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Cellvizio® 100 Series System 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, vessels and their organization or architecture. The Cellvizio® 100 Series System F400-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.

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

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

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

The CystoFlex™ (F, UHD-R) and UroFlex™ B of 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™ UHD 5 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Confocal Miniprobes™ are used with Cellvizio® 100 Series System (F400-v2), which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.

Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow. Fluorescein Sodium can be used as a contrast agent with Cellvizio® 100 Series system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration; it is delivered independent of Cellvizio® 100 Series system in accordance with Fluorescein Sodium instruction for use.

The provided text describes a submission for 510(k) clearance for the Cellvizio® 100 Series System with Confocal Miniprobes™. This submission seeks to extend the indications for use to include the visualization of blood flow when using Fluorescein Sodium as a contrast agent.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria in a dedicated table format with specific performance metrics (e.g., sensitivity, specificity, resolution targets met in a study). Instead, the acceptance is based on demonstrating substantial equivalence to previously cleared predicate devices and a reference device, particularly for the extended indication of visualizing blood flow with Fluorescein Sodium.

The "reported device performance" in this context refers to the device's established technical design, operating principle, safety profile, and imaging capabilities, which are asserted to be unchanged from previously cleared versions. For the newly added indication (blood flow visualization with Fluorescein Sodium), the performance is implicitly accepted by demonstrating technical similarity and comparable indications for use with the reference device (Zeiss CONVIVO).

The relevant comparison tables are:

Table 7-2: Comparison of Predicate Device to Cellvizio® 100 Series system with Confocal Miniprobes™ with extended Indications for Use with Fluorescein Sodium contrast agent. This table highlights the technical, biological, and application/usage equivalence to the predicate device.

Table 7-3: Comparison of Indication for Use between the Subject Device and Previously Cleared Reference Device (Zeiss CONVIVO K181116). This table shows that the subject device has a "Similar Indication for Use for blood flow visualization with Fluorescein Sodium" compared to the reference device.

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

The document states: "Clinical demonstration based on literature review has been carried out to support this submission, as described in section 13." However, Section 13 is not provided in the input text. Therefore, specific details about the sample size of a test set, if any, and its data provenance (country, retrospective/prospective) are not available in the provided text. The submission primarily relies on demonstrating substantial equivalence rather than presenting new clinical study data with a distinct test set.

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

Since a specific test set with ground truth established by experts is not detailed in the provided text, this information is not available. The reliance is on existing literature and clinical findings.

4. Adjudication method for the test set:

Again, as a specific test set with expert ground truth is not detailed, the adjudication method is not available.

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:

The document does not mention nor describe any MRMC comparative effectiveness study or the use of AI. The device is an imaging system, and the submission is focused on extending its indications based on existing technology and literature.

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

The document describes the Cellvizio® 100 Series System as an imaging device that provides visualization. The context implies diagnostic aid for a human operator. There is no mention of a standalone algorithm or its performance.

7. The type of ground truth used:

The submission relies on "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and international independent Health Technology Assessment organizations" as mentioned in the summary. This suggests that the ground truth for the claims of blood flow visualization is derived from broad clinical experience and validated medical knowledge, rather than a single, prospectively established dataset with a specific ground truth method like pathology or expert consensus related to a new study.

8. The sample size for the training set:

As this is a submission for an imaging device and not an AI/ML algorithm that requires a "training set" in the traditional sense, information on a training set sample size is not applicable and not provided.

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

Similarly, as there's no mention of a training set for an AI/ML algorithm, this information is not applicable and not provided. The device's performance is intrinsically linked to its established optical and technical characteristics, as verified in previous clearances and further supported by a literature review for the extended indication.

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