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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.

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

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.

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