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The intended use of the Sysmex® CA-7000 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.

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The Sysmex® Automated Coagulation Analyzer CA-7000 performed a clinical correlation study and a precision study to demonstrate its performance claims as being similar to predicate devices.

1. Table of acceptance criteria and the reported device performance:

The document describes two types of studies: "Summary of Method Comparison Studies Between CA-6000 or BCS" and "Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000".

Acceptance Criteria for Method Comparison Studies (Implied via Predicate Equivalence):
The acceptance criteria for the method comparison studies are implicitly defined by demonstrating substantial equivalence to the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 and Behring Coagulation System (BCS™ System)). This is primarily evaluated through the Coefficient of Correlation (r), which should be close to 1 (indicating a strong positive linear relationship), and visual inspection of the Regression Equation.

Reported Device Performance (Method Comparison Studies):

Acceptance Criteria for Precision Studies:
The acceptance criteria for precision are not explicitly stated as numerical thresholds (e.g., maximum allowable %CV). However, the intent is to demonstrate acceptable within-run, between-run, and total precision for each assay at different control levels. The reported %CV values should be within generally accepted clinical laboratory standards for these types of assays.

Reported Device Performance (Precision Studies):

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

• Sample Size for Test Set (Clinical Correlation Studies):
  • The sample sizes varied by assay, ranging from 104 (Derived Fibrinogen) to 381 (Thrombin Time). All specific sample sizes are listed in the table above under "Sample Number (n)".
• Data Provenance:
  • The document states: "During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." This suggests a mix of prospective and retrospective samples, likely collected to represent a clinically relevant range.
  • There is no explicit mention of the country of origin for the clinical data. The manufacturing site is Sysmex Corporation, Kobe, Japan, and the distributor is Dade Behring Inc. in the US, but this does not specify the origin of the clinical samples.

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. The study compares the new device's readings against predicate devices, implying that the predicate devices' results serve as the reference or "ground truth" for the comparison. There is no mention of independent experts establishing a ground truth for the clinical correlation studies.

4. Adjudication method for the test set:

• This information is not applicable as the ground truth was established by comparing to predicate devices, not by expert consensus requiring adjudication.

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 information is not applicable. The device is an automated coagulation analyzer, which does not involve "human readers" or "AI assistance" in the context of interpreting medical images or data by human clinicians. It is a laboratory instrument that outputs numerical results.

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

• Yes, the entire study focuses on the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-7000. It is an automated system designed to operate "without human-in-the-loop performance" for the actual coagulation test execution and measurement. The results are generated directly by the analyzer.

7. The type of ground truth used:

• The "ground truth" for the method comparison studies was the results obtained from the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 or Behring Coagulation System (BCS™ System)). This is a form of comparative (or reference method) ground truth where an established, cleared device's performance serves as the benchmark.
• For precision studies, the concept of "ground truth" is different; it's about the device's internal consistency and reproducibility, which is assessed inherently by statistical analysis of repeated measurements on control samples.

8. The sample size for the training set:

• This information is not applicable. This device is a traditional laboratory instrument, not an AI/machine learning model that typically requires a "training set" in the common sense of AI development. It operates based on established chemical and optical principles.

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

• This information is not applicable for the same reasons as #8.

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The BCS™ System is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Activated Partial Thromboplastin Time (APTT), Antithrombin Illa, Batroxobin, D-dimer, Deficient Plasmas, Derived Fibrinogen, Factor V Leiden, Fibrinogen, Heparin, Lupus Anticoagulants, Prothrombin Time (PT), Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, von Willebrand factor.

The current BCS™ System was originally determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) Premarket Notification 14.1 Subsequent to its clearance, the indications for use of the instrument was modified under 510(k) Premarket Notifications, K992959, K000973 and K002080 for the modified under 510(R) I Temarket Nothlouisms, Roseson, I s cleared to perform coagulometric, chromogenic, and immunochemical tests, such as the routine tests: orothrombin 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.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the BCS™ System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The coefficient of correlation must be >= 0.95"). Instead, it presents the "Device Performance Characteristics" as the results of a correlation study against a predicate device. The implied acceptance is that the correlation values are high enough to demonstrate substantial equivalence.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the implied acceptance criteria is a method comparison study evaluating plasma samples on the modified BCS™ System against the predicate device, the Sysmex® CA-6000 System.

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

• Sample Size (Test Set):
  • LA1 Screening Reagent (seconds & normalized): 202 samples
  • LA2 Confirmation Reagent (seconds & normalized): 196 samples
  • LA1/LA2 Ratio (raw & normalized): 194 samples
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device modification, it's highly likely to be prospective data collected specifically for this submission to demonstrate performance in a controlled environment. The manufacturer, Dade Behring Inc., has locations in Germany and the USA, but the specific origin of the samples is not provided.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus interpretation. The study is a method comparison against a legally marketed predicate device (Sysmex® CA-6000 System). The results from the predicate device serve as the reference for comparison, not an expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a method comparison study between two automated systems, not a study involving human interpretation that would require adjudication.

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

No. This document describes an automated coagulation analyzer (BCS™ System). It does not involve human readers or AI assistance in the interpretation of results. It compares the performance of one automated device against another.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study of the BCS™ System. The device itself is an automated system; there is no human-in-the-loop performance component described in the context of generating the quantitative results being evaluated. The comparison is between two fully automated systems.

7. The Type of Ground Truth Used

The "ground truth" for this study was the results obtained from the legally marketed predicate device, the Sysmex® CA-6000 System. This is a common approach in 510(k) submissions for demonstrating substantial equivalence of in vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not provide information on a training set. This type of 510(k) submission for a device modification typically focuses on verification and validation studies of the modified device's performance, often through method comparison or clinical validity studies. Development and training data for the device's algorithms (if any, though this is a photometric coagulation analyzer rather than a complex AI system) are usually not detailed in 510(k) summaries unless they specifically pertain to a new algorithm or AI component.

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

Not applicable, as no training set information is provided in the document.

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