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The Sysmex CS-2100i is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.

For determination of:

• Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
• Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• D-dimer with INNOVANCE® D-Dimer.

The performance of this device has not been established in neonate and pediatric patient populations.

The Sysmex CS-2100i is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated:

• Reagents
• Controls
• Calibrators
• Consumable materials

The subject of this 510(k) notification is to expand the use of the INNOVANCE® D-Dimer for the exclusion of Deep Vein Thrombosis on Sysmex CS-2100i. All other established indications, performance and technology characteristics as cleared under K151259 remain unchanged.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

The document describes the Sysmex CS-2100i, a fully automated blood coagulation analyzer, and focuses on the expansion of its use for the INNOVANCE® D-Dimer assay for the exclusion of Deep Vein Thrombosis (DVT).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the DVT exclusion performance. Instead, it reports the diagnostic performance metrics obtained from the study. The implication is that these reported metrics were deemed acceptable for market clearance.

Note: The FDA's clearance implies that the reported NPV of 99.7% (and 99.1% standardized) met the necessary threshold for indicating substantial equivalence for DVT exclusion, as a high NPV is critical for "ruling out" the disease.

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

• Total Initial Patient Sample Size: 1907 consecutive outpatients.
• Excluded from Analysis: 368 patients (including 213 with previously documented or chronic DVT).
• Patients for Final Analysis: 1317 patients.
  • US Sites: 803 patients
  • OUS (Outside US) Sites: 514 patients
• Data Provenance: Multicenter study. Data was collected prospectively from patients in the US and Europe (OUS sites are likely European, given the company's origin in Germany). The study included consecutive outpatients presenting to emergency or ambulatory departments.

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

The document specifies that the reference standard for DVT diagnosis involved imaging methods, e.g., ultrasound, and a 3-month follow-up to evaluate potential DVT development. It does not explicitly state the number or specific qualifications of experts (e.g., radiologists, vascular specialists) involved in interpreting these imaging studies or clinical follow-ups. However, "Reference (Imaging and 3-month follow-up)" implies that the ground truth was established by standard clinical diagnostic procedures, which inherently involve qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for conflicting interpretations of imaging results or clinical diagnoses. It states that patients with "no or a positive D-dimer result with the D-dimer assay used at the respective study center were evaluated by imaging methods, e.g. ultrasound," and "Patients with a negative D-dimer result with the D-dimer assay used at the respective study center underwent imaging at the physician's discretion." All patients with a negative clinical diagnosis were followed up. This suggests that the final clinical diagnosis, incorporating imaging and follow-up, served as the ground truth. There is no mention of multiple expert readers or a consensus process for the ground truth determination itself, beyond the standard practices for diagnostic imaging interpretation and clinical follow-up.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The study described is a diagnostic accuracy study for the device (Sysmex CS-2100i with INNOVANCE® D-Dimer) in a standalone manner compared to clinical ground truth. It is not an MRMC comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.

6. Standalone Performance Study

Yes. The study evaluates the standalone performance of the INNOVANCE® D-Dimer assay on the Sysmex CS-2100i system. The performance metrics (Sensitivity, Specificity, NPV, PPV) are calculated for the device's output (D-dimer result

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The Sysmex CS-2100i is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.

For determination of:

• Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
• Activated Partial Thromboplast Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• D-dimer with INNOVANCE® D-Dimer.

The performance of this device has not been established in neonate and pediatric patient populations.

The Sysmex CS-2100i is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated: Reagents, Controls, Calibrators, Consumable materials. The subject of this 510(k) notification are reagent applications which perform the coagulation tests Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®; Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL; Fibrinogen (Fbg) with Dade® Thrombin Reagent; Antithrombin (AT) with INNOVANCE® Antithrombin; and D-dimer with INNOVANCE® D-Dimer. The analysis principles used on the instrument are reflected by the reagent application testing provided in this 510(k) notification and is described in the below table.

Device Acceptance Criteria and Study Analysis for Sysmex CS-2100i

This document summarizes the acceptance criteria applied to the Sysmex CS-2100i automated coagulation analyzer and the studies conducted to demonstrate its performance, as described in the provided FDA 510(k) summary.

Device Name: Sysmex CS-2100i
Intended Use: Fully automated blood coagulation analyzer for in vitro diagnostic use, analyzing clotting, chromogenic, and immunoassay methods in clinical laboratories, for determination of PT, APTT, Fibrinogen, Antithrombin, and D-dimer.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for certain performance metrics (e.g., specific thresholds for correlation coefficients or CVs). However, it consistently states that "All reagents met the pre-determined acceptance criteria" and "Results from each application met the pre-established acceptance criteria." The table below presents the reported performance data from the studies, which implicitly represent the device meeting the acceptance criteria set by the manufacturer.

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

• Method Comparison Studies: Samples were collected at three external sites in the United States. The studies were retrospective, comparing the new device (Sysmex CS-2100i) against the predicate device (Sysmex CA-1500) using the same samples.
  • Sample Sizes (n) per application (across all 3 sites combined):
    • PT (seconds): 460
    • PT (INR): 454
    • APTT: 432
    • Fibrinogen: 356
    • Antithrombin: 372
    • D-dimer: 349
• Reproducibility Studies: Samples were collected at two external sites in Germany and one external site in the United States. The studies involved conducting multiple runs over 20 days.
  • Sample Sizes: The exact number of individual patient samples used is not specified, but the study design involves multiple replicates of various samples (likely control materials and patient samples spanning the reportable range) over 20 days.
• Detection Capability Studies: Not specified, but involved calibrated assays measured on the Sysmex CS-2100i.
• Linearity & Measuring Range Studies: Not specified, but involved calibrated assays measured on the Sysmex CS-2100i.
• Reference Interval Studies: Conducted at three clinical study sites in the United States. The number of samples for each application is not explicitly stated.
• D-Dimer PE Exclusion Validation Study: This was a multi-center study using frozen specimens collected prospectively from outpatients presenting with suspected PE.
  • Initial Enrollment: 1930 consecutive outpatients.
  • Patients after exclusions: 1834 patients.
  • Patients for final analysis: n=1467.
  • Data Provenance: Combined US and OUS (Outside US, likely European, given the mention of European population prevalence).

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the studies (method comparison, reproducibility, detection capability, linearity, reference interval).

For the D-Dimer PE Exclusion Validation Study:

• The "ground truth" for PE diagnosis was established by imaging methods (e.g., spiral CT and/or VQ scan) for patients with positive D-dimer results or at physician's discretion, and clinical follow-up after three months to evaluate potential development of PE for patients with negative D-dimer results. This indicates clinical diagnostic standards were used, but not necessarily an "expert panel" establishing ground truth for the test set itself in terms of interpretation of the device results.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for any of the test sets. For the D-Dimer PE exclusion study, the reference standard involved objective imaging and clinical follow-up rather than expert consensus on test results.

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

No, an MRMC comparative effectiveness study was not done. The studies focused on comparing the performance of the new instrument (Sysmex CS-2100i) to a predicate instrument (Sysmex CA-1500) and establishing its analytical and clinical performance characteristics (e.g., reproducibility, linearity, detection capability, PE exclusion). There is no mention of human readers or evaluating their improvement with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are standalone performance evaluations of the Sysmex CS-2100i instrument. The device is an automated coagulation analyzer that provides quantitative results for various assays. The studies assess the accuracy, precision, and clinical utility of these quantitative measurements as performed by the instrument itself, without direct human-in-the-loop interpretation that would alter the algorithm's output. The D-Dimer PE exclusion study evaluated the D-dimer assay's performance on the Sysmex CS-2100i against a clinical cut-off, which is a standalone assessment of the device's diagnostic performance for that specific indication.

7. The Type of Ground Truth Used

• Method Comparison: The predicate device (Sysmex CA-1500) served as the reference or "ground truth" for comparison, as the study aimed to demonstrate substantial equivalence between the new and predicate devices.
• Reproducibility, Detection Capability, Linearity, Reference Interval: These studies establish the inherent analytical performance characteristics of the device. The ground truth here is derived from controlled measurements against expected values (e.g., known concentrations for linearity, statistical analysis of repeated measurements for reproducibility).
• D-Dimer PE Exclusion Validation Study: The ground truth for the presence or absence of Pulmonary Embolism was established by a combination of:
  • Imaging methods: (e.g., spiral CT and/or VQ scan).
  • Clinical follow-up: After three months to assess for the development of PE.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as this is an in vitro diagnostic device for quantitative measurements, not a machine learning or AI algorithm in the context typically requiring explicit training and testing sets from labeled data for learning. The instrument's algorithms are pre-defined based on physicochemical principles.

If "training set" is implicitly referring to data used to initially develop or calibrate the methods on the instrument prior to the validation studies, that information is not provided in this 510(k) summary. The presented studies are validation studies performed on the final device design.

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

As noted above, no explicit "training set" is mentioned in the context of machine learning. The device utilizes established methodologies (clotting, chromogenic, immunochemical) for which the "ground truth" for method development would be based on well-characterized calibrators and reference materials, following standard laboratory practices for IVD development. However, details of such development-phase activities are not part of this 510(k) submission.

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