(93 days)
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):
| Test | Predicate Device | Sample Number (n) | Coefficient of Correlation (r) | Regression Equation |
|---|---|---|---|---|
| Prothrombin Time (Innovin®, seconds) | CA-6000 | 155 | 0.999 | Y = 0.97X + 0.38 |
| Prothrombin Time (Innovin®, INR) | CA-6000 | 155 | 0.999 | Y = 0.95X + 0.04 |
| Prothrombin Time (Thromborel® S, seconds) | BCS | 174 | 0.997 | Y = 1.09X - 1.54 |
| Prothrombin Time (Thromborel® S, % PT) | BCS | 168 | 0.984 | Y = 0.98X - 3.40 |
| Derived Fibrinogen | CA-6000 | 104 | 0.991 | Y = 1.02X + 0.12 |
| Activated Partial Thromboplastin Time | CA-6000 | 151 | 0.997 | Y = 1.03X - 0.01 |
| Fibrinogen (Clauss) | CA-6000 | 134 | 0.994 | Y = 0.91X + 0.05 |
| Factor VII | BCS | 124 | 0.993 | Y = 1.14X - 2.66 |
| Factor VIII | BCS | 143 | 0.977 | Y = 1.10X - 4.46 |
| Protein C, coagulometric | BCS | 139 | 0.994 | Y = 1.14X - 4.77 |
| Thrombin Time | CA-6000 | 381 | 0.981 | Y = 0.78X + 2.72 |
| Batroxobin Time | BCS | 169 | 0.987 | Y = 1.02X + 0.75 |
| Lupus Anticoagulant LA1 Screening Reagent | CA-6000 | 136 | 0.996 | Y = 0.92X - 1.25 |
| Lupus Anticoagulant LA2 Confirmation Reagent | CA-6000 | 136 | 0.953 | Y = 0.66X + 10.59 |
| Lupus Anticoagulant LA1/LA2 Ratio | CA-6000 | 136 | 0.987 | Y = 1.00X - 0.08 |
| Antithrombin III | BCS | 166 | 0.997 | Y = 0.96X - 1.07 |
| Heparin, chromogenic | BCS | 115 | 0.982 | Y = 1.02X + 0.01 |
| Plasminogen, chromogenic | BCS | 142 | 0.994 | Y = 0.96X + 0.55 |
| a2- Antiplasmin, chromogenic | BCS | 144 | 0.982 | Y = 0.95X + 3.18 |
| Protein C, chromogenic | BCS | 156 | 0.996 | Y = 0.98X - 0.63 |
| Factor VIII, chromogenic | BCS | 136 | 0.990 | Y = 1.10X - 1.52 |
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):
| Assay / Control Level | n | Mean | Within Run %CV | Between Run %CV | Total %CV |
|---|---|---|---|---|---|
| Prothrombin Time (Innovin®, seconds) | |||||
| Control Plasma N | 40 | 11.9 | 0.4 | 0.2 | 0.4 |
| Ci-Trol® Control Level 3 | 40 | 37.2 | 0.5 | 2.0 | 2.1 |
| Prothrombin Time (Innovin®, INR) | |||||
| Control Plasma N | 40 | 1.1 | 0.4 | 0.2 | 0.4 |
| Ci-Trol® Control Level 3 | 40 | 3.4 | 0.5 | 2.1 | 2.1 |
| Prothrombin Time (Thromborel®S, seconds) | |||||
| Control Plasma N | 40 | 12.0 | 0.4 | 0.5 | 0.6 |
| Control Plasma P | 40 | 25.1 | 0.9 | 1.1 | 1.4 |
| Prothrombin Time (Thromborel®S, % of norm) | |||||
| Control Plasma N | 40 | 91.9 | 0.6 | 0.6 | 0.8 |
| Control Plasma P | 40 | 36.1 | 1.0 | 1.2 | 1.5 |
| Derived Fibrinogen (Innovin®, g/L) | |||||
| Control Plasma N | 40 | 1.9 | 5.4 | 2.2 | 5.5 |
| Path. plasmapool | 40 | 5.7 | 3.2 | 1.3 | 3.3 |
| Activated Partial Thromboplastin Time (Actin® FSL, seconds) | |||||
| Control Plasma N | 40 | 29.6 | 0.7 | 0.3 | 0.7 |
| Ci-Trol® Control Level 3 | 40 | 70.4 | 0.6 | 0.4 | 0.7 |
| Fibrinogen (Clauss) (Thrombin, g/L) | |||||
| Control Plasma N | 40 | 2.5 | 1.4 | 0.7 | 1.5 |
| Control Plasma P | 40 | 0.9 | 2.5 | 1.2 | 2.6 |
| Factor VII (Innovin®) | |||||
| Control Plasma N | 40 | 99.7 | 2.4 | 3.4 | 4.1 |
| Control Plasma P | 40 | 31.5 | 1.7 | 2.4 | 2.8 |
| Factor VIII (Actin® FSL) | |||||
| Control Plasma N | 40 | 104.6 | 6.5 | 5.2 | 8.1 |
| Control Plasma P | 40 | 33.8 | 5.9 | 3.9 | 6.8 |
| Protein C Coagulometric (Protein C Reagent, % norm) | |||||
| Control Plasma N | 40 | 112.5 | 3.2 | 1.2 | 3.2 |
| Control Plasma P | 40 | 40.9 | 4.3 | 2.4 | 4.6 |
| Thrombin Time (Test Thrombin Reagent, seconds) | |||||
| Control Plasma N | 40 | 16.5 | 0.6 | 1.1 | 1.3 |
| Path. plasmapool | 40 | 19.7 | 3.5 | 4.4 | 5.5 |
| Batroxobin Time (Batroxobin Reagent, seconds) | |||||
| Control Plasma N | 40 | 20.1 | 1.1 | 0.6 | 1.2 |
| Path. plasmapool | 40 | 58.3 | 1.2 | 0.7 | 1.4 |
| Lupus Anticoagulant (LA1 Screening, seconds) | |||||
| Control Plasma N | 40 | 36.1 | 1.6 | 2.7 | 3.1 |
| LA Control High | 40 | 90.6 | 1.5 | 1.5 | 2.1 |
| Lupus Anticoagulant (LA2 Confirmation, seconds) | |||||
| Control Plasma N | 40 | 34.6 | 1.0 | 0.4 | 1.0 |
| LA Control High | 40 | 40.4 | 1.0 | 0.9 | 1.3 |
| Lupus Anticoagulant (LA1 / LA2, ratio) | |||||
| Control Plasma N | 40 | 1.04 | 1.0 | 2.5 | 2.7 |
| LA Control High | 40 | 2.24 | 1.2 | 0.9 | 1.5 |
| Antithrombin III (Berichrom™ Antithrombin III (A)) | |||||
| Control Plasma N | 40 | 92.6 | 1.6 | 0.7 | 1.7 |
| Control Plasma P | 40 | 31.7 | 1.8 | 0.7 | 1.9 |
| Heparin (Berichrom™ Heparin Reagent) | |||||
| Ci-Trol® Heparin Control Low | 40 | 0.06 | 7.3 | 6.1 | 9.2 |
| Ci-Trol® Heparin Control High | 40 | 0.22 | 1.9 | 2.1 | 2.8 |
| Plasminogen (Berichrom™ Plasminogen Reagent, % norm) | |||||
| Control Plasma N | 40 | 101.4 | 1.2 | 1.4 | 1.8 |
| Control Plasma P | 40 | 34.6 | 1.3 | 2.5 | 2.8 |
| α2-Antiplasmin (Berichrom™ α2-Antiplasmin, % norm) | |||||
| Control Plasma N | 40 | 98.8 | 1.5 | 0.9 | 1.7 |
| Control Plasma P | 40 | 35.4 | 3.2 | 1.8 | 3.5 |
| Protein C (Berichrom™ Protein C Reagent, % norm) | |||||
| Control Plasma N | 40 | 101.9 | 1.7 | 0.8 | 1.8 |
| Control Plasma P | 40 | 33.3 | 2.7 | 2.4 | 3.5 |
| Factor VIII Chromogenic (% norm) | |||||
| Control Plasma N | 40 | 107.5 | 1.7 | 3.8 | 4.2 |
| Control Plasma P | 40 | 29.6 | 1.4 | 2.4 | 2.8 |
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.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.