The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.

The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.

The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

AI/ML Overview

The provided 510(k) summary for the iScience Surgical Fiberoptic Illuminator (K062259) does not contain the level of detail typically found in a clinical study for medical device clearance. This submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and a limited in-vitro test rather than a full clinical study with acceptance criteria and statistical analysis of performance.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in the text. I will extract the information that is available and note when details are missing.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" as applied to a quantitative performance metric is not explicitly stated in the document. The study's conclusion is qualitative, focused on the sufficiency of illumination.

Acceptance Criteria (Implicit)	Reported Device Performance
Sufficient illumination for advancing microcannula into intraocular structures in enucleated cadaver eyes.	"Both illumination sources provided sufficient illumination at the tip of the iScience Surgical iTrack Ophthalmic Microcannula to advance it into intraocular structures."

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The study states "enucleated cadaver eyes," implying more than one, but no specific number is given.
- Data Provenance: Retrospective (cadaveric eyes), country of origin not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The statement "demonstrated equivalent results" implies an assessment was made, but the number or qualifications of individuals performing this assessment are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, an MRMC comparative effectiveness study was not done. This study is an in-vitro comparison of two illumination devices, not an AI-assisted diagnostic device study. The concept of "human readers improve with AI" is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. The study was an in-vitro comparison of two illumination devices, one of which (the subject device) uses a different light source technology than its predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the qualitative assessment of "sufficient illumination" for the task of advancing the microcannula into intraocular structures. This would likely be assessed by an expert (e.g., an ophthalmic surgeon), but this is not explicitly stated.
The sample size for the training set:
- Not applicable. This is an in-vitro operational test, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable. This is an in-vitro operational test, not a machine learning model.

Summary

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510(k) Summary K062259

K973229

510(k) Summary

Submitter's Name:	iScience Surgical Corporation
Submitter's Address:	4055 Campbell Avenue, Menlo Park, CA 94025
Submitter's Telephone:	Phone (650) 421-2700
Contact Name:	Grace Bartoo
Date Summary was Prepared:	May 3, 2006
Trade or Proprietary Name:	iScience Surgical Fiberoptic Illuminator
Common or Usual Name:	Fiberoptic Illuminator (FI)
Classification Name:	Endoilluminator
Predicate Devices:	Device Name 510(k) Number Synergetics Synerlight Fiberoptic K964005

HEXON Illumination System

Description of the Device and Summary of the Technological Characteristics:

Illuminator

Substantial Equivalence:

The product's technical features are substantially equivalent to the Synergetics Synerlight Fiberoptic Lightsource (K964005) marketed by Synergetics, Inc., and the HEXON lllumination System (K973229) marketed by Dutch Ophthalmic Research Center. Like the iScience Surgical Fiberoptic Illuminator, these predicate devices also are indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator is designed to be used exclusively with the iScience Surgical iTrack Ophthalmic Microcannula. The iScience Surgical Fl differs from the predicate devices by utilizing a laser diode as the light source as compred to a metal halide light source. The use of a laser diode illumination source eliminates the need for filtering out potentially harmful wavelengths and lowers the power requirements of the device. The maximum output power of the device is 200 µW, significantly less than either the Synerlight or HEXON Illumination Systems. Additionally the iScience Surgical FI is battery powered compared to AC powered.

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In-vitro testing of the iScience Surgical Fl and the HEXON Illuminator, both used with the iScience Surgical iTrack Ophthalmic Microcannula in enucleated cadaver eyes, demonstrated equivalent results. Both illumination sources provided sufficient illumination at the tip of the iScience Surgical iTrack Ophthalmic Microcannula to advance it into intraocular structures.

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Image /page/2/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 the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

iScience Surgical c/o Neil E. Devine Jr. Intertek Testing Services 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K062259

Trade/Device Name: iScience Surgical Fiberoptic Illuminator Regulation Number: 21 CFR 876.1500 Regulation Name: Fiberoptic Illuminator Regulatory Class: II Product Code: MPA Dated: August 3, 2006 Received: August 4, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Neil E. Devine Jr.

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, percents 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 (240) 276-0115. Also, please note the regulation only) fed "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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

M.B. Egelnisi MD

Malvina B. Eydelman, 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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Indications for Use

510(k) Number (if known): Device Name: iScience Surgical Fiberoptic Illuminator

Indications for Use:

The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

ffice of Device Evaluation (ODE)

O'Terin L. McCarthy
Division Sign Off

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

510(k) Number K062259

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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.