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.

Device Description

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.

AI/ML Overview

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

Performance Metric	Acceptance Criteria	Reported Device Performance
Reliable Detection of Platelet Function Reduction	Not specified in text	The TEG reliably detects a reduction in platelet function (aggregation) in the presence of anti-platelet drugs.
Correlation with Optical Aggregometry	Not specified in text	TEG measurements correlate well with the optical aggregometry method.
Specific Quantitative Metrics (e.g., Sensitivity, Specificity, Agreement, R-squared)	Not specified in text	Not specified in text

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.

Summary

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SEP = 1 2004

510(k) Summary

K041502

Submitter's Name / Contact Person

Haemoscope Corporation	Eli Cohen, Ph.D.
5693 West Howard Street	President and CEO
Niles IL 60714	Tel: (847) 588-0453 / (800) 438-2834

General Information

Device Trade Name	Thrombelastograph® (TEG®) Platelet Mapping™ Assay
Common / Usual Name	Platelet Aggregation Assay
Classification Name	Automated Platelet Aggregation System
Classification	This device has been classified by the Hematology and PathologyDevices Panel (81) into Class II (21 CFR 864.5700).

Device Description

Intended Use

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, tirofibin, or eptifibatide. For Professional Use Only.

Predicate Devices

The TEG Platelet Mapping Assay is substantially equivalent to the following devices:

Thrombelastograph® Coagulation Analyzer (TEG®) 5000 Series .
. Chrono-log Corp. Optical Aggregation Systems and Reagents

Summary of Studies

The TEG Platelet Mapping Assay was subjected to testing to verify the reliability of the assay and to demonstrate substantial equivalence. 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.

Conclusion

The data and information provided in this submission demonstrate substantial equivalence and support clearance of the 510(k) premarket notification for the TEG Platelet Mapping Assay.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Eli Cohen, Ph.D. President and CEO Haemoscope Corporation 5693 West Howard Street Niles Illinois 60714

SEP - 1 2004

Rc: K041502

Trade/Device Name: Thrombelastograph® (TEG®) Platelet Mapping™ Assay Regulation Number: 21 CFR § 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: II Product Code: JOZ Dated: June 4, 2004 Reccived: June 7, 2004

Dear Dr. Cohen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that I·DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sinccrely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D., Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K041502
Device Name:	Thrombelastograph ® (TEG ® ) Platelet Mapping TM Assay

Indications For Use:

The TEG® Platelet Mapping Assay is intended for use with Intended Use: 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.

Joachim Bautista
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041502

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.5700 Automated platelet aggregation system.

(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).