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The intended use of the Sysmex® CA-6000 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 the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT) .
• Activated Partial Thromboplastin Time (APTT) .
• Fibrinogen (Clauss) .
• Thrombin Time .
• Extrinsic Factors (II, V, VII, X) ●
• Intrinsic Factors (VIII, IX, XI, XII) ●
• Batroxobin .
• . Protein C

Chromogenic Analysis Parameters

• Antithrombin III .
• . Plasminogen
• Factor VIII .

Calculated Parameters

• PT Ratio .
• PT INR .
• Protein C .
• Heparin ●
• a2-Antiplasmin .
• Derived Fibrinogen .
• Factor Assays % Activity .

The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.

Here's a breakdown of the acceptance criteria and study information for the Sysmex® Automated Coagulation Analyzer CA-6000 based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its substantial equivalence to a predicate device, the Behring Coagulation Timer (BCT). This means the performance of the CA-6000 is deemed acceptable if it demonstrates similar performance to the BCT.

Note: The document focuses primarily on correlation with the predicate device and precision, rather than specific numeric thresholds for accuracy. The "acceptance criteria" here are implied to be achieving strong correlation and acceptable precision, demonstrating similar performance to the established predicate.

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

• Sample Size:
  • Factor VIII Chromogenic Assay: n = 92
  • α2-Antiplasmin Chromogenic Assay: n = 128
  • Precision Studies: 40 samples for each control level (CPN and CPP) for both Factor VIII and α2-Antiplasmin.
• Data Provenance: Retrospective and prospective. The studies "evaluated specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The location of these individuals and patients is not explicitly stated (e.g., country of origin), but given the applicant is Dade Behring Inc. Miami, FL, and Sysmex Corp. Japan, it's likely a mix, potentially with US-based clinical samples. The "in-house correlation studies" suggest internal testing.

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

This information is not provided in the document. For diagnostic devices like this, patient samples with known clinical conditions (pathological conditions) serve as the "ground truth" for evaluating accuracy and correlation. However, the specific process for establishing these "known clinical conditions" or whether expert review was involved is not detailed.

4. Adjudication Method for the Test Set

This information is not provided. As the study focuses on quantitative correlation with a predicate device and precision, inter-rater adjudication of results is not typically a direct component. The predicate device's results serve as the reference for comparison.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The Sysmex CA-6000 is an automated analyzer, not an AI-assisted diagnostic tool for human readers. Its primary function is to perform tests and output quantitative results, rather than to aid human interpretation of complex images or data in an MRMC setting.

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

Yes, the provided studies essentially represent standalone performance. The Sysmex® CA-6000 is an "Automated Coagulation Analyzer." The studies described (method comparison and precision) evaluate the device's performance in generating results directly from samples, independent of human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the device's internal methods for assay execution and result calculation.

7. Type of Ground Truth Used

The ground truth used for the method comparison studies was derived from the predicate device's measurements (Behring Coagulation Timer - BCT) and from patient specimens with "different pathological conditions" and "apparently healthy individuals". The BCT's results served as the reference for determining the CA-6000's correlation. For the precision studies, the "ground truth" is the inherent variability of the assay on control materials and patient samples under repeated measurements.

8. Sample Size for the Training Set

The document does not provide information on a "training set". This type of device (automated analyzer) is typically developed and validated using engineering principles, analytical studies, and comparison to existing, cleared devices, rather than machine learning models that require distinct training sets.

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

Since no training set is mentioned or applicable in the context of this device's development as described, this information is not applicable.

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The intended use of the Sysmex® CA-6000 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 the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT)
• Activated Partial Thromboplastin Time (APTT)
• Fibrinogen (Clauss)
• Thrombin Time

Chromogenic Analysis Parameters

• Antithrombin III
• Plasminogen
• Extrinsic Factors (II, V, VII, X)
• Intrinsic Factors (VIII, IX, XI, XII)
• Batroxobin
• Protein C
• Protein C
• Heparin

Calculated Parameters

• PT Ratio
• PT INR
• Derived Fibrinogen

The Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer. It is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

1. Acceptance Criteria and Reported Device Performance:

Note: The document states the performance claims of the proposed device are "similar to the predicate device" based on correlation studies. There are no explicit numeric acceptance criteria provided in the given text for the coefficient of correlation, but the high values reported (all above 0.949) indicate a strong correlation, satisfying the broad "similar" claim.

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

• Test Set Sample Sizes:
  • Batroxobin: 173 samples
  • Protein C, Chromogenic: 113 samples
  • Heparin, Chromogenic: 59 samples
  • Protein C, Coagulometric: 88 samples
• Data Provenance: The studies were "in-house correlation studies." Specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but the manufacturing site is Kobe, Japan, and the importer is in Long Grove, IL, USA, and the distributor is in Newark, DE, USA. The study design is prospective in the sense that specimens were "evaluated" for the purpose of the comparison.

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

Not applicable. This study is a method comparison study between a new device and a predicate device, not a diagnostic accuracy study requiring expert adjudication for ground truth. The "ground truth" for each sample is the measurement produced by the predicate device (BCT or BFA).

4. Adjudication Method for the Test Set:

Not applicable. See point 3. This was a direct comparison between the new device's readings and the predicate device's readings.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the instrumental performance of an automated coagulation analyzer compared to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the context of comparing the new device (Sysmex CA-6000) against predicate devices (BCT and BFA). The provided data represents the performance of the Sysmex CA-6000 in measuring various coagulation parameters, showing its direct correlation with established methods.

7. Type of Ground Truth Used:

The "ground truth" for the method comparison studies was the measurements obtained from the established predicate devices: the Dade Behring Coagulation Timer (BCT) and the Behring Fibrintimer A (BFA). This is a form of comparative measurement against a recognized standard.

8. Sample Size for the Training Set:

Not applicable. This device is an automated coagulation analyzer, not an AI/machine learning algorithm requiring a separate "training set" in the conventional sense for model development. The study described is a validation of the instrument's measurement performance against predicate devices.

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

Not applicable. See point 8.

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