The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic inaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories.

Device Description

The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. As such, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving their fulfillment.

Here's a breakdown of what can be extracted and what is missing:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, it compares the technological characteristics of the subject device to its predicate devices to demonstrate substantial equivalence. The implication is that if the new device has similar characteristics, it will perform equivalently.

Specification	Acceptance Criteria (Implied: Substantially Equivalent to Predicates)	Reported Device Performance (GF-UE160-AL5)	Predicate Device 1 (GF-UC140P-A1.5) Performance	Predicate Device 2 (GF-UM130) Performance
Field of View (Optical)	100° (video)	100° (video)	Same (100° video)	Same (100° video)
Direction of View	55° forward-oblique	55° forward-oblique	Same (55° forward-oblique)	Same (55° forward-oblique)
Depth of Field	3~100mm	3~100mm	Same (3~100mm)	Same (3~100mm)
Outer Diameter of Distal End	Similar to predicates	⌀ 13.8mm	⌀ 14.2mm	⌀12.7mm
Outer Diameter of Insertion Tube	Similar to predicates	⌀ 11.8mm	Same (⌀ 11.8mm)	⌀ 10.5mm
Angulations (Up, Down, Left, Right)	130° (Up), 90° (Down), 90° (Left), 90° (Right)	130° (Up), 90° (Down), 90° (Left), 90° (Right)	Same	Same
Working Length	1250mm	1250mm	Same (1250mm)	Same (1250mm)
Instrument Channel	Similar to predicates	⌀ 2.2mm	⌀ 2.8mm	⌀ 2.2mm
Contact Method	Balloon Method/De-Aerated Water Immersion Method	Balloon Method/De-Aerated Water Immersion Method	Same	Same

The "acceptance criteria" here are implicitly that the new device's specifications are comparable to, or within acceptable variations of, the predicate devices, thereby ensuring equivalent safety and effectiveness.

2. Sample size used for the test set and the data provenance

The document describes a submission for substantial equivalence based on technological characteristics and intended use comparison. It does not refer to a clinical "test set" in the context of performance evaluation with patient data. Therefore, there is no information on:

Sample size used for a test set.
Data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical test set for performance evaluation is described, there is no information on:

Number of experts used to establish ground truth.
Qualifications of those experts.

4. Adjudication method for the test set

Similarly, as there is no clinical test set for performance evaluation, there is no information on an adjudication method.

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

The device is an endoscope and ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.

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

This point is not applicable as the device is not an algorithm for standalone performance. It is a medical imaging device used by a human operator.

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

The document does not describe a study involving "ground truth" as typically understood in performance validation of diagnostic accuracy (e.g., against pathology). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

The document describes a comparison to predicate devices, not a machine learning model. Therefore, there is no information on a "training set" sample size.

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

As there is no training set for a machine learning model, this question is not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission to the FDA. It is not a clinical study designed to test novel performance claims against specific acceptance criteria.

Purpose: To demonstrate that the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System is substantially equivalent to legally marketed predicate devices, specifically the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660).
Methodology: Direct comparison of technological characteristics (physical specifications, optical characteristics, angulations, etc.) and intended use between the subject device and the predicate devices.
Conclusion: The submission concludes that "When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness." The FDA concurred with this finding of substantial equivalence.
Key Finding for Equivalence: The key "performance" demonstrated is that the device's technical specifications and intended use are similar enough to existing, cleared devices that it can be considered equally safe and effective without requiring new clinical performance data.

Summary

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Date: Date: __________________________________________________________________________________________________________________________________________________________________

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510(K) Summary

Olympus GF-UE160-AL5 Endoscope used with Aloka Model SSD- 5000 Diagnostic Ultrasound System

This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.

This premarket notification has been submitted by Olympus American, Inc. and covers the Olympus GF-UE160-AL5 endoscope used with the Aloka SSD-5000 diagnostic ultrasound system.

1. GENERAL INFORMATION

Applicant:

Submission Correspondent:	Laura Storms-TylerDirector, Regulatory Affairs and Quality AssuranceOlympus America Inc.Two Corporate Center Drive, Melville, NY 11747-9058Phone: 631-844-5688Fax: 631-844-5554
Official Correspondent:	Laura Storms-TylerDirector, Regulatory Affairs and Quality AssuranceOlympus America Inc.Two Corporate Center Drive, Melville, NY 11747-9058Phone: 631-844-5688Fax: 631-844-5554Establishment Registration No.: 2429304

2. DEVICE IDENTIFICATION

Trade/Common Name: The proprietary name is the Olympus GF-UE160-AL5 Gastro-video Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. The common name for this type of device is an Ultrasound Gastro-video Scope.

Regulation Number/Name: The items in this submission are covered under the following classification:

90 IYN	Ultrasonic Pulsed Doppler Imaging System	21 CFR 892.1550
90 ITX	Diagnostic Ultrasound Transducer	21 CFR 892.1570
90 IYO	Ultrasonic Pulsed Echo Imaging System.	21 CFR 892.1560
70 FDF	Endoscope and accessories	21 CFR 876.1500

The above have been classified as regulatory Class II.

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510(K) Summary

3. Predicate Devices:

The Olympus GF-UE160-AL5 Endoscope is substantially equivalent to the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660). Both predicates share common indications and some features.

4. Device Description: The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.

5. Intended Use:

6. Comparison of Technological Characteristics:

Below is the comparison table between the subject device and its predicate devices
Specifications	Subject DeviceGF-UE160-A1.5	Predicate Devices
		GF-UC140P-A1.5(K011314)	GF-UM130(K971660)
Optical Characteristics:
Field of View:	100° (video)	Same	Same
Direction of View:	55° forward-oblique	Same	Same
Depth of Field:	3~100mm	Same	Same
Outer Diameter of Distal End	⌀ 13.8mm	⌀ 14.2mm	⌀12.7mm
Outer Diameter of Insertion Tube	⌀ 11.8mm	Same	⌀ 10.5mm
Angulations:
Up:	130°	Same	Same
Down:	90°	Same	Same
Left:	90°	Same	Same
Right:	90°	Same	Same
Working Length	1250mm	Same	Same
Instrument Channel	⌀ 2.2mm	⌀ 2.8mm	⌀ 2.2mm
Contact Method	Ballon Method/De-Aerated Water ImmersionMethod	Same	Same

n the subject, douing and its prodicate

8. Conclusion:

When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing health, human services, and well-being. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

Olympus America, Inc. % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K051541

Trade Name: Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: FDF and ITX Dated: June 9, 2005 Received: June 10, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Aloka SSD-5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

GF-UE160-AL5

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Page 2 - Mr. Devine

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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 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) 276-0120. 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/industry/support/index.html

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Page 3 – Mr. Devine

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for use statement

510(K) Number (if known):
Device Name:	Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System
Indications For Use:	The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.The Aloka SSD-5000 (K033311) is an all-digital diagnostic ultrasonic scanner with a digital beam former supporting gray scale, spectral Doppler and Color Flow imaging. Depending on the probe, the Aloka SSD-5000 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications. The Aloka SSD-5000 is a Track 3 system and is not indicated for ophthalmic applications.

510(K) Number (if known):

Device Name:

Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System

Indications For Use:

The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.The Aloka SSD-5000 (K033311) is an all-digital diagnostic ultrasonic scanner with a digital beam former supporting gray scale, spectral Doppler and Color Flow imaging. Depending on the probe, the Aloka SSD-5000 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications. The Aloka SSD-5000 is a Track 3 system and is not indicated for ophthalmic applications.

く Prescription use (Pet 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR *)! Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

and Radiological Devices 510(k) Number _

Page 1 of 1

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4.3.1

Diagnostic Ultrasound Indications for Use Form

SSD-5000

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		See Below
Abdominal		P	P	P		P	P		See Below
Intraoperative (specify)		P	P	P		P	P		See Below
Intraoperative Neurological		P	P	P		P	P		See Below
Pediatric		P	P	P		P	P		See Below
Small Organ (specify)		P	P	P		P	P		See Below
Neonatal Cephalic		P	P	P		P	P		See Below
Adult Cephalic		P	P	P		P	P		See Below
Cardiac		P	P	P		P	P		See Below
Transesophageal		P	P	P		P	P		See Below
Transrectal		P	P	P		P	P		See Below
Transvaginal		P	P	P		P	P		See Below
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		See Below
Laparoscopic		P	P	P		P	P		See Below
Musculo-skeletalConventional		P	P	P		P	P		See Below
Musculo-skeletal Superficial		P	P	P		P	P		See Below
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/Bflow/PWD. Intra-operative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Preseription Use (Per 21 CFR 801.109)

Prescription Use
(Division Sign/Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051541

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Diagnostic Ultrasound Indications for Use Form GF-UE160-AL5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		See Below
Intraoperative (specify)		N	N	N		N	N		See Below
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		N	N	N		N	N		See Below	Non-Cardiac
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.,

Intraoperative : Gastro-intestinal tract & surrounding abdominal organs

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Hodgon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051541

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.