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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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