The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

AI/ML Overview

The provided text is a 510(k) summary for the MicroVision, Inc. Fiber Optic Endoillumination Probe. It does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a clinical or performance study with defined metrics. Instead, this document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested elements for a study that "proves the device meets acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a report of such a study.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't define quantitative acceptance criteria for performance; instead, it establishes equivalence based on descriptive characteristics.

Comparison Criteria	Acceptance Criteria (Implicit for Equivalence)	Reported Device Performance (MicroVision Fiber Optic Endoillumination Probe)
Device Type: Fiber Optic Probe	Must be a Fiber Optic Probe	Yes
Indication: Intraocular illumination in vitreoretinal surgery	Must be indicated for intraocular illumination in vitreoretinal surgery	Yes
Patient Contact Materials	Must use PMMA, fluoropolymer fiber, and medical grade Surgical stainless steel	Yes (PMMA and fluoropolymer fiber and medical grade Surgical stainless steel)
Sterilization Method	Must have a validated sterilization method	Validated ETO
Packaging	Must have validated packaging	Validated Heat Sealed Tyvek

Study Details (Not Applicable/Cannot be Extracted from a 510(k) Summary for Substantial Equivalence):

The 510(k) summary is a premarket notification to demonstrate substantial equivalence, not a detailed report of a performance study with specific acceptance criteria in the sense of clinical trial outcomes or detailed engineering specifications. It relies on comparing descriptive and technological characteristics to a legally marketed predicate device.

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

Not applicable. This document describes the device itself and its comparison to a predicate, not a performance study on a test set. There is no mention of a "test set" of patients or data.

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)

Not applicable. Ground truth establishment for a test set is not relevant to a 510(k) substantial equivalence submission for this type of device. The "ground truth" here is essentially the characteristics of the predicate device.

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

Not applicable. No test set or adjudication process is described.

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 device is a fiber optic endoillumination probe, a physical medical device for illumination during surgery, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical surgical tool, not an algorithm.

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

For the purpose of substantial equivalence: The "ground truth" is the established characteristics and performance of the predicate device (Infinitech, Inc. Fiber Optic Probe, K870942). The claim is that the new device is functionally identical or very similar.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

Not applicable. No training set is involved.

Summary

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SEP 1 4 1998

510(k) Summary Fiber Optic Endoillumination Probe (per 21 CFR 807.92)

K982462

SUBMITTER NAME AND ADDRESS 1.

MicroVision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, NH 03874-1651

Leonard Kastrilevich, President Contact Person: Telephone: 603-474-5566 ← -

Date Prepared: July 13, 1998

2. DEVICE NAME

Fiber Probe Trade Name: Fiber Optic Endoillumination Probe Proprietary Name: Light, Surgical, Fiberoptic Classification name:

3. PREDICATE DEVICE

Infinitech, Inc. Fiber Optic Probe (K870942)

4. DEVICE DESCRIPTION

5. INTENDED USE

The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

Operational and technological characteristics form the basis for the determination of substantial equivalence of the Fiber Optic Endoillumination Probe with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics.

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COMPARISON TABLE

Comparison Criteria	MicroVision, Inc.Fiber OpticEndoillumination Probe	Infinitech, Inc.Fiber OpticProbe
Device Type: Fiber OpticProbe	Yes	Yes
Indication: Intraocularillumination in vitreoretinalsurgery	Yes	Yes
Patient Contact Materials:PMMA and fluoropolymerfiber and medical gradeSurgical stainless steel	Yes	Yes
Sterilitzation Method	Validated ETO	Not Known
Packaging	Validated Heat SealedTyvek	Not Known

September 19.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1998

Mr. Leonard Kastrilevich President Microvision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, New Hampshire 03874-1651

Re: K982462

Trade Name: Fiber Optic Endoillumination Probe Regulatory Class: II Product Code: FFS Dated: July 13, 1998 Received: July 15, 1998

Dear Mr. Kastrilevich:

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 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). 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

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Page 2 - Mr. Leonard Kastrilevich

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) 594-4595. 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/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Fiber Optic Endoillumination Probe

Indication For Use:

ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

(Per 21 CFR 801.109)

Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

(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 General Restorative Devices
510(k) Number 14982462

Prescription Use X OR

Over-The-Counter Use

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.