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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180, BF TYPE 1T180, BF TYPE Q180: 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.

VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).

VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS XENF TYPE VTY1: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea).

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the airways, tracheobronchial tree, nasal lumens and airway anatomy.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA II Xenon Light Source Olympus CLV-180.
• EVIS EXERA II Video System Center Olympus CV-180,
• EVIS EXERA II Bronchovideoscope Olympus BF -P180, BF -1T180, BF -Q180 .
• VISERA Rhino-Laryngo Videoscope Olympus ENF-V2, XENF-VTY1

The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional fitter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI) employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.

The CV-180 incorporates the following features:
The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscope.
The CV-180 processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and ridid endoscope models, including gastroscopes, ultrasound gastroscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes, for conventional white light endoscopy. The flexible endoscopes which are the subject of this premarket notification are bronchoscope and rhino-laryngoscope models listed in Table 16-2.

Additionally, when they are combined with the new bronchovideoscopes (BF-P180, BF-1T180, BF-Q180), and rhino-laryngo videoscopes (ENF-V2, XENF-VTY1), both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A; the NBI filter in the CLV-180 is inserted on the light axis when the NBI mode is selected.

The new endoscopes are basically identical to each predicate device shown in Table 16-2 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.

The provided document, a 510(k) summary for the EVIS EXERA II 180 System, outlines the device's technical specifications and claims substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document's purpose is to demonstrate substantial equivalence to existing legally marketed devices, primarily by showing that the new device has "no significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the system." (Page 8). This is a different kind of submission than one requiring a clinical performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on comparing the specifications of the subject device (EVIS EXERA II 180 System) components (Light Source, Video System Center, Bronchovideoscopes, Rhino-Laryngo Videoscopes) to their respective predicate devices.

Missing Information from the Provided Document:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are mentioned.
• Sample Size and Data Provenance (Test Set): There is no mention of a test set, sample size, or data provenance.
• Number of Experts and Qualifications (Ground Truth for Test Set): No experts or ground truth establishment for a test set are described.
• Adjudication Method: No adjudication method is mentioned.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is described.
• Standalone Performance Study: No standalone performance study of an algorithm is described. The device is an endoscopic system, not an AI algorithm.
• Type of Ground Truth Used: No ground truth types (e.g., pathology, outcomes data) are mentioned for a performance study.
• Sample Size for the Training Set: There is no mention of a training set or its sample size.
• How Ground Truth for the Training Set was Established: No information on training set ground truth establishment is provided.

The document is purely a technical comparison for substantial equivalence rather than a clinical performance study.

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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

The superDimension/Bronchus is a device that guides a bronchoscope and bronchial tool to a target in the bronchial tree on a path indicated by CT scan, and to visualize the interior of the tree and target

Here's an analysis of the provided text regarding the superDimension/Bronchus device, focusing on acceptance criteria and study details.

Based solely on the provided text, there is very limited information about specific acceptance criteria or a detailed clinical study demonstrating the device meets those criteria. The submission is a 510(k) summary, which often provides high-level information.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The document states that the device meets these criteria rather than defining specific thresholds or metrics for the criteria (e.g., "guiding accuracy must be within X mm"). This is common in 510(k) summaries which declare substantial equivalence rather than presenting detailed performance specifications.

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

• Sample Size: The document does not specify the sample size for the clinical evaluation (test set), nor does it break down the number of animal subjects. It only states "animal tests" and "a clinical evaluation."
• Data Provenance: The document doesn't specify the country of origin for the clinical data. It does state that superDimension Ltd. is located in Herzliya, Israel, which might imply the study was conducted there, but this is not explicitly stated for the clinical evaluation. It also doesn't explicitly state if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• The adjudication method is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• There is no mention of an MRMC comparative effectiveness study in the provided text.
• Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from this document.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• The device's intended use is to "aid the physician in guiding endoscopic tools," implying a human-in-the-loop system. The document does not describe any "standalone" performance evaluation of the algorithm without human intervention. Its stated purpose is as a guidance tool, not an autonomous diagnostic or procedural tool.

7. The Type of Ground Truth Used

• The document does not explicitly state the type of ground truth used for its "clinical evaluation" or "animal tests." Given the device's function as a guidance system for the tracheobronchial tree, potential ground truths could include:
  • Direct visualization/localization: Confirmation of tool tip position relative to the target using a reference standard (e.g., fluoroscopy, repeat CT scan with markers, direct visual confirmation if accessible).
  • Pathology/Biopsy results: If the guidance was for biopsy, the success of reaching a lesion later confirmed by pathology might be an indirect measure.
  • Expert Consensus: Clinical assessment by experienced bronchoscopists regarding the accuracy and ease of guidance.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This is a pre-market submission for a device, not a detailed paper about algorithm development. It's likely that the product integrates software and algorithms, but the specifics of their development and training are not disclosed here.

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

• Since there's no mention of a training set or its sample size, there's also no information on how its ground truth was established.

Summary of Missing Information:

This 510(k) summary provides a high-level overview focused on establishing substantial equivalence. It lacks the granular detail about clinical study design, specific performance metrics, ground truth establishment, or expert involvement that would typically be found in a detailed clinical report or peer-reviewed publication. The "Performance Data" section indicates that tests were done and standards met, but not the specifics of how these were measured or the quantitative results beyond a general conclusion of safety and effectiveness.

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