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510(k) Data Aggregation
(130 days)
The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:
- APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
- dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.
Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.
The provided document describes the Pool Norm device, a normal human plasma pool intended for use as a normal control for activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays. The study presented focuses on the device's precision performance.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the reported precision study. However, the study aims to demonstrate repeatability (within-run precision) and within-laboratory precision, which are standard measures for the performance of control materials. The reported performance is given as Standard Deviation (SD) in seconds and Coefficient of Variation (CV) in percentage for three different lots of Pool Norm on three different analyzer types.
Since explicit acceptance criteria are not provided, we will assume that the reported precision values are considered acceptable by the manufacturer for the intended use of the device. A common industry expectation for coagulation controls is a CV of less than 5% for within-laboratory precision, though this can vary. All reported CVs are well below this general benchmark.
| Assay | Analyzer Type | Sample Pool Norm Lot | Perfromance Metric | Reported Performance (SD (sec) / CV (%)) | (Assumed) Acceptance Criteria (Example) |
|---|---|---|---|---|---|
| STA® - PTT A | STA-R® | 110150 | Repeatability | 0.3 sec / 1.0 % | CV < 2% (Typical for APTT repeatability) |
| Within-Lab Precision | 0.6 sec / 1.7 % | CV < 5% (Typical for APTT W-L precision) | |||
| STA® - Staclot® dRVV Screen | STA-R® | 110150 | Repeatability | 0.3 sec / 0.8 % | CV < 2% (Typical for dRVVT repeatability) |
| Within-Lab Precision | 0.6 sec / 1.4 % | CV < 5% (Typical for dRVVT W-L precision) | |||
| STA® - Staclot® dRVV Confirm | STA-R® | 110150 | Repeatability | 0.3 sec / 0.8 % | CV < 2% (Typical for dRVVT repeatability) |
| Within-Lab Precision | 0.5 sec / 1.3 % | CV < 5% (Typical for dRVVT W-L precision) | |||
| STA® - PTT A | STA Compact® | 110150 | Repeatability | 0.5 sec / 1.6 % | CV < 2% |
| Within-Lab Precision | 0.7 sec / 2.1 % | CV < 5% | |||
| STA® - Staclot® dRVV Screen | STA Compact® | 110150 | Repeatability | 0.3 sec / 0.7 % | CV < 2% |
| Within-Lab Precision | 0.6 sec / 1.6 % | CV < 5% | |||
| STA® - Staclot® dRVV Confirm | STA Compact® | 110150 | Repeatability | 0.3 sec / 0.9 % | CV < 2% |
| Within-Lab Precision | 0.5 sec / 1.4 % | CV < 5% | |||
| STA® - PTT A | STA Satellite® | 110150 | Repeatability | 0.1 sec / 0.4 % | CV < 2% |
| Within-Lab Precision | 0.3 sec / 0.9 % | CV < 5% | |||
| Note: The "Assumed Acceptance Criteria" are typical industry benchmarks for precision of coagulation controls and are not explicitly stated in the document as acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: For each lot of Pool Norm tested on each analyzer, "N" is reported as 80. The study was performed for 20 days, with 2 runs per day. This means 40 measurements per lot for repeatability (2 runs x 20 days) and 40 measurements per lot over 20 days for within-laboratory precision. The "N=80" stated in the tables likely refers to the total number of data points collected for the precision calculation (e.g., 2 runs/day * 20 days * 2 replicates per run or similar, though the details of the "N=80" are not fully elaborated beyond the 20 days, 2 runs per day). Given the context of a precision study, N=80 refers to the total number of individual measurements used for calculation within each lot and assay combination.
- Data Provenance: The study was "performed in-house". The company, Diagnostica Stago, is based in Gennevilliers, France. Therefore, the data provenance is likely retrospective (as it's a pre-submission study report) and from France (where the company is located).
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 "Pool Norm" device is a control material, not a diagnostic device that interprets patient data. The study is evaluating the precision (reproducibility) of the control material itself when used in coagulation assays. Ground truth in the sense of a clinical diagnosis or interpretation derived from expert review is not relevant here. The "ground truth", if one were to stretch the definition, would be the true, intrinsic coagulation activity of the plasma pool, which is measured by the assays.
4. Adjudication method for the test set
This information is not applicable. Since there is no "ground truth" based on expert interpretation, there is no need for an adjudication method. The study is a quantitative measurement of inherent device variability.
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 a laboratory reagent (a normal human plasma pool for use as a control), not an AI-powered diagnostic imaging system or similar device that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a diagnostic reagent, and the study evaluates its precision, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the typical diagnostic sense is not applicable. The study assesses the inherent precision of the control material (Pool Norm) through repeated quantitative measurements in standard laboratory assays (APTT, dRVVT). The "true" value of the control's coagulation time is inherent to the material and is estimated by the mean (X) of the repeated measurements.
8. The sample size for the training set
This information is not applicable as there is no "training set" for this type of device. The study is a performance validation of a reagent, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set or clinical "ground truth" in this context.
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