The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum.

Device Description

Olympus Prealbumin Calibrator

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called "Olympus Prealbumin Calibrator". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with diagnostic AI/imaging devices.

The device in question is a calibrator, which is a substance specifically designed to set or check the accuracy of an instrument. Its performance is typically assessed by ensuring it produces accurate and precise results when used with the associated assay and analyzer, rather than through studies involving human readers or ground truth established by experts interpreting medical images or pathology.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance with human-in-the-loop, training set details) are not applicable to this type of device and its regulatory submission.

However, I can extract the relevant information where available and note where other information is not present or applicable.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report device performance in a table format. A 510(k) submission for a calibrator would typically include performance data demonstrating accuracy, precision, and stability when used with the target assay. This data is usually compared against established benchmarks or the predicate device's performance, but this specific information is not detailed in the provided K letter or "Indications for Use Statement".

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

Not explicitly stated in the provided documents. For a calibrator, the "test set" would typically involve multiple runs/replicates on an analytical instrument, and the data provenance would relate to the laboratory conditions and samples used for validation.

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

Not applicable. For a calibrator, "ground truth" is typically established by reference methods or validated standards of known concentration, not by expert interpretation.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not relevant for a calibrator.

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. An MRMC study is relevant for AI-powered diagnostic tools that assist human readers in interpreting medical images or data. This device is a calibrator.

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

Not applicable. This device is a physical calibrator used with an analytical instrument, not an algorithm. Its performance is inherent in its chemical composition and stability.

7. The type of ground truth used:

Likely "Reference Standards" or "Known Concentrations". For a calibrator, the ground truth is established by precisely manufacturing the calibrator with a known concentration of the analyte (Prealbumin in this case), often verified against recognized reference materials or methods. The document does not explicitly state this, but it's standard for calibrators.

8. The sample size for the training set:

Not applicable. A calibrator does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, no training set for a calibrator device.

Summary regarding the device and its assessment:

The Olympus Prealbumin Calibrator is a Class II device (21 CFR 862.1150) intended to "provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum."

The 510(k) process determined it was "substantially equivalent" to legally marketed predicate devices, meaning it performs as safely and effectively as existing devices. This determination is based on a comparison of intended use, technology, and performance data (e.g., precision, accuracy, stability, interfering substances), which would have been submitted in the full 510(k) application but are not detailed in the provided letter or "Indications for Use" statement.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.

AUG 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Campbell Senior Manager, RA/QC Olympus 3131 West Royal Lane Irving, TX 75063-3104

K032285 Re:

Trade/Device Name: Olympus Prealbumin Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 24, 2003 Received: July 24, 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. Iisting 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 (OS) 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). 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.

Sincerely vours,

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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Olympus Prealbumin Calibrator 510(K) Premarket Notification

Indications for Use Statement

510(k) Number (if known):

Device Name:

Olympus Prealbumin Calibrator

Indications for Use:

Carol C Benson for Jean Cooper, DYI

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032285

(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)

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Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.