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The 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 is indicated for in vascular areas, including microvasculature and capillaries.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug.

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

The AlveoFlex™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories.

The CholangioFlex™ (-, -C) Confocal Miniprobes™ are 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 (-, -C) Confocal Miniprobes™ are 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 but not limited to EUS-FNA, EBUS-TBNA and TBNA).

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

The CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.

Confocal Miniprobes™ are used with Cellvizio® 100 series (F800) system, 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 orqanization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

To achieve this function, the Cellvizio® 100 series system F800 with its Confocal Miniprobes™ has been designed:

• . To excite fluorescent components within the human tissue with the laser light emitted by the Cellvizio® at 785nm.
• To receive fluorescence signal emitted from tissue microstructures within the spectral detection . bandwidth of the Cellvizio® 800-905 nm.

ICG absorbs light in the near-infrared (NIR) region within a range of 780 nm to 805 nm with a peak absorption of 805 nm and emits fluorescence within a range of 810 nm to 850 nm with a peak emission of 820 nm (cf. ICG labeling).

Therefore, the Cellvizio® 100 series system F800 can excite ICG circulating in the vascular and lymphatic systems and image signal emitted by ICG in these two systems.

Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with a peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm (cf. Pafolacianine Sodium labeling).

Therefore, the Cellvizio® 100 series F800 model can:

• A excite ICG in the vascular system or the Ivmphatic system and image signal emitted by ICG in the vascular system or the lymphatic system after ICG has been administered to the patient according to its approved labeling.
• A excite pafolacianine or tissues that have taken up pafolacianine and image signal emitted by pafolacianine or tissues that have taken up pafolacianine after pafolacianine has been administered to the patient according to its approved labeling.

The provided text describes a 510(k) premarket notification for the Cellvizio® 100 series system, which is a confocal laser system with fiber optic probes intended for imaging the internal microstructure of tissues. This submission asserts substantial equivalence to a predicate device (VS3 Iridium System, K210265) and a reference device (Cellvizio 100 Series System with Confocal Miniprobes, K191144).

However, the provided text does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for the device's capability to image internal microstructure, ICG, or pafolacianine. Instead, the "proof" the device meets its intended use is demonstrated through a comparison to predicate and reference devices, and through various performance testing studies, implying that the device performs comparably to or as described for these existing cleared devices.

Given this, I will infer the "acceptance criteria" based on the successful comparability shown in the performance testing and the claim of substantial equivalence. The study proves the device meets (implicitly defined) acceptance criteria by demonstrating its functional equivalence to previously cleared devices for imaging various tissues and contrast agents.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for Cellvizio® 100 series system with Confocal Miniprobes™

The Cellvizio® 100 series system with Confocal Miniprobes™ is intended to allow imaging of the internal microstructure of tissues, including the identification of cells, vessels, and their organization or architecture. For the F800 model, it also includes imaging with ICG and pafolacianine contrast agents. The acceptance criteria are implicitly defined by demonstrating comparability to the predicate and reference devices in their stated functions, and by successful outcomes in various performance tests.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, the "study" proving the device meets acceptance criteria primarily relies on:

• Bench Testing: Demonstrating the device's fundamental capabilities with contrast agents.
• Animal Studies: Showing in vivo performance specifically for pafolacianine.
• Clinical Studies (literature review): Referencing existing studies using the F800 model with ICG.
• Comparison to Predicate/Reference Devices: Highlighting identical or comparable characteristics and performance parameters.

Here's the breakdown of the additional requested information:

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

• Bench Testing (F800 with ICG/Pafolacianine):
  • Sample Size: Not explicitly quantified in terms of number of samples or runs, but refers to "different concentrations" for in vitro imaging of ICG and pafolacianine, and "human cervical carcinoma cell line" for pafolacianine.
  • Data Provenance: In vitro data, likely internal company data or performed by a certified lab. Country of origin not specified.
  • Retrospective/Prospective: Not specified, but generally bench testing results are reported as part of a prospective submission process.
• Animal Testing (F800 with Pafolacianine):
  • Sample Size: "tumor-bearing mice in vivo" - specific number of mice not quantified.
  • Data Provenance: Animal study data. Country of origin not specified.
  • Retrospective/Prospective: Not specified, but generally animal studies for regulatory submissions are prospective.
• Clinical Testing (F800 with ICG):
  • Sample Size: "Five (5) studies have been reported." Sample sizes within these five studies are not detailed.
  • Data Provenance: Clinical studies conducted using the Cellvizio® 100 series F800. Country of origin not specified, but likely international as it's a global company.
  • Retrospective/Prospective: The text mentions "studies have been reported," implying they are existing, likely retrospective literature reviews.

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

• Not explicitly stated. For bench and animal studies, "ground truth" would be established through laboratory controls, known concentrations, and histological/pathological analysis confirming tumor presence or cellular structures. For the clinical studies mentioned, the "ground truth" would be based on the clinical diagnosis and assessment from the original studies. The qualifications of the individuals interpreting the images or establishing ground truth are not provided in this summary.

4. Adjudication Method for the Test Set:

• None explicitly mentioned for the reported studies. For the clinical studies (literature review), the adjudication method would depend on the methodology of those individual studies.
• For the bench and animal tests, the results are presented as direct observations ("capable of imaging," "demonstrated adequate resolution and sensitivity").

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:

• No, an MRMC comparative effectiveness study was not done. This device is an imaging system providing real-time visualization of microstructure; it's not an AI-powered diagnostic algorithm designed to assist human readers in image interpretation or to provide automated diagnoses. Therefore, this type of study is not applicable.

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

• Not applicable. This device is a live imaging system used by a human operator; it is not an algorithm for standalone image analysis or diagnosis. Its performance is inherent in its ability to capture and display microscopic images.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Bench Testing: Known concentrations of ICG/pafolacianine, known cell lines (human cervical carcinoma).
• Animal Testing: Likely a combination of in vivo imaging correlated with ex vivo histological/pathological analysis of targeted cells/tissues to confirm pafolacianine uptake and tumor presence.
• Clinical Testing (literature review): The "clear visualization of the cellular cytoarchitecture" in these studies would imply clinical assessment and potentially correlation with biopsy/pathology, depending on the individual study designs. The document does not specify the exact ground truth methodology for these reported studies.

8. The Sample Size for the Training Set:

• Not applicable. This is a medical imaging device, not an AI/ML algorithm that requires a training set. The device's functionality is based on its optical and laser engineering.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, there is no training set for this device.

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