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Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation: Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation Baseline Platelet Count

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

*P<0.001 two-sided test of positive association significant

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

• Sample Size:
  • For Collagen: N = 189 samples
  • For ADP: N = 225 samples
• Data Provenance:
  • Country of Origin: Not explicitly stated, but implied to be within the United States due to the FDA 510(k) submission.
  • Retrospective or Prospective: Prospective. The data was "generated by testing male and female adults...at three clinical sites." This implies a planned collection of new data.
  • Population: Male and female adults, between the ages of 18 and 85, including healthy volunteers, patients undergoing cardiopulmonary bypass surgery, and patients undergoing cardiac catheterization.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The ground truth (predicate method) used was based on platelet aggregometry on platelet rich plasma (PRP), which is a standardized clinical laboratory method. It's implied that the results from the PRP aggregometer, when operated according to manufacturers' recommendations, served as the referent.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative study between a new device and a predicate device (the "ground truth" here). The comparison was statistical (regression analysis, Kendall Tau, Spearman Rho), not expert adjudication of disagreements.

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 explicitly described. The study compared the new device's output to the established predicate device's output, not the performance of human readers with vs. without AI assistance.

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

Yes, the study primarily evaluated the standalone performance of the Plateletworks device (algorithm only), comparing its output to the output of the predicate device (PRP aggregometry). There is no mention of human-in-the-loop performance in the context of this study.

7. The Type of Ground Truth Used

The ground truth used was the results from platelet aggregometry on platelet rich plasma (PRP), which is a widely accepted and established clinical laboratory method for measuring platelet aggregation. This can be categorized as a "clinical reference method" or "predicate device gold standard."

8. The Sample Size for the Training Set

The document does not provide any information about a separate training set or its sample size. The description focuses solely on the "testing" or "validation" data used for the substantial equivalence comparison. It's possible that the "Plateletworks methodology" was developed using internal data, but this is not disclosed in the provided summary.

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

Since no training set is described, there is no information on how ground truth for a training set might have been established. It's likely that the device's algorithms were developed or adapted in-house by Array Medical, Inc., rather than through a formal, externally validated "training set" in the context often seen with AI/machine learning.

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The MAX-ACT Activated Clotting Time test tubes are intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.

The MAX-ACT Activated Clotting Time test tubes utilize a "cocktail" of particulate activators (including celite, kaolin, and glass particles) and is intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.

Here's a breakdown of the acceptance criteria and study information for the MAX-ACT Activated Clotting Time Test Tube, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined performance acceptance criteria. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Array Medical Actalyke C-ACT test tube, K964609) through correlation studies. The reported performance is presented as correlation coefficients.

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

• In-vitro study:
  • Sample Size: 72 samples (derived from 3 normal, healthy volunteers by adding increasing amounts of heparin).
  • Data Provenance: In-house study, in-vitro heparinization of normal donor blood. The country of origin is not explicitly stated but can be inferred as the US given the submission to the FDA. Retrospective/Prospective: Not explicitly stated, but the description of generating samples suggests a controlled, prospective approach.
• Clinical studies:
  • Total Sample Size: 330 paired blood samples.
  • Breakdown by Study Group:
    • Bypass Patients: 239 patient samples (from n=30 patients)
    • Aprotinin Bypass Patients: 28 patient samples (from n=6 patients)
    • Pediatric Bypass: 41 patient samples (from n=5 patients)
    • Catheterization Patients: 22 patient samples (from n=10 patients)
  • Data Provenance: Clinically collected samples from patients (adult bypass, pediatric bypass, cardiac catheterization) at "numerous institutions." The country of origin is not explicitly stated, but given FDA submission, it's likely primarily US data. Retrospective/Prospective: The description "collected... before, during, and following heparinization" suggests these were prospectively collected as part of the study.

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

This type of information is not provided in the given document. The "ground truth" in this context is the measurement provided by the legally marketed predicate devices (C-ACT, FTCA510, ACTII/K-ACT/FTKACT). These are established laboratory tests, and their results are considered the standard for comparison rather than requiring expert consensus on individual results.

4. Adjudication Method for the Test Set

This type of information is not applicable to this study. The study compares a new device's readings to those of a predicate device. There is no mention of human interpretation or a need for adjudication.

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

No, a MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic device (activated clotting time measurement), not on the diagnostic accuracy of human readers with or without AI assistance.

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

Yes, the performance data presented is that of the device (MAX-ACT Activated Clotting Time Test Tube) in a standalone capacity, i.e., without a human-in-the-loop evaluating its output in a diagnostic context. It compares the MAX-ACT's readings directly to those of established ACT tests.

7. The Type of Ground Truth Used

The ground truth used for comparison was the readings obtained from legally marketed predicate Activated Clotting Time (ACT) tests. Specifically, these included:

• Array Medical Actalyke C-ACT
• HEMOCHRON CA510
• HEMOCHRON FTKACT
• ACTII/K-ACT

These predicate devices serve as the established standard for measuring ACT.

8. The Sample Size for the Training Set

This document does not mention a 'training set.' The MAX-ACT device is a physical test tube containing "a cocktail of particulate activators." It’s not an AI/ML algorithm that requires a training set in the conventional sense. The studies described are for validation and demonstration of equivalence, not for training an algorithm.

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

As there is no training set for this device, this question is not applicable.

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The Actalyke Activated Clotting Time System and Test Tubes are intended for use in the measurement of the activated clotting time test (ACT). Current markets using the ACT include: bypass surgery, vascular surgery, transplant surgery, renal dialysis, ECMO, cardiac catheterization and Percutaneous Transluminal Coronary Angioplasty (PTCA), Critical Care, and other medical therapies requiring heparin anticoagulation.

The Actalyke System is a portable, battery operated device designed to perform a range of whole blood coagulation tests at the patient's bedside using Activated Clotting Time (ACT) measurement techniques. Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism. Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube. When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates. As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point. Each Actalyke test tube has a barcode label affixed to it, which is read by the Actalyke instrument to determine the test tube type (i.e., celite, kaolin, or glass bead), If the result is printed (optional), the normal range for the identified test tube type will be printed. The lot number and expiration date of each tube are also identified on the barcode label.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Actalyke System appear to be based on demonstrating "normal ranges" and "high correlation" with the legally marketed predicate device, the HEMOCHRON Whole Blood Coagulation System, across different test tube types (Celite, Kaolin, Glass Bead). Since specific quantitative acceptance thresholds are not explicitly stated, the reported performance is compared directly to the predicate device's performance in the provided tables.

Summary of Reported Device Performance:

• Normal Range Studies: The Actalyke System, using its own tubes, demonstrated normal ranges largely overlapping with or comparable to the Hemochron system using its own tubes, when tested on healthy patient samples (as shown in the detailed tables for Celite, Kaolin, and Glass Bead).
• Correlation Studies (with varying heparin): The Actalyke Instrument and Actalyke ACT tubes showed "high correlation" with the Hemochron Instrument and Hemochron ACT tubes across different heparin concentrations for all three tube types (Celite, Kaolin, Glass Bead), indicating similar performance in measuring coagulation time under anticoagulation. This was visually represented and stated generally as "high correlation" in the DATA SUMMARY.

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

• Sample Size (Normal Range Studies):
  • Celite Normal Range Study: 15 patient samples (S011-S024 excluding some, plus S002).
  • Kaolin Normal Range Study: 15 patient samples (S033-S040, S004, S005, S009, S030, S031, S037, plus 11L001).
  • Glass Bead Normal Range Study: 15 patient samples (S051, S027, S025, S052, S028, S019, S035, S045, 11L001, S049, S048, S006, S016, S030, S009).
• Sample Size (Correlation Studies):
  • The sample size for the heparin correlation studies is not explicitly stated as a number of individual patients. However, the data represents "mean data" for varying heparin concentrations (0, 1, 3, 5 u/ml for Celite & Kaolin; 0, 0.3, 0.6, 1, 2 u/ml for Glass Bead), suggesting multiple measurements per heparin concentration. Given the normal range studies used 15 patients, it's plausible similar numbers were used for correlation, but it's not confirmed.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The patient IDs (e.g., S011, S002) suggest individual patient data was collected, but we cannot deduce if it was prospective or retrospective from the provided text.

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

Not applicable. This device measures a physical property (clotting time) directly, rather than relying on expert interpretation of images or other qualitative data. The "ground truth" is the measured Activated Clotting Time (ACT) itself, or comparison to an established, legally marketed device (HEMOCHRON system).

4. Adjudication Method (for the test set)

Not applicable. As noted above, the device measures a physical property directly. There is no qualitative assessment or interpretation by experts that would require an adjudication method. The study design involves direct comparison of measurements between the Actalyke system and the predicate device.

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

No. This is not applicable to the Actalyke System. An MRMC study typically involves human readers interpreting cases (e.g., medical images) with and without AI assistance to assess changes in diagnostic performance. The Actalyke System is a point-of-care coagulation analyzer, not an AI-powered diagnostic imaging tool that assists human readers.

6. Standalone Performance Study

Yes, a standalone performance was done in the "Normal Range Study" for each tube type. The Actalyke instrument was used with Actalyke tubes to establish normal ranges, which were then compared to the normal ranges obtained by the Hemochron instrument with Hemochron tubes. Additionally, the correlation studies implicitly demonstrate standalone performance when the Actalyke instrument is used with Actalyke tubes across varying heparin concentrations.

7. Type of Ground Truth Used

The ground truth used is predominantly:

• Comparison to a Legally Marketed Predicate Device: The performance of the Actalyke System is evaluated by comparing its results directly to those obtained from the HEMOCHRON Whole Blood Coagulation System, which is the established standard.
• Measured Activated Clotting Time (ACT): For the normal range studies, the ACT measurements from healthy individuals define the "normal range." For the correlation studies, the measured ACT values at different heparin concentrations serve as the primary data point for comparison.

8. Sample Size for the Training Set

Not applicable. The Actalyke System does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It is a hardware device based on magnetic detection principles. The studies described are performance validation studies, not training of an algorithm.

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

Not applicable, as there is no "training set" for this device.

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