OCULAR CONFORMER by XAVIER A. GUERRA, OCULARIST, INC.

Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and t fitted post-enucleation/evisceration surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, as well as patients with trauma or other socket and eyelid anomalies. Proper expansion therapy, with the sential anomaries proper expansion chocariers, is essential in sequential, increasing Stac Controlmose), and eyelid development in infants and children.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ocular Conformer" device. This document primarily focuses on regulatory approval and does not contain information about a study that would establish acceptance criteria or demonstrate device performance as typically expected for medical device software or AI.

Therefore, I cannot extract the requested information points because they are not present in the provided text. The document is a clearance letter, not a study report.

Here's why each point cannot be addressed based on the provided text:

A table of acceptance criteria and the reported device performance: Not present. The letter states the device is "substantially equivalent" to a predicate device, which is a regulatory standard, not a performance metric for this type of detailed analysis.
Sample size used for the test set and the data provenance: Not present. There is no mention of a test set or data for a study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No test set or ground truth establishment is described.
Adjudication method: Not present. No study or adjudication process is detailed.
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 present. This device ("Ocular Conformer") is a physical medical device (an ocular prosthetic), not an AI or software device that would typically undergo such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

Summary

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Image /page/0/Picture/1 description: The image shows the 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 it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Xavier A. Guerra, Ocularist 4640 Centerview Drive ... . ..... San Antonio, TX 78228

Re: K970319 Trade Name: Ocular Conformer Regulatory Class: II Product Code: 86 HQN

Dated: April 15, 1997 Received: April 21, 1997

JUL - 7 1997

Dear Mr. Guerra:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Xavier A. Guerra, Ocularist

This letter will allow you to begin marketing your device as described in your 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (il known); K970 31 9

Ocvice Name: OCULAR CONFORMER

Indications I-or Usc:

(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)

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Over The-Counter Use __

(Optional Format 1-2-90)

Downe kachner
Miller & Zois

hthalmic Devices 970319

Regulation Number and Section

§ 886.3130 Ophthalmic conformer.

(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](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 § 886.9.