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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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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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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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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.

Ask a specific question about this device

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.

CelioFlex™ UHD 5 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.

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.

CelioFlex™ UHD 5 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. The CelioFlex™ UHD 5 confocal Miniprobe is a CystoFlex™ UHD R Confocal Miniprobe with an additional "Grabule" component and with an optical fiber of 3 meters vs. 2 meters. The Grabule is a metallic part glued to the distal tip and the adjacent part of the sheath of the CelioFlex™ UHD 5 Confocal Miniprobe. The Grabule has been designed as a grip for laparoscopic forceps, facilitating user control of the Miniprobe distal tip during laparoscopic procedures. Both the stainless steel 316L metal comprising the Grabule and the epoxy glue (Epotek 301) used to cement the Grabule to the Miniprobe are currently used in the CystoFlex™ UHD R Miniprobe reference device. The Grabule shields the Miniprobe tip from potential wear that repeated handling by forceps might cause.

During standard laparoscopic procedures, CelioFlex™ UHD 5 Confocal Miniprobe is inserted through a pre-installed trocar. When the CelioFlex™ UHD 5 appears on the laparoscope monitor, the surgeon grasps the distal tipped Grabule with the laparoscopic fenestrated forceps to position the Confocal Miniprobe facing the tissue to be imaged.

The provided text is a 510(k) summary for the CelioFlex™ UHD 5 Confocal Miniprobe. It describes the device, its intended use, and its comparison to predicate and reference devices. However, it does not contain a study that demonstrates the device meets specific performance acceptance criteria related to its imaging capabilities or a comparison to a gold standard of truth for diagnostic accuracy.

The "Testing Completed" section lists engineering and manufacturing verification and validation tests, not clinical performance studies with acceptance criteria for diagnostic accuracy. These include:

• Sterilization Efficacy Verification: "All requirements met, Test Passed"
• Reprocessing Sterilization Validation: "All requirements met, Test Passed"
• Biocompatibility (Cytotox) Validation: "All requirements met, Test Passed"

These tests confirm that the device is safe and functions as intended from a manufacturing and material perspective, and that additions like the "Grabule" and increased fiber length do not compromise these aspects. They are not performance metrics for diagnostic accuracy or imaging quality in a clinical context that would typically involve acceptance criteria like sensitivity, specificity, or image resolution compared to a "ground truth".

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of diagnostic performance, as such a study is not present in the provided document.

To directly answer your numbered points based on the provided text's limitations:

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

   • No acceptance criteria for diagnostic accuracy/imaging performance are provided.
   • The reported device performance relates to manufacturing and safety conformity:
     • Sterilization Efficacy Verification: All requirements met, Test Passed
     • Reprocessing Sterilization Validation: All requirements met, Test Passed
     • Biocompatibility (Cytotox) Validation: All requirements met, Test Passed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as detailed clinical performance studies for diagnostic accuracy are not described in this summary. The "tests" mentioned are likely lab-based engineering/manufacturing verification.

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 applicable. "Ground truth" in the diagnostic sense is not established in the described testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 endoscope component, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable, as this summary does not describe an AI/ML device or its training.

9. How the ground truth for the training set was established: Not applicable.

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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 endoscopic accessories.

The subject device, "Cellvizio® 100 Series F700-v2 system with Confocal Miniprobes" operates in the same way as the predicate devices in order to provide confocal images of the internal microstructure of tissues in anatomical tracts. The only difference between the devices is the laser used for imaging at 785nm, along with the filters that have been adapted to this wavelength. The Cellvizio® 100 Series F700-v2 system is equipped with a laser emitting at 785nm whereas predicate devices are equipped witha laser emitting at 488nm or 660nm.

Here's a breakdown of the acceptance criteria and study information for the Cellvizio® 100 Series System with Confocal Miniprobes™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify sample sizes for test sets in terms of patient data or image data. The performance data primarily relies on engineering and regulatory compliance testing.

The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated beyond stating "Performance Data on which Substantial Equivalence is Based". Given the nature of the tests (laser safety, electrical safety, spectral sensitivity, software validation), these are typically conducted in a laboratory setting by the manufacturer or accredited testing facilities.

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

This information is not provided in the document. The study described focuses on technical and regulatory compliance rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or described in this document as the evaluation is based on technical specifications and functional equivalence, not on clinical performance requiring expert consensus on a test set.

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

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety/performance testing, not on comparative clinical effectiveness with or without AI assistance. The document is for a device that provides images, and the "AI" aspect (if any) is not discussed in terms of improving human reading.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is an imaging system (endoscope and accessories) that produces images for human interpretation. There is no mention of an "algorithm only" or standalone performance study as there isn't an explicit algorithm being independently evaluated separate from the human-in-the-loop use. The primary focus is the performance of the hardware (laser, filters, electrical components, software) to produce images.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on established engineering standards and regulatory requirements. For example:

• Laser Safety: Ground truth is defined by the limits and specifications in IEC 60825-1:2007 and 21 CFR Part 1040.
• Electrical Safety: Ground truth is defined by the requirements in IEC 60601-1 series.
• Spectral Sensitivity: Ground truth would be the expected or specified spectral response of the system.
• Software Validation: Ground truth is the software design specifications and expected functionality.
• Image Quality: The ground truth for "similar image performance" is qualitative comparison against the predicate device's known image output.

It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

The document does not mention a training set. This type of submission (510(k) for a hardware modification) does not typically involve machine learning or AI models that require training sets in the computational sense. The "software validation" mentioned refers to traditional software engineering validation, not AI model training.

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

As there is no training set mentioned, this question is not applicable to the provided document.

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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 endoscopic accessories.

Cellvizio® 100 Series is a confocal laser imaging system with a variety of fiber optic probes (Confocal Miniprobes™) that is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory, accessed through an endoscope. Cellvizio® 100 Series is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers which is the raw component of the Confocal Miniprobes™. Cellvizio® 100 Series is composed of several components, including: Main opto-electronical components: Laser Scanning Unit (LSU) Confocal Miniprobes™ Confocal Processor with Cellvizio® Software Peripherals: Foot-switch Keyboard Trackball Screen Video converter lsolation transformer User documentation: Cellvizio® 100 Series System User Guide, Confocal Miniprobes™ User Guide and Reprocessing Instructions Accessories (such as Cletop-S Confocal Miniprobes™ connector cleaning system, Confocal Miniprobes™ clip, storage box, caps, späre fuses) All components are integrated into a cart.

The provided document describes a Special 510(k) submission for the Cellvizio® 100 Series, focusing on device modifications. This type of submission is used when changes do not alter the scientific premise, technological characteristics, or intended use of the device, implying that the established performance criteria from previous clearances (K051585 and K061666) are still valid. The submission primarily aims to demonstrate that the upgrades do not introduce new concerns regarding safety or effectiveness and do not affect image quality and imaging performance compared to the predicate devices.

Therefore, the document does not contain a specific study designed to prove the device meets new acceptance criteria for diagnostic performance, nor does it provide a table of acceptance criteria with reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity). Instead, the performance evaluation is focused on maintaining equivalence with predicate devices through bench testing.

Here's an attempt to answer the questions based on the available information, noting where specific details are not provided:

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

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or present a table comparing such criteria to reported device performance.
Instead, the performance evaluation is focused on demonstrating that "the upgrades made to the system do not introduce any new concerns related to the safety or effectiveness compared to the predicate devices" and that "both software and hardware updates do not affect image quality and imaging performance."

The implicit acceptance criteria are that the Cellvizio® 100 Series performs equivalently or better than the predicate devices (Cellvizio® F-400 System (K051585) and Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (K061666)) in terms of safety, effectiveness, image quality, and imaging performance.

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

The document mentions "bench testing" using "representative tissue samples." It does not specify the sample size of these tissue samples. There is no information regarding the country of origin of the data or whether the testing was retrospective or prospective in a clinical setting.

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)

The document refers to "comparison of images obtained in bench testing." It does not specify if experts were used to establish a ground truth for these images, nor does it mention the number or qualifications of any potential experts. Given it's a Special 510(k) for device modifications, the focus is on technical equivalence rather than establishing new clinical diagnostic accuracy with expert-derived ground truth.

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

No details on an adjudication method are provided, as the testing described is technical bench testing rather than a clinical study requiring adjudicated interpretations.

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 MRMC comparative effectiveness study is mentioned. The device described is an imaging system, not an AI-assisted diagnostic tool in the context of this submission. The product "Cellvizio" is a confocal laser endomicroscope used for direct visualization of tissue microstructure.

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

This question is not applicable. The Cellvizio® 100 Series is an imaging system that provides images for human interpretation, not a standalone diagnostic algorithm.

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

For the "representative tissue samples" used in bench testing, the ground truth for image quality and performance would likely be based on technical specifications and visual comparison by engineers or trained personnel, ensuring the images generated by the modified device are comparable to those from the predicate device. There is no indication of clinical ground truth (e.g., pathology) being established for these samples in this specific submission.

8. The sample size for the training set

This question is not applicable. The document describes an imaging system, not an AI/ML algorithm that requires a training set.

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

This question is not applicable, as no training set for an AI/ML algorithm is described.

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