PATHFINDER by MASSIE RESEARCH LABORATORIES, INC.

This appears to be a 510(k) clearance letter from the FDA for a device named "Anterior Segment Analysis Device" (or later, "Pathfinder"). This type of document (a 510(k) clearance letter) does not typically contain the detailed technical study information like acceptance criteria, performance metrics, sample sizes, or ground truth establishment methods.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, not on proving clinical efficacy or detailing specific performance studies in the same way a PMA (Premarket Approval) would. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent.

Therefore,Based on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and the study that proves the device meets those criteria. The document is a regulatory clearance letter, not a technical study report.

Here's what I can infer from the document, and what I cannot:

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

Cannot provide. This information is not present in the 510(k) clearance letter. The letter states the device is substantially equivalent to a predicate, but doesn't detail performance metrics or acceptance criteria for that equivalence.

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

Cannot provide. This information is not present in the 510(k) clearance letter.

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):

Cannot provide. This information is not present in the 510(k) clearance letter. The letter mentions "ophthalmic imaging," implying ophthalmologists would be involved, but no specifics are given.

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

Cannot provide. This information is not present in the 510(k) clearance letter.

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:

Highly unlikely to be relevant or present. The device name "Anterior Segment Analysis Device" and "Pathfinder" suggests an imaging or analysis tool, but the provided text does not describe an AI component or a study on human reader improvement with AI assistance. It's a 2004 clearance, predating widespread clinical AI in many fields.
Cannot provide specifics. This information is not present in the 510(k) clearance letter.

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

Cannot provide. This information is not present in the 510(k) clearance letter.

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

Cannot provide. This information is not present in the 510(k) clearance letter.

8. The sample size for the training set:

Cannot provide. This information is not present in the 510(k) clearance letter.

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

Cannot provide. This information is not present in the 510(k) clearance letter.

In summary, the provided document is a formal FDA clearance letter, confirming regulatory approval based on substantial equivalence. It does not contain the detailed technical data or study methodology you are requesting. To find such information, you would typically need access to the full 510(k) submission document or a peer-reviewed publication about the device's development and testing.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

Massie Research Laboratories, Inc. c/o N.A. (Bert) Massie, Ph.D. 5775 W. Las Positas Blvd Suite 200 Pleasanton, CA 94588-4084

Re: K031788

Trade/Device Name: Anterior Segment Analysis Device Regulation Number: 21 CFR 886.1850 Regulatory Class: Class II Product Code: MXK Dated: July 31, 2004 Received: August 2, 2004

Dear Mr. Massie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Clerosury to regars actuent date of the Medical Device Amendments, or to commerce price to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, Books requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (800 a0070) als. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oucements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be devised that i Dr rivetion that your device complies with other requirements of the Act that I DA has made a acterialized administered by other Federal agencies. You must of any I edelin Statutes and regurements, including, but not limited to: registration and listing compry with and 100 recess requirements Part 801); good manufacturing practice requirements as set (21 CFR Part 807), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- N.A. (Bert) Massie, Ph.D.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. 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,

Alegi Rosenthal

A. Ralph Rosenthal, M.D. 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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K031788 510(k) Number :

Device Name:

Pathfinder or other to be determined

Indications for use:

For general ophthalmic imaging, visualization, and fluorescein angiography including anterior and posterior segments of the eye.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean L Keefe

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.