CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ by HAI LABORATORIES, INC.

The provided text is a 510(k) substantial equivalence letter and associated indications for use for the HAI Clinical Specular Microscope, Model HAI CL-1000xyz.

Unfortunately, this document does not contain the detailed information required to answer your request about acceptance criteria and the specific study proving the device meets those criteria.

Here's why and what's missing:

Nature of the document: A 510(k) clearance letter primarily states that a new device is substantially equivalent to a legally marketed predicate device. It signifies that the FDA has determined the device is as safe and effective as a previously cleared device. It generally does not include the detailed performance study data, acceptance criteria, or statistical analyses that would be found in a full submission.
Approval Date: The letter is dated April 26, 2004, which is before the widespread use and regulatory guidelines for AI/ML-driven devices. Specular microscopes primarily rely on optical principles, not AI, for their core function.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method for the test set: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. It's highly unlikely for this type of device from 2004.
If a standalone study was done: Not present in this document.
The type of ground truth used: Not present.
The sample size for the training set: Not present (and not applicable for a non-AI/ML device).
How the ground truth for the training set was established: Not present (and not applicable).

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2004

HAI Laboratories. Inc. c/o Mr. Richard C. Lanzillotto 30 Northpoint Road South Beach, NY 117891

Re: K994340

Trade/Device Name: Clinical Specular Microscope, Model HAI CL-1000xyz Regulation Number: CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NQE Dated: September 20, 2000 Received: December 23, 1999

Dear Mr. Lanzillotto:

This letter updates our substantially equivalent letter of September 20, 2000 regarding the product code and classification regulation of your device. Specular microscopes are now regulated under §886.1850 (AC-powered slitlamp biomicroscope) and are listed under a new product code (NQE). This letter is for informational purposes. No further action is required on your part at this time.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Mr. Richard C. Lanzillotto

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Alard M. Wiggle
J. A. Ralph Rosenthal, M.D.

A. Ralph Rosenthal. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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HAI Laboratories, Inc. HAI CL-1000xyz

Abbreviated 510K 12/21/99

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Clinical Specular Microscope Model HAI CL-1000xyz

Indications for Use:

The Clinical Specular Microscope Model HAI CL-1000xyz is intended to be used to examine the cornea of the eye.

Contraindications: Warnings and Precautions

CAUTION "Federal Law restricts this device to sale by or on the order of a physician or practitioner"

Also, see attached.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Dennis L. McCarthy
(Division Sign-Off)

Division of Ophthalmic 510(k) Number

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.