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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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The Cellvizio® I.V.E. 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 and vessels and their organization or architecture.

The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.

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 Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

The CholangioFlex™ N 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 N 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 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 Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Confocal Miniprobes™ are used with Cellyizio® I.V.E. 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 organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.

The provided text is a 510(k) Premarket Notification summary for the Cellvizio® I.V.E. system with Confocal Miniprobes™. This submission is primarily to extend the device's Indications for Use to include imaging blood flow in vascular areas when used with Fluorescein Sodium as a contrast agent.

Based on the document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., sensitivity, specificity, accuracy thresholds). Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices. The "performance" assessment is based on the device having the "same intended use," "same operating principle," "same technological characteristics," "same design," and "same biocompatible materials" as predicate and reference devices, especially in the context of the new expanded indication.

Therefore, the "acceptance criteria" are implied to be equivalence to the performance of the predicate and reference devices under the expanded use case (imaging blood flow with Fluorescein Sodium), as the core technology and hardware are unchanged.

2. Sample sizes used for the test set and the data provenance

The document explicitly states: "As no technical change is being made to the subject/reference device, all testing required has been provided in the previous submission (K193416)." And further, regarding co-packaging: "Therefore, no additional testing was performed for the co-packaging of Sodium Fluorescein with Cellvizio® I.V.E the Confocal Miniprobes™."

This indicates that no new clinical study or test set data was generated for this specific 510(k) submission (K212322). The basis for substantial equivalence is the prior clearance of the Cellvizio® I.V.E. system (K193416 as a reference device) and the Cellvizio® 100 Series system with Fluorescein (K191144 as a predicate device). The document does not provide details about the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) of the studies that supported those previous clearances.

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

Since no new human reading study or clinical test set was conducted for this submission (K212322), this information is not provided. The substantial equivalence argument relies on the inherent capabilities of the device, which were previously established and deemed safe and effective in earlier clearances.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study or human reading test set was conducted for this submission.

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

Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool for human readers, and no MRMC study was performed for this submission.

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

This refers to the performance of the device itself as an imaging system. The "performance" is demonstrated through its physical and optical characteristics (e.g., field of view, depth of observation, lateral resolution, real-time image visualization frequency), which are stated to be "Same" as previously cleared devices. The document essentially argues that the device's technical specifications and resulting image quality are equivalent to the predicate and reference devices, implying equivalent "standalone" performance. No new quantitative performance metrics (like accuracy against a ground truth for a specific disease) are presented as part of this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this specific 510(k), since the submission is based on substantial equivalence to existing devices and expanding an indication for an existing capability (blood flow imaging with a contrast agent), no new ground truth establishment is detailed. The performance of confocal endomicroscopy in general (the technology this device uses) is inherently about visualizing microstructures and blood flow. The "truth" would logically be the real-time images themselves, and in a clinical context, a physician's interpretation of those images in conjunction with other diagnostic information. For the original clearances of the predicate and reference devices, ground truth for imaging capabilities would typically involve:

• Physical/Optical Measurements: Demonstrating adherence to specifications for resolution, field of view, depth of observation.
• Bench Testing/Phantom Studies: Using known physical models to assess image quality.
• Pre-clinical (animal) and Clinical Studies: Demonstrating the ability to visualize the intended structures (cells, vessels, blood flow) in vivo, often compared to histological confirmation or other established imaging modalities if applicable to the initial clearances.

8. The sample size for the training set

Not applicable. This submission is for an imaging device, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable, as there is no AI algorithm being trained for this submission.

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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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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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Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems 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 their organization or architecture.

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).

AQ-Flex™ 19 Confocal Miniprobes™ is used with Cellvizio® 100 Series system to provide imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories. It is designed to be used during transbronchial needle aspiration (TBNA), endoscopic ultrasound transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures.

There are no changes in design, materials, or function between the subject AQ-Flex™ 19 device and the cleared AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844), except for the length of the AQ-Flex 19 which has been reduced from 4 to 3 meters (AQ-Flex™ 19 Confocal Miniprobe™ has previously been cleared with a length of 4 meters).

A locking accessory already available in the package of the predicate device is used as an aid to secure placement inside the needle used during EUS-FNA procedures and can also be used during TBNA, and EBUS-TBNA procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobe™ AQ-Flex™ 19:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily focuses on bench testing and compatibility assessments, not clinical performance studies with human data in the test set.

• Mechanical tests for sharp edges: 25 samples ("Pass (25/25)")
• Mechanical strength test (insertion/extraction and bending): 25 samples ("Pass (25/25)")
• Protrusion test: 5 samples ("Pass (5/5)")

The provenance of this data is not explicitly stated as country of origin, retrospective, or prospective. Given that these are primarily compatibility and mechanical tests, they are likely prospective bench tests conducted by the manufacturer.

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

The document does not mention human experts being used to establish ground truth for the "test set" in the context of clinical performance. The "ground truth" for the mechanical and compatibility tests would primarily be adherence to engineering specifications and international standards (like ISO 8600-1), which are verified by testers, not expert clinicians establishing a diagnostic truth.

4. Adjudication Method for the Test Set

Not applicable as the reported tests are primarily objective mechanical and compatibility tests against predefined criteria and standards, not subjective assessments requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study in this document. The device is a confocal laser imaging system for visualizing tissue microstructure, and the submission is for an expanded indication of use for an existing component (AQ-Flex™ 19 Confocal Miniprobe™) in specific endoscopic procedures. There is no AI component or human-in-the-loop performance evaluation described.

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

Not applicable. This device is an imaging tool that provides visual information to a human operator, not an AI algorithm performing a diagnostic task independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests reported is primarily:

• Adherence to engineering specifications and standards (e.g., ISO 8600-1 for smooth distal surface, absence of spikes/edges).
• Verification of mechanical integrity and functionality after stress tests.
• Compliance with safety standards (e.g., laser safety).
• Internal validation of performance characteristics (e.g., image quality, resistance to reprocessing).

There is no mention of clinical ground truth such as pathology or outcomes data in this submission for the expanded indication.

8. The Sample Size for the Training Set

Not applicable. This document describes the testing and validation for a hardware device and its accessories, not the development or training of an algorithm or AI system.

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

Not applicable, as there is no training set for an algorithm described in this document.

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The Cellvizio® 100 Series systems with Confocal Miniprobes™are confocal laser systems 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 CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures.

CranioFlex™ (-,-C) Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the brain through contact of their distal tip with the tissue. They are designed to be used and manually handled during neurosurgical procedures.

This document is a 510(k) Premarket Notification for the Cellvizio 100 Series Systems with Confocal Miniprobes, specifically the CranioFlex™ (-,-C) Confocal Miniprobes, for use in neurosurgical procedures.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria or performance metrics for an AI/algorithm-based device. The device described (Cellvizio with CranioFlex™ Miniprobes) appears to be an optical imaging system that provides direct visualization, not an AI or algorithm that interprets images or assists human readers. Therefore, many of the requested elements for AI acceptance criteria and studies (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for AI) are not applicable to this type of medical device submission.

The document primarily focuses on comparing the subject device's technological characteristics and intended use to a predicate neuro-endoscope and previously cleared reference devices from the same manufacturer.

Based on the provided text, here's an attempt to address the requested information, highlighting where the information is not applicable (N/A) due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for AI/algorithm-based devices (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to a predicate device. This is achieved through qualitative comparisons of design, materials, indications for use, and technological characteristics, along with verification that risks are acceptable and don't raise new questions of safety or effectiveness.

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

The document does not describe a "test set" in the context of an algorithm evaluation with a specific number of cases or data provenance. The assessment for this 510(k) is based on technical comparison and risk analysis, not a prospective clinical study with a defined test set.

• Sample Size for Test Set: N/A (Not an algorithm evaluation study requiring a test set of cases).
• Data Provenance: N/A (The submission primarily relies on design specifications, materials, and comparison to predicate/reference devices, along with in-house testing for sterilization and biocompatibility). There is a mention of a "clinical feasibility study published in a peer reviewed journal" being used to confirm risk assessment, but no details on size, type, or provenance of that dataset are provided.

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

N/A. As this is not an AI/algorithm-based device being validated against a ground truth dataset, this information is not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not applicable to this type of device submission.

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

N/A. This is not an AI-assisted diagnostic device; it's an imaging tool that provides direct visualization. Therefore, an MRMC study assessing AI assistance is not applicable.

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

N/A. This is a direct visualization device, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A. The "ground truth" for this submission is implicitly the safety and effectiveness of the legally marketed predicate device (KARL STORZ Flexible Video-Neuro-Endoscope System) and the established safety and performance of the manufacturer's own reference devices (GastroFlex™ Confocal Miniprobes). The CranioFlex™ Miniprobe is asserted to be fundamentally the same device as the GastroFlex™ but with an expanded indication for use into neurosurgery, hence the comparison to a neuro-endoscope predicate.

8. The sample size for the training set

N/A. This is not an AI/machine learning device.

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

N/A. This is not an AI/machine learning device.

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The Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™ are confocal laser systems 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™ (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 endoscope or 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™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.

The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

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

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.

The provided document is a 510(k) premarket notification for the "Cellvizio 100 Series System with Confocal Miniprobes™". It describes the device, its intended use, and argues for substantial equivalence to previously cleared devices.

Crucially, this document states that "As no change is being made to the devices, all testing required has been provided in previous submissions." It also notes that "Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14."

This K172844 clearance is an update to the Indications for Use based on existing data and literature, rather than presenting new primary study data for the device's performance against acceptance criteria. Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria for a new device or significant modification is not explicitly present in this document.

The document discusses the capabilities of the device in terms of optical resolution for imaging cells and vessels, referencing it as "proven optical resolution capabilities" and citing "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies." However, it does not provide the specifics of the studies that generated this evidence within this submission.

Therefore, many of your requested points about acceptance criteria and a study proving their achievement cannot be directly extracted from this particular 510(k) summary. This document is a re-submission leveraging prior clearances and general scientific understanding.

Based on the provided text, here's what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new study in this document. The device's "proven optical resolution capabilities" and ability to "image cells, vessels, and their organization or architecture" serve as implicit performance expectations, derived from prior clearances (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).
• Reported Device Performance: The document states that the device's "fundamental system capabilities in terms of optical resolution, field of view, etc. as compared to the size of cells and vessels are independent of anatomical location" and that "all of these Confocal Miniprobe™ capabilities are well above what is required to image cells, vessels, and their organization or architecture as described in Section 14." No specific numerical performance metrics are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not provided. The submission relies on "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies" and previous clearance data, rather than a new, specific test set for this particular submission.

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)

• Not explicitly stated in this document. The "independent clinical findings" mentioned imply expert input, but details on the number or qualifications of experts involved in prior studies or literature review are absent from this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided.

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

• Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance in the way an AI algorithm for image interpretation would. The document does not describe an MRMC study.

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

• Not applicable. This is a direct visualization device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The implicit ground truth for the device's performance relates to its ability to image the "internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture." This would typically be confirmed via a comparison to histology/pathology, or by expert observation using the device itself, but the specific studies and their ground truth methodology are not detailed in this summary. The mention of "Real World Evidence" and "clinical findings" suggests real-world diagnostic outcomes and expert interpretations.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. This is not an AI/machine learning device.

In summary, the provided document (K172844) is a regulatory submission focused on clarifying and expanding the Indications for Use of a previously cleared device. It relies on the substantial equivalence principle and existing evidence (prior clearances, literature review, and "Real World Evidence") rather than presenting new, detailed study results for acceptance criteria. Therefore, specific details about sample sizes, expert qualifications, and study methodologies for proving the device's performance against defined acceptance criteria are not contained within this specific document. These details would presumably be in the support documentation for the original clearances (e.g., K111047, K122042, etc.) or the referenced scientific literature.

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Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CelioFlex™ UHD Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.

CelioFlex™ UHD Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the internal microstructure of body cavities, organs, and canals through contact of their distal tip with the tissues. They are designed for use during laparoscopic surgical procedures, including robot-assisted procedures.

CelioFlex™ UHD Confocal Miniprobes™ have a "grabule" (previously cleared in K151593 and K160416) on their distal tip. The "grabule" has been designed as a grip for laparoscopic grasping accessories, facilitating user control of the miniprobe distal tip during conventional laparoscopic procedures while preventing potential wear to the Miniprobe tip that repeated handling by forceps might cause. The diameter of the "grabule" is fitted for insertion of CelioFlex™ UHD Confocal Miniprobes™ through trocars with diameter larger or equal to 5 mm.

CelioFlex™ UHD Confocal Miniprobes are also compatible with laparoscopy robot-assisted procedures. Robotic arm graspers can be used to manipulate CelioFlex™ UHD Confocal Miniprobes.

During robotic-asisted procedures, CelioFlex™ UHD Confocal Miniprobes™ are inserted through a pre-installed trocar. When the CelioFlex™ UHD distal end appears on the monitor. the surgeon uses the robotic accessory to grasp the distal part of the Confocal Miniprobe™ or "grabule", with the laparoscopic grasper to position the Confocal Miniprobe-TM facing the tissue to be imaged.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CelioFlex™ UHD Confocal Miniprobes™:

Acceptance Criteria and Device Performance

The provided documentation describes the acceptance criteria and performance for the CelioFlex™ UHD Confocal Miniprobes™ used with Cellvizio® 100 Series Systems, specifically focusing on their use during robot-assisted laparoscopic procedures.

Table 1: Acceptance Criteria and Reported Device Performance

Study Information

The document describes verifications and validations performed, primarily to demonstrate the substantial equivalence of the device for robot-assisted procedures, building upon previous clearances for conventional laparoscopic use.

1. Sample Size, Test Set, and Data Provenance:

   • Test Set Sample Size:
     • For the "Grasp and Release Test with grasping robotic accessory," 8 samples were used.
     • For the "Bend and Flexibility Test with grasping robotic accessory," 8 samples were used.
     • For the other tests (Biocompatibility, Reprocessing, Laser Safety, Imaging Quality, Trocar Compatibility), the specific sample sizes are not explicitly stated in this summary, but they are implied to be part of the predicate device submissions (K151593 and K160416).
   • Data Provenance: The studies described are prospective in nature, as they involve performing specific tests on the devices to assess their performance under defined conditions. The country of origin of the data is not specified, but the applicant's address is Paris, France.

2. Number and Qualifications of Experts for Ground Truth:

   • This document focuses on device performance and safety testing rather than diagnostic accuracy involving human experts. Therefore, the concept of "experts used to establish the ground truth" in a clinical diagnostic sense is not directly applicable here. The "Pass" results are based on meeting predefined engineering and safety requirements.

3. Adjudication Method for Test Set:

   • Again, this is not a clinical study involving human interpretation of results requiring adjudication. The tests have clear pass/fail criteria based on objective measurements and observations (e.g., "no loss of imaging performance or broken and/or loose components").

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This document pertains to the physical and functional performance of a medical device (endoscopic probe) and its safety for a specific surgical procedure, not the diagnostic accuracy or interpretative performance of a reading algorithm or human readers.

5. Standalone (Algorithm Only) Performance Study:

   • No, a standalone (algorithm only) performance study was not done. This device is a physical diagnostic tool (a confocal miniprobe) used by a surgeon, not an AI algorithm. The performance being evaluated is the physical integrity and imaging capability of the probe itself during manipulation.

6. Type of Ground Truth Used:

   • The "ground truth" used for these tests is based on engineering specifications, safety standards, and functional performance criteria. For example, the criteria dictate that the device must maintain imaging performance and not break or loosen components after specific manipulation cycles. This is not clinical pathology, expert consensus on diagnostic findings, or outcomes data in the usual sense for an AI diagnostic device.

7. Sample Size for Training Set:

   • There is no training set mentioned or implied, as this is not an artificial intelligence or machine learning device. The "training" in this context refers to the development and previous testing of the predicate devices.

8. How Ground Truth for Training Set was Established:

   • Since there is no training set, this question is not applicable.

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Cellvizio® 100 Series Systems with Confocal Miniprobes™ are systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CelioFlex™ UHD 5-C Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

CystoFlex™ UHD R-C Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

Confocal Miniprobes are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

Both CystoFlex UHD R-C and CelioFlex™ UHD 5-C have an achromatic UHD optical distal head that provide high resolution imaging for 488 to 785nm laser emission.

A "-C" suffix has been added to the commercial name of these Confocal Miniprobes compared to the predicate devices when used with a Cellvizio 100 Series (800) which has been previously cleared as Cellvizio 100 Series with F700-v2 system (K133466).

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

This document is a 510(k) summary for the Cellvizio® 100 Series Systems with Confocal Miniprobes™ (CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C). The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically CystoFlex UHD R (K141358) and CelioFlex UHD 5 (K151593), and the reference device Cellvizio 100 Series F700-V2 system (K133466), which has been re-named to Cellvizio 100 Series (800) with F800-V2.

Key takeaway: The document states that "No change is being made to the fundamental technology and operating principle of the previously cleared CystoFlex™ UHD R & CelioFlex™ UHD 5 Confocal Miniprobes." The suffix "-C" was added for commercial reasons when used with the Cellvizio 100 Series (800). Therefore, the acceptance criteria and performance data primarily refer to the studies previously conducted for the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a device that has "no change... to the fundamental technology and operating principle" of its predicate, the acceptance criteria and reported performance mirror those established for the original predicate devices (K141358 and K151593). The document explicitly states: "All the verification and validation testing were performed on predicate devices... and have shown that subject devices... meet the design specification and user needs." and "The result from these performance evaluations demonstrated that the CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C met the acceptance criteria defined in the product specification and performed comparably to the predicate device."

Study Information:

Since "all verification and validation testing were performed on predicate devices," the following answers refer to the studies for the predicate devices as implied by this submission. The provided document is a 510(k) summary, which generally summarizes existing data rather than providing full study protocols or detailed results. As such, specific details for some points are not explicitly stated in this summary.

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

• Sample Size: Not explicitly stated in this summary for each test. Testing would involve multiple units/samples for each specific test (e.g., multiple probes for reprocessing, multiple runs for biocompatibility tests).
• Data Provenance: Not explicitly stated, but typically these tests are conducted in controlled lab environments or testing facilities, often within the manufacturer's R&D or by certified third-party testing labs. The product is manufactured in France (Mauna Kea Technologies, 9 rue d'Enghien F-75010 Paris, France). It is reasonable to assume the testing was conducted in Europe or by international standards-compliant labs, but specific country of origin for the data is not given.
• Retrospective or Prospective: These are predominantly prospective verification and validation tests conducted to demonstrate compliance with standards and specifications for the initial clearance of the predicate devices.

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

• Not applicable/Not stated. The tests described are primarily engineering, electrical, optical, and biological safety tests against established international and national standards (ISO, AAMI, IEC, CFR). The "ground truth" is adherence to these quantifiable technical and safety standards, rather than expert interpretation of medical images. For functional tests, "qualified physicians" are mentioned for the intended use, but not for establishing ground truth of the technical performance tests themselves.

4. Adjudication method for the test set:

• Not applicable. These are technical and safety tests, not clinical performance studies requiring adjudication of medical diagnoses. The results are typically pass/fail against predetermined acceptance criteria based on industry standards and device specifications.

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. This device is an imaging system (confocal miniprobes), not an AI-powered diagnostic or assistive tool. It provides images of the "internal microstructure of tissues." The document describes technical performance and safety, not diagnostic efficacy or AI assistance.

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

• No. This device is an imaging hardware system. It does not contain an "algorithm only" component for standalone performance evaluation in the context of AI.

7. The type of ground truth used:

• Established Technical and Safety Standards: The ground truth for this device's performance is adherence to recognized international and national standards for medical devices, optics, laser safety, biocompatibility, and reprocessing (e.g., ISO, AAMI, IEC, 21 CFR).
• Internal Specifications: Company-defined specifications regarding device functionality, image quality (e.g., resolution using USAF test chart), and durability (e.g., number of uses) also serve as ground truth for acceptance.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endloscopic accessories.

The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endloscopic accessories.

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.

The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

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.

The Uroflex™B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscopic accessories.

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.

The CystoFlex UHD R Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

AlveoFlex™. ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, AQ-Flex™. UroFlex™ B and CystoFlex™ UHD R are Confocal Miniprobes which are compatible with specific high level disinfection and low temperature sterilization methods as described in the reprocessing instructions.

Materials, design and intended use of the aforementioned Confocal Miniprobes remain exactly the same as what were previously cleared in K111047. K122042. K123676. K132389 and K141358 respectively.

Low temperature sterilization methods will be added to the reprocessing instructions. Compatibility and efficacy of these methods with Confocal Miniprobes have been validated. The extent of validation testing relevant to this submission is provided below

• 1. Validation of an additional low temperature sterilization system (STERRAD 100NX EXPRESS) on AQ-Flex™ 19 (K123673), UroFlex™ B (K132389) and CystoFlex™ UHD R (K141358).
• 2. Validation of compatibility with low temperature sterilization systems (STERRAD 100S, and 100NX (EXPRESS)) with CholangioFlex™ (K122042), GastroFlex™ UHD, ColoFlex™ UHD and AlveoFlex™ (K111047).

Verification and validation testing confirm that GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™ Confocal Miniprobes™ can be reprocessed safely using STERRAD® sterilization systems 100S and 100NX (EXPRESS) according to reprocessing instructions.

The provided text describes a 510(k) premarket notification for a medical device family (Cellvizio 100 Series System with Confocal Miniprobes), specifically focusing on the addition of low-temperature sterilization methods to their reprocessing instructions. The primary study presented is a performance evaluation to confirm the compatibility and efficacy of these sterilization methods.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Family: Cellvizio 100 Series System with Confocal Miniprobes
(Including AQ-Flex™, UroFlex™ B, CystoFlex™ UHD R, ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, and AlveoFlex™)

Specific Device Performance:

• AQ-Flex™ 19, UroFlex™ B, and CystoFlex™ UHD R: "can safely and efficiently be reprocessed using STERRAD® 50, 200, 100S, 100NX EXPRESS and 100NX Duo cycles according to reprocessing instructions. Chemical resistance [material compatibility implied] as well as a sterility assurance level (SAL) of 10-$^6$ has been demonstrated."
• GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™: "Can be reprocessed using STERRAD® sterilization systems 100S, 100NX EXPRESS according to reprocessing instructions... The compatibility with these sterilization methods has been demonstrated." |
  | Functional Performance | Maintain mechanical (insertion/removal/tensile) & optical performance after reprocessing | Confirmed: "Functional testing post sterilization validation included visual assessment of component condition, insertion and removal tests, tensile strength and optical performance assessment." |
  | Biocompatibility | No unacceptable biological response after contact with reprocessed device | Confirmed: "Biocompatibility per relevant portions of ISO 10993-1" was tested for Cytotoxicity, Sensitization, and Irritation. The summary implies these tests were met as part of demonstrating safe reprocessing. |

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

• Sample Size: The document does not explicitly state the numerical sample size for the "test set" (i.e., the number of miniprobes subjected to the full battery of sterilization and functional tests). It refers to "the products" and specific models (AQ-Flex™ 19, UroFlex™ B, CystoFlex™ UHD R, GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™, CholangioFlex™). Typically, for sterilization validation, multiple units of each device type and/or material are tested.
• Data Provenance: The data is likely prospective as it involves specific validation testing for the new sterilization methods. There's no information about the country of origin of the data beyond the applicant being "Mauna Kea Technologies, F-75010 Paris, France."

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

Not applicable. This study focuses on validating physical and functional properties (sterilization efficacy, material compatibility, functional performance, biocompatibility) rather than a diagnostic performance where expert ground truth would be required. The "ground truth" here is objective measurements against established engineering and biological standards (e.g., SAL of $10^{-6}$, ISO 10993-1).

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving reader interpretations of images or data where a consensus among experts is needed to establish ground truth. This study involves laboratory validation.

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

Not applicable. This is not a study assessing AI performance or human reader performance. It's a technical validation study for reprocessing instructions of an endoscope accessory.

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

Not applicable. This device is not an AI algorithm. It is a medical device (confocal miniprobe) that requires human operation with an endoscope, and the study focuses on its physical properties after reprocessing.

7. The type of ground truth used

The ground truth used for this study is based on objective engineering and biological standards.

• Sterilization Efficacy: Sterility Assurance Level (SAL) of $10^{-6}$ as per industry standards and regulatory requirements. This is typically verified through biological indicator testing.
• Material Compatibility & Functional Performance: Performance against predefined specifications for visual integrity, mechanical function (e.g., tensile strength, insertion/removal forces), and optical performance after a specified number of reprocessing cycles.
• Biocompatibility: Conformance to relevant portions of ISO 10993-1 (e.g., passing tests for cytotoxicity, sensitization, irritation).

8. The sample size for the training set

Not applicable. This is a validation study for physical device properties, not a machine learning study that would involve training data.

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

Not applicable. As there is no training set for this type of validation, there is no ground truth established for it.

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