(155 days)
The SeptiCyte RAPID test 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 PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID 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 RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.
The SeptiCyte RAPID test 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 PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID 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 RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.
The provided document is a 510(k) clearance letter for the SeptiCyte RAPID device, but it does not contain the detailed acceptance criteria, study design, or performance data that would typically be found in a summary of safety and effectiveness or a clinical study report. Therefore, I cannot fully answer your request based only on the provided text.
However, I can extract information about the device's intended use and general context, and explain what kind of information would be needed to answer your questions if it were present.
Based on the provided text:
The document concerns the SeptiCyte RAPID device, a gene expression assay using reverse transcription polymerase chain reaction.
Intended Use: The SeptiCyte RAPID test is used:
- In conjunction with clinical assessments and other laboratory findings.
- As an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation.
- In patients suspected of sepsis on their first day of ICU admission.
- It generates a "SeptiScore" with four discrete Interpretation Bands indicating the increasing likelihood of infection-positive systemic inflammation.
- It's for in-vitro diagnostic use on the Biocartis Idylla System.
To answer your specific questions, the following information would be required from a more detailed submission document (e.g., 510(k) Summary of Safety and Effectiveness):
1. A table of acceptance criteria and the reported device performance
- This would typically include metrics like Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and possibly AUC, along with the predefined acceptance thresholds for these metrics. The provided document does not include this table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for the test set or its provenance (country/retrospective/prospective).
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)
- The document does not provide details on ground truth establishment, expert number, or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe an adjudication method.
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
- The SeptiCyte RAPID is described as a "gene expression assay" and not explicitly as an AI/CADe/CADx device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely for this type of device, unless it has a human interpretation component, which is not evident here. The document does not mention an MRMC study or effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The SeptiCyte RAPID operates by quantifying gene expression to generate a "SeptiScore." This implies a standalone algorithmic assessment based on biological markers. The device is intended to be used "in conjunction with clinical assessments and other laboratory findings," suggesting it provides data for clinicians to interpret, rather than replacing clinical judgment. However, the performance of the device itself (its ability to differentiate sepsis) would be evaluated in a standalone manner. The document does not explicitly state a standalone study was done, but given the nature of the device, its core performance would be standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document does not specify the type of ground truth used to establish reference for sepsis diagnosis in the study. For sepsis, ground truth is often clinical diagnosis based on a combination of criteria (e.g., Sepsis-3 definitions, physician review, culture results, organ dysfunction).
8. The sample size for the training set
- The document does not mention any details about a training set size.
9. How the ground truth for the training set was established
- The document does not mention any details about how the ground truth for a training set was established.
In summary: The provided FDA clearance letter is a regulatory approval notice and lacks the detailed technical and clinical study information required to answer most of your questions. This detailed information would typically be found in the 510(k) "Summary of Safety and Effectiveness" document submitted by the manufacturer to the FDA.
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.