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The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory.

The T-TAS 01 PL chip is intended for use in the clinical laboratory for the analysis of the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC

The T-TAS 01 system is an in vitro diagnostic device that is comprised of tabletop instrument controlled by a dedicated PC and a disposable, single-use flow chamber. The PL Chip for T-TAS 01 is designed to specifically measure platelet thrombus formation (PTF) under physiological conditions on a collagen-coated analytical path consisting of 26 microcapillary channels. Platelet thrombus formation is a direct indicator of the patient's primary hemostatic function. The assay is performed under arterial flow conditions using benzylsulfonyl-D-Arg-Pro-4-amidinobenzylamide (BAPA)-anticoagulated whole blood samples. BAPA is an anticoagulant that inhibits thrombin and factor Xa, blocking the coagulation cascade and allowing the PL assay to specifically measure only the platelet thrombus formation process (primary hemostasis). During the assay, the blood sample is exposed to arterial shear stresses at 1,500 s-1 in the presence of a collagen-coated surface, which causes platelet attachment to collagen mediated by von Willebrand factor (vWF), and platelet activation. Platelet activation causes the release of endogenous factors contained within the platelets that recruit and activate other platelets and cause aggregation, and platelet thrombus formation. The growing platelet thrombus causes occlusion of the microcapillary channels, which increases the flow pressure within the assay chip. The process of platelet thrombus formation in the flow chamber is continuously monitored by a pressure sensor that tracks pressure changes in the flow path. Results are calculated automatically within 10 minutes or when the pressure a reading reaches 60 kPa above the baseline pressure, whichever occurs first. Results are displayed as AUC, which is the flow pressure curve over 10 minutes.

AUC results less than 260 are associated with abnormal primary hemostatic function.

The provided text is a 510(k) Summary for the T-TAS 01 System with PL Chip, an automated platelet aggregation system. It details the device's intended use, comparison to a predicate device, and non-clinical and clinical performance data.

Here's an analysis to extract the requested information, noting that this document describes a diagnostic test, not an AI model. Therefore, some questions related to AI-specific studies (e.g., human-in-the-loop, AI effect size, training data ground truth establishment) are not directly applicable or answerable from this document.

Device Name: T-TAS 01 System with PL Chip

Device Type: Automated Platelet Aggregation System (In Vitro Diagnostic, IVD)

Acceptance Criteria for Performance (based on clinical performance data):

The device's performance is demonstrated through its ability to differentiate between individuals with normal primary hemostatic function and those with impaired function due to specific conditions. The key metric is the Area Under the Pressure-Time Curve (AUC), with a cutoff of **

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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 Chrono-log Model 490 4+4 Aggregometer is intended for use for in-vitro diagnostic use for measuring Platelet Aggregation in Platelet Rich Plasma.

This device is intended to be used in a clinical laboratory environment by laboratory technicians.

For use only with light transmission aggregometry assays cleared for use with the Chrono-log Platelet Aggregometry systems.

The Chrono-log™ Model 490 4+4 Aggregometer measures platelet function on patient samples using LTA which measures a change in optical density of platelet rich plasma. The Model 490 4+4 is also used to run the Ristocetin Cofactor Assay to aid in diagnosis of patients with von Willebrand disease. The instrument comes with a starter kit of reagents and supplies. The output of the Model 490 4+4 can be connected to either a strip chart recorder or to a Computer. Software is provided with the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 490 4+4 Aggregometer.

LTA or Born method of platelet aggregation measures the change in optical density of a Platelet Rich Plasma (PRP) sample in comparison to optical density of a Platelet Poor Plasma (PPP) sample. The PRP sample, platelets in a suspension of plasma, is isolated from an anticoagulated blood sample by a relatively low centrifugation. The PPP sample is prepared by centrifuging the blood sample at a relatively high force. The Chrono-log sample chambers are designed so that a beam of infra red light shines through two cuvettes. one containing PRP (the sample) and one containing PPP (the reference). Silicon photodiodes detect the light able to pass through the samples: PRP is arbitrarily considered to be 0% light transmission or 0% aggregation: PPP is considered to be 100% light transmission or 100% aggregation. When a stimulus is added to the cuvette containing PRP and the platelets respond forming aggregates, more light is allowed to pass through the PRP sample. The change in light transmission, recorded over time, shows a trend towards the platelet poor plasma, or 100% light transmission. A graphical tracing of the change in optical density during the course of platelet aggregation is produced either on a strip chart recorder or on a computer using Chrono-log provided software. This device is designed to be used in the clinical laboratory as an in vitro diagnostic tool. The 490 4+4 varies from the predicate devices only in the number of channels.

The document describes the acceptance criteria and the study proving the device, Chrono-log™ Platelet Aggregometer, Model 490 4+4, meets these criteria, primarily through demonstrating substantial equivalence to a predicate device (Chrono-log™ Whole Blood Lumi-Aggregometer Model 700).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "strong correlation" and "good agreement" with the predicate device, as well as maintaining performance specifications (though specific numerical targets for metrics like R-squared or bias are not explicitly stated as pre-defined acceptance criteria, they function as such in the reported performance metrics). The device's performance is gauged by the Coefficient of Variation (which seems to be used interchangeably with R-squared in this context, given the R2 mentions in the conclusion) between the new device and the predicate.

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

• Test Set Sample Size:
  • Optical Aggregation: 114 comparison tests in total.
  • Volume Comparison: A "small subset" of tests was used to compare 500uL and 250uL samples (8 normal samples in 500 µL, 8 aspirin samples in 500 µL, 8 normal samples in 250 µL, 8 aspirin samples in 250 µL).
• Data Provenance:
  • The study involved "patient samples" from "four normal, healthy, drug-free subjects" and "a subject taking aspirin." Additionally, samples treated with ticagrelor and GPIIb/IIIa antagonist, and deficient vW plasma with lyophilized platelets were used to demonstrate abnormal results.
  • The document does not explicitly state the country of origin for the data/samples but implies it was conducted by the manufacturer, Chrono-log Corp., based in Havertown, PA, USA.
  • Retrospective or Prospective: The testing appears to be prospective or specially collected for this comparison study, as it describes the collection and testing of specific subject samples (normal, aspirin, treated with inhibitors) on both the new and predicate devices.

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

The document does not describe the use of experts to establish a "ground truth" for the performance study. The study focuses on demonstrating equivalence to a predicate device using measured values of platelet aggregation, not on expert interpretation of results. The "ground truth" for the device's function is the direct measurement of optical density changes in plasma samples, interpreted as percentage aggregation.

4. Adjudication Method for the Test Set

Not applicable. The study compares objective quantitative measurements from two devices, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a measurement instrument (platelet aggregometer) and its performance is evaluated based on quantitative agreement with a predicate device, not on human reader performance or improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily demonstrates standalone performance of the device (Chrono-log Model 490 4+4) by comparing its measurements directly to those of the predicate device (Chrono-log Model 700). There is no AI algorithm involved; it's a direct hardware and measurement comparison. The software provided with the computer interface option is explicitly stated to "collect data only" and "is not used for diagnosis or treatment and does not have any control over or input into the Model 490 4+4 Aggregometer."

7. Type of Ground Truth Used

The "ground truth" is established by the measurements from the predicate device (Chrono-log Model 700). The study aims to show that the new device's measurements are substantially equivalent to those of the already legally marketed and established predicate device. It relies on the predicate device's accepted performance as the de facto standard for comparison.

8. Sample Size for the Training Set

Not applicable. This device is a medical measurement instrument, not an AI/ML model that requires a "training set" in the conventional sense. The "training" for the device would be its engineering design, calibration, and manufacturing processes.

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

Not applicable, as there is no training set for an AI/ML model. The predicate device's established performance serves as the reference point for the new device's engineering design and verification.

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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 CORA PlateletMapping System is intended for in vitro diagnostic use to provide qualitative assessment of platelet function. The CORA System records the kinetic changes in a sample of heparinized whole blood as the sample clots.

The CORA System PlateletMapping Assay Cartridge provides four channels of dried-in-place reagents, HKH (Kaolin with Heparinase), Activator F, AA and ADP (one reagent in each channel). In combination, MA parameter results from these four reagents are used to calculate the parameters platelet % Inhibition and % Aggregation for AA and ADP.

Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests.

The CORA System with CORA PlateletMapping Assay Cartridge is indicated for use with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the CORA PlateletMapping System is used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions.

The CORA PlateletMappingSystem consists of a four-channel diagnostic analyzer with integrated computer module, system reagents (ActF, AA, ADP and HKH) and microfluidic test cartridge. Reagents are dried-in-place within the cartridges during manufacturing.

To perform a test, a disposable CORA PlateletMapping Assay Cartridge is inserted into the analyzer. Blood is added to an entry port on the cartridge and drawn into the cartridge under analyzer control. The amount of the sample drawn into the cartridge is automatically determined by the volume of the blood chambers in the cartridge. Once in the disposable, the sample is metered into as many as four separate analysis channels, depending upon the assay being performed. Reconstitution of reagents dried within the cartridge is accomplished by moving the sample back and forth through reagent chambers, under the control of microfluidic valves and bellows within the cartridge. After each sample has been mixed with reagent, it is delivered to a test cell where it is monitored for changes due to coagulation. Excess sample material is moved under microfluidic control into an enclosed waste chamber within the cartridge.

The CORA technology is based on a disposable containing up to four independent measurement cells. Each cell consists of a short vertically-oriented injection molded tube (ring) with a diameter of 2.5mm and a length of 4.5mm. Detection of clotting in the CORA System is performed optically. Under control of the analyzer, approximately 20uL of prepared sample is delivered to the tube, where a meniscus naturally forms at each end of the tube. The tube is positioned so that the lower meniscus partially blocks light traveling from a collimated source toward a photodiode.

During testing, a piezoelectric actuator drives the measurement cell(s) through a motion profile composed of summed sinusoids at different frequencies. The profile has a maximum amplitude of under 10um and contains frequencies from 10-500Hz. Some, but not all, of the measurement cell motion will induce motion in the sample meniscus, which will be detected by the photodiode. The resulting motion of the meniscus is monitored optically and analyzed by the analyzer to calculate the resonant frequency and modulus of elasticity (stiffness) of the sample. By performing a Fast Fourier Transform (FFT) on meniscus motion data, it is possible to determine the frequencies of input motion that caused the greatest deflection of the sample (these are called the resonant frequencies).

Resonance is the tendency of a material or structure to oscillate with greater amplitude at some frequencies than others. The exact frequencies at which resonance occurs will depend on the stiffness and mass of the sample. Stiffness, in turn, is a function of a material's modulus of elasticity and the boundary conditions to which the material is exposed, such as the geometry and materials of a test cell. By holding these boundary conditions and sample mass constant from run to run, the CORA System allows direct comparison of elasticity between samples.

In a typical test, blood that has been delivered to the measurement cell will not clot for several minutes. During this time the sample has no inherent stiffness except that provided by surface tension, and since this remains constant the measured resonant frequencies will not change. Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the test tube (ring) and the resonant frequency will rise with increasing firmness of the clot. The CORA Analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide parameters describing the clot. Results are presented in a format identical to the TEG 5000.

The CORA System with PlateletMapping Assay is intended for in vitro diagnostic use to provide a qualitative assessment of platelet function. The system records kinetic changes in heparinized whole blood samples as they clot, calculating % Inhibition and % Aggregation for AA and ADP parameters.

Here's an analysis of the acceptance criteria and the study performance for the CORA System with PlateletMapping Assay:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical performance. Instead, it presents the device's sensitivity and specificity and compares them to the predicate device, the TEG 5000 Platelet Mapping Assay.

For analytical precision, the reported data indicates the variability (SD and %CV) across various factors (reagent lot, operator, analyzer, day, and repeatability) for MA parameters in HKH, and indicates that the percent positive and negative agreement for AA and ADP % aggregation inhibition at low and high level is 100%. However, no specific acceptance criteria for precision are provided.

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

• Reference Range Determination (Clinical Performance):

  • Sample Size: Up to 55 normal volunteer subjects were taken at each of the three clinical sites, totaling approximately 150 samples.
  • Data Provenance: Prospective, collected from normal volunteer subjects by three clinical sites representing demographic populations of the three areas regarding age, race, and gender.

• Method Comparison (Clinical Performance):

  • Sample Size: Not explicitly stated, but the study was conducted on "patient samples" from "surgical patients and normal donors (for CORA)." The sensitivity and specificity percentages are derived from these samples.
  • Data Provenance: The patients were undergoing heart surgery or PCI procedures, with blood samples drawn pre- and post-surgery and in the ICU. This indicates a prospective collection within a clinical setting. The study was conducted at three clinical sites.

• Analytical Precision (Non-Clinical Performance):

  • Sample Size: For HKH, blood draws from 3 donors (Hypo, Normal, Hyper). For AA and ADP Percent Aggregation and Inhibition, blood draws from 2 donors (Normal, Abnormal). Each testing scenario involved 5 non-consecutive days, 2 operators, 3 reagent lots, 12 analyzers, and 2 replicates. This results in n=120 for each MA parameter level (Hypo, Hyper, Normal) for HKH.
  • Data Provenance: The testing was performed in Coramed's laboratory, suggesting internally generated data.

• Interference (Non-Clinical Performance):

  • Sample Size: Not explicitly stated.
  • Data Provenance: Performed in Coramed's laboratory.

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

The document does not specify the use of experts to establish a "ground truth" in the traditional sense (e.g., radiologists interpreting images).

• For the Reference Ranges, the ground truth is established by selecting "normal volunteer subjects" and then deriving the range from their results. This is based on a statistical approach to define normalcy within the tested population.
• For the Method Comparison, the ground truth for determining disease status (e.g., platelet dysfunction) is implicitly established through clinical diagnosis of "surgical patients or PCI procedures" who are known to have conditions where blood hemostasis properties evaluation is desired. However, the exact method of confirming ground truth for individual results to calculate sensitivity and specificity (e.g., by another gold standard method, pathology, or expert clinical diagnosis) is not detailed. The comparison is made against the TEG 5000 as a predicate, which usually implies that the predicate serves as a reference, but a true independent ground truth for classification is not explicitly defined in the provided text.

4. Adjudication Method (for the test set)

No adjudication method involving experts is mentioned for clinical performance results. The sensitivity and specificity would be derived by comparing the CORA device's output against the "true" clinical status of the patients, or the predicate device's output, but the process of determining that "true" status is not elaborated in terms of an adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is an in vitro diagnostic device for assessing platelet function, not an imaging device typically involving human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or described in this document.

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

Yes, the studies presented appear to be standalone performance assessments of the CORA System. The "system" is an automated analyzer that generates quantitative results (MA, % Aggregation, % Inhibition). Its performance (precision, reference ranges, sensitivity, specificity) is evaluated directly, without explicitly describing a human-in-the-loop interaction in the context of the performance data. While the "results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests," this statement refers to the clinical application rather than the performance study design.

7. The Type of Ground Truth Used

• Reference Ranges: The ground truth is effectively derived from the measurements of a healthy reference population (normal volunteer subjects) to establish what is considered "normal."
• Method Comparison: The ground truth for calculating sensitivity and specificity is implicitly clinical diagnosis of patients undergoing cardiovascular procedures, where blood hemostasis evaluation is desired. However, the specific gold standard or method used to classify each patient's 'true' platelet function status (e.g., by another established assay, pathology, or expert clinical assessment) against which the CORA results are benchmarked is not explicitly defined. The comparison also heavily relies on the predicate device (TEG 5000), suggesting that the predicate might serve as a de facto reference for classification if an independent gold standard was not available or used. It states "studies were conducted... on patient samples following CLSI EP09-A3 Guideline," which typically involves comparison to a reference method.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of an AI/machine learning model. The CORA System is an automated diagnostic device based on physical measurement techniques (e.g., resonance, optical detection), not typically an AI system that requires a training set. The descriptions of "precision testing" and "reference ranges" are for analytical and clinical validation, not algorithm training.

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

Since no "training set" for an AI/machine learning model is described, the question of how its ground truth was established is not applicable.

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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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The Multiplate 5.0 aggregometer is intended for in vitro use to measure platelet aggregation in response to Arachidonic acid or ADP in citrated whole blood samples for the qualitative assessment of platelet function.

The ADPtest reagent is a lyophilized preparation of adenosine-5-diphosphate for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.

The ASPItest reagent is a lyophilized preparation of arachidonic acid (AA) for in vitro diagnostic use to measure platelet aggregation for the qualitative assessment of platelet function. For professional laboratory use only.

For use as an assayed quality control verification of the resistance measure of impedance aggregometry.

The Multiplate® 5.0 measures platelet function in whole blood samples using electrical impedance. The Multiplate technology employs multiple electrodes in a disposable test cell. Four electrodes form two independent sensor units allowing for two measurements on the same sample. Five independent channels of the instrument allow for testing of multiple reagents or samples simultaneously.

The instrument provides a five channel aggregometer and an integrated computer system with associated software and is connected to a computer screen, keyboard, mouse, and an electronic pipette. The software is used for data collection and is not used for diagnosis or treatment.

Currently, two test reagents (ADP and Arachidonic acid) are available that activate platelets through specific platelet membrane receptor/signal transduction pathways in order to measure platelet function or alterations in function.

The Multiplate 5.0 device measures platelet aggregation in whole blood samples. This device report focuses on its performance compared to a predicate device (Chrono-log Model 700) and its ability to assess platelet function.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for agreement, sensitivity, or specificity. Instead, the "Performance" section reports the observed agreement and diagnostic accuracy against the predicate device and physician panel review, respectively. Therefore, the reported performance metrics can be considered the de facto "acceptance criteria" against which the device passed for substantial equivalence demonstration.

2. Sample Size and Data Provenance for the Test Set

• Sample size for agreement study (Test Set 1): 171 patients.
• Sample size for sensitivity/specificity study (Test Set 2): 91 patients.
• Data Provenance: The document states "Multi-center studies were run," implying prospective data collection across multiple sites. There is no explicit mention of the country of origin of the data, but the submitting company is based in Germany. The data is implicitly prospective, as it was collected to compare the Multiplate 5.0 to the predicate device and against clinical status.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of experts: The document mentions a "physician panel" for establishing Platelet Function Status for the sensitivity/specificity study. The exact number of physicians on this panel is not specified.
• Qualifications of experts: Not specified beyond being a "physician panel." Their specific specialty (e.g., hematologist, critical care physician) or years of experience are not provided.

4. Adjudication Method (Test Set)

• For the agreement study with the predicate device, there was no independent adjudication method described. The comparison was direct measurement of the Multiplate 5.0 against the Chrono-log Model 700.
• For the sensitivity/specificity study, the "Platelet Function Status of each sample was based upon a physician panel's review of each patient's clinical history." This implies a form of consensus or collective decision-making by the panel, but the specific adjudication method (e.g., unanimous, majority vote, 2+1) is not detailed.

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

No, an MRMC comparative effectiveness study that assesses human readers' improvement with vs. without AI assistance was not conducted. This device is an automated platelet aggregation system, not an AI diagnostic tool that assists human interpretation of images or data. The studies involved a direct comparison between devices or device output against clinical ground truth.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was performed. The reported performance metrics (agreement, sensitivity, specificity) reflect the performance of the Multiplate 5.0 device (the "algorithm only," as it's an automated system) without human interpretation or intervention in the measurement process itself. The software for data collection is explicitly stated as "not used for diagnosis or treatment," reinforcing that the device itself generates the results.

7. Type of Ground Truth Used

• For agreement studies: The ground truth was the results obtained from the predicate device (Chrono-log Model 700).
• For sensitivity and specificity studies: The ground truth was the "Platelet Function Status" based on a physician panel's review of each patient's clinical history. This can be categorized as expert consensus / clinical diagnosis.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. Given that this is a 510(k) submission for a device measuring electrical impedance (a well-established physical principle) rather than an AI/machine learning algorithm that requires extensive training, it's highly probable that there wasn't a "training set" in the modern machine learning sense. The device's operational parameters would likely be derived from engineering principles and validation, rather than data-driven training.

9. How Ground Truth for the Training Set Was Established

As no "training set" is mentioned or implied for a machine learning context, the concept of establishing ground truth for a training set does not apply in this document. The device operates based on physical principles and pre-defined reagents, with performance validated against clinical samples and a predicate device.

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The Dade® PFA-100® Platelet Function Analyzer and associated reagents are in vitro diagnostic devices intended to aid in the detection of platelet dysfunction in citrated human whole blood.

To aid in the detection of platelet dysfunction in citrated human whole blood.

The PFA-100® system provides a tool for clinicians to use in the detection of platelet dysfunction induced by intrinsic platelet defects, von Willebrand factor (vWF) functional deficiencies, or exposure to platelet inhibiting agents. The PFA-100® system simulates, under high shear stress, the interaction of platelets with an injured blood vessel. These conditions allow the PFA-100® system to measure in vitro platelet function as related to primary hemostasis.

This 510(k) summary (K060489) for the Dade® PFA-100® Platelet Function Analyzer and Reagents primarily references existing literature to demonstrate performance, rather than presenting a single, dedicated device performance study with specific acceptance criteria. This is common for submissions claiming substantial equivalence to an already marketed device (K970505 and K002885).

Therefore, the acceptance criteria are not explicitly stated in a quantitative form with pass/fail thresholds for the new device itself. Instead, the submission uses existing studies to show that the device performs similarly to or confirms known clinical observations related to platelet function.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details are inferred or not explicitly stated for a "new device" performance study but rather for established device performance:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the acceptance criteria are not explicitly defined for a new device study. Instead, the performance is demonstrated through studies showing the PFA-100's ability to detect platelet dysfunction and assess DDAVP treatment, with specific sensitivity, specificity, and efficiency values reported for various conditions. These values, derived from previously published studies, implicitly serve as the "performance" against which the device's utility is being demonstrated.

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

The submission references multiple studies, each with its own sample size and provenance:

• Cariappa et al.: 52 patients. Data provenance not specified (retrospective/prospective, country).
• Lippi et al.: 52 patients. Data provenance not specified (retrospective/prospective, country).
• Fressinaud et al.: 41 patients (23 VWD Type I). Data provenance not specified (retrospective/prospective, country).
• Koscielny et al. (First Entry): 5649 patients. Data provenance not specified (retrospective/prospective, country).
• Koscielny et al. (Second Entry):
  • 256 impaired hemostasis in prospective study.
  • 5102 (317 impaired hemostasis) in retrospective study.
  • Combined total of 5649 patients in the overarching study.
  • Data provenance not specified for country of origin, but study design (prospective/retrospective) is mentioned for parts of it.

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

The provided text does not contain any information regarding the number of experts or their qualifications used to establish ground truth for the cited studies. The "ground truth" was established using a combination of other diagnostic assays and clinical outcomes (e.g., bleeding history, aggregometry, bleeding time, VWF assays, PT, aPTT, FVIII activity, RIPA, VWF multimers, pathology for VWD/platelet defects, and observation of DDAVP treatment response).

4. Adjudication Method for the Test Set

The provided text does not contain any information on adjudication methods for establishing ground truth in the cited studies. Given the nature of the studies (often using multiple clinical and laboratory assessments to reach a diagnosis), it's likely a form of comprehensive clinical diagnosis rather than a single adjudication process for an AI model.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done or reported in this submission. The PFA-100 is an automated diagnostic device, not an AI-assisted interpretation tool for human readers in the context of what an MRMC study typically assesses for AI.

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

Yes, the performance reported for the PFA-100 system is standalone performance. The PFA-100 is an automated instrument that directly measures platelet function and provides quantitative results (Closure Times). The "device performance characteristics" section describes the output solely based on the device's measurements in various clinical scenarios, without human-in-the-loop interaction in generating the primary analytical results.

7. The Type of Ground Truth Used

The ground truth for the cited studies was established using a combination of clinical diagnoses, other laboratory assays, and observed patient outcomes/responses to treatment.

Examples include:

• Clinical diagnosis of platelet defects or VWD: Based on bleeding history and a battery of tests (bleeding time, aggregometry, platelet count, PT, aPTT, VWF assays, VWF:Ag, VWF:RCo, FVIII activity, RIPA, VWF multimers, flow cytometry).
• Response to DDAVP treatment: Normalization of PFA CTs and assessment of blood usage.
• Impaired hemostasis: Based on clinical picture and a range of diagnostic tests.

8. The Sample Size for the Training Set

The device is a PFA-100 instrument and reagents, which functions based on physical principles (simulating shear stress and platelet-collagen interaction), not a machine learning or AI algorithm that typically requires a "training set" in the presented context. Therefore, the concept of a "training set sample size" as used for AI/ML development does not apply here. The device's operational parameters and reagents are developed through R&D and calibration rather than typical machine learning training.

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

As explained above, since this is not an AI/ML device, the concept of a "training set" and establishing "ground truth for a training set" in that specific context is not applicable. The device's design and calibration would have been based on established hematological principles and empirical testing to ensure accurate and reproducible measurement of platelet function.

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For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.

The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Chrono-log Model 700 Whole Blood Lumi-Aggregometer:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than establishing explicit acceptance criteria with pre-defined thresholds for performance. The "acceptance criteria" here are implicitly linked to achieving a high correlation with the predicate devices, indicating comparable performance.

Here's a table summarizing the reported device performance, with the understanding that the "acceptance criteria" were met by demonstrating strong correlation:

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