IMMULITE® Troponin I is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

Device Description

IMMULITE® Turbo Troponin I is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. Turbo Troponin I is a solid-phase, two-site chemiluminescent enzyme IMMULITE® IMMODETTE Thiroo - Hopenin 1- 15-a USMULITF Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma.

AI/ML Overview

The provided text is a 510(k) summary for the IMMULITE® Turbo Troponin I device, which is an in vitro diagnostic assay. It primarily focuses on regulatory approval and substantial equivalence to a predicate device.

Unfortunately, the provided document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies. Specifically, it lacks:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, and details on ground truth establishment (number of experts, qualifications, adjudication).
Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Sample size and ground truth establishment for the training set.

The document states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration (FDA) used to find DPC substantial equivalence for IMMULITE® Turbo Troponin I." However, this summary itself does not present that data, but rather attests to its submission to the FDA.

Therefore,Based on the provided document, here's what can be extracted:

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

This information is not provided in the given 510(k) summary. The document states that data was presented to the FDA to establish substantial equivalence, but the specifics of that data, including performance metrics against acceptance criteria, are not detailed in this summary.

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

This information is not provided in the given 510(k) summary.

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):

This information is not provided in the given 510(k) summary. Given that this is an in vitro diagnostic device for quantitative measurement of Troponin I, the "ground truth" would typically come from clinical diagnosis (e.g., diagnosis of Acute Myocardial Infarction by clinicians) and potentially other established diagnostic methods, rather than expert interpretation of images/signals by a specific number of experts in the way that an AI for imaging would. However, the details of how this was established are absent.

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

This information is not provided in the given 510(k) summary.

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:

This information is not applicable/not provided. This device is an automated immunoassay analyzer for quantitative measurement of a biomarker (Troponin I), not an AI-assisted diagnostic imaging device requiring human "readers" in the context of MRMC studies.

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

The device described is an "Automated Immunoassay Analyzer" that performs "quantitative measurement of troponin I". This implies a fully automated, standalone performance of the analytical measurement. However, the performance metrics of this standalone operation are not detailed in the summary. The intended use specifies it is "an aid in the diagnosis of acute myocardial infarction (AMI)," meaning the result requires interpretation by a clinician, but the measurement itself is automated.

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

The device is intended as "an aid in the diagnosis of acute myocardial infarction (AMI)." Therefore, the "ground truth" for evaluating its effectiveness would likely be based on:
* Clinical diagnosis of AMI: Established by a combination of clinical symptoms, ECG changes, and other cardiac biomarker levels (e.g., CK-MB, Myoglobin, serial Troponin measurements if a reference method was used).
* Outcomes data: Although typically not the primary "ground truth" for an acute diagnostic, long-term patient outcomes linked to a confirmed AMI diagnosis would be relevant.

The specific method for establishing this ground truth in the study is not described in the summary.

8. The sample size for the training set:

This information is not provided in the given 510(k) summary. For an immunoassay device, the concept of a "training set" in the context of machine learning (as often implied by this question in AI/ML performance studies) is usually not directly applicable. Instead, there would be studies for assay development, optimization, calibration, and validation, which involve significant sample testing. The details of these are not here.

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

This information is not provided in the given 510(k) summary.

Summary

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g 1999 JUN

510(k) Summary Safety and Effectiveness

K991795

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name:	Diagnostic Products Corporation
Address:	5700 West 96th StreetLos Angeles, California 90045-5597
Telephone Number:	(310) 645-8200
Facsimile Number:	(310) 645-9999
Contact Person:	Edward M. Levine, Ph.D.Director of Clinical Affairs
Date of Preparation:	May 25, 1999
Device Name:
Trade:	IMMULITE® Turbo Troponin I
Catalog Number:	LSKTI1 (100 tests), LSKTI5 (500 tests)
Common:	Reagent system for the determination of troponin I inserum, heparinized, or EDTA plasma.
Classification:	Class II device, 75-MMI (21CFR 862.1215)
Manufacturer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597
Sole U.S. Importer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597
Establishment RegistrationNumber	DPC's Registration Number is 2017183
Description of Device:	IMMULITE® Turbo Troponin I is a clinical device for usewith the IMMULITE® Automated Immunoassay Analyzer.

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Intended Use of the Device:

Turbo Troponin I is a solid-phase, two-site chemiluminescent enzyme IMMULITE® IMMODETTE Thiroo - Hopenin 1- 15-a USMULITF Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).

Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug I he until prosence in this sating DPC substantial equivalence for IMMULITE® Turbo Troponin I.

Edinco Lecca

Edward M. Levine, Ph.D. Director of Clinical Affairs

5/24/99

Date

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ਹੈ ।ਰਿਹੇਰੇ JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

K991795 Re: Trade Name: Immulite Turbo Troponin I Regulatory Class: II Product Code: MMI Dated: May 25, 1999 Received: May 26, 1999

Dear Dr. Levine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".

Sincerely vours,

Steven Putman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: IMMULITE® Turbo

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescripti (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.