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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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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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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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