor are any performance results. The "results" column in the environmental tests simply states "Passed" for each test.
2. Sample size used for the test set and the data provenance: No test set related to diagnostic performance is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to diagnostic performance is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as there is no diagnostic performance test set.
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: Not applicable. This device is a trending display, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for diagnostic performance is mentioned.
8. The sample size for the training set: No training set is mentioned as this is a software/hardware upgrade for data display, not an AI model requiring training.
9. How the ground truth for the training set was established: Not applicable.

Summary of Testing (as provided in the document - focused on functionality and environmental robustness):

The "Summary of Testing" section is focused on demonstrating the functional robustness and safety of the Trending Option within the Adult Star Ventilator system, not its diagnostic or clinical performance.

Environmental Tests:
These tests ensure the device can operate reliably under various environmental conditions.

System Level Tests:
These tests validate the correct implementation of the design and its compatibility with other ventilator options.

Study Description (as inferred from the document):

The "study" described is a series of engineering and system integration tests to ensure the new "Trending Option" hardware and software upgrade for the Infrasonics Adult Star Ventilator functions correctly, is environmentally robust, and does not negatively impact the performance of the core ventilator or its existing options.

• Test Sets: The "test sets" for these studies would be the specific hardware and software configurations of the ventilator subjected to the environmental and system-level tests. No specific "sample size" in terms of patient data or cases is mentioned because the device is not performing a diagnostic task.
• Data Provenance: Not applicable in the context of diagnostic performance. The "data" being tested is the device's functional integrity.
• Ground Truth: For functional tests, the "ground truth" is that the device should operate according to its design specifications without failure. For environmental tests, the "ground truth" is that it should withstand specified conditions without malfunction. This is established by engineering standards and design requirements rather than clinical experts.
• Training Set: Not applicable as this is not a machine learning or AI-based diagnostic device.

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