The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

Device Description

The Medical Light Source was specifically designed for medical applications. Therefore, the highest safety requirements for the patient as well as for the physician are applied. The Light Source combines highest illumination requirements with high-resolution video capabilities through an integrated highresolution ¼", ½" or 1/3" CCD camera board.

AI/ML Overview

This document does not contain information about specific acceptance criteria or an analytical study with performance metrics for the Acueity Medical Light Source beyond general claims of safety and effectiveness.

Based on the provided text, the device's approval relied on demonstrating substantial equivalence to a predicate device (Welch Allyn Illumination Platform K951647) rather than meeting predefined numerical performance targets in a study specific to this submission.

Here's a breakdown of why the requested information cannot be extracted and what the document does state:

Missing Information:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not detailed performance metrics against specific criteria.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set with ground truth.
4. Adjudication method for the test set: 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: Not applicable. This device is a light source and video system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding acceptance criteria and study:

The document states:

Substantial Equivalence: "The Acuiety Light Source and Video Camera System is substantially equivalent to the Welch Allyn Illumination Platform (K951647). The Medical Light Source is substantially equivalent to the predicate device in intended use, technological characteristics, materials, manufacturing processes, and components."
General Testing: "All necessary testing was performed on the Medical Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the device does not raise new questions of safety and effectiveness."

Conclusion:

The provided 510(k) summary is for a medical light source and video camera system, not an AI-powered diagnostic device. Its approval hinges on demonstrating substantial equivalence to a previously cleared predicate device, rather than through a study with specific, numerically defined acceptance criteria for performance as would be expected for a novel AI or diagnostic tool. The document confirms that "all necessary testing was performed" to support this claim of substantial equivalence and to ensure safety and effectiveness, but it does not specify what those "necessary testing" protocols entailed or provide quantitative results for them.

Summary

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SEP = 5 2003 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

A. Name, Address, Phone and Fax number of the Applicant

Acueity, Inc. 100 Hamilton Avenue, Suite 140 Palo Alto. CA 93401

(650) 473-9910 Telephone: Fax: (650) 473-9306

B. Contact Person

Nancy Lincé Requlatory Affairs Consultant Telephone: (650) 759-6186

C. Date Prepared

July 15, 2003

D. Device Name

Trade Name: Medical Light Source Classification Name: Endoscopic Accessories

ய் Device Description

F. Intended Use

The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device

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Acueity, Inc.

is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

Substantial Equivalence G.

The Acuiety Light Source and Video Camera System is substantially equivalent to the Welch Allyn Illumination Platform (K951647). The Medical Light Source is substantially equivalent to the predicate device in intended use, technological characteristics, materials, manufacturing processes, and components.

H. Device Testing Results and Conclusion

All necessary testing was performed on the Medical Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the device does not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2003

Acueity, Inc. c/o Ms. Michelle Weidman KEMA Medical 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K032430

Trade/Device Name: Medical Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCW Dated: August 21, 2003 Received: August 22, 2003

Dear Ms. Weidman:

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. Iisting 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 - Ms. Michelle Weidman

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, permits 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 (301) 594-4659. Also, please note the regulation entitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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510(k) Number (if known): K_O32430

Device Name: Medical Light Source

Indications For Use:

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K82430

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

ાર (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.