This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).

Device Description

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, GIF-XP190N is an additional component of the EVIS EXERA III VIDEO SYSTEM.

The subject endoscope could be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment within the upper digestive tract.

AI/ML Overview

The provided document is a 510(k) summary for the EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested for AI/device performance studies.

Instead, it refers to:

Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.
Design verification tests and their acceptance criteria identified and performed as a result of this risk analysis assessment.
Software validation activities performed in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Application of standards like IEC 60601-2-18, IEC 60601-1-2, and ISO 14971.

This type of submission primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics and safety standards, rather than providing a performance study with detailed acceptance criteria of the kind typically found for diagnostic AI algorithms (e.g., sensitivity, specificity, AUC).

Therefore, I cannot populate the table and answer all the questions directly from the provided text about how the device meets acceptance criteria in a diagnostic performance study context. The document states that the device was found to be "substantially equivalent" to its predicate based on the non-clinical testing performed, implying the acceptance criteria for those engineering and safety tests were met.

Here's what I can extract and infer based on the request and the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance (Inferred from document)
Safety and Effectiveness (Overall)	Device does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate.	"Substantially Equivalent": The FDA determined the device is substantially equivalent to the predicate, implying it meets the necessary safety and effectiveness thresholds for its intended use as defined by regulatory standards (e.g., no significant changes that would impact safety/effectiveness compared to the K100584 predicate).
Risk Management	Risks are identified, evaluated, controlled, and their acceptability is determined in accordance with ISO 14971:2007.	Risk analysis was carried out and design verification tests and their acceptance criteria were identified and performed, indicating risks were managed to an acceptable level.
Software Validation	Software validation activities performed according to FDA Guidance for Software Contained in Medical Devices (Device classified as "Minor Level of Concern").	Software validation activities were successfully performed, demonstrating compliance with FDA guidance.
Electrical Safety & EMC	Compliance with relevant medical electrical equipment standards (e.g., IEC 60601-2-18, IEC 60601-1-2).	The device applies IEC 60601-2-18 and IEC 60601-1-2, implying it passed tests demonstrating compliance with these standards for safety and electromagnetic compatibility.
Biocompatibility/Material Safety (Implied)	Materials used are safe for patient contact and do not elicit adverse biological responses.	While not explicitly stated as "acceptance criteria met," the substantial equivalence determination and risk analysis process would have covered material safety. The document states "no significant changes in... material or design that could affect the safety or effectiveness."
Functional Performance (Implied from changes)	Features like new integrated scope connector, new nozzle, and compatibility with High-Frequency Electrocautery perform as intended without compromising overall device functionality or safety.	These new features are incorporated, and the device is deemed substantially equivalent, indicating they function correctly and safely.

Regarding the other points:

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

The document does not provide details on sample sizes for specific performance tests in the context of a diagnostic dataset (e.g., image sets for an AI algorithm). The non-clinical testing refers to engineering, safety, and software validation tests, not a performance evaluation on clinical 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 or not provided. This information is typically relevant for studies validating diagnostic AI where expert consensus or pathological confirmation establishes ground truth for image data. This submission is for a medical device (endoscope), not a diagnostic AI algorithm that interprets images.

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

Not applicable or not provided. See explanation for point 3.

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 is not a diagnostic AI device requiring an MRMC study to compare human performance with and without AI assistance. It is a gastrointestinal videoscope.

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

Not applicable. This device is an endoscope, not a standalone algorithm.

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

The "ground truth" for this device's validation revolves around engineering specifications, safety standards, and functional performance criteria. For example, ground truth for electrical safety is defined by IEC standards, for material safety by biocompatibility tests, and for mechanical integrity by durability tests. It's not clinical "ground truth" derived from patient diagnostic labels.

8. The sample size for the training set

Not applicable or not provided. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

Not applicable or not provided. See explanation for point 8.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device (an endoscope) through compliance with engineering, safety, and software standards, rather than a clinical performance study of a diagnostic AI algorithm. Therefore, many of the specific questions about AI study methodology cannot be answered from this text.

Summary

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K123317

DEC 1 1 2012

510(k) SUMMARY

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N

October 24, 2012

General Information 1

OLYMPUS MEDICAL SYSTEMS CORP. I Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 l Official Correspondent: Sheri L. Musgnung · Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com Aizu Olympus Co., Ltd. . Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

2 Device Identification

체 GASTROINTESTINAL VIDEOSCOPE Device Trade Name: ENIS EXERA 111 OLYMPUS GIF-XP190N
Common Name: GASTROINTESTINAL VIDEOSCOPE
미 Regulation Number: 876.1500
트 Regulation Name: Endoscope and Accessories
. Regulatory Class:

트 Classification Panel: Gastroenterology and urology
ll
Product Code: FDS (gastroscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum)
25

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Predicate Device Information 3

Subject Device(Part of this submission)	Predicate Device	PredicateDevice510(k) No.
EVIS EXERA III GASTROINTESTINALVIDEOSCOPEOLYMPUS GIF TYPE XP190N	EVIS EXERA II GASTROINTESTINALVIDEOSCOPEOLYMPUS GIF TYPE XP180N	K100584

Device Description 4

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, GIF-XP190N is an additional component of the EVIS EXERA III VIDEO SYSTEM.

5 Indications for Use

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).

Comparison of Technological Characteristics 6

· The endoscope incorporates the following features compared to the predicate device: (1) A new Integrated scope connector that includes both the Light-quide and electronic-contact (video scope connection), (2) New nozzle, (3) Compatibility with High-Frequency Electrocautery.

7 Summary of non-clinical testing

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

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The following standards have been applied to the EVIS EXERA III GASTOROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N of EVIS EXERA III VIDEO SYSTEM:

· IEC 60601-2-18
· IEC 60601-1-2
י ISO 14971

8 Conclusion

When compared to the predicate device, the EVIS EXERA III GASTOROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N of the EVIS EXERA III VIDEO SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2012

OLYMPUS MEDICAL SYSTEMS CORPORATION % Ms. Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610

K123317 Re:

Trade/Device Name: GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, NWB Dated: November 27, 2012 Received: November 28, 2012

Dear Ms. Musgnung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Sheri L. Musgnung

You must comply with all the Act's requirements, including, but not limited to: registration and I va mast CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements medial as not requality systems (QS) regulation (21 CFR Part 820); and if applicable, the as set form in and radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you desire speeffice and AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 4123319

Device Name: GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N Indications For Use:

GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and duodenum).

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Benjamin R. Fjisher -S 2012.12.11 14:50:23 -05'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number

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.