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For Sysmex® CS-2100i:

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
• . Coagulation Factor V with Dade® Innovin®
• . Coagulation Factor VII with Dade® Innovin®
• . Protein C with Protein C Reagent
• . Antithrombin (AT) with INNOVANCE® Antithrombin
• Protein C with Berichrom® Protein C
• D-dimer with INNOVANCE® D-Dimer

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

For Coagulation Factor V Deficient Plasma:

In vitro diagnostic reagent for the determination of the activity of coagulation factor V in human plasma.

For Coagulation Factor VII Deficient Plasma:

In vitro diagnostic reagents for the determination of the activity of coagulation factor II (prothrombin), coagulation factor VII and coagulation factor X in human plasma by coagulometric methods.

For Protein C Reagent:

Protein C Reagent is a coagulation test for the quantitative determination of protein C activity in human plasma.

For Berichrom® Protein C:

For the quantitative determination of functionally active protein C using a chromogenic substrate as an aid in the diagnosis of inherited and acquired deficiencies.

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, and Consumable materials. The subject of this 510(k) notification are reagent applications which perform the coagulation tests Coagulation Factor V with Dade® Innovin®, Coagulation Factor VII with Dade® Innovin®, Protein C with Protein C Reagent and Protein C with Berichrom® Protein C.

The document describes the performance data for the Sysmex® CS-2100i Automated Blood Coagulation Analyzer and its associated reagents for several coagulation factors and proteins. The study aims to demonstrate substantial equivalence to a predicate device, the Sysmex® CA-1500.

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

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

The document does not explicitly state numerical acceptance criteria for all performance metrics (e.g., a specific threshold for %CV for reproducibility). However, it repeatedly states that "Results from each application met the predetermined acceptance criteria" and "Data for all tested reagents met the predetermined acceptance criteria."

Based on the provided tables and text, the implicit acceptance criteria relate to:

• Method Comparison: Strong correlation (high 'r' value) and a slope and intercept close to 1 and 0, respectively, indicating comparable results to the predicate device.
• Reproducibility: Within-run, between-run, between-day, and total %CVs within acceptable ranges for clinical laboratory assays, demonstrating precision.
• Detection Capability (Limit of Quantitation): Measured Limit of Quantitation being at or below the claimed Lower Limit of Clinically Reportable Range, with acceptable maximum total error.
• Linearity/Measuring Range: Measured linear range encompassing or exceeding the claimed clinically reportable range.
• Reference Interval: Establishment of reference intervals from a healthy population.

Below is a table summarizing the reported device performance for several key metrics:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Method Comparison:
  • Sample Sizes: N = 589 for Factor V, N = 492 for Factor VII, N = 584 for Protein C Reagent, N = 507 for Berichrom® Protein C. These are patient samples.
  • Data Provenance: Conducted at four external sites in the United States. This suggests prospective collection for the study, as samples were "measured on both the predicate device... as well as the new device... in random order."
• Reproducibility Studies:
  • Sample Sizes: Not explicitly stated as a count of unique patient samples, but the study involved "two runs per day, with two replicates per run" over "Twenty-day precision studies." These likely used control materials and potentially some patient-derived pools to cover the measuring interval.
  • Data Provenance: Conducted at two external sites in Germany and one external site in the United States. Prospective.
• Detection Capability (Limit of Quantitation) & Linearity:
  • Sample Sizes: Not explicitly detailed, but these studies typically involve dilutional series of control or spiked samples.
  • Data Provenance: Not specified, but likely conducted by the manufacturer or at external sites involved in the broader study.
• Reference Interval:
  • Sample Sizes: N = 193 for Factor V, Factor VII, and Protein C Reagent; N = 191 for Berichrom® Protein C. These are samples from "healthy subjects" to establish reference intervals.
  • Data Provenance: Conducted at three clinical study sites in the United States. The study population "did not include neonate and pediatric sample populations." This is 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)

This device is an in vitro diagnostic (IVD) instrument for blood coagulation studies. The "ground truth" in this context refers to the accuracy and precision of the measurements relative to established analytical methods or reference values, rather than consensus interpretation by human experts.

• The study used a predicate device (Sysmex® CA-1500) as the comparator for method comparison, which is considered a legally marketed and presumably accurate device for the same intended use.
• Ground truth for things like reference intervals would be established by measuring samples from a statistically relevant population of healthy individuals and determining the distribution of results, following CLSI guidelines (EP28-A3c).
• Ground truth for linearity and detection capability would be established using validated methods, often involving known dilutions or spiked samples.

Therefore, the concept of "number of experts" and "qualifications of experts" for establishing ground truth is not directly applicable in the same way as for medical image analysis where human interpretation is the ground truth standard. The accuracy of the device is assessed by its analytical performance against recognized standards and methods, not subjective expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for an in vitro diagnostic device study assessing analytical performance. Adjudication methods are typically used in studies where human interpretation or classification is involved, such as in clinical trials or image analysis, to resolve discrepancies between readers. Here, the comparison is quantitative instrument-to-instrument.

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

Not applicable. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers. The study focuses on comparing the analytical performance of the new instrument against a predicate instrument.

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

This study is inherently a standalone performance evaluation of the Sysmex® CS-2100i instrument when used with its associated reagents. The instrument is an automated analyzer producing quantitative results. The comparison is against another automated instrument (the predicate), not against unassisted human performance or an "AI assistance" scenario.

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

The ground truth for this device's performance evaluation is based on:

• Established analytical methods and predicate device measurements: For method comparison, the results from the predicate device (Sysmex® CA-1500), which is a legally marketed device for the same purpose, serve as the comparative standard.
• CLSI (Clinical and Laboratory Standards Institute) guidelines: These provide the statistical and methodological framework for evaluating analytical performance parameters like precision, linearity, and detection capability.
• Measurements from healthy donor populations: For establishing reference intervals.

8. The sample size for the training set

The document does not explicitly describe a "training set" in the context of machine learning or AI. This is an IVD device, and its development would involve internal validation and optimization by the manufacturer, but the submitted performance data represents the final validated product. The studies described are for performance validation and comparison, not for training a model.

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

As there is no "training set" discussed in the context of an AI/ML model for this IVD device, this question is not applicable. The device's operational parameters and algorithms for measurement are established through engineering design, chemical/biological principles, and internal development/validation processes, adhering to industry standards and regulatory requirements.

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