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The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

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The provided text is a 510(k) premarket notification letter from the FDA. It does not contain the detailed acceptance criteria or the study information requested. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input.

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The TEG® Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.

The TEG Platelet Mapping Assay consists of a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function.

The provided text is a 510(k) summary for the Thrombelastograph® (TEG®) Platelet Mapping™ Assay. It describes the device's intended use and claims substantial equivalence to predicate devices based on a summary of studies. However, the document does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria. The "Summary of Studies" section is very high-level and lacks the quantitative data, sample sizes, and methodological details required to answer most of your questions.

Therefore, I cannot populate the table or provide detailed answers to many of your questions based solely on the provided text.

Here's an attempt to answer what is possible and highlight what's missing:

Acceptance Criteria and Device Performance Study

As per the provided text, specific quantitative acceptance criteria for the TEG® Platelet Mapping™ Assay are not explicitly stated. The "Summary of Studies" broadly indicates that "Test results demonstrate that the TEG reliably detects a reduction in platelet function (aggregation) in the presence of anti-platelet drugs, and that the TEG measurements correlate well with the optical aggregometry method." Without specific metrics (e.g., sensitivity, specificity, correlation coefficient thresholds), it is impossible to create a table of acceptance criteria and reported performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified in the provided text. The study design details are absent.

4. Adjudication method for the test set

• Not specified in the provided text.

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/Not specified. The device is a diagnostic assay, and the context does not suggest a multi-reader, multi-case study in the typical sense for image interpretation or similar AI-assisted diagnostic tasks. There is no mention of "human readers" or "AI assistance" in the description of the TEG Platelet Mapping Assay.

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

• The TEG® Platelet Mapping™ Assay is described as components (blood modifiers, agonists) used with the Thrombelastograph (TEG) Hemostasis Analyzer. The summary states that "the TEG reliably detects a reduction in platelet function." It implies an automated measurement by the device itself, rather than human interpretation. So, yes, the study primarily focused on the standalone performance of the assay and analyzer system. However, specific details of this standalone performance are not provided.

7. The type of ground truth used

• The text states the TEG measurements "correlate well with the optical aggregometry method." This suggests that optical aggregometry (a recognized method for assessing platelet function) was likely used as a comparator or a form of "ground truth" for validation. The "presence of anti-platelet drugs" also indicates a clinical context for evaluating reduced platelet function, implying either known drug administration or clinical outcomes as partial ground truth.

8. The sample size for the training set

• Not specified in the provided text. This device is described as an "assay" and a "system," not explicitly an AI/ML algorithm that undergoes discrete "training" and "test" phases in the modern sense. While internal development and calibration would involve data, it's not documented as a distinct "training set" in this summary.

9. How the ground truth for the training set was established

• Not specified in the provided text.

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The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series is a noninvasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulations are commonly used to assess clinical conditions such as post-operative hemorrhage and / or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.

The TEG - 5000 Series Analyzer consists of a two-column TEG instrument, a computer interface module, software, and disposable sample cups and pins. The TEG measures the clot's physical property by the use of a special stationary cylindrical cup that holds the blood and is oscillated. A pin is suspended in the blood by a torsion wire and is monitored for motion. The torque of the rotation cup is transmitted to the immersed pin only after fibrin-platelet bonding has linked the cup and pin together. The strength of these fibrin-platelet bonds affects the magnitude of the pin motion, such that strong clots move the pin directly in phase with the cup motion. The magnitude of the output is, therefore, directly related to the strength of the formed clot. As the clot retracts or breaks apart, these bonds are broken and the transfer of cup motion is diminished.

The provided text describes the Thrombelastograph Coagulation Analyzer TEG - 5000 Series and its substantial equivalence to a predicate device (TEG - 3000S Analyzer). However, it does not contain detailed acceptance criteria or a specific study that quantifies the device's performance against such criteria in a granular manner.

The submission focuses on establishing substantial equivalence based on:

• Same intended use, principles of operation, and function.
• Minor technological differences (improved functional fibrinogen level determination, improved sample cup system, improved software menu) that do not raise new questions of safety or effectiveness.
• Comparative performance testing and software validation testing to demonstrate the device "meets established design specifications and performance requirements" and "performs as well as the predicate device."

Without specific numerical acceptance criteria and a detailed study explicitly laying out performance metrics against those criteria, it's not possible to fully complete the requested table and sections. However, based on the provided text, here's what can be inferred or stated about the study and criteria if we interpret "acceptance criteria" broadly as the demonstration of substantial equivalence and meeting design specifications:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Comparative performance testing and software validation testing was performed," but does not specify the sample size used for any test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth in the context of the performance testing. The "ground truth" for the device, being an in-vitro diagnostic, would likely be comparison against established laboratory methods or the performance of its predicate device, rather than expert consensus on patient conditions. Clinical assessments by qualified professionals are mentioned as being part of the overall patient diagnosis, in conjunction with TEG results, but not as part of establishing ground truth for the device's technical validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method as it does not detail a study involving multiple readers or complex diagnostic assessments requiring such a process.

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

No MRMC comparative effectiveness study was described or implied. This device is an in-vitro diagnostic instrument measuring coagulation parameters. The concept of "human readers improve with AI vs. without AI assistance" typically applies to image-based diagnostic AI, which is not the nature of this device.

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

The device itself is a standalone instrument that measures and reports coagulation parameters. Its performance testing would implicitly be "standalone" in the sense that it evaluates the instrument's ability to accurately measure these parameters. The text states it "provides a quantitative and qualitative indication" and "records kinetic changes." Therefore, a standalone performance evaluation would have been conducted to assess its accuracy and reliability in generating these readings. However, the details of this evaluation (e.g., specific metrics like accuracy, precision, linearity) are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device (Thrombelastograph), the "ground truth" for its performance testing would most likely involve comparison to established reference methods or the predicate device's measurements for various coagulation parameters using control samples, spiked samples, or clinical samples. It would not typically involve expert consensus, pathology, or direct outcomes data as the primary ground truth for the device's analytical performance. The document explicitly states that TEG results should be considered along with "other coagulation laboratory tests" and "clinical assessment," implying these other tests or assessments form a broader context for ground truth, but not for the device's intrinsic analytical performance validation in this submission.

8. The sample size for the training set

This device appears to be primarily an analytical measurement tool rather than an AI/machine learning algorithm that requires a separate "training set." While it has "software," the primary function described is physical measurement and reporting, not complex pattern recognition learned from data. Therefore, the concept of a "training set" in the context of machine learning does not seem applicable here, and no information about a training set is provided. The "software validation testing" would focus on ensuring the software correctly processes the physical measurements and reports them accurately according to its design specifications.

9. How the ground truth for the training set was established

As explained above, a "training set" as commonly understood in AI/ML is not applicable to this device based on the information provided. Therefore, this question is not relevant to the described device. If the software does contain algorithms that were "trained" in some way, the document does not elaborate on this or how any ground truth for such training would have been established.

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