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The AggreGuide A-100 ADP Assay is used with the AggreGuide A-100 instrument in non-CLIA waived physician's office or clinical laboratory for the detection of platelet dysfunction in patients age 22 or older receiving P2Y 12 antiplatelet drugs, prasugrel and ticagrelor, using 3.2% sodium citrated whole blood. The AggreGuide A-100 ADP Assay is a semi-quantitative assay. The level of platelet aggregation is determined by the platelet activity index (PAI) where values

The AggreGuide A-100 ADP Assay is an individual use, disposable assay cartridge for use with the AggreGuide A-100 instrument. The cartridge contains preloaded freeze dried agonist. The level of platelet aggregation induced by the adenosine diphosphate (ADP) agonist in a sample of whole blood is detected within the cartridge. The amount of platelet aggregation is measured by detecting and quantifying the laser light scattering caused by platelet aggregates. P2Y12 inhibitor drugs e.g. clopidogrel, and ticagrelor are known to inhibit the level of platelet aggregation, causing platelet dysfunction.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states numerical acceptance criteria for sensitivity. Specificity is provided as a reported value, implying it met an internal or expected threshold, though the exact numerical acceptance criterion for specificity isn't listed.

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

The sample sizes for the sensitivity analysis (test set) are:

• Prasugrel: 43 patients for both Post-Loading (24 hours) and Post-Maintenance (7 days).
• Ticagrelor: 85 patients for Post-Loading (3-6 hours) and 143 patients for Post-Maintenance (7 days).

The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. However, the study is described as "clinical testing" and evaluated against a "clinical truth data set comprising off-therapy (baseline) versus on-therapy with P2Y12 inhibitor medications. On-therapy clinical truth utilized high potency P2Y12 medications at a time of full-effect," which suggests a prospective clinical study design.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications. It simply refers to a "clinical truth data set."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for establishing the ground truth of the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study evaluated the standalone performance of the AggreGuide A-100 ADP Assay and compared its performance (sensitivity values) against another device (VerifyNow) on the same clinical truth data set, but not in the context of human reader improvement with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The reported sensitivity and specificity values are for the AggreGuide A-100 ADP Assay as a diagnostic device, without human intervention in the interpretation of the primary PAI result. The document says, "The level of platelet aggregation is determined by the platelet activity index (PAI) where values

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The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.

My apologies, but this document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, especially in the context of a conventional medical device study (e.g., diagnostic accuracy, comparative effectiveness).

Here's why and what the document does provide:

Why the requested information is not present:

• This is a 510(k) Substantial Equivalence Submission for MODIFICATIONS, not an original submission or a study report. The document details changes made to an already cleared device (K122162). Its purpose is to demonstrate that the modified device is still substantially equivalent to the original, cleared device, and that the modifications do not raise new questions of safety or effectiveness.
• The document focuses on verification and validation of changes: The "Summary of Performance Data" (Section 7) explicitly states that "The risk analysis method used to assess the impact of the modifications was ISO 14971:2007, 'Medical devices -- Application of risk management to medical devices'." It then lists results for specific changes: laser diode part replacement, QC2 implementation, software updates, shelf life extension, and User's Manual revision.
• No clinical performance data was collected for this submission: Section 8 explicitly states, "The modifications did not require collection of clinical performance data." This directly contradicts the need for most of the information you asked for (e.g., sample size for test set, ground truth, expert adjudication, MRMC studies, standalone performance).

What the document does provide (related to your request, but not directly answering it):

• Device Name: AggreGuide A-100 AA assay, AggreGuide A-100 Instrument
• Indications for Use: "The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician."
• Predicate Device: AggreGuide A-100 AA assay and AggreGuide A-100 Instrument, 510(k) document number K122162.
• Specific Modifications:
  • Laser Diode Part: Changed from Sanyo DL-4140-001S to QSI QL7816SA-L
  • Quality Control Cartridge: Modified to QC2 cartridge
  • Software: Updated from Version 4.91 to Version 5.10
  • Test Cartridge Shelf Life: Extended from 12 months to 18 months
  • User's Manual: Revised from LBL-0014-C to LBL-0014-E

Given this, I cannot fill in the table or provide the specific details you requested because the document is a regulatory submission for changes to an existing device, and clinical performance data was explicitly not required for this submission. The "acceptance criteria" discussed are related to the successful verification and validation of these specific hardware/software/shelf-life changes, not the overall diagnostic accuracy of the device against a clinical ground truth.

If you had a document for the original 510(k) clearance (K122162), it might contain some of the performance data you're looking for, but this particular document does not.

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The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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 antiplatelet agents. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.

The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.

Here's a breakdown of the acceptance criteria and study details for the AggreGuide A-100, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined quantitative acceptance criteria for all performance aspects. However, it presents clinical performance results for sensitivity and specificity. Based on the clinical testing section, the implicit acceptance criteria are that the device demonstrates a clinically acceptable level of sensitivity and specificity for detecting aspirin-induced platelet dysfunction.

(Note: The document directly states "Sensitivity" in a table, and then provides a table titled "Pre 325mg Aspirin" that effectively describes the true negative rate (specificity) and false positive rate. The "Post 325mg Aspirin" table provides the true positive rate (sensitivity) and false negative rate. I've used these to construct the performance table.)

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

• Test Set Sample Size:
  • Total screened: 169 healthy subjects.
  • For aspirin-induced dysfunction detection: 138 subjects were given aspirin and tested.
  • For baseline (aspirin absent) assessment: 167 subjects (after 2 exclusions).
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a clinical testing conducted for the purpose of this submission. The nature of the study (administering aspirin to healthy subjects) suggests a prospective study.

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

The document does not specify the use of experts or their qualifications for establishing ground truth in the clinical study. It describes a "qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion." The ground truth appears to be established by:
* Aspirin Administration: Whether a subject was given 325 mg of aspirin (to induce platelet dysfunction).
* Clinical Observation/Reference Method (Implied): The study design implies that "aspirin ingestion" itself serves as the ground truth for platelet dysfunction, and the device's ability to detect this is assessed. There's no mention of a separate "gold standard" laboratory test or expert consensus.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1). The performance data is presented as direct results from the AggreGuide A-100, compared against the known condition of aspirin ingestion or absence.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in this summary. The study assessed the standalone performance of the AggreGuide A-100, not its effectiveness in assisting human readers.

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

Yes, a standalone performance study was done. The clinical testing section directly evaluates the AggreGuide A-100 system's ability to detect platelet dysfunction due to aspirin ingestion. The device produces a "Platelet Activity Index (PAI)," and the study assesses how well this PAI correlates with the presence or absence of prescribed aspirin. There is no mention of a human in the loop interpreting the device's output and then making a diagnosis.

7. The Type of Ground Truth Used

The ground truth used was primarily based on aspirin administration.

• "Aspirin 325 mg Present" was the ground truth for aspirin-induced platelet dysfunction.
• "Aspirin 325 mg Absent" was the ground truth for normal platelet function (or at least, not aspirin-induced dysfunction).

This is a form of clinical condition or intervention as ground truth, rather than pathology, expert consensus, or outcomes data in the traditional sense for diagnostic assays.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. The description of performance testing focuses solely on the clinical validation study described. For a device like this (an in-vitro diagnostic instrument), "training" might refer to internal development and calibration, but a distinct "training set" for statistical model development and validation as seen in AI/ML products is not discussed.

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

Since a separate training set is not explicitly mentioned as distinct from the reported clinical testing, the method of establishing its ground truth is not provided.

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