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SeptiCyte™ LAB is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene™ Blood RNA Tube. SeptiCyte™ LAB is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic in patients suspected of sepsis on their first day of ICU admission. The test generates a score (SeptiSCORE™) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte™ LAB is in-vitro diagnostic use.

SeptiCyte™ LAB is an in vitro diagnostic test to be used when prescribed by a clinician in professional settings such as central hospital laboratories. SeptiCyte™ LAB is a reverse transcription quantitative polymerase chain reaction (RT-gPCR)-based laboratory test that quantifies the relative expression levels of four host response genes (CEACAM4, LAMP1, PLA2G7, PLAC8) using RNA extracted from the whole blood of critically ill patients suspected of sepsis. It is a kit developed specifically for the Applied Biosystems® 7500 Fast Dx Real-Time PCR System. SeptiCyte™ LAB serves as an indicator of the host response to infection in systemically inflamed patients by measuring the expression of specific genes with roles in immune function, and infection. More specifically it aids in differentiating infection-positive systemic inflammation (IPSI) from infection-negative systemic inflammation (INSI).

SeptiCyte™ LAB measures the relative expression levels of the four genes by threshold cycle (Ct) in RT-qPCR. Ct values are linearly combined in a SeptiSCORE™ ranging from 0 to 10 by SeptiCyte™ Analysis software. The higher the SeptiSCORE™ value, the greater the likelihood of IPSI; the lower the SeptiSCORE™, the less likely the condition is caused by infection (INSI).

The provided text describes the SeptiCyte™ LAB device, an in vitro diagnostic test for aiding in the differentiation of infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis.

Here's the breakdown of the acceptance criteria and study details:

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

The document does not explicitly state "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it describes "Primary Endpoint" and "Secondary Endpoint" which the clinical study "met." I will use these endpoints as the de facto acceptance criteria.

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

• Sample Size: 447 adult patients
• Data Provenance: Observational, prospective clinical trials conducted across eight clinical sites in the US and Europe.

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

• Number of Experts: Three medical experts.
• Qualifications of Experts: Assumed to be medical professionals with expertise in critically ill patients and sepsis diagnosis, as they were referred to as an "RPD panel" and "medical experts" providing "independent clinical case review." Specific experience duration (e.g., "10 years experience") is not provided.

4. Adjudication method for the test set

The adjudication method involved a "majority opinion of three medical experts."

• Consensus RPD: Subjects were stratified by diagnosis (SIRS, Sepsis, or Indeterminate) according to the majority opinion. Indeterminate cases (n=37) were excluded from the analysis.
• Forced RPD: Subjects were stratified by diagnosis (SIRS or Sepsis) according to the majority opinion, with no Indeterminate category allowed, forcing all patients into either SIRS or sepsis categories.

This closely resembles a 3+1 or simply majority consensus method, where at least two out of three experts had to agree for a definitive diagnosis.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with AI assistance was not done. The study evaluated the standalone performance of the SeptiCyte™ LAB device in relation to a retrospective physician diagnosis, and its contribution to logistic regression models alongside other clinical variables. There is no mention of human readers interpreting images or data with and without AI assistance.

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

Yes, the primary and secondary endpoints evaluate the performance of the SeptiSCORE™ (generated by the device's algorithm) as a standalone diagnostic aid. The SeptiSCORE™ was compared against a ground truth established by medical experts (RPD). The logistic regression models also assessed the SeptiSCORE's contribution amongst other variables, indicating its standalone diagnostic utility.

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

The ground truth used was expert consensus (Retrospective Physician Diagnosis or RPD), established by a panel of three medical experts. This diagnosis was made after the patient was discharged from the hospital and after all clinical information was available at discharge, and the experts were blinded to the SeptiCyte™ LAB test results.

8. The sample size for the training set

The document does not specify the sample size for a training set. The clinical study described involved 447 patients, which served as the evaluation (test) set for the device's performance. Information about a separate training set used to develop the SeptiSCORE™ algorithm is not provided in this document.

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

Since the document does not mention a specific training set or its sample size, it does not describe how ground truth for a training set was established.

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