Search Results

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."

Ask a specific question about this device

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.

Ask a specific question about this device