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The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.

AITRICS-VC is a clinical decision support software that receives in-hospital patient information, including physiological parameters such as vital signs and blood test results from EHR and conducts rule-based calculations for conventional early warning scores, which include NEWS (National Early Warning Score), MEWS (Modified Early Warning Score), and qSOFA (quickSOFA).

The AITRICS-VC screens patients who meet predefined criteria based on single values of physiological parameters and early warning scores. It displays a multi-patient dashboard and detailed pages for individual patients via a web browser on clinicians' PCs.

Here's an analysis of the AITRICS-VC device based on the provided FDA 510(k) summary, structured to address your specific questions.

Currently, this document lacks specific details on the acceptance criteria and performance of the AITRICS-VC, as well as the specifics of any studies conducted to validate its performance. The document focuses on regulatory approval based on substantial equivalence to a predicate device and adherence to harmonized non-clinical standards.

Therefore, many sections of your request cannot be fully answered with the provided information. However, I will extract and present all available relevant information and note where data is missing.

Description of Acceptance Criteria and Device Performance

The provided document describes the AITRICS-VC as a standalone software intended to analyze patient data from an EHR and display data when vital signs, blood test results, or conventional early warning scores (MEWS, NEWS, qSOFA) exceed predefined thresholds.

Crucially, the document explicitly states: "No new issues of safety or effectiveness are introduced as a result of using this device. This device does not require clinical data." This indicates that a detailed clinical performance study with acceptance criteria and reported performance metrics was not deemed necessary by the FDA for this 510(k) clearance, as the device's function is primarily to aggregate and display data based on predefined thresholds, not to make diagnostic or treatment recommendations or to generate novel risk scores.

Given this, the "acceptance criteria" primarily relate to the software's functionality, safety, and adherence to specified standards, rather than direct clinical efficacy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance metrics from a clinical study are NOT available. The document focuses on non-clinical performance data and substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

The document states, "This device does not require clinical data." Therefore, there is no mention of a clinical "test set" in terms of patient data used for performance evaluation in a hypothesis-driven study.

The "tests" mentioned are non-clinical and relate to software engineering, usability, and alarm systems. No sample size for a patient-based test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical "test set" and corresponding performance study are described, there is no mention of experts establishing ground truth for such a set. The device operates on predefined thresholds for existing clinical scores and vital signs, not on novel diagnostic interpretations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

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. The document does not mention any MRMC comparative effectiveness study. The AITRICS-VC is described as a display tool that aids clinicians in understanding a patient's condition, not as an AI that directly assists in diagnosis or interpretation to improve human reader performance in a quantifiable way.

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

The device is inherently "standalone" in that it is software only ("AITRICS-VC is stand-alone software"). However, its intended use is to "display data" for clinicians "to aid in understanding a patient's current condition." It is explicitly stated that it is "not intended to replace bedside patient monitors or clinicians' clinical decision-making."

Therefore, its performance is as an information display system based on predefined rules/thresholds, rather than a diagnostic algorithm generating an output that would typically undergo standalone performance evaluation like sensitivity and specificity. The non-clinical tests confirm that the software "performs as intended," which implies standalone functionality as designed.

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

Not applicable in the context of a clinical performance study. The "ground truth" for the device's function is the predefined thresholds for vital signs, blood test results, and conventional early warning scores (MEWS, NEWS, qSOFA). The software's "truth" is whether it correctly identifies and displays patients whose data meet these established clinical thresholds.

8. The sample size for the training set

Not explicitly mentioned in the document for the AITRICS-VC's core functionality. The AITRICS-VC identifies patients where "vital signs, blood test results, or conventional early warning scores such as MEWS, NEWS, and qSOFA exceed predefined thresholds." These scores (MEWS, NEWS, qSOFA) are established clinical tools, and their underlying models (if any) would have been "trained" on historical data as part of their initial development, separate from the AITRICS-VC software. The AITRICS-VC itself seems to implement these existing rule-based calculations.

If there is any machine learning component beyond rule-based calculations that involved training, the document does not elaborate on it or provide a training set size.

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

Not applicable/Not mentioned. Similar to the training set size, the "ground truth" for the existing conventional early warning scores (MEWS, NEWS, qSOFA) would have been established during their development. The AITRICS-VC's function is to apply these scores and thresholds, not to develop new ones.

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