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The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and K3-EDTA (venous) anticoagulated whole blood.

The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of sepsis manifesting within the first 3 days after testing. IVD CAPSULE PSP generates PSP values that fall within one of three discrete Interpretation bands based on increasing likelihood of sepsis.

The test is intended for professional use in clinical laboratory settings. It is indicated for use in adult patients at high risk of sepsis presenting to intensive care units (ICUs).

The IVD CAPSULE PSP is a single-use, semi-quantitative immunofluorescence assay used to determine the concentration of the pancreatic stone protein (PSP) in a human whole blood sample. The test kit contains the following components: Capsule, Special pipette (abioPIPETTE), Vial containing a detection reagent (abioMIX), Desiccant bag. The main component is the capsule, a high impact polystyrene plastic cartridge. The capsule allows dispensing the blood-abioMIX solution onto the loading port with a membrane separator. A second membrane drives the sample by capillary force to nanofluidic biosensors containing a read-out area where PSP is captured by specific antibodies and fluorescently detected. The concentration of captured PSP is proportional to the fluorescence generated by the fluorophore conjugated to the detection antibody. The capsule also contains an RFID tag programmed with biosensor configuration and lot-specific information.

The abioSCOPE is a tabletop diagnostic device that measures analytes in biological samples using test-specific capsules (IVD CAPSULE). It is operated through a high-resolution touchscreen. It is composed of a fully automated fluorescence microscope and a tray for the IVD CAPSULE. The abioSCOPE uses a laser to excite molecular complexes inside the biosensors, leading to fluorescence emission. The abioSCOPE then calculates the concentration of the analyte.

The acceptance criteria and the study proving the device meets these criteria are detailed as follows for the IVD CAPSULE PSP device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided focus on the clinical performance of the device, specifically its ability to classify patients into sepsis risk categories based on PSP concentrations.

Note: While explicit "acceptance criteria" are not formally listed in the provided text in a quantitative manner for clinical performance, the performance data presented (Predictive Value and Likelihood Ratio) implicitly serves as the successful fulfillment of typical clinical performance expectations for a diagnostic aid.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 497 patients (referred to as the "Full ITD Population" for the clinical study AB-PSP-002).
• Data Provenance: Multicentric, prospective, observational clinical study (AB-PSP-002; NCT04105699) conducted across six Intensive Care Unit (ICU) centers in the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Three medical doctors.
• Qualifications of Experts: Experts in critical care medicine and the assessment of infection and sepsis. They were not otherwise involved in the study.

4. Adjudication Method for the Test Set

The ground truth was established by an External Independent Review Committee (EIRC) consisting of three medical doctors.

• Adjudication Method: The EIRC independently adjudicated all subjects based on the Sepsis-3 definition, determining whether each patient had sepsis or not at each day within the first 3 days of ICU stay. They were blinded to the PSP results. This implies a consensus-based approach, likely a 3-0 agreement or 2-1 majority rule, though the exact decision process (e.g., 2+1, 3+1) is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the IVD CAPSULE PSP device in aiding sepsis early detection, not on comparing human readers with and without AI assistance.

6. If a Standalone Study Was Done

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The study evaluated the IVD CAPSULE PSP device's ability to classify sepsis risk based on PSP concentrations, and its diagnostic performance was compared against the EIRC's clinical diagnosis, which served as the ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus (clinical diagnosis), established by an External Independent Review Committee (EIRC) based on the Sepsis-3 definition.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a separate training set for the clinical performance evaluation. It mentions that cut-off values were established from a previous international multicentric observational clinical study. This implies a training set was used to determine these cut-off values, but the size of that specific training population is not provided in this document. The listed clinical performance data are from the AB-PSP-002 study (n=497) which serves as the validation/test set for the specified cut-offs.

For the analytical performance, training sets were implicitly used for calibration curve establishment, but specific sizes are not detailed beyond mentioning "Abionic has established an in-house higher order calibrator."

9. How the Ground Truth for the Training Set Was Established

For the clinical performance aspect:
The document states that cut-off values were "established from a previous international multicentric observational clinical study." While the specific methodology for establishing ground truth in that precursor study is not detailed here, it is reasonable to infer a similar approach relying on clinical criteria for sepsis diagnosis by medical experts was employed. The current document focuses on the validation of these pre-established cut-offs using the AB-PSP-002 study.

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