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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 Behring Coagulation System (BCS) is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Prothrombin Time (PT), Activated Pattial Thromboplast Time (APTT), Antithrombin Illa, Batroxibin, D-dimer, Deficient Plasmas, Fibrinogen, Heparin, Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, Von Willebrand factor.

The current BCS was determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) notification K970431. The current BCS was cleared to perform coagulometric and chromogenic tests, such as the routine tests prothrombin time, partial thromboplastin time, and fibrinogen, as well as the special tests, single factor determination antithrombin IIIa, protein C and plasminogen. The modified BCS has the ability to perform coagulometric, chromogenic and immunochemical assays (e.g., latex enhanced turbidimetric test Advanced D-Dimer). The addition of the immunochemical measuring method is the subject of this modification.

The provided text describes the Behring Coagulation System 510(k) Modification (K992959). The modification allows the system to perform immunochemical assays, specifically referencing the Advanced D-Dimer test.

Here’s a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state the pre-defined acceptance criteria (e.g., "correlation coefficient must be greater than X"). It only reports the results of the performance studies. The implication is that these results were deemed acceptable for substantial equivalence.

2. Sample Size and Data Provenance

• Correlation Study:

  • Test Set Sample Size: 316 samples
  • Data Provenance: Not explicitly stated, but the submission is from Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), suggesting data could be from either or both regions. The text does not specify if it was retrospective or prospective.

• Precision Study:

  • Test Set Sample Size: Not explicitly stated as a single number but involved "two levels of control material and two levels of human plasma pools."
  • Data Provenance: Not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention using experts to establish ground truth. The studies described are comparative in nature (comparing the modified device's performance to a predicate device or established methods).

4. Adjudication Method

• The document does not mention any adjudication method.

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

• No MRMC study was performed or reported. This device is an automated coagulation system and not an imaging or diagnostic device that would typically involve human reader interpretation for a MRMC study.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The Correlation and Precision studies are standalone performance evaluations demonstrating the device's accuracy and reproducibility. The comparison to the Asserachrom® D-Di for correlation and the NCCLS Guideline EP5-A for precision indicates an evaluation of the device's performance properties.

7. Type of Ground Truth Used

• For the Correlation study: The "ground truth" was established by another commercially available and presumably validated assay, the Asserachrom® D-Di, which served as the reference method for comparison.
• For the Precision study: The "ground truth" or reference was based on established control material and human plasma pools, evaluated according to NCCLS Guideline EP5-A.

8. Sample Size for the Training Set

• The document does not mention any training set sample size. This device is an in vitro diagnostic instrument; typical AI/Machine Learning models that require distinct training and test sets are not explicitly described for its core functionality here. The "modification" refers to the ability to perform a new type of assay (immunochemical), which relies on established photometric principles rather than a learning algorithm that needs a training phase in the typical sense of AI.

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

• As no training set is described (see point 8), the method for establishing ground truth for a training set is not applicable/not mentioned.

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