MEDPOR OCULAR CONFORMER by POREX SURGICAL, INC.

An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye. The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile

AI/ML Overview

The provided text is a 510(k) summary for the MEDPOR® Ocular Conformer. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in the way a clinical trial or algorithm validation study would.

Therefore, the requested information elements related to performance metrics, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable to this type of regulatory submission. The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of its characteristics.

Here's a breakdown based on the provided text:

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

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device. This means the device must be as safe and effective as a legally marketed device that does not require premarket approval.
Reported Device Performance: The document explicitly states: "The device of this submission is identical to the predicate device in all aspects except for minor dimensional changes." This statement itself serves as the "reported performance" against the acceptance criterion of substantial equivalence.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to predicate device (Wilson Ophthalmic Corp. Ophthalmic Conformer)	Device is identical to predicate in all aspects except for minor dimensional changes.

2. Sample sized used for the test set and the data provenance

Not Applicable. This submission does not involve a "test set" in the sense of a clinical or performance study where data is collected and analyzed against specific metrics. The substantial equivalence argument is based on the device's design, materials, and intended use.

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

Not Applicable. There was no "test set" or "ground truth" to be established by experts for performance evaluation in this context.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication was performed for device performance.

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. This is not an AI-powered device, and no MRMC study was conducted.

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

Not Applicable. This is not an algorithm, and no standalone performance study was conducted.

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

Not Applicable. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.

8. The sample size for the training set

Not Applicable. This is not a device that involves machine learning or a "training set."

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

Not Applicable. No training set or ground truth for it was established.

Summary

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K9712034

Image /page/0/Picture/1 description: The image shows the logo for Porex Surgical Inc. The logo consists of a square grid pattern with a circle in the center on the left side. To the right of the grid is the word "POREX" in large, bold letters, with the words "SURGICAL INC." in smaller letters underneath.

4715 Roosevelt Highway, College Park, GA 30349-2417 USA (404) 969-8145 · (800) 521-7321 · Fax: (404) 969-8045

JAN 20 1998

510(k) SUMMARY

Manufacturer and Submitter

Porex Surgical, Inc. 4715 Roosevelt Highway College Park, GA 30349

Tel: (770) 969-8145 Fax: (770) 969-8045

Contact: Howard Mercer, Ph.D.

Date: Mav 30. 1997

Trade Name: MEDPOR® Ocular Conformer Classification Name: Ophthalmic Conformer - Class II Device

Substantially equivalent to: A) Ophthalmic Conformer marketed by Wilson Ophthalmic Corp.

Device description:

The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile

Comparison with predicate device

The device of this submission is identical to the predicate device in all aspects except for minor dimensional changes

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. In the center of the logo is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Howard A. Mercer, Ph.D. c/o Porex Technologies 500 Bohannon Road Fairburn, GA 30213-2828

Re: K972034 Trade Name: Medpor Ocular Conformer Regulatory Class: II Product Code: 86 HQN Dated: November 7, 1997 Received: November 10, 1997

Dear Dr. Mercer: . . .

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. Howard Mercer

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 Roerl forenthal

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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510(k) Number : K972034

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Daine R. Lochner.
(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K972034

Prescription Use: X
(Per 21CFR801.109_

Over the Counter Use: ________________________________________________________________________________________________________________________________________________________

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.