In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers. Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.

Device Description

Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant)

AI/ML Overview

This looks like a 510(k) summary for an Olympus HbA1c Reagent Test System. Unfortunately, the provided text does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The document is a letter from the FDA confirming clearance of the device due to substantial equivalence to a predicate device. It states the device name, regulation number, and indications for use. It does not include the actual study data or the specific acceptance criteria used for clearance.

To answer your questions, I would need to see the full 510(k) submission, specifically the sections detailing the performance studies.

Therefore, for your current input, I can only provide the following:

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

Not provided in the given text. This information would typically be in a separate section of the 510(k) submission, detailing analytical and clinical performance studies.

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

Not provided in the given text.

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):

Not applicable/provided in the given text. For an in vitro diagnostic (IVD) like an HbA1c test, "ground truth" is typically established by reference methods or validated laboratory assays, not by expert interpretation in the same way as imaging studies. No information on experts is present.

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

Not applicable/provided in the given text. Adjudication methods like 2+1 are common in imaging studies where human interpretation is involved. For a quantitative IVD, the "truth" is usually a numerical value from a reference method.

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 device is an in vitro diagnostic reagent system, not an AI-assisted diagnostic tool that aids human readers in interpreting images or other complex data. MRMC studies are not relevant for this type of device.

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

Not applicable. This is an automated reagent-based test system, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human interpretive input beyond sample handling and instrument operation. The concept of "human-in-the-loop" as it applies to AI/CAD devices is not relevant here.

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

Not provided in the given text. For an HbA1c test, the ground truth would typically be established by a recognized reference method for HbA1c (e.g., NGSP-certified methods).

8. The sample size for the training set:

Not applicable/provided in the given text. This is a reagent test system, not a machine learning algorithm that requires a "training set" in the conventional AI sense. Calibration and validation are part of its development, but not "training" like an AI model.

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

Not applicable/provided in the given text. (See point 8).

Summary

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Image /page/0/Picture/1 description: The image shows a circular seal or logo. The text around the top half of the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized graphic that resembles a bird in flight or a person reaching upwards. The image is in black and white and appears to be a scan or photocopy.

Public Health Service

NOV 1 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Campbell Senior Manager, Regulatory Affairs/Quality Assurance Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104

K031380 Re:

Trade/Device Name: Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assays Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: August 4, 2003 Received: September 9, 2003

Dear Mr. Campbell:

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 FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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).

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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.

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). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Ko31380 510(k) Number (if known):

Device Name:

Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant)

Indications for Use:

In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers.

Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.

(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)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031380### PAGE NUMBER 97

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).