RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES by FCI OPHTHALMICS, INC.

I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a device called "Retinal Detachment Implants." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about:

Acceptance criteria for the device's performance.
A study that proves the device meets specific performance criteria.
Device performance data (e.g., sensitivity, specificity, accuracy).
Sample sizes for test or training sets.
Data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
MRMC comparative effectiveness studies or their effect sizes.
Standalone algorithm performance.
Type of ground truth used.
How ground truth for the training set was established.

The document is purely an administrative clearance letter, not a technical report detailing performance studies.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 1998

Ms. Anne Bohsack Vice President, General Manager FCI Ophthalmics, INC. P.O. Box 465 Marshfield Hills, MA 02051

K980816 Re: Trade Name: Retinal Detachment Implants Regulatory Class: II Product Code: 86 HQX Dated: July 31, 1998 Received: August 3, 1998

Dear Ms. Bohsack:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(ts) noticelly equivalent (for the indications for above and we have determined the ocvice is seed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been the enactment unte of the Medical Device 11.1.6 Easy of Food, Drug, and Cosmetic Act reclassified in accordance with the provisions on the general controls provisions of the (Act). You may, therefore, market the actives requirements for annual registration,
Act. The general controls provisions of the Act include requirements for annual mishanding Act. I he 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 (Premarket Approval), it may be subject to such additional controls. Existing major (I remarket reproval), it they be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Farls 600 to 0731 11 Jacouning Practice requirements, as set forth in the Quality System Current Good Hamanaceaning Frices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such periodio Q . Inspections 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 - Ms. Anne Bohsack

This letter will allow you to hegin 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. lorenttal

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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K980816 . 510(k) Number (if known): _ Retinal Detachment Implants - :: Device Name:

Indications For Use:

Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K980816

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
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(Optional Format 1-2-96)3

Regulation Number and Section

§ 886.3340 Extraocular orbital implant.

(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.