The intended use of this device is to provide illumination to the tip of the phacoemulsification tip cap sleeve to aid in the safe removal of the cataract lens. The illumination that is provided at the tip of the sleeve will provide enhanced visualization within the eve, so the powerful overhead surgical lights that are currently used can have decreased light levels during surgery. The Phaco Illuminator tip cap has the same intended use as many competitive Phaco tip caps already in commercial distribution.

Infusion Sleeve for Cataract Surgery Handpieces which also provides illumination.

Device Description

This device is a modification of the silicone sleeve in current use. The modification consists of a silicone sleeve that does not contain opaque additives or tints. This clear sleeve allows for transmission of light to the surgical site when coupled to a fiber optic light pipe. The fiber optic light pipe attaches to the side of a phacofraqmentation handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the Welch Allyn Phaco Illuminator, a surgical illuminating infusion sleeve. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way modern AI/medical device submissions typically do.

Therefore, many of the requested categories for a rigorous AI/device study are not applicable or cannot be extracted from this document. This submission pre-dates the common methodologies for evaluating AI performance in healthcare.

Here's an attempt to answer the questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the document:

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

The document does not explicitly define acceptance criteria as quantitative thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Michael Reynard, M.D.'s Accessory Illuminating Infusion Sleeve, 510(k) #K964018) and adherence to general safety standards. The "performance" is described in terms of improved illumination and visualization, but without quantifiable measures.

Criterion Type	Specific Criterion / Aspect Evaluated	Reported Device Performance / Comparison to Predicate
Intended Use	Provide illumination at surgical site of intraocular structures	Same as predicate device. "The Phaco Illuminator tip cap has the same intended use as many competitive Phaco tip caps already in commercial distribution."
FDA Class	Class II medical device	Same as predicate device (Class II).
Infusion Sleeve Material	Silicone	Same as predicate device (Silicone). Materials are identical to predicate device materials with a history of contact bio-compatibility.
Illumination Source	Light source through fiber optics	Welch Allyn #46100 Xenon Light Source through fiber optics (predicate used unspecified light source through fiber optics). "Effectiveness... improved by the source of illumination being at the tip... This results in improved illumination and visualization during the phacoemulsification procedure for the physician."
Sterility	Conventional methods including autoclave	Disposable - one time use (Predicate was autoclavable). This represents a difference, but is assessed as safe and acceptable.
Design	Silicone sleeve illuminated by external light source	Same as predicate device.
Where Used	Hospital, Surgical Center	Same as predicate device.
Safety Factors	Established over many years and widely used method of cataract surgery	Same as predicate device. "The device offers a potentially lower risk of light dibtribution [exposure] as it minimizes the need for high powered overhead surgical lights." Specific safety areas considered: Toxicity (bio-compatible materials), Electrical (agency approvals for light source), Light Output (consistent with previous safe use, reference ACGIH and Endoscopic Illumination), Corrosion (non-corrosive), Explosion (highly unlikely), Surface Temperature (evaluated), Mechanical/Sharp Edges (blended and rounded, shape established as safe), Safety/Risk Analysis (performed, risks reduced to acceptable level).

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

Sample Size: Not Applicable. This submission does not involve a "test set" in the context of an algorithm or diagnostic device evaluation common today. It's a review of a physical medical device.
Data Provenance: Not Applicable.

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)

Number of Experts: Not Applicable.
Qualifications of Experts: Not Applicable.

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

Adjudication Method: Not Applicable.

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

MRMC Study: No, this was not done. The device is a direct illumination tool, not an AI-powered diagnostic or assistive tool for human readers.
Effect Size: Not Applicable.

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

Standalone Performance: Not Applicable. This is a physical surgical device, not an algorithm.

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

Type of Ground Truth: Not Applicable in the sense of a diagnostic or AI study. The "ground truth" for this submission is historical data and established safety standards for similar devices and materials (e.g., bio-compatibility of silicone, electrical safety standards for light sources, historical safe use of phacoemulsification techniques). The "effectiveness" is based on the physical principle of localized illumination and an assertion of improved visualization.

8. The sample size for the training set

Sample Size: Not Applicable.

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

Ground Truth for Training Set: Not Applicable.

Summary

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971750

"510(k) SUMMARY" Summary of Safety and Effectiveness

JUN 30 1997 Welch Allyn Inc. Submitter's Name & Address: 4341 State Street Road P.O. Box 220 Skaneateles Falls, N.Y. 13153-0220

Colin Wolff Contact Person & Telephone: (315) 685-2525

Date Summary Prepared: May 2, 1997

Device Name: Classification Name - Surgical Lamp Common/Usual Name - Illuminating Infusion Sleeve Proprietary Name - Welch Allyn Phaco Illuminator

Predicate Device: Accessory Illuminating Infusion Sleeve by Michael Reynard, M.D. (ref. 510 (k) #K964018)

Device Description, Intended Use & Effectiveness:

The effectiveness of the device is improved by the source of illumination being at the tip of the instrument rather than only from an outside source. This results in improved illumination and visualization during the phacoemulsification procedure for the physician.

Technological Characteristics:

See attachment "A" for a comparison of the Phaco Illuminator to the predicate device.

Safety:

Numerous safety areas are being investigated and reviewed to ensure

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2002

that the Welch Allyn model #16000 Phaco Illuminator is as safe, or chat than existing similar devices already in commercial sirer than on-oting device offers a potentially lower risk of light dibtribution. There as it minimizes the need for high powered experience to the of the specific safety areas considered are as follows:

The infusion sleeve is manufactured of materials that Toxicity are identical to predicate device materials. They have a history of contact bio-compatibility. This has been established over many years as a widely used method of cataract surgery.
The #46100 Light Source currently has agency approvals Electrical as a surgical light source based on standards from UL 2601-1, CSA C22.2 No. 601.1-M90, and IEC 601-1, 601-1-2, CE, IEC 801-2,3,4,5, EN55011, AS3200.
Light output levels will be consistent with Light l Output previous safe use journal publications reflecting similar devices in the field. Reference Stds. ACGIH and Endoscopic Illumination.
Device is non-corrosive. Corrosion -
Highly unlikely; manufactured of non-explosive Explosion materials. The lamp is securely contained within the housing.
All surfaces will be evaluated for patient and Surface l Temperature practitioner contact.
Mechanical - All contact surfaces have been blended and The shape of the Illuminating Infusion (Sharp Edges) rounded. Sleeve has been established over many years as a widely used and safe configuration for cataract surgery.
Safety/Risk -A safety and risk analysis will also be performed, ensuring all risks will be reduced to an acceptable level.

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Attachment: "A"

Chart of Predicate Device Comparison

Similarities of the Welch Allyn model #16000 Phaco Illuminator to the Predicate Device Dr. Reynard Phacoilluminator (ref. 510(k) #K964018):

TechnicalSpecifications	Dr.ReynardPhacoilluminator	W.A. #16000Phaco Illuminator
Intended use:	Provideillumination atsurgical site ofintraocularstructures	Same
FDA Class:	II	II
Infusion SleeveMaterial	Silicone	Same
Illumination:	Light sourcethrough fiberoptics	Welch Allyn #46100Xenon Light Sourcethrough fiberoptics
Sterility:	Conventionalmethods includingautoclave	Disposable - onetime use
Design:	Silicone sleeveilluminated byexternal lightsource	Same
Where used:	Hospital, SurgicalCenter	Same
Safety Factors:	Established overmany years andwidely used methodof cataract surgery	Same

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 30 1997

Mr. Colin Wolff Quality Engineer Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0187

Re: K971750 Trade Name: Welch Allyn #6000 Phaco Illuminator Regulatory Class: II Product Code: 86 HQC Dated: May 2, 1997 Received: May 12, 1997

Dear Mr. Wolff:

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 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. Colin Wolff

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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INDICATIONS STATEMENT

Page 1 of ਜ

★971750 510(k) Number (if known):

Phaco Illuminator . -Device Name: -

Indications For Use:

Infusion Sleeve for Cataract Surgery Handpieces which also provides illumination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qaryl Kautme

(Division Sign-Off) Division of Ophthalmic Devices K971750 510(k) Number _

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.