The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.

Device Description

Subject Devices:
Model A2765 Working element, for probes
Model A0561 Guiding tube, for probes, with retractor
Model A0562 Guiding tube, for probes
Model A2891 Injection cannula, 1,2 mm x 420 mm

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Olympus Working Element for Probes.

Crucially, the provided document is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than presenting detailed, independent clinical studies with specific acceptance criteria and performance metrics like those for a novel AI device.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI-specific metrics is not available in this type of regulatory document. This summary primarily outlines the device's intended use and lists predicate devices.

Let's break down what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are stated, nor is there a report of device performance against such criteria.

This document is a 510(k) premarket notification, which establishes substantial equivalence through comparison to legally marketed predicate devices, not through a formal clinical trial with quantitative performance outcomes and pre-defined acceptance criteria. The "performance" demonstrated is implicitly that the device is as safe and effective as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a "test set" in the context of an AI or diagnostic performance study. The 510(k) process relies on equivalence to predicate devices, material safety, and functionality, not a clinical study on a specific test set.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. There is no mention of a study involving experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is more common for evaluating diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This document is for a medical instrument, not a diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical working element for endoscopic procedures, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. As a mechanical device, the "ground truth" concept in the statistical sense for diagnostic or AI performance does not apply. Safety and efficacy are typically established through engineering tests, biocompatibility, sterilization validation, and comparison to predicate devices, not "ground truth" derived from patient data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is irrelevant.

In summary: The provided 510(k) document is a regulatory submission for a medical instrument. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment, which are typical for diagnostic or AI-powered devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Olympus Winter & IBE. Below the logo is the business address, which is Kuehnstr. 61, D-22045 Hamburg. The mailing address is Postfach 70 17 09, D-22017 Hamburg. The telephone number is (040) 6 69 66-0, and the telefax number is (040) 6 68 15 91.

992141 Pri of 2

510(k) SUMMER

OLYMPUS WORKING ELEMENT FOR PROBES

This summery of 510(k) safety and effectivness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Device Name:	Olympus Working Element for Probes
Common/Usual Name:	Working Element
Classification Name:	ENDOSCOPE AND/OR ACCESSORIES
Classification:	CFR 876.1500	Class II

Subject Devices:

Model	Description
A2765	Working element, for probes
A0561	Guiding tube, for probes, with retractor
A0562	Guiding tube, for probes
A2891	Injection cannula, 1,2 mm x 420 mm

Predicate Devices:

Manufacturer	Description	510(k)
Richard Wolf	Working element with open handle and probe guide channelType 8654.281	unknown
Richard Wolf	Injection cannula flexible, 4.5 FrType 8654.951	unknown
Olympus	Working elementO3523	K790071
Olympus	Working element, V-spring typeA3573	K904939
Olympus	Working element, V-spring typeA2496	K904939
Olympus	Knife, semi circular, 3 Fr. channel, for A2496	K904939
Olympus	Stricture scalpel hollow, for use of a 5 Fr. guide catheter	K790071

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Prepared & Submitted By:(Contact Person)	Mrs. Laura Storms-TylerOlympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, NY 11747-3157Phone: 516-844-5688FAX: 516-844-5416	K992141Pg 208?
Summary Preparation Date:	September 6, 1999

Statement of Intended Use:

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, each head represented by a simple, curved line.

SEP 2 9 1999

Olympus Winter & IBE c/o Mrs. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Incorporated Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K992141 Olympus Working Element for Probes Dated: September 8, 1999 Received: September 9, 1999 Regulatory Class: II 21 CFR $876.1500/Procode: 78 FDC

Dear Mrs. Storms-Tyler:

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 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 Requlations, 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.

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 requlation 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,

[signature]

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 9921 41 510(k) Number (if known):

Device Name:

Olympus working element for probes, guiding tubes and injection cannula.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Presciption Use		OR	Over-the Counter Use
(per 21CFR 801.109)			(Optional Format 1-2-96)
	(Division Sign-Off)and Radiological Devices510(k) Number	Division of Reproductive, Abdominal, ENT,

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.