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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 < 260 suggesting abnormal primary hemostatic function. Additional testing may be necessary to identify the cause(s) of abnormal primary hemostatic function. The test has been evaluated in patients taking antiplatelet therapy, in patients with von Willebrand disease, and in patients with Glanzmann's thrombasthenia. Other primary hemostasis disorders have not been evaluated.

The BAPA tube for T-TAS 01 is intended to be used for the collection, transport, and storage of blood specimens for use with the T-TAS 01 system.

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 < 260 AUC suggesting abnormal primary hemostatic function.

Since this is a diagnostic device comparison to a predicate, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device (Dade Behring PFA-100) and by providing clinical performance metrics (negative agreement and sensitivity) for various target populations. The document does not explicitly state pre-defined quantitative acceptance criteria thresholds for these metrics that were required for clearance, but rather presents the results.

1. Table of Acceptance Criteria and Reported Device Performance

Given that explicit "acceptance criteria" (thresholds for success) are not stated in the document as typical for AI/ML performance metrics, we will present the key performance indicators reported and their values. The underlying "acceptance" is the FDA's determination of substantial equivalence based on these results.

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

• Clinical Performance Test Set Sample Size:
  • Healthy Donors: 142 individuals
  • Aspirin Monotherapy: 57 patients
  • Clopidogrel + ASA DAPT: 18 patients
  • Prasugrel + ASA DAPT: 15 patients
  • Ticagrelor + ASA DAPT: 14 patients
  • von Willebrand Disease: 25 patients (12 Type 1, 10 Type 2, 3 Type 3)
  • Glanzmann's Thrombasthenia: 3 patients
  • Total Clinical Subjects: 142 + 57 + 18 + 15 + 14 + 25 + 3 = 274 subjects across 6 investigational sites.
• Data Provenance: The study was conducted at 6 investigational sites. The document does not explicitly state the country of origin, but given it's an FDA submission, the primary data likely comes from the US. It is a prospective collection of data for the purpose of this clinical evaluation, as it refers to "subjects enrolled at ... investigational sites."

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

This is a diagnostic device for measuring a physiological parameter (platelet thrombus formation) based on direct blood sample analysis. The "ground truth" is established by the patient's diagnosed medical condition or medication use (e.g., "healthy donor," "patients taking antiplatelet therapy," "patients with von Willebrand disease," "patients with Glanzmann's thrombasthenia") and, in some cases, by other laboratory tests (e.g., PFA-100 results, vWF activity, FVIII:C levels to confirm vWD).

Therefore, the concept of "experts establishing ground truth" in the sense of image annotation or AI model output review by multiple radiologists is not directly applicable here. The "experts" are the physicians who diagnosed the patients and the laboratory personnel who performed confirmatory tests. The document does not specify the number or qualifications of these individuals directly, as their role is standard medical practice for diagnosis.

4. Adjudication Method for the Test Set

Not applicable in the context of this diagnostic device study. Ground truth is based on clinical diagnosis and other objective laboratory parameters, not on interpretation requiring adjudication among human readers/experts.

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

Not applicable. This is not an AI-based device, nor does it involve human readers interacting with an AI system. It is an automated in vitro diagnostic test.

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

The T-TAS 01 System is a standalone automated diagnostic device. Its performance, as measured by AUC, is the "algorithm only" or "device only" performance. The results (AUC values) are automatically calculated by the instrument when the pressure reading reaches 60 kPa or after 10 minutes.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth was established by:

• Clinical Diagnosis: Patients with a history of conditions associated with impaired primary hemostatic function (e.g., Von Willebrand disease, Glanzmann's thrombasthenia) or those confirmed to be taking antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor).
• Absence of Diagnosis/Conditions: For the healthy control group, individuals without a history of inherited or acquired platelet dysfunction, and without laboratory evidence of von Willebrand disease.
• Confirmatory Laboratory Tests: For von Willebrand disease patients, comparison to PFA-100 Col/EPI and Col/ADP sensitivity, and reference to vWF activity and FVIII:C results.

8. The Sample Size for the Training Set

This document describes the validation of a lab diagnostic device, not an AI/ML model. Therefore, the concept of a "training set" for model development is not explicitly discussed. The device's underlying principles (measuring pressure changes due to platelet adhesion and aggregation) are based on established physiological and engineering principles, not on learned patterns from a training dataset in the AI sense.

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

Not applicable, as this is not an AI/ML device relying on a training set in the typical AI sense. The device is designed and validated based on known biological mechanisms and engineering specifications.

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