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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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