(85 days)
The Olympus Lyophilized Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Olympus America, Inc. regarding a device called "Olympus Lyophilized Calibrator." This document primarily deals with the regulatory approval of a calibrator (a lab reagent used to ensure the accuracy of other tests) rather than a diagnostic device that performs analysis or interpretation of medical images or data.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for device performance in the context of a typical AI/medical imaging device is not applicable to this document.
The document states: "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."
This means the device's acceptance was based on showing substantial equivalence to existing predicate devices, not on a detailed clinical performance study against specific acceptance criteria in the way a diagnostic AI algorithm would be evaluated.
To directly address the user's request with respect to this document:
- A table of acceptance criteria and the reported device performance: Not applicable. The document does not contain this information for a diagnostic AI device. The acceptance was based on substantial equivalence to a predicate device for its intended use as a calibrator.
- Sample sized used for the test set and the data provenance: Not applicable. This information is not provided as it's not a diagnostic AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant here.
- Adjudication method: Not applicable.
- 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 is not a diagnostic AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a calibrator, not a standalone diagnostic algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic performance. For a calibrator, "ground truth" would relate to its known, accurate concentration values used to calibrate other assays.
- The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text does not contain the type of information requested, as it pertains to the regulatory approval of a laboratory calibrator, not a diagnostic AI device.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white 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 image of three human profiles facing to the right, with flowing lines beneath them that resemble water or fabric.
NOV 2 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Campbell Senior Manager, RA/QA Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104
Re: K032665
Trade/Device Name: Olympus Lyophilized Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 27, 2003 Received: August 28, 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).
{1}------------------------------------------------
Page 2 -
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 yours,
Steven Putman
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
{2}------------------------------------------------
103266 Indications for Use Statement
510(k) Number (if known):
03265
Olympus Lyophilized Calibrator
Indications for Use:
Device Name:
The Olympus Lyophilized Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.
Carol Benson (B Jean Cooper, DVM
Division Sign-Off
Division sign on
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032665
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use OR (Optional Format 1-2-96) (per 21 CFR 801.109)
PAGE NUMBER 64
§ 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.