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The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. For in vitro diagnostic use. For professional use only.

The VerifyNow System is a turbidimetric-based optical detection system that measures plateletinduced aggregation. The system consists of an instrument, a disposable test device and quality control materials. Quality control measures include an instrument based electronic quality control (EOC). two levels of wet quality controls (WOC), internal quality controls, and shipping controls. The instrument controls all assay sequencing, temperature, reagent-sample mixing and performs self-diagnostics. The degree of platelet function is determined and the result is displayed.

The VerifyNow PRUTest device contains three lyophilized reagent pellets in separate reaction chambers within the test device: 1) ADP pellet consisting of a preparation of Fibrinogen and BSA coated beads, adenosine-5-diphosphate (ADP), prostaglandin E1 (PGE1), dye, buffer, and a preservative; 2) TRAP pellet (Internal Control) consisting of a preparation of iso-TRAP (Thrombin Receptor Activating Peptide), Fibrinogen and BSA coated beads, buffer, dye, and a preservative; and 3) No-Agonist Pellet (NAP) consisting of a preparation of BSA coated beads, dye, buffer, and a preservative.

The provided text describes the performance studies for the VerifyNow PRUTest device, demonstrating its substantial equivalence to a predicate device (VerifyNow P2Y12 Assay).

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a single table of "acceptance criteria" for all tests, but rather describes the criteria within the context of each study. Below is a compilation of the criteria and performance for the key studies described:

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The VerifyNow-P2Y12 Assay is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

The VerifyNow System is a turbidimetric based optical detection system, which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone instrument and disposable assay device with reagents based on microbead agglutination technology. The quality control system includes an electronic control, an assay device internal control, and two levels of liquid control. The instrument controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics.

The assay device contains a lyophilized preparation of human fibrinogen coated beads. adenosine-5-diphosphate (ADP), a peptide, a fatty acid, buffer, and preservative. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the assay device by the instrument, with no blood handling required by the user.

Fibrinogen-coated microparticles are used in the VerifyNow-P2Y12 assay device to bind activated platelet GP IIb/Illa receptors. ADP is incorporated into the assay to activate platelets, and the reagent is formulated to specifically measure P2Y12 - mediated platelet aggregation.

When the activated platelets are exposed to the fibrinogen-coated microparticles, aggregation occurs in proportion to the number of activated platelet receptors. The VerifyNow-P2Y12 Assay reports results in P2Y12 Reaction Units (PRU).

Here's a breakdown of the acceptance criteria and study information for the Accumetrics VerifyNow P2Y12 Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria for the VerifyNow P2Y12 Assay. Instead, it presents performance characteristics and demonstrates its ability to measure changes in P2Y12 receptor blockade in response to clopidogrel and its specificity compared to Light Transmittance Aggregometry (LTA).

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

• Sample Size for Main Performance Study: 147 subjects.
• Sample Size for Specificity Study: 10 individuals/blood donors.
• Data Provenance: The studies were performed in "clinical studies at 4 centers". The country of origin is not explicitly stated, but given the FDA 510(k) submission, it is highly likely to be within the United States. The studies appear to be prospective, as they involve "patients treated with clopidogrel" and include "before and after clopidogrel administration" measurements. The specificity study also involved drawing blood and adding inhibitors, indicating a prospective experimental design.

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

The submission does not rely on expert opinion to establish ground truth in the traditional sense for diagnostic image analysis or clinical endpoint assessment. Instead, the "ground truth" is established by:

• Pharmacological Intervention: The known effect of clopidogrel (a drug specifically designed to block the P2Y12 ADP receptor) is used as a reference for assessing the device's ability to measure P2Y12 receptor blockade.
• Predicate Device Comparison: The CHRONO-LOG Optical Aggregometer (Light Transmittance Aggregometry - LTA) with 5 uM ADP as the agonist serves as the comparative method. LTA is a well-established method for measuring platelet aggregation.
• Known Inhibitors: In the specificity study, a known specific P2Y12 inhibitor, 2-methylthio-AMP (2MeSAMP), was added to blood samples to establish the "ground truth" for maximal P2Y12 inhibition.

Therefore, no external "experts" were explicitly used to interpret data for ground truth establishment; rather, established biochemical and pharmacological principles and comparative methods were employed.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established through pharmacological means and comparison to a predicate device, not through expert consensus on interpretations that would require adjudication.

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

No. This is an in-vitro diagnostic (IVD) device for measuring a biological marker (platelet P2Y12 receptor blockade). MRMC studies are typically applicable to medical imaging devices where human readers interpret images, and the AI's role is to assist or replace that interpretation. This submission describes standalone device performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies described are standalone performance evaluations of the VerifyNow P2Y12 Assay. The device measures in vitro platelet function automatically and provides a quantitative result (PRU). There is no human interpretation of an algorithm's output or human-in-the-loop component described in the performance evaluation.

7. Type of Ground Truth Used

The ground truth used is a combination of:

• Pharmacological Effect: The known and expected biological response to a specific drug (clopidogrel) that targets the P2Y12 receptor.
• Comparative Reference Method: Light Transmittance Aggregometry (LTA) using 5 uM ADP as an agonist, which is a recognized method for assessing platelet aggregation.
• Known Biochemical Inhibition: The use of a specific chemical inhibitor (2MeSAMP) to induce a known level of P2Y12 inhibition.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning model development. This is a traditional IVD device, not an AI/ML-driven device that typically requires distinct training and test sets for model development and evaluation. The described studies are performance evaluations of a pre-defined assay.

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

Not applicable, as a distinct training set for an AI/ML model is not described or implied in this 510(k) summary. The device's underlying principles (turbidimetric optical detection, fibrinogen-coated beads, ADP, specific additives) are based on established biochemical and biophysical mechanisms, not data-driven machine learning.

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The VerifyNow Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood for the point of care or laboratory setting.

This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®).

The VerifyNow System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone instrument and disposable assay device with reagents based on microbead agglutination technology. The quality control system includes an electronic quality control, an assay device internal control, and two levels of external, wet quality control controls. The instrument controls assay sequencing, establishes the assay temperature, controls the reagentsample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics.

The assay device contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, a peptide, bovine serum albumin, buffer, and stabilizer. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the assay device by the instrument, with no blood handling required by the user. Fibrinogen-coated microparticles are used in the VerifyNow-Aspirin assay device to bind activated platelet GP IIb/Ila receptors. When the activated platelets are exposed to the fibrinogen-coated microparticles, aggregation occurs in proportion to the number of activated platelet receptors. To ensure consistent and uniform activation of the platelets, the agonist arachidonic acid is incorporated into the assay device. The VerifyNow-Aspirin Assay reports results in Aspirin Reaction Units (ARU).

Acceptance Criteria and Device Performance Study for VerifyNow-Aspirin Assay

This document summarizes the acceptance criteria for the VerifyNow-Aspirin Assay and the study conducted to demonstrate the device meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds for sensitivity and specificity. However, the reported performance results can be interpreted as the achievement for acceptance.

Note: The acceptance criteria are "implied" because the document states "The VerifyNow-Aspirin Assay was evaluated against the presence and absence of aspirin ingestion. The concordance table below illustrates performance results." This suggests that the reported numbers were deemed acceptable by the FDA for substantial equivalence.

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

• Sample Size for Test Set:

  • Total subjects: 136
  • Subjects tested before and after 325 mg aspirin ingestion: 71
  • Subjects on chronic 81 mg/day aspirin therapy (single post-aspirin time point): 65
  • Total number of individual test results in the concordance table: 245 (Aspirin Present) + 0 (Aspirin Present, Negative result) + 23 (Aspirin Absent, Positive result) + 141 (Aspirin Absent, Negative result) = 409 test results. These results are derived from the 136 subjects.

• Data Provenance: The study was a "multi-center clinical trial." The country of origin is not explicitly stated, but given the FDA 510(k) submission, it is highly likely the data includes or originates from studies conducted in the United States. The data is prospective as subjects were recruited and tested specifically for the study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth ("Aspirin State: Present / Absent") appears to be determined by documented aspirin ingestion or lack thereof.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study evaluated the standalone performance of the VerifyNow-Aspirin Assay against the patient's aspirin status, not against human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was performed. The reported sensitivity and specificity values are for the VerifyNow-Aspirin Assay itself, with its specified cutoff of 550 ARU, in determining aspirin ingestion status.

7. Type of Ground Truth Used

The type of ground truth used was documented aspirin ingestion status. Subjects were classified as "Aspirin Present" if they had ingested aspirin (either 325mg before testing or chronic 81mg/day therapy) or "Aspirin Absent" if they had not ingested aspirin. This is a direct measure based on treatment, not expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set

The document does not explicitly state a separate sample size for a training set. The clinical trial described appears to be the primary dataset for performance evaluation. It is possible that the cutoff of 550 ARU was determined from a portion of this data or prior developmental studies, but this is not detailed.

9. How Ground Truth for the Training Set Was Established

As a separate training set is not explicitly mentioned, the method for establishing ground truth for any potential internal training or development would likely be the same as for the test set: documented aspirin ingestion status of the subjects.

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The Ultegra® Rapid Platelet Function Assay-ASA (RPFA-ASA) is a qualitative test to aid in the detection of platelet dysfunction due to aspirin (ASA) ingestion in citrated whole blood for the point of care or laboratory setting.

Not for use in patients with underlying congenital platelet abnormalities, patients with non-ASA induced acquired platelet abnormalities or in patients receiving non-ASA anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®)).

The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone analyzer and disposable test cartridge with reagents based on microbead agglutination technology. The quality control system includes an electronic control and two levels of liquid control. The analyzer controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics.

The test cartridge contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, buffer, and preservative. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the test cartridge by the analyzer, with no blood handling required by the user. Fibrinogen-coated microparticles are used in the Ultegra RPFA-ASA cartridge to bind to available platelet receptors. When the activated platelets are exposed to the fibringgen-coated microparticles, agglutination occurs in proportion to the number of available platelet receptors. To ensure consistent and uniform activation of the platelets, cationic propyl gallate (c-PG) is incorporated into the assay cartridge to induce platelet activation without fibrin formation. The Ultegra Analyzer is designed to measure this agglutination as an increase in light transmittance. Utregra RPFA-ASA Assay results are reported as Aspirin Reaction Units (ARU).

Acceptance Criteria and Device Performance Study for Accumetrics Ultegra® System Rapid Platelet Function Assay -ASA (RPFA-ASA)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for sensitivity and specificity. The implied criteria are that the device performance should be acceptable for its intended use as a qualitative test to aid in the detection of platelet dysfunction due to aspirin ingestion.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • "ASA Present" group (Post-ASA): 143 samples
  • "ASA Absent" group (Pre-ASA): 140 samples
  • Total Patients: 148 patients (each patient provided samples at two time points: pre-ASA and post-ASA).
• Data Provenance:
  • Country of Origin: Not specified in the provided document, but the study was a multi-center clinical trial.
  • Retrospective or Prospective: Prospective. Samples were obtained from subjects before and after aspirin ingestion as part of the trial design.

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

Not applicable. The ground truth for this study was established based on documented aspirin ingestion status, not expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on the aspirin ingestion status of the patients. The device results (ARU

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The Ultegra Rapid Platelet Function Assay - TRAP (RPFA -TRAP) is a semi-quantitative, whole blood platelet function assay used to measure glycoprotein (GP) IIb/Illa receptor blockade in patients treated with abciximab or eptifibatide. Ultegra RPFA-TRAP results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone analyzer and disposable test cartridge with reagents based on microbead agglutination technology. The quality control system includes an electronic control and two levels of liquid control. The analyzer controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics. The test cartridge contains a lyophilized preparation of human fibrinogen coated beads, thrombin receptor activating peptide (iso-TRAP), buffer, and preservative. The patient sample is whole blood, which is automatically dispensed from the blood collection tube into the test cartridge by the analyzer, with no blood handling required by the user.

The Ultegra RPFA Assay is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen coated microparticles agglutinate in whole blood in proportion to the number of unblocked platelet GP Ilb/Illa receptors. The rate of microbead agglutination is more rapid and reproducible if platelets are activated. Therefore the reagent iso-TRAP is incorporated into the assay to induce platelet activation without fibrin formation. As activated platelets bind and agglutinate fibrinogen coated beads, there is an increase in light transmittance which is measured by the Ultegra Analyzer. Results are reported in Platelet Aggregation Units (PAU).

The provided document is a 510(k) summary for the Accumetrics Ultegra® System Rapid Platelet Function Assay (RPFA), focusing on its substantial equivalence to a predicate device. It primarily describes the device, its intended use, and a comparative performance study. It does not explicitly state "acceptance criteria" as typical clinical trial endpoints with specific thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, the study's goal was to demonstrate "substantial equivalence" to a predicate device based on correlation and visual overlap of inhibition curves.

Here's an attempt to extract and interpret the requested information based on the provided text, acknowledging that some specific criteria (like numerical acceptance thresholds) are not explicitly stated.

Acceptance Criteria and Device Performance Study for Accumetrics Ultegra® System RPFA

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria for a "new" device approval (e.g., target sensitivity, specificity) are not present in this 510(k) summary for a substantial equivalence claim, the acceptance was based on demonstrating correlation and similar performance to the predicate device.

• Slope: 2.91
• Intercept: -48.58
• Correlation (r): 0.89 |
  | Time Course of Platelet Inhibition (Abciximab treated patients) | Visual overlap and similar trends in platelet inhibition over time compared to the predicate device and an independent receptor blockade assay (RBA). | Figure 1 (description): Shows overlap in time course of platelet inhibition for RPFA, AGG (CHRONO-LOG), and RBA. |
  | Time Course of Platelet Inhibition (Eptifibatide treated patients) | Visual overlap and similar trends in platelet inhibition over time compared to the predicate device and an independent PAC1 Flow Cytometric Assay. | Figure 2 (description): Shows overlap in time course of platelet inhibition for RPFA, Agg (CHRONO-LOG), and PAC1. |
  | Claim of Substantial Equivalence | Performance characteristics demonstrate that the new device is "substantially equivalent" to the predicate device. | "The Ultegra RPFA-TRAP performance was compared with the performance of the CHRONO-LOG Platelet Aggregometry in multi-center clinical trials... The results of the multi-center clinical studies demonstrate that the performance of the Ultegra RPFA-TRAP is substantially equivalent to that of the predicate device, CHRONO-LOG platelet aggregometer." |

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

• Sample Size (Test Set):
  • Abciximab treated patients: 120 patients
  • Eptifibatide treated patients: Number not explicitly stated, but "samples were obtained... from patients treated with eptifibatide."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but clinical trials were "multi-center," indicating multiple locations. Given the 510(k) submission to the FDA, it is highly likely the studies were conducted in the USA.
  • Retrospective or Prospective: The description "Multi-center clinical trials were designed to study GP IIb/IIa receptor blockade in patients undergoing percutaneous coronary intervention and receiving abciximab or eptifibatide. Samples were obtained... at three time points: 1) Baseline... 2) During... and 2) Post..." strongly suggests a prospective collection of data during the course of patient treatment.

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

This study relies on a comparative approach against a predicate device (CHRONO-LOG Platelet Aggregometer) and other established assays (RBA, PAC1 Flow Cytometric Assay), rather than establishing "ground truth" through expert consensus on individual case interpretations. The performance of these comparator methods is the standard against which the Ultegra RPFA-TRAP is measured. Therefore, information on the number and qualifications of experts for establishing ground truth in the traditional sense is not applicable or provided.

4. Adjudication Method for the Test Set

Not applicable. The study compares the device's measurements against those of established laboratory methods, not against expert interpretation of images or clinical outcomes requiring adjudication.

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 study is for an in-vitro diagnostic device measuring a physiological parameter, not for an imaging device requiring human reader interpretation. The comparison is between the new device and existing laboratory tests for platelet function.

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

Yes, the performance study describes the standalone performance of the Ultegra RPFA-TRAP system "assay." The system performs the measurement and reports results (Platelet Aggregation Units) without human interpretation as part of its core function, akin to other laboratory assays. The "correlation" and "time course of inhibition" figures represent this standalone output compared to other standalone laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement obtained by established comparator methods for platelet function inhibition. Specifically:

• CHRONO-LOG Platelet Aggregometer: A predicate device commonly used for measuring platelet aggregation.
• Receptor Blockade Assay (RBA): Measures the percentage of blocked GP IIb/IIIa receptors.
• PAC1 Flow Cytometric Assay: Another method for assessing platelet inhibition.

These methods, rather than clinical outcomes or pathology, serve as the reference for validating the new device's measurements.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. This is a 510(k) submission focused on clinical performance for demonstrating substantial equivalence. For algorithmic devices, training data is often distinct from validation data, but this document does not distinguish such sets for the Ultegra RPFA. The assay itself consists of reagents and an analyzer, implying a development and optimization process (which would involve internal testing/training) rather than an explicit "training set" for an AI algorithm.

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

Since an explicit "training set" is not detailed, the method for establishing its "ground truth" is also not provided. For an IVD device like this, the development process would involve optimizing reagent formulations and analyzer parameters to accurately measure platelet function, likely using reference methods and well-characterized samples during the development and internal validation phases. However, this is not described in the 510(k) summary as a dedicated "training set" process with ground truth establishment in the context of an AI/ML algorithm.

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The Ultegra Rapid Platelet Function Assay (RPFA) is a semi-quantitative, whole blood platelet function assay used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab. Ultegra RPFA results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone analyzer and disposable test cartridge with reagents based on microbead agglutination technology. The quality control system includes an electronic control and two levels of liquid control. The analyzer controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics. The test cartridge contains a lyophilized preparation of human fibrinogen coated beads, thrombin receptor activating peptide (iso-TRAP), buffer, and preservative. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the test cartridge by the analyzer, with no blood handling required by the user.

The Ultegra RPFA is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen coated microparticles agglutinate in whole blood in proportion to the number of unblocked platelet GP Ilb/IIIa receptors. The rate of microbead agglutination is more rapid and reproducible if platelets are activated. Therefore the reagent iso-TRAP is incorporated into the assay to induce platelet activation without fibrin formation. As activated platelets bind and agglutinate fibrinogen coated beads, there is an increase in light transmittance. The analyzer is designed to measure this change in optical signal due to agglutination.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, or correlation. Instead, it presents a comparative study against a predicate device and relies on the statistical measures derived from that comparison to demonstrate substantial equivalence. Therefore, the "acceptance criteria" are implied by the results of the comparison to the predicate.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Patients: 120 patients
  • Samples: Patients had samples taken at three time points (Baseline, During infusion, Post infusion), implying 360 total samples (120 patients * 3 time points), though this is not explicitly stated as 360 unique measurements for correlation.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the US FDA, and the company is based in San Diego, California, suggesting a US-centric study.
  • Retrospective or Prospective: Prospective. The study was "designed to study GP IIb/IIIa receptor blockade in patients undergoing percutaneous coronary intervention and receiving abciximab." Samples were "obtained at four clinical sites" at specific, defined time points.

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

The concept of "experts establishing ground truth" as typically seen in image or data interpretation studies is not directly applicable here. The ground truth for the device's performance is established by comparison to:

• Predicate Device: CHRONO-LOG Platelet Aggregometry. This is considered the established method.
• Reference Method: Receptor Binding Assay (RBA). This is presented as another objective measure of GP IIb/IIIa receptor blockade.

Therefore, no human experts were involved in subjectively interpreting images or data to create a "ground truth" for the test set. The ground truth is derived from established laboratory methods.

4. Adjudication Method

Not applicable. As described above, the ground truth is established by objective laboratory measurements from a predicate device and a reference method, not through expert review that would require adjudication.

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

No, an MRMC comparative effectiveness study was not performed. This type of study primarily applies to scenarios where human readers interpret data (e.g., medical images) and AI provides assistance. The Ultegra RPFA is an automated analytical device, not a human-in-the-loop diagnostic aid.

6. Standalone Performance Study

Yes, a standalone performance study was done for the Ultegra RPFA in comparison to a predicate device and a reference method. The "Performance Characteristics" section details this study, comparing the Ultegra RPFA's results directly against:

• CHRONO-LOG Platelet Aggregometry (predicate)
• Receptor Binding Assay (RBA) (a different, objective measure of the same physiological effect)

The reported correlation (r=0.89) and the visual overlap in Figure 1 demonstrate the Ultegra RPFA's standalone performance in relation to these established methods.

7. Type of Ground Truth Used

The ground truth used was based on results from a predicate device (CHRONO-LOG Platelet Aggregometry) and an objective reference method (Receptor Binding Assay - RBA). These are considered direct laboratory measurements of platelet function and receptor blockade.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. This likely indicates that the device's algorithms were developed and optimized internally by Accumetrics, and the described clinical study served as a validation/test set to demonstrate performance rather than a training set for machine learning models. Clinical trials of this nature in medical device submissions often focus on validation against established methods.

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

Since no separate "training set" with ground truth establishment is described, this question is not applicable based on the provided text. The development of the device likely involved internal verification and validation against known standards and laboratory results, but these details are not part of this 510(k) summary.

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