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The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests.

The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The manufacturer has modified the series to include two new models with immunological testing capability. The proposed Sysmex CA-500 series can now provide accurate and precise test results for up to five parameters simultaneously and in random access. The CA-500 uses clot, chromogenic and immunological detection technologies for determination of the various parameters.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document presents two types of performance data: method comparison studies (comparing the CA-500 to predicate devices) and precision studies (evaluating the CA-500's internal consistency). The "acceptance criteria" are implied by the results needing to demonstrate substantial equivalence and acceptable precision for in vitro diagnostic use. Specific quantitative criteria are provided for the precision study.

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

• Test Set Sample Sizes:
  • Method Comparison Studies:
    • D-Dimer Assay: 390 samples
    • PT (Thromborel® S): 248 samples
    • Derived Fibrinogen (Thromborel® S): 248 samples
    • PT (Innovin®): 243 samples
    • Derived Fibrinogen (Innovin®): 247 samples
    • PT (Thromboplastin C Plus): 245 samples
    • Derived Fibrinogen (Thromboplastin C Plus): 245 samples
    • APTT (Actin®): 864 samples
    • APTT (Actin® FS): 857 samples
    • APTT (Actin® FSL): 864 samples
  • Precision Studies:
    • For each assay and control level, 40 measurements (e.g., PT (Thromborel® S) at Control Plasma N: 40 measurements; PT (Thromborel® S) at Ci-Trol® Level 3: 40 measurements, etc.).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes the samples as "citrated human plasma" and refers to "Control Plasma N" and "Path. Plasmapool" for validation, suggesting laboratory-obtained samples rather than patient-specific demographic data from a specific geographical location.

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

This information is not provided in the document. For in vitro diagnostic devices like this coagulation analyzer, the "ground truth" is typically established by the reference methods performed on the predicate device or by established control materials with known values, not by independent expert interpretation in the same way it would be for imaging diagnostics. The study compares the new device's results to those of the predicate devices.

4. Adjudication method for the test set:

This information is not applicable for this type of device study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved to establish ground truth. For an automated coagulation analyzer, the "ground truth" for method comparison is the measurement obtained from the predicate device, and for precision, it's the instrument's own internal consistency against known controls.

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:

This is not applicable to this device. The Sysmex® Automated Coagulation Analyzer CA-500 is an automated instrument, not an AI-assisted diagnostic tool that human readers use. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

The performance presented for the Sysmex® Automated Coagulation Analyzer CA-500 is inherently standalone (algorithm/instrument only performance). As an automated analyzer, its primary function is to process samples and provide results without direct human interpretive intervention at the point of measurement. The studies quantify the agreement of its measurements with predicate devices and its internal precision.

7. The type of ground truth used:

The ground truth used for these studies is based on:

• Reference measurements from legally marketed predicate devices: For the method comparison studies, the results obtained from the Sysmex® Automated Coagulation Analyzer CA-7000 and CA-6000 (which are themselves established and cleared devices) served as the reference standard against which the CA-500's measurements were compared.
• Known values of control materials: For the precision studies, "Control Plasma N," "Ci-Trol® Level 3," "Path. Plasmapool," "Adv. D-D Control 1," and "Adv. D-D Control 2" were used. These are standard laboratory control materials with established reference ranges or target values that enable the assessment of an instrument's accuracy and precision.

8. The sample size for the training set:

This information is not provided and is generally not applicable in the context of traditional automated laboratory instruments. These instruments are typically developed and validated using engineering principles, analytical chemistry, and statistical methods rather than machine learning models that require distinct "training sets." The studies described are validation and performance testing, not model training.

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

As noted in point 8, the concept of a "training set" and "ground truth for the training set" as used in machine learning is not applicable to this device and its validation. The device's operational parameters and algorithms are designed and verified against established principles of coagulation testing and validated using control materials and comparison with predicate devices.

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The BCT™ System is an automated coaqulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters:

• Activated Partial Thromboplastin Time (APTT)
• Antithrombin IIIa
• Batroxobin
• D-dimer
• Deficient Plasmas
• Derived Fibrinogen
• Fibrinogen
• Heparin
• Lupus Anticoagulants
• Prothrombin Time (PT)
• Plasminogen
• Protein C-clotting
• Protein C-chromogenic
• Thrombin Time
• von Willebrand factor

The current BCT™ System was originally determined to be substantially equivalent as a coagulation analyzer in 510(k) Premarket Notification K955278. Subsequent to its clearance, the indications for use of the instrument were expanded through two additional Premarket Notifications, K001064 and K001067 for the addition of various analytes. The current BCT™ System was cleared to perform coagulometric, and chromogenic tests, such as the routine tests: prothrombin time, partial thromboplastin time, heparin, and fibrinogen, as well as the special tests: single factor determination, antithrombin IIIa, batroxobin, plasminogen, protein C, and D-dimer. The inclusion of the new testing parameter, lupus anticoagulants (LA), is the subject of this modification. The addition of the new proposed analyte to the instrument was accomplished without modification to the instrument principle, operation, hardware or instruction manual.

This document describes the modification of the Dade Behring BCT™ System to include the new testing parameter, lupus anticoagulants (LA). The study demonstrates that the modified BCT™ system is substantially equivalent to the Sysmex® CA-6000 System for measuring Lupus Anticoagulants.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for this 510(k) modification are based on demonstrating substantial equivalence to a predicate device (Sysmex® CA-6000 System) through correlation and precision studies. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient) are not stated, the reported performance data is presented to show strong correlation, suggesting the device meets internal benchmarks for equivalence.

Correlation Study (Method Comparison):

Precision Study (Implied Acceptance Criteria for %CV based on typical industry standards for coagulation assays):

Study Conclusion: The consistently high correlation coefficients (most above 0.96, with the lowest being 0.882) and low coefficients of variation (all below 2.2%) demonstrate that the BCT™ System's performance for LA testing is comparable to the predicate device and exhibits good precision. This data supports the claim of substantial equivalence.

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

• Sample Sizes:
  • LA 1 Screening Reagent (seconds, normalized): 207 samples
  • LA 2 Confirmation Reagent (seconds, normalized): 208 samples
  • LA 1/LA 2 Ratio (normalized): 206 samples
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the study "evaluated plasma samples."

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

• This study is a method comparison and precision study for a diagnostic instrument's analytical performance, not a study involving diagnostic image interpretation or complex clinical decision-making by human experts. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists, pathologists) is not directly applicable.
• The "ground truth" or reference method for the method comparison study is the Sysmex® CA-6000 System using Dade Behring LA 1 and LA 2 Reagents.
• For the precision study, the "ground truth" is established by the known values of the control materials used.

4. Adjudication Method for the Test Set:

• Not applicable as this is an analytical performance study comparing instrument measurements, not a study requiring human adjudication of diagnostic findings.

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 not an MRMC study and does not involve human readers or AI assistance in diagnostic interpretation. It is a comparison of two automated coagulation analyzers.

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

• Yes, this study represents the standalone performance of the BCT™ System for measuring Lupus Anticoagulants. The data presented is the direct output of the instrument's analytical capabilities compared to a predicate device and control materials.

7. The Type of Ground Truth Used:

• Method Comparison Study: The ground truth is the measurements obtained from the predicate device, the Sysmex® CA-6000 System, which is a legally marketed device already established for these specific coagulation assays.
• Precision Study: The ground truth is the assigned values of the control materials (LA Control High, LA Control Low, Control Plasma N).

8. The Sample Size for the Training Set:

• The document does not mention a "training set" as this is a traditional analytical validation study for a medical device, not a machine learning or AI algorithm development study. The instrument's method for measuring LA is established, and this study validates its performance.

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

• Not applicable, as there is no "training set" in the context of this type of analytical device validation. The "ground truth" for the performance evaluation (test set) is described in point 7.

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