These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Device Description

The subject devices, Olympus EVIS EXERA Bronchovideoscope XBF-160Y3AC, XBF-1T160Y3AC, and I XBF-Q160Y2AC are identical to the predicate devices, BF-160 and BF-1T160, in intended use. These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. As for the device specifications, they are basically identical to the BF-160 and BF-1T160 with the exception that the subject devices are now compatible with steam sterilization (autoclave) in addition to ETO gas sterilization. The XBF-Q160Y2AC is loaded with higher pixels in the CCD compared to the predicate device, BF-160. The increase of the number of pixels has contributed to the expansion of image size. However, the resolution at optimum working distance of the XBF-Q160Y2AC is basically the same as that of the predicate device. Therefore, optical performance of the XBF-Q160Y2AC before and after clinical use is identical to the predicate device.

In addition to the above scopes, this submission also includes the following devices:

XMAJ-178 (Sterilization Tray) MAJ-1214 (Water-resistant Cap) FB-52C-1 Biopsy Forceps FG-36D Grasping Forceps IE-2P Magnetic Extractor NM-8L-1 Injector NM-9L-1 Injector M1-1G Measuring Device M2-1C Measuring Device
M2-2C Measuring Device

AI/ML Overview

This document is a 510(k) summary for a medical device submission, specifically for new bronchovideoscope models and accessories. It does not describe an AI-powered device or a study involving AI. Therefore, most of the requested information about acceptance criteria for an AI device and a study proving it meets those criteria cannot be extracted from this text.

The document focuses on demonstrating substantial equivalence to a predicate device (an older model of bronchoscope) by comparing technological characteristics and re-processing methods. It explicitly states that clinical data is not necessary for its evaluation of safety and efficacy because there are no significant changes from the predicate device.

Here's a breakdown of what can be answered and what cannot:

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

Cannot be provided. This document is for a traditional medical device (a bronchoscope) and not an AI device. It does not mention any performance metrics or acceptance criteria typically associated with AI, such as sensitivity, specificity, or AUC. The "performance" discussed relates to physical specifications like diameter and reprocessing methods, and the resolution of the XBF-Q160Y2AC is reported as "basically the same as that of the predicate device" at optimum working distance.

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

Cannot be provided. No test set or clinical data is used or described.

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)

Cannot be provided. No ground truth establishment for a test set is discussed.

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

Cannot be provided. No test set or adjudication is mentioned.

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

Cannot be provided. This is not an AI device, and no MRMC study is described.

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

Cannot be provided. This is not an AI algorithm.

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

Cannot be provided. No ground truth is established for device performance in the context of clinical efficacy or diagnostic accuracy. The basis for safety and effectiveness is simply substantial equivalence to a predicate device, meaning its characteristics are "basically identical" or improved without altering the fundamental performance.

8. The sample size for the training set

Cannot be provided. There is no training set mentioned, as this is not an AI device undergoing machine learning.

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

Cannot be provided. No training set or ground truth for it is mentioned.

Summary of Device Rationale from the Document:

The company is seeking 510(k) clearance for new bronchoscope models (XBF-160Y3AC, XBF-1T160Y3AC, XBF-Q160Y2AC) and accessories. The primary rationale for approval is that these new devices are "substantially equivalent" to previously cleared predicate devices (BF-160 and BF-1T160).

The main differences highlighted are:

Reprocessing: The new devices are compatible with steam sterilization (autoclaving) in addition to ETO gas sterilization, which was the method for the predicate devices.
Physical Dimensions: Minor differences in distal end outer diameter and insertion tube outer diameter are noted.
Inner Channel Diameter: Mostly identical, with a specific note for XBF-1T160Y3AC matching its predicate.
Image Quality (XBF-Q160Y2AC): This specific model has higher pixels in the CCD leading to an expanded image size, but the resolution at optimum working distance is "basically the same as that of the predicate device."

The conclusion explicitly states: "When compared to the predicate device, XBF-160Y3AC, XBF-1T160Y3AC and XBF-Q160Y2AC ... do not present any significant changes in intended use, method of operation, material... Therefore, clinical data is not necessary for its evaluation of safety and efficacy." This means the basis for clearance is technical and functional similarity, not a clinical study demonstrating performance against specific criteria, especially not for an AI application.

Summary

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SMDA 510(k) SUMMARY EVIS EXERA Bronchovideoscope Olympus XBF-1T160Y3AC, XBF-160Y3AC, XBF-Q160Y2AC, its accessories and ancillary equipment

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

1. GENERAL INFORMATION

Applicant	Olympus Corporation34-3 Hirai Hinode-machi,Nishitama-gun, Tokyo, 190-0182, JapanEstablishment Registration No.: 3003637092
Submission Correspondent	Akiko FukagawaOlympus Corporation2951 Ishikawa-cho,Hachioji-shi, Tokyo, 192-8507, JapanPhone: +81-426-2891Fax: +81-426-3174E-mail: akiko_fukagawa@ot.olympus.co.jpEstablishment Registration No.: 8010047
Official Correspondent	Tina Steffanie-OakAssociate Manager, Regulatory Affairs/Clinical MonitorOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-9058Phone: 631-844-5477Fax: 631-844-5554Establishment Registration No.: 2429304

2. Device Identification

Trade Name:	EVIS EXERA Bronchovideoscope Olympus XBF-160Y3AC,XBF-1T160Y3AC, XBF-Q160Y2AC, its accessories and ancillaryequipment
Common Name:	Bronchoscope
Regulation Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	21 CFR 874.4680
Class:	II
Product Code:	EOQ

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3. Predicate Device

Predicate Device Name	Manufacturer	510(k) Number
EVIS EXERA BronchovideoscopeOlympus BF type 160	Olympus Corporation	K023984
EVIS EXERA BronchovideoscopeOlympus BF type 1T160	Olympus Corporation	K023984
Olympus Sterilization Trays	Olympus Winter & Ibe GMBH	K033222

4. Device Description

In addition to the above scopes, this submission also includes the following devices:

XMAJ-178 (Sterilization Tray) MAJ-1214 (Water-resistant Cap) FB-52C-1 Biopsy Forceps FG-36D Grasping Forceps IE-2P Magnetic Extractor NM-8L-1 Injector NM-9L-1 Injector M1-1G Measuring Device M2-1C Measuring Device
M2-2C Measuring Device

5. Intended Use of the device

EVIS EXERA Bronchovideoscope

Accessories to the EVIS EXERA Bronchovideoscope

XMAJ-178 (Sterilization Tray)

The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving.

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MAJ-1214 (Water-resistant Cap)

The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing.

FB-52C-1 (Biopsy Forceps)

The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree.

FG-36D (Grasping Forceps)

This instrument has been designed to be used with Olympus endoscopes to retrieve foreign r not morth has been specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs.

IE-2P (Magnetic Extractor)

The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree.

NM-8L-1/NM-9L-1 (Injector)

These instruments have been designed to be used with an Olympus endoscope to perform r noo internaments have bomucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree.

M1-1C/M2-1C/M2-2C (Measuring Device)

These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial tree.

6. Comparison of Technological Characteristics

Below is the comparison table between the subject devices and predicate device.

Specifications	Subject DeviceXBF-160Y3AC	Subject DeviceXBF-1T160Y3AC	Subject DeviceXBF-Q160Y2AC	Predicate DeviceBF-160 (K023984)
Reprocessing	ETO/Autoclaving	ETO/Autoclaving	ETO/Autoclaving	ETO
Distal end OuterDiameter	$\phi$ 4.9 mm	$\phi$ 5.9 mm	$\phi$ 5.5 mm	$\phi$ 5.3 mm
Insertion TubeOuter Diameter	$\phi$ 4.9 mm	$\phi$ 6.0 mm	$\phi$ 5.3 mm	$\phi$ 5.2 mm
Inner ChannelDiameter	$\phi$ 2.0 mm	$\phi$ 2.8 mm*	$\phi$ 2.0 mm	$\phi$ 2.0 mm

*Inner Channel Diameter of XBF-1T160Y3AC is identical to that of the other predicate device, BF-1T160.

7. Materials

Biocompatibility testing was performed in accordance with Japan's Ministry of Health and Welfare notification "GUIDELINES FOR BASIC BIOLOGICAL EVALUATION OF MEDICAL DEVICES" (issued on June 27 1995), YAKKI No.99.

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8. Conclusion

When compared to the predicate device, XBF-160Y3AC, XBF-1T160Y3AC and XBF-Q160Y2AC vvien oompared the prodicant changes in intended use, method of operation, material, or do hot most portule any organisativeness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.