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The device is a plasma based functional IVD assay for the decemination of resistance to activated protein C caused by the factor V Leiden mulation (EV-QEAC) vated protein C castin bascu for the december (FV: CS00) on automation of resistance to activated protein C caused by the factor V Leiden mulation (FV: (SOO) on automated a the super of of C backed by the factor v Leiden mulation (FV:Q506) on automated and

Pefakit® APC-R Factor V Leiden is an in vitro diagnostic test kit containing 3 vials each of the following 4 lyophilized reagents: R1: APC / RVV-V (+APC) Reagent (APC, RVV-V, Polybrene, Hepes, BSA) R2: APC / RVV-V (-APC) Reagent (RVV-V, Polybrene, Hepes, BSA) R3: PTA Reagent (Prothrombin Activator, EDTA, Hepes, BSA) R4: Dilution Plasma (Human Plasma, processed) For Quality Assurance/Quality Control the corresponding control kit 'Pefakit® APC-R Factor V Leiden Controls' has to be used. It contains 3 vials each of the following 2 lyophilized control 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

This 510(k) summary describes the Pefakit® APC-R Factor V Leiden, an in vitro diagnostic test kit used to detect resistance to activated protein C caused by the Factor V Leiden mutation. The summary details the device's technological characteristics, non-clinical and clinical study results, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the direct comparison to the predicate device and the claims of "superior" performance in certain aspects. The submission doesn't explicitly state quantitative acceptance criteria targets but rather compares performance to the predicate device and internal standards.

2. Sample Size Used for the Test Set and Data Provenance

The exact sample sizes for the test sets in the clinical studies are not explicitly stated in this 510(k) summary. It mentions "clinical studies at two haematology laboratories of big central Hospitals in Europe (CIMCLD/AKH, Vienna) and the USA (Duke University Medical Center/DUMC, Durham/Raleigh NC)."

Data Provenance:

• Country of Origin: Europe (Vienna, Austria) and USA (Durham/Raleigh NC, Duke University Medical Center).
• Retrospective or Prospective: The summary does not explicitly state if the studies were retrospective or prospective, but the phrasing "In these studies both tests showed to have comparable precision..." and "For all other possible interference factors included in these studies no correlation could be found between patient parameters and test outcome" suggests a prospective collection or at least a controlled comparison of samples within the designated studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The summary does not specify the number of experts or their qualifications used to establish the ground truth for the clinical study test sets. It refers to "donors confirmed to be normal wild-type by FV Leiden PCR testing" and "donors confirmed to be heterozygous by FV Leiden PCR testing" for the control plasmas C1 and C2, respectively. This implies that PCR testing was the method of establishing the true genotype, but not who performed or confirmed these results.

4. Adjudication Method for the Test Set

The summary does not describe any adjudication method for the test set. The ground truth for the control plasmas was established by PCR. For the clinical studies, it is implied that the assessment of diagnostic sensitivity and specificity was based on the underlying Factor V Leiden status of the patients, likely confirmed by a gold standard method.

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 device is an in vitro diagnostic (IVD) test kit for functional assay, not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance is not applicable to this type of device. The study compared the performance of the new IVD device against a predicate IVD device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

The device is an IVD test kit, designed to be run on automated or semi-automated blood coagulation analyzers. Its performance is inherent to the chemical reactions and detection methods of the reagents. Therefore, the "standalone performance" is its intended use, without human interpretation of the raw chemical reaction, but rather the interpretation of the results provided by the machine. The summary reports its standalone performance in terms of precision, sensitivity, specificity, and resistance to interferences.

7. The Type of Ground Truth Used

The primary ground truth mentioned for the control plasmas is molecular pathology, specifically "FV Leiden PCR testing." For the broader clinical studies, it is strongly implied that the ground truth for the Factor V Leiden mutation status of the patient samples was also established through molecular diagnostics (e.g., PCR or similar genotyping methods), given that the device aims to detect resistance caused by the Factor V Leiden mutation.

8. The Sample Size for the Training Set

The summary does not explicitly mention a "training set" as this is not an AI/ML device in the modern sense. The development of the assay would have involved internal testing and optimization (potentially using various sample sizes for method development), but the submission focuses on the validation studies, not the development phase. The "in-house testing" for precision and diagnostic performance can be seen as part of the internal validation and optimization, but a distinct "training set" is not delineated.

9. How the Ground Truth for the Training Set Was Established

As there is no explicitly defined "training set" in the context of an AI/ML device, this question is not directly applicable. However, for the development and in-house validation of the assay, the ground truth for establishing performance metrics (like sensitivity and specificity) would have been established through a reference method, most likely molecular genotyping (e.g., PCR) for the Factor V Leiden mutation. The control plasmas (C1 and C2) are described as confirmed by FV Leiden PCR testing, indicating this was the gold standard used.

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