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The EVIS Bronchofibervideoscope Olympus BF type XP160F has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

This document describes the Olympus EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F. The information provided heavily relies on a comparison to predicate devices for demonstrating substantial equivalence rather than explicit acceptance criteria with performance metrics from a dedicated study.

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

Since no explicit "acceptance criteria" are detailed as performance benchmarks, the substantial equivalence report implies that the device's performance is acceptable if it is equivalent to or better than the predicate devices for key characteristics. The "reported device performance" in this context refers to the specified characteristics of the subject device itself.

Study Information (Based on Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to existing legally marketed devices, rather than a dedicated clinical or performance study with acceptance criteria and corresponding results. The fundamental argument is that the subject device (BF type XP160F) is "basically identical" to the predicate device (BF-XP40) except for the control section and CCD, which are equivalent to the BF-160. Therefore, the "study" is a comparison of specifications and intended use.

1. Sample size used for the test set and data provenance:

   • N/A. No formal "test set" in the sense of patient or image data was used for performance validation against acceptance criteria. The evaluation is based on comparing device specifications.
   • The "data provenance" concerning the predicate devices' performance would be their approval through previous 510(k) submissions, demonstrating their safety and effectiveness.

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

   • N/A. No ground truth was established by experts for a test set in this 510(k) submission. The FDA reviews the provided technical specifications and comparisons to predicate devices.

3. Adjudication method for the test set:

   • N/A. No adjudication method was used as there was no test set requiring expert interpretation or consensus.

4. 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:

   • No. This device is a bronchoscope, a medical imaging and interventional tool. It is not an AI-powered diagnostic or assistive device, so an MRMC study is not applicable.

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

   • No. This device is an instrument operated by a human, not a standalone algorithm.

6. The type of ground truth used:

   • The "ground truth" implicitly used is the established safety and effectiveness of the legally marketed predicate devices based on their demonstrated performance and compliance with relevant standards. The subject device claims equivalence by maintaining similar or improved specifications.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for this device.

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