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The device is a box containing lyophilized pooled plasmas from donors genotyped for the factor V Leiden mutation (FV : Q506) to be reconstituted with water by the user. Controls on the factor plasmas of either donors with helerazurous EV: O56 minuter by the user. Con plasmas of either donors with heterozygous FV:Q506 mutation or normal wild-type pattern. These controls are intended to be your for wolf These controls are intended to be used for quality assurance in connection with the IVD device 'Pefakit® APC-R Factor V Leiden'.

Pefakit® APC-R Factor V Leiden Controls is an in vitro diagnostic controls kit containing 3 vials each of the following 2 Ivophilized plasmas: C1: pooled human plasma from donors confirmed to be normal wild-type by FV Leiden PCR testing C2: pooled human plasma from donors confirmed to be heterozygous by FV Leiden PCR testing.

The provided 510(k) summary for "Pefakit® APC-R Factor V Leiden Controls" does not contain detailed acceptance criteria or a specific study designed to prove that the device meets those criteria in the way a diagnostic imaging or AI-based device submission might. This device is a quality control product, and its evaluation focuses on demonstrating substantial equivalence to a predicate device and stability, rather than diagnostic performance against specific metrics like sensitivity or specificity.

However, based on the information provided, we can infer some "acceptance criteria" related to its function as a control and summarize the relevant studies.

Acceptance Criteria and Reported Device Performance

Study Details

The primary "study" supporting this device is comprised of non-clinical tests for stability and batch variability, and clinical studies where these controls were used in conjunction with the principal diagnostic device (Pefakit® APC-R Factor V Leiden) to demonstrate its own substantial equivalence, implicitly validating the controls.

1. Sample size used for the test set and the data provenance:

• Non-clinical (Batch-to-batch variability): Three pilot batches of increasing size (100, 250, and 1000 device boxes) were used. Data provenance is "in-house."
• Clinical (Suitability for intended use): The controls were used in "clinical studies" for the basic test device (Pefakit® APC-R Factor V Leiden). These studies were conducted at "two haematology laboratories of big central Hospitals in Europe (Clinical Institute for Medical and Chemical Laboratory Diagnostics/Allgemeines Krankenhaus [CIMCLD/AKH], Vienna) and the USA (Duke University Medical Center [DUMC], Durham/Raleigh NC)." The report does not specify the number of patient samples (cases) or control runs used during these clinical studies, nor if it was retrospective or prospective, though it implies prospective use within larger test validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the controls themselves: The genotyping of pooled human plasma donors for Factor V Leiden (normal wild-type and heterozygous) was confirmed by "FV Leiden PCR testing." The individuals or experts performing this PCR testing and interpreting the results are not specified, nor are their qualifications. This is the "ground truth" for the control material itself.
• For the clinical studies: The "clinical studies" were performed at "two haematology laboratories." The experts involved in generating the results and assessing the suitability of the controls would be laboratory personnel and medical professionals at these sites, but their specific number and qualifications are not detailed.

3. Adjudication method for the test set:

• For the non-clinical stability and batch variability tests, no adjudication method is mentioned, as these are objective measurements.
• For the clinical studies where the controls were used, no specific adjudication method is described for the evaluation of the controls. The controls were stated to "prove suitable" and "equivalent," implying a successful outcome based on laboratory protocols.

4. 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:

• Not applicable. This device is a quality control reagent, not an AI-assisted diagnostic tool. No MRMC study was conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Partially applicable/Inferred. The non-clinical stability and batch variability tests could be considered "standalone" as they evaluate the product's intrinsic properties. The "testing" itself (e.g., clotting time measurements) would be performed by lab equipment (an "algorithm" in a broad sense, or an automated process) and then interpreted by human operators. However, this is not an AI algorithm.

6. The type of ground truth used:

• Molecular (PCR testing): The "ground truth" for the control material (C1 and C2) is the confirmed genotype of the pooled human plasma donors, established by FV Leiden PCR testing.

7. The sample size for the training set:

• Not applicable. This is a quality control product, not a machine learning algorithm that requires a training set. The "samples" referred to are the batches of control material and the donors from whom the plasma was collected.

8. How the ground truth for the training set was established:

• Not applicable. (See point 7). However, the ground truth for the source plasma was established via "FV Leiden PCR testing."

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