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510(k) Data Aggregation
(43 days)
Reagent for the quantitative determination of the functional activity of protein S in human plasma.
Protein S Ac is a reagent intended for the quantitative determination of the functional activity of protein S in human plasma. Protein Ca proteolytically cleaves F Va which is generated during the activation of the coagulation cascade by RVV (venom of Vipera russelli). In this reaction protein S acts as a cofactor which accelerates the reaction. As a result, the coagulation time increases proportionally to the activity of protein S in the sample. The addition of deficient plasma ensures that the test mixture has a sufficient supply of fibrinogen, Factor V and the other necessary coagulation factors. Coagulation is triggered at the level of Factor X by the FX activator of RVV. FXa forms thrombin from prothrombin under the action of the remaining Factor Va. The resulting thrombin finally converts fibrinogen to fibrin.
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1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with pass/fail thresholds. Instead, it presents performance metrics against a predicate device and precision data. Thus, the table below reflects the reported performance which implies its acceptability for market clearance.
| Metric (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Correlation Coefficient (vs. Predicate Device) | 0.919 |
| Slope (vs. Predicate Device) | 0.961 |
| Intercept (vs. Predicate Device) | +1.534 |
| Within-series Variation (Normal Plasma) | 3.6% - 5.1% |
| Day-to-day Variation (Normal Plasma) | 2.0% - 4.1% |
| Total Precision (Normal Plasma) | 4.6% - 5.5% |
| Within-series Variation (Deficient Plasma) | 4.7% - 9.2% |
| Day-to-day Variation (Deficient Plasma) | 1.9% - 7.7% |
| Total Precision (Deficient Plasma) | 4.8% - 11.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 239 patient samples
- Data Provenance: The document does not specify the country of origin. It can be inferred as retrospective, as it refers to "patient samples" that were already collected and tested 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 comparison is made against a predicate device's results, not an independent expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the comparative nature with a predicate device, it's unlikely an adjudication method for ground truth was used in the traditional sense. The predicate device's results served as the reference.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the device is an in-vitro diagnostic (IVD) reagent for quantitative determination, not an imaging or AI-assisted diagnostic tool that involves human readers. Therefore, no effect size of human reader improvement with AI assistance is mentioned.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
The device, "Protein S Ac," is a reagent for quantitative determination. Its performance is inherently "standalone" in that it produces a result based on its chemical reactions and instrument measurement, without a human in the loop interpreting the result for diagnosis within the testing process itself. The presented precision and correlation data represent the standalone performance of the reagent and associated instrument (Sysmex CA 1500).
7. Type of Ground Truth Used
The "ground truth" for the comparative study was the results obtained from the predicate device, STA® Staclot® Protein S kit (K913424).
8. Sample Size for the Training Set
This information is not provided in the document. The document describes a performance evaluation of the final product, not the development or training of a model.
9. How the Ground Truth for the Training Set Was Established
This information is not provided because the document does not discuss a training set or the development of a predictive model that would require such training. The provided text focuses on the performance of a reagent against an existing predicate device.
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