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510(k) Data Aggregation
(117 days)
Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Sigma Diagnostics ALEXIN 14 HS contains purified rabbit brain and soy phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma.
Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. The study aimed to demonstrate its substantial equivalence to Dade Actin-FS.
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly state "acceptance criteria" in a numerical sense, but rather demonstrates substantial equivalence through correlation and regression with a predicate device, and provides precision data. For the purpose of this analysis, we will infer the acceptance criteria from the reported performance, implying that the achieved correlation and precision were considered acceptable for substantial equivalence.
| Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (ALEXIN™ HS) |
|---|---|---|
| Correlation with Dade Actin-FS (Optical Mode) | High correlation (e.g., > 0.95 or similar to predicate) | 0.97 |
| Correlation with Dade Actin-FS (Mechanical Mode) | High correlation (e.g., > 0.95 or similar to predicate) | 0.97 |
| Correlation on KC 4A analyzer | High correlation (e.g., > 0.95 or similar to predicate) | 0.96 |
| Regression Equation (Optical Mode) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.81 x + 0.31 |
| Regression Equation (Mechanical Mode) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.84 x + 0.28 |
| Regression Equation (KC 4A analyzer) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.94 x + 0.08 |
| Within-Run Precision (Control I CV%) | Low variability (e.g., typically < 5%) | 2.00 % |
| Within-Run Precision (Control II CV%) | Low variability (e.g., typically < 5%) | 1.68 % |
| Within-Run Precision (Control III CV%) | Low variability (e.g., typically < 5%) | 1.92 % |
| Total Precision (Control I CV%) | Low variability (e.g., typically < 10%) | 3.49 % |
| Total Precision (Control II CV%) | Low variability (e.g., typically < 10%) | 2.74 % |
| Total Precision (Control III CV%) | Low variability (e.g., typically < 10%) | 2.85 % |
2. Sample size used for the test set and the data provenance:
- Sample Size for Equivalence Study: 153 random frozen patient samples were used for comparison between ALEXIN™ HS and Dade Actin-FS in both optical and mechanical modes. An additional 97 random frozen samples were used for correlation on the KC 4A analyzer.
- Data Provenance: The data provenance (e.g., country of origin, specific clinics) is not specified. The samples were "random frozen patient samples," implying they were clinical samples, but whether they were retrospective or prospective is not explicitly stated. Given the context of a 510(k) submission for substantial equivalence, it's common for such data to be retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this study. The study uses a predicate device (Dade Actin-FS) as the reference for comparison, not an independent "ground truth" established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable to this study. The study involves direct comparison of numerical results from two analytical devices, not subjective assessments requiring expert 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 to this study. This device is an in-vitro diagnostic (IVD) reagent for automated laboratory testing (Activated Partial Thromboplastin Time, APTT), not an AI-assisted diagnostic imaging or interpretation tool that would involve human "readers" or an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is an "algorithm only" in the sense that it's a reagent used in an automated analyzer to produce a numerical result. The performance described is the standalone performance of the reagent in conjunction with the analytical instruments (optical, mechanical, KC 4A) in comparison to a predicate reagent. There is no human interpretation or intervention in the generation of the APTT value itself.
7. The type of ground truth used:
The "ground truth" in this study is the results obtained from the predicate device, Dade Actin-FS. The study aims to demonstrate substantial equivalence to this legally marketed device, rather than establishing biological or clinical truth via pathology, outcomes data, or expert consensus.
8. The sample size for the training set:
This information is not applicable to this study. This device is a chemical reagent, not an AI or machine learning model that requires a "training set" in the conventional sense. The "development" of the reagent would involve chemical formulation and optimization, not data-driven model training.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
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