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HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C ( APC).

Patients with the Factor V-L (mutalion R506Q), are exposed to an increased thrombotic risk.

Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit.

Factor V-L Cafibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit.

Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quarti V-L Kit.

(Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts:

DVVtest, DVVconfirm are registered trademarks from American Diagnostica, Inc.

The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-7). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.

• 1. HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
     R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water.

R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water.

Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:

• 2. Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
• 3. BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
• BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
• BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HEMOCLOT Quanti V-L device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it demonstrates consistency with a predicate device and molecular biology results. The performance is presented as direct agreement percentages.

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

• Comparison with Predicate Device (COATEST APCr):
  • Sample Size: 189 total samples (108 Normal, 70 Abnormal, 10 inconclusive/borderline based on detailed table analysis: 108 Normal + 1 Abnormal + 2 Inconclusive=111 from Predicate Normal; 7 Abnormal + 70 Abnormal + 1 Inconclusive = 78 from Predicate Abnormal). However, the "Sample Size" row explicitly states 189 for the overall comparison.
  • Data Provenance: "combined from 4 studies (2 in US, 2 in Europe)." This indicates a retrospective or prospective collection across multiple sites. The specific nature (retrospective/prospective) is not explicitly stated, but clinical studies often involve a mix.
• Comparison with Molecular Biology:
  • Sample Size: 21 total samples (15 Normal, 6 Abnormal).
  • Data Provenance: Not explicitly stated, but implied to be part of the overall validation studies.

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

The document does not mention the use of "experts" for establishing ground truth in the traditional sense of clinical readings.

• For the comparison with the predicate device, the "ground truth" for the test set was the classification (Normal/Abnormal) provided by the COATEST APCr kit. This is a laboratory diagnostic assay, not an expert human interpretation.
• For the comparison with Molecular Biology, the "ground truth" was the molecular biology result itself (indicating presence or absence of the R506Q mutation). This is an objective genetic test, not subject to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by another diagnostic assay (COATEST APCr) or molecular biology, there was no human adjudication process involved. The results were compared against these established methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This study is for an in vitro diagnostic (IVD) assay, which measures an analytical marker in human plasma. It does not involve human readers interpreting images or data, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable here.

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

Yes, this entire study represents the standalone performance of the HEMOCLOT Quanti V-L device. It evaluates the device's ability to classify samples as Normal, Abnormal, or Inconclusive based on its own measurements, compared against a predicate device and a molecular biology reference. There is no human interpretation involved in the direct result generation of the HEMOCLOT Quanti V-L assay itself.

7. The Type of Ground Truth Used

• Comparison with Predicate Device: The ground truth was the result obtained from the COATEST APC Resistance V (K963111) predicate device.
• Comparison with Molecular Biology: The ground truth was the molecular biology result for the Factor V Leiden (mutation R506Q). This is pathology/genetic testing data, considered a highly objective measure for the presence of the mutation.

8. The Sample Size for the Training Set

The document doesn't explicitly mention a separate "training set" for the HEMOCLOT Quanti V-L assay in the context of machine learning or AI. For IVD kits like this, the "training" typically refers to the optimization and validation performed by the manufacturer during product development, using various samples to establish assay parameters, linearity, sensitivity, specificity, and reproducibility. The performance data presented here is the validation or "test" set used to demonstrate substantial equivalence.

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

As there's no mention of a traditional machine learning "training set" with separate ground truth establishment, this question is not fully applicable in the context of this document. For IVD development, the "ground truth" for calibrators, controls, and method development would have been established through highly characterized reference materials, potentially confirmed by molecular methods or established clinical diagnoses of FVL status.

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cryocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor V Leiden mutation.

cryocheck Clot APCR consists of:

• 5 x 2.0 mL Activator Reagent (APC-AR) .
• 5 x 4.0 mL Russell's Viper Venom Reagent (APC-RV)

Here's a breakdown of the acceptance criteria and study information for the cryocheck™ Clot APCR™ device, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or correlation. Instead, it frames the acceptance criteria implicitly as "comparable precision," "identical results when challenged with interfering substances and factor deficiencies," and "identical sensitivity and specificity" when compared to the predicate device. The primary performance metric reported is a correlation coefficient.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 207 clinical samples.
• Data Provenance: The document states that clinical tests were performed "at Precision BioLogic and a US university hospital-based clinical coagulation laboratory." This indicates the data is prospective clinical data collected from human subjects (patients). The clinical samples were from "the target population for the assay."

3. Number of Experts and Their Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The comparison is made against a predicate device, implies that the predicate device's results are considered the reference standard, rather than independently established expert ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. The comparison appears to be a direct one-to-one comparison of results between the new device and the predicate device for each sample.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The study focuses on comparing the new device's performance to a predicate device, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, the study is a standalone performance study. The device itself is an in vitro diagnostic (IVD) assay that provides a result (clotting time ratio). The "performance" being evaluated is the accuracy and reliability of this assay in classifying samples compared to the predicate device. There is no human-in-the-loop component described for the operation of this specific device or its interpretation in the context of the study.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the results obtained from the predicate device (GradiLeiden V). The study compared the cryocheck Clot APCR's performance to the GradiLeiden V results across the 207 clinical samples.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its size. Since this is an in vitro diagnostic assay rather than an AI/machine learning algorithm, the concept of a distinct training set in the typical machine learning sense does not apply. The development of the assay would involve R&D and validation, but not a "training set" in the computational context.

9. How Ground Truth for Training Set Was Established

As noted above, the concept of a training set as it applies to AI/ML is not relevant here. The "ground truth" for the development and validation of such an assay would typically be established through robust laboratory methods, perhaps using known Factor V Leiden positive and negative samples, and comparison to established clinical diagnostic methods, but specific details of this process for assay development are not provided in the 510(k) summary.

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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.

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The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.

Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.

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GradiLeiden V is a simple functional clotting test system intended for screening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.

The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.

Here's a breakdown of the acceptance criteria and study information for the GradiLeiden V Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Size: 164 individuals (This number includes 35 oral anticoagulated plasmas, 21 heparinized plasmas, and 12 Lupus Anticoagulant positive plasmas, alongside other samples).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Australia, suggesting the data may originate from there or an international collaboration. It describes the comparison as "GradiLeiden V was compared against the predicate device in a series of clotting assays," implying a prospective approach for the comparison study, but the source of the patient samples (retrospective/prospective collection) is not specified.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The ground truth was established by "DNA analysis," which implies a laboratory-based, molecular diagnostic method rather than expert interpretation of a diagnostic image or clinical presentation.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on DNA analysis, not expert consensus requiring adjudication.

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 is not an AI-based diagnostic device; it's a laboratory clotting test. The comparison was between two laboratory tests (GradiLeiden V and Coatest APC Resistance V) with ground truth established by DNA analysis.

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

   • Yes, a standalone performance was done for the GradiLeiden V device. Its performance was evaluated against DNA analysis as the ground truth.

6. The type of ground truth used:

   • DNA analysis (specifically mentioned: "all results confirmed by DNA analysis"). This is a highly accurate, molecular diagnostic method for determining Factor V Leiden status.

7. The sample size for the training set:

   • Not explicitly stated. The document focuses on the test set used for validation. The device's cut-off of 1.57 was "obtained by ROC analysis," which implies a dataset was used to determine this threshold, but whether this constitutes a distinct "training set" in a machine learning sense, or if it was part of the overall validation process, is not detailed.

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

   • Assuming the "training set" (or data used for ROC analysis) was drawn from similar sources as the test set, the ground truth would have been established by DNA analysis.

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Cryo✓Check™ PNP Platelet Lysate is intended for use in the Platelet Neutralization Procedure (PNP) which is useful in detecting the presence of lupus anticoagulants (LA) in human plasma.

Cryo Check™ PNP Platelet Lysate is prepared from human platelets obtained from normal healthy donors. The platelets are collected, washed, and resuspended in buffer and then frozen and thawed to yield a suspension of ruptured platelet membranes. This suspension is aliquoted into cryovials and stored frozen.

The provided text describes the performance of the Cryo✓Check™ PNP Platelet Lysate, but it does not explicitly state acceptance criteria in a formal, quantifiable manner. Instead, the conclusions of the non-clinical performance data serve as the de facto acceptance criteria, implying that the device's performance should be "comparable," "consistent," and "stable" to that of the predicate device or under various conditions.

Here's an attempt to structure the information based on the provided text, interpreting the conclusions as the performance goals the device met:

1. Table of Acceptance Criteria and Reported Device Performance

Lupus Plasmas (n=10):
Cryo✓Check™ PNP Platelet Lysate Mean Correction: 15.72 sec
BIO/DATA Platelet Extract Mean Correction: 14.56 sec
Correlation Coefficient: 0.987

Conclusion: "Cryo✓Check™ PNP Platelet Lysate demonstrated comparable specificity to the predicate device when tested against normal plasma and lupus anticoagulant positive patient plasmas when used in a platelet neutralization procedure." |
| Criterion 2: Consistent Vial-to-Vial Reactivity Over 8-hour Period
(Implicit: Low variability in correction times for both normal and lupus plasmas across multiple vials over 8 hours.) | 8 Hour Open Vial Stability Study (MLA 900 C Analyzer):
Normal Plasma (5 vials):
Mean Correction (Time=0 hrs): 4.7 sec (SD 0.292)
Mean Correction (Time=8 hrs): 3.84 sec (SD 0.358)

Lupus Plasma (5 vials):
Mean Correction (Time=0 hrs): 12.6 sec (SD 1.39)
Mean Correction (Time=8 hrs): 11.0 sec (SD 0.358)

Conclusion: "PNP procedures using Cryo✓Check™ PNP Platelet Lysate exhibited consistent vial to vial reactivity over an 8-hour period." |
| Criterion 3: Stability on Automated Coagulation Analyzer for Greater Than 8 Hours
(Implicit: Neutralization results should remain consistent over at least 8 hours when run on an automated analyzer.) | 14 Hour On-Board Stability Study (MDA 180 Analyzer):
Normal Control (CCN-10):
Neutralization (0 min): -4.6 sec
Neutralization (8 hr): -4.4 sec
Neutralization (14 hr): -3.9 sec
Mean Neutralization (0-14 hr): -4.14 sec (Std. Dev. 0.291)

Lupus Positive Control (CCLP-10):
Neutralization (0 min): 17.3 sec
Neutralization (8 hr): 17.5 sec
Neutralization (14 hr): 18.9 sec
Mean Neutralization (0-14 hr): 17.2 sec (Std. Dev. 0.819)

"in-house" positive control (HRF):
Neutralization (0 min): 28.3 sec
Neutralization (8 hr): 29.9 sec
Neutralization (14 hr): 31.2 sec
Mean Neutralization (0-14 hr): 29.8 sec (Std. Dev. 1.055)

Conclusion: "Cryo✓Check™ PNP Platelet Lysate is stable for greater than 8 hours on an MDA 180 automated coagulation analyzer." |
| Criterion 4: Consistent Results Across Different Automated Coagulation Systems
(Implicit: Neutralization results for normal patient samples should be comparable, even if absolute values differ, between different types of coagulation analyzers.) | Comparison of Reactivity on 2 Automated Coagulation Analyzers (25 Normal Patient Samples):
MDA 180 (Photo-Optical Clot Detection): Mean neutralization: -2.084 sec (Std dev 1.051)
Stago ST4 (Mechanical Clot Detection): Mean neutralization: -3.664 sec (Std dev 1.151)

Conclusion: "Cryo✓Check™ PNP Platelet Lysate yielded consistent results when used on 2 different automated coagulation systems." (Note: While mean values differ, the 'consistency' likely refers to the overall behavior and relative neutrality shown for normal samples on both systems.) |

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

• Test 1 (PNP Comparison to Predicate Device):

  • Sample Size: 5 normal plasma samples, 10 lupus plasma samples.
  • Data Provenance: Not explicitly stated, but clinical samples are implied ("normal and known lupus anticoagulant positive patient samples"). Likely in vitro/laboratory-based.

• Test 2 (8 Hour Open Vial Stability):

  • Sample Size: 5 vials of Cryo✓Check™ PNP Platelet Lysate paired with one "Normal Plasma: Cryo✓Check™ Normal (CCN)" and one "Lupus Plasma: Cryo✓Check™ Lupus (CCLP)".
  • Data Provenance: In vitro, using commercially available control plasmas.

• Test 3 (14 Hour On-Board Stability):

  • Sample Size: One lot of Cryo✓Check™ PNP Platelet Lysate tested with three control plasmas (Normal, Lupus Positive, HRF "in-house" positive control) over 14 time points.
  • Data Provenance: In vitro, using commercially available and "in-house" control plasmas.

• Test 4 (Coagulation Analyzer Comparison):

  • Sample Size: 25 normal patient samples.
  • Data Provenance: Not explicitly stated, but "Normal Patient Samples" implies retrospective or prospective collection from patients. Likely from Canada, given the submitter's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a diagnostic reagent, and the 'ground truth' in these studies is established by the clinical classification of the plasma samples (normal vs. lupus anticoagulant positive) and measurement against established laboratory methods (APTT, Platelet Neutralization Procedure). No human expert interpretation of images or other subjective data is involved. The ground truth for plasma samples (e.g., "Lupus Plasma") would have been established through prior diagnostic testing, but the details of those classifications are not provided.

4. Adjudication Method for the Test Set

Not applicable. As this involves laboratory measurements with quantitative outputs (seconds for APTT and correction), not subjective interpretation, an adjudication method for a test set is not relevant in the way it would be for, e.g., image analysis by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret cases with or without AI assistance. The described studies are non-clinical performance evaluations of a laboratory reagent.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are standalone performance evaluations in the context of a laboratory reagent. The device (Cryo✓Check™ PNP Platelet Lysate) is evaluated on its own performance characteristics (specificity, stability, consistency) in conjunction with standard laboratory instruments and established protocols (PNP, APTT). There is no "human-in-the-loop" AI component.

7. The Type of Ground Truth Used

The ground truth used for these studies is clinical classification of patient plasma samples (normal vs. known lupus anticoagulant positive) and established laboratory methods (specifically, the Platelet Neutralization Procedure (PNP) and Activated Partial Thromboplastin Time (APTT) measurements). For the stability and analyzer comparison studies, commercially available control plasmas and patient samples classified as "normal" or "lupus positive" served as the reference.

8. The Sample Size for the Training Set

Not applicable. This device is a laboratory reagent; there is no mention of an algorithm or AI that would require a "training set." The studies performed are validation studies for the performance characteristics of the physical reagent.

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

Not applicable, as there is no training set for an algorithm.

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COATEST APC RESISTANCE V or V S test is based on the use of activated protein C in an APTT clotting assay, as was the original test kit.

1. Acceptance Criteria and Reported Device Performance

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

The provided text describes several studies that collectively form the basis of the test set.

• Study 1 (Correlation and Discrimination):
  • Sample Size: 218 acutely ill patients with suspected venous thrombosis or pulmonary emboli and family members.
  • Data Provenance: Retrospective (implied, as patients are "acutely ill" suggesting existing conditions) and likely from clinical settings where these patients were managed. No specific country of origin is mentioned.
• Study 2 (Correlation and Discrimination):
  • Sample Size: 399 plasmapheresis donors.
  • Data Provenance: Retrospective (implied, as donors would have already provided samples). No specific country of origin is mentioned.
• Instrument Studies:
  • Thrombolyzer: 97 patients with myocardial infarction and 132 healthy controls.
  • MLA/Electra 900C: 50 thrombotic patients or family members.
  • ACL 300 & ST-4 (OAC patients): 147 patients on OAC therapy (ACL 300) and 129 patients on OAC therapy (ST-4).
  • ACL 300 & ST-4 (Healthy Controls): 61 healthy controls (ACL 300) and 62 healthy controls (ST-4).
  • Heparin Patients: Implied within the OAC/healthy control groups, all genotyped for Factor V.
  • Phospholipid Antibody Syndrome Patients: Samples from these patients were also tested, but no specific number is provided.
  • Data Provenance for Instrument Studies: Retrospective, as these are existing patient samples and controls. No specific country of origin is mentioned.

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

The text does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method like 2+1 or 3+1. The ground truth appears to be solely based on Factor V gene nucleotide determination (FV:Q506 mutation).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a diagnostic assay, not an AI-assisted interpretation tool for human readers.

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

Yes, the studies described are standalone performance evaluations of the COATEST APC™ RESISTANCE V or V S assay. The device itself performs the measurement and provides a result (APC ratio), which is then interpreted against established cut-off values. There is no human-in-the-loop performance described in the context of improving the device's output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth used for the test sets was Factor V gene nucleotide determination specifically for the FV:Q506 mutation at position 1691. This is a genetic-level diagnostic certainty.

8. The Sample Size for the Training Set

The document does not separately describe a distinct "training set." The studies appear to be validation or test sets. It's possible that the initial development and optimization of the assay (which would involve some form of "training") utilized samples, but those are not clearly delineated as a separate training set with specific numbers in this summary.

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

As no distinct training set is identified, the method for establishing its ground truth is not specified. However, by extension, if any samples were used for initial assay development, their ground truth would likely also be based on Factor V gene nucleotide determination, similar to the test sets.

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