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510(k) Data Aggregation
(49 days)
Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) is used to determine the level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent blood clots) in plasma. The determination is used to monitor the administration of heparin in the treatment of thrombotic disorders. The determination may also be used to aid in the diagnosis of a congenital deficiency of antithrombin III.
Antithrombin III (ATIII) is the major inhibitor of plasma thrombin and factor Xa. It is also an important inhibitor of activated factors IXA., Xla, and Xlla. The inhibitory activity of ATIII towards thrombin is greatly increased (2-3 orders of magnitude) in the presence of heparin. In the present two-stage method, thrombin is added to a plasma dilution containing antithrombin III in the presence of LMW heparin. After an initial incubation period (stage 1) residual thrombin is determined with a thrombin-specific chromogenic substrate (stage 2). The residual thrombin activity is inversely proportional to the antithrombin III concentration. The use of bovine thrombin and low heparin levels reportedly reduce the interference of HCII in amidolytic assays. Proprietary formulations used in the manufacture of this ATIII assay have lowered the interference from HCII to a level where discrimination between normal and abnormal levels is similar to that achieved by factor Xa based ATIII assays.
The provided text describes the "Sigma Accucolor Antithrombin III Assay Kit (CRS117A)" and its substantial equivalence determination. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format. Instead, it demonstrates performance through comparative studies with predicate devices and precision studies.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (CRS117A) |
|---|---|---|
| Correlation with Diapharma Coamatic assay (MLA-1000C) | High correlation (e.g., >0.90) | Correlation coefficient (r) = 0.98; Equation: y = 0.91x₁ + 7.85 |
| Correlation with Sigma CRS105A assay | High correlation (e.g., >0.90) | Correlation coefficient (r) = 0.93; Equation: y = 1.03x₂ - 2.3 |
| Within-run CV (Precision) | Low (e.g., <5%) | Less than 3% |
| Total Precision | Low (e.g., <10%) | Less than 6% |
| Linearity | Demonstrated linearity over a relevant range | Linear to 140% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 114 samples
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of a 510(k) submission for substantial equivalence, it's typically retrospective analysis of existing samples or a prospective study designed for comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study compares the new device's results with other existing assays, which serve as the reference, rather than establishing a new "ground truth" through expert consensus on the samples.
4. Adjudication Method for the Test Set
This information is not provided in the document. The study describes a direct comparison of quantitative results between assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is an in vitro diagnostic (IVD) assay kit for measuring Antithrombin III levels, not an AI-assisted diagnostic imaging or analysis tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device in the sense that the kit directly measures AT-III levels. There is no "human-in-the-loop" interaction for interpretation or modification of the direct quantitative result from the assay. The results are read from an automated analyzer.
7. The Type of Ground Truth Used
The "ground truth" for this study is effectively the results obtained from the predicate devices (Sigma Accucolor Antithrombin III Assay kit (CRS105A) and Diapharma Coamatic assay). The study's goal was to demonstrate substantial equivalence by showing high correlation and similar performance to these established methods, not to establish a new, independent ground truth.
8. The Sample Size for the Training Set
This information is not provided in the document. For an IVD kit of this nature, there isn't typically a "training set" in the machine learning sense. The assay method is developed and optimized, then validated.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable for a chemical assay kit. The method's accuracy and reliability are established through analytical validation and comparison to recognized methods, not via "ground truth" establishment for a training set in a machine learning context.
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