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The Cellvizio® I.V.E. with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture.

The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts. i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.

The AlveoFlex™N Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

The CholangioFlex™ N Confocal Miniprobe™ is intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

The AQ-Flex™ 19 N Confocal Miniprobe™ is intended to allow imaging of anatomical tracts. i.e.; gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA).

The CystoFlex™ F N, CystoFlex™ R N and Uroflex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts. i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The CelioFlex™ 5 N Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The subject device Cellvizio® I.V.E. system with Confocal Miniprobes™ is a confocal laser imaging system that can be used with a variety of Confocal Miniprobe™ (fiber optic probes) to allow real-time imaging of the internal microstructure of tissues by direct contact with the tip of the Confocal Miniprobe™ during existing medical procedures, such as endoscopy or endoscopic or open surgical procedures. The technology provides the physician with additional information in the form of real-time images during these open or minimally invasive procedures.

The Cellvizio® I.V.E. system with Confocal Miniprobes™ represents a refinement of the currently cleared and marketed predicate device, the Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844). Design modifications and refinements include:

• 1. Improving the integration of the system in endoscopy, interventional, or surgical operating suites by reducing the global footprint of the system.
• 2. lmproving the user interface and ease-of-use of the system by replacing the keyboard and the trackball of the Cellvizio® 100 series with a touchscreen for review and interaction with the software and the addition of a separate remote (external) display screen for live imaging. This configuration allows better positioning of the physician's line of site during procedures.
• 3. Simplifying the connection of the Miniprobes to the system. This improvement has no impact on other parts of the Confocal Miniprobe design, in particular the sheathed fiber and that are the patientcontacting parts are unchanged.
• 4. The addition of "autofocus," allowing automatic positioning of the laser focal point for optimal optical injection from the Optical Scanning Unit into the fibers.

The Cellvizio® I.V.E. system with Confocal Miniprobes™ is a refinement of the existing Cellvizio 100 Series System with Confocal Miniprobes™ (K172844). The provided text describes the device, its intended use, and various tests performed to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document states that "The results from these performance evaluations demonstrated that the Cellvizio® I.V.E system with Confocal Miniprobes™ met the acceptance criteria defined in the product specification and the performance is equivalent to the predicate device." However, specific numerical acceptance criteria (e.g., minimum resolution in microns, specific electrical safety thresholds, or maximum cytotoxicity levels) are not explicitly provided in the given text. Instead, the compliance is generally stated in relation to recognized standards.

Therefore, the table below will list the tests performed and the general performance statement.

2. Sample Size for Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of clinical or image-based performance as would be relevant for an AI/ML device for diagnostic interpretation. The listed tests are engineering and regulatory compliance validations rather than a clinical performance study involving patient data. For example:

• Biocompatibility tests involve material samples.
• Reprocessing tests involve device components.
• Laser safety, imaging quality (resolution using a test chart), software V&V, electrical safety, and usability tests are performed on the device system itself or its software.

Therefore, the concept of a "test set" related to patient data or clinical images, as commonly understood for AI/ML device studies, is not applicable or detailed in this submission. Data provenance (country of origin, retrospective/prospective) is also not relevant or mentioned for these types of engineering and regulatory tests.

3. Number of Experts and Qualifications for Ground Truth

Again, since this submission focuses on engineering and regulatory compliance rather than clinical diagnostic performance using patient data, the concept of "ground truth" established by experts for a test set (e.g., radiologists interpreting images) is not applicable or mentioned.

4. Adjudication Method for Test Set

No adjudication method is described because there are no human interpretations of patient data in a test set to adjudicate.

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

An MRMC comparative effectiveness study, which typically evaluates how human readers' performance improves with AI assistance, was not performed or mentioned in this submission. This device appears to be an imaging system, not an AI-powered diagnostic interpretation tool for image analysis.

6. Standalone Performance Study

A standalone performance study (algorithm only, without human-in-the-loop performance) was not performed or mentioned. The device is an imaging system designed to provide real-time images for a physician during existing medical procedures.

7. Type of Ground Truth Used

For the engineering and regulatory tests performed:

• Biocompatibility: Ground truth is established by adherence to ISO standards and laboratory testing results against specified limits.
• Reprocessing Effectiveness: Ground truth is adherence to AAMI TIR standards and demonstration of cleanliness/sterility.
• Laser Safety, Electrical Safety & EMC: Ground truth is compliance with IEC and CFR standards, measured against defined technical specifications.
• Imaging Quality: Ground truth for resolution is based on objective measurements using a calibrated test chart (1951 USAF resolution test chart) against internal standards and ISO 8600-1.
• Software V&V: Ground truth is compliance with FDA guidance and IEC 62304.
• Usability: Ground truth is compliance with IEC 62366-1, validated by an external laboratory.

There is no mention of ground truth based on expert consensus, pathology, or outcomes data as would be used for clinical performance studies.

8. Sample Size for the Training Set

This submission describes a medical imaging device (hardware and embedded software) and its regulatory compliance. It is not an AI/ML diagnostic algorithm that would typically have a "training set" of data in the common sense. Therefore, a sample size for a training set is not applicable or mentioned.

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

As there is no "training set" for an AI/ML algorithm in this context, the method for establishing its ground truth is not applicable or mentioned.

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