OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used with the SSD-Alpha5 (K041916) and SSD-Alpha10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, display monitor, and endo-therapy accessories such as aspiration blopsy needle. The subject device is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs.

AI/ML Overview

The provided document (K070983) is a 510(k) premarket notification decision letter from the FDA for the Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner expected for a de novo device or a more complex AI-driven medical device.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details typical for an AI/ML device.

Here's why and what information can be extracted/inferred:

Type of Device: The device is an ultrasonic broncho-fibervideoscope, which is a hardware device for endoscopy with integrated ultrasound capabilities. It's not an AI/ML diagnostic software.
Regulatory Pathway: The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, fundamental technological characteristics, and safety and effectiveness as the predicate, or that any differences do not raise new questions of safety or effectiveness. Formal clinical studies with performance metrics against acceptance criteria are often not required if engineering and non-clinical bench testing are sufficient to support equivalence.
Date: The document is dated 2017, predating widespread FDA guidance and requirements for AI/ML device performance studies outlining the specific details you've asked for.

Based on the available document, here's what can be stated about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "performance" demonstrated for a 510(k) device like this typically involves:

Bench Testing: Verification of technical specifications (e.g., ultrasound frequency, imaging depth, image quality, mechanical dimensions, electrical safety, biocompatibility, sterilization efficacy).
Verification and Validation (V&V): Ensuring the device meets its design inputs and intended use through various tests.

The document implicitly "accepts" the device's performance by finding it substantially equivalent to the predicate devices. This means its performance is considered comparable and safe/effective for its intended use.

No explicit table of acceptance criteria or numerical performance results (e.g., sensitivity, specificity, AUC) are provided in this regulatory letter. The letter is a communication of regulatory decision, not a detailed study report.

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

Test Set Sample Size: Not applicable in the context of typical AI/ML performance studies. For a hardware device, V&V tests would use units of the device itself and potentially phantoms or in-vivo animal models (not specified in this letter).
Data Provenance: Not applicable in the AI/ML sense. The "data" here would be the results of engineering tests, not patient data for algorithm training/testing.

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

Experts: Not explicitly stated. For a physical device, ground truth during testing would likely be established through engineering measurements, expert medical assessment of image quality (e.g., by radiologists, pulmonologists, gastroenterologists familiar with endoscopic ultrasound), and potentially histological evaluation if biopsy results were part of functional testing (again, not detailed here).
Qualifications: Not specified within the letter.

4. Adjudication Method:

Adjudication Method: Not applicable or specified for this type of device and regulatory submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, this type of study is not mentioned as having been conducted or required for this 510(k) submission. MRMC studies are typically used to assess the impact of diagnostic aids (like AI) on physician performance. The device itself is a diagnostic tool, not an AI aid to another diagnostic process.

6. Standalone Performance:

Standalone Performance: Not applicable in the context of an AI algorithm. The performance of the device (XBF-UC180F-DT8) and its associated ultrasound system (ALOKA SSD-Alpha 5/10) is its standalone performance as a diagnostic imaging system. The letter doesn't isolate specific performance metrics outside of the combined system's functionality.

7. Type of Ground Truth Used:

Ground Truth: For a traditional diagnostic imaging device like this, ground truth in V&V trials would typically involve:
- Phantom studies: Known physical properties measured by other means.
- Pathology/Histology: For biopsy capabilities.
- Clinical correlation: Experienced clinician interpretation or follow-up.
- Engineering specifications: Meeting design requirements.
  The document doesn't specify which ground truth methods were primarily used for the 510(k) submission.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided FDA 510(k) letter for the Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope is a regulatory outcome document demonstrating substantial equivalence. It does not contain the detailed performance study information that would be found in a submission for an AI/ML-driven diagnostic device.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MAY 1 7 2017

Olympus Medical Systems Corporation Ms. Laura Storms-Tyler Director, Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610

Re: K070983

Trade/Device Name: XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: PSV, IYN, ITX Dated: May 29, 2007 Received: May 31, 2007

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent (SE) letter of July 5, 2007 and our subsequent corrected SE letter of July 27, 2015.

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. You must

{1}------------------------------------------------

Page 2 - Ms. Laura Storms-Tyler

comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go

to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Eric A. Mann -S 2017.05.17 14:13:13 -04'00'

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

4.3.1 Diagnostic Ultrasound Indications for Use Form

70943 LYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)		N	N	N	N	N	N	(Note 2)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)(Note 1)		N	N	N	N	N	N	(Note 2)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Note 1: Specification for "Other" :

Airways and tracheobronchial tree.

Note 2: "Combined mode operation" includes: B/M,B/PWD,B/CD/PWD

Signature

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

{3}------------------------------------------------

4.3.1 Diagnostic Ultrasound Indications for Use Form

K070983

7.5 MHz linear array transducer used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM

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

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (specify)
	Intraoperative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)		P	P	P		P	P	(Note 2)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other (spec.)(Note 1)		P	P	P		P	P	(Note 2)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vesselOther (spec.)

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

Additional Comments:

Note 1: Specification for "Other" :

Airways and tracheobronchial tree.

Note 2: "Combined mode operation" includes: B/M,B/PWD,B/CD/PWD

Helut leen

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

{4}------------------------------------------------

K070993

510(k) SUMMARY

JUL - 5 2007

March 26, 2007

ー General Information

4.2.1

XBF-UC180F-DT8

Manufacture's Name: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT

Address:

34-3 Hirai Hinode-Machi. Nishitama-gun, Tokyo 190-0182, Japan

Corresponding Official: Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance

484-896-5688

Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610,

Telephone:

FacsImile: 484-896-7128

E-mall:

Laura storms-tyler@olympus.com

2951 Ishikawa-cho, Hachioji-shi,

Applicant's Name: OLYMPUS MEDICAL SYSTEMS CORP.

Address:

4.2.2

Initial Distributor Name/Title/Firm:

Address:

Olympus America Inc.

Tokyo, Japan 192-8507

3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610,

Telephone:

484-896-5688

SSD-Alpha 5 / 10

ALOKA CO., LTD.

6-22-1, Mure Mitaka-Shi, Tokyo 181-8622, Japan

Richard J Cehovsky RA/QA Coordinator

ALOKA CO. LTD USA 10 Fairfield blvd. Wallingford, CT 06492

203-269-5088

{5}------------------------------------------------

2 Device Identification

. Device Trade Name:

OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM

Common Name:	Ultrasonic Endoscope
Regulation Number:	892.1570 Diagnostic Ultrasound Transducer892.1550 Ultrasonic Pulsed Doppler Imaging System876.1500 Endoscope and Accessories
Regulatory Class:	II

Product Code: 90-ITX/78-KOG/90IYN

ਡ Predicate Device Information

Ultrasonic Endoscope

Subject device	Predicate device
	Name	Control number
XBF-UC180F-DT8ULTRASONICBRONCHOFIBERVIDEOSCOPE	BF-UC160F-OL8EVIS EXERA ULTRASONICBRONCHOFIBERVIDEOSCOPE	K042140
SSD-Alpha 5	ALOKA SSD-ALPHA 5ULTRASOUND SYSTEM	K041916
SSD-Alpha 10	ALOKA SSD-ALPHA 10ULTRASOUND SYSTEM	K043196

4 Device Description

5 Indications for Use

The use of of OLYMPUS XBF- UC180F-DT8 indications for ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM are as follows:

{6}------------------------------------------------

Transesophageal(non-cardiac) l
I Airways and tracheobronchial tree

6 Comparison of Technological Characteristics

When the OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM is compared to its predicate device, the device does not incorporate any significant changes in its intended use, method of operation, material or design that could affect the safety and effectiveness, Technological characteristics of ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM is identical to the predicate devices identified in above item 3.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.