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da Vinci Fluorescence Imaging Vision System

Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Fluorescence Imaging Vision System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

da Vinci Firefly Imaging System

Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The da Vinci Fluorescence Imaging Vision System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci Si Surgical System. The da Vinci Fluorescence Imaging Vision System consists of enhanced, existing components of the da Vinci Si Surgical System: 8.5 mm or 12 mm endoscopes (0 degree or 30 degree) optimized for NIR fluorescence imaging, the 3D High-Definition (HD) stereoscopic camera head, the fluorescence-capable illuminator for use with the existing video processor unit (light source), and supporting software functions. There are no changes to the device components from the previously cleared version of the device (K210918).

The da Vinci Firefly Imaging System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci Xi and da Vinci X Surgical Systems. The da Vinci Firefly Imaging System consists of enhanced, existing components of the da Vinci Xi and da Vinci X Surgical Systems: an 8 mm endoscope (0 degree or 30 degree) optimized for NIR fluorescence imaging, the fluorescence-capable Endoscope Controller, and supporting software functions. There are no changes to the device components from the previously cleared version of the device (K210918).

The provided text is a 510(k) summary for the da Vinci® Fluorescence Imaging Vision System and da Vinci® Firefly Imaging System. It describes a labeling change to add interstitial administration of ICG for visualization of the lymphatic system.

Here's the information about acceptance criteria and studies as derived from the document:

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

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on demonstrating that the labeling modification (adding interstitial ICG administration for lymphatic visualization) has "no impact on the safety or effectiveness" of the device. The substantial equivalence argument is primarily based on the fact that no modifications are being made to the technological characteristics of the subject devices from a previously cleared version (K210918).

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 does not describe a new clinical study with a specific test set. This 510(k) is for a labeling change, not a new device or significant modification requiring extensive re-testing. The previous clearance (K210918) would have involved relevant performance data, but details are not provided in this specific document.

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, as a new test set and associated ground truth establishment were not part of this 510(k) submission for a labeling change.

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

Not applicable, as a new test set and adjudication for new performance claims were not part of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The described devices are imaging systems, not AI-powered diagnostic tools, and no MRMC study is mentioned in this submission.

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

Not applicable. The devices are imaging systems with a human operator (surgeon) in the loop for visualization.

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

Not explicitly stated in this document. Given that this is a labeling change based on an existing device, the "ground truth" for its original clearance (K210918) would likely have been established through a combination of clinical observation during surgical procedures using ICG, potentially corroborated by other intraoperative imaging methods or anatomical knowledge, to confirm accurate visualization of vessels, blood flow, and bile ducts. For the new indication (lymphatic system visualization), it relies on the known biological interaction of ICG with the lymphatic system when administered interstitially, and the device's ability to image this fluorescence.

8. The sample size for the training set

Not applicable. This submission relates to a labeling change for an already cleared device, not the development of a new algorithm requiring a training set.

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

Not applicable, as no new training set is described in this document.

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Da Vinci Fluorescence Imaging Vision System:

The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common hepatic duct), using near infrared imaging.

Fluorescence imaging of billary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for billiary duct visualization.

Da Vinci Firefly Imaging System:

The da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Firended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Two subject devices, the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System, are bundled in this submission.

The da Vinci Fluorescence Imaging Vision System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci Si Surgical System. The da Vinci Fluorescence lmaging of enhanced, existing components of the da Vinci Si Surgical System: 8.5 mm or 12 mm endoscopes (0 degree) optimized for NIR fluorescence imaging, the 3D High-Definition (HD) stereoscopic camera head, the fluorescence-capable illuminator for use processor unit (light source), and supporting software functions. There are no changes being made to the described components from the previously-cleared version of the device (K124031).

The da Vinci Firefly Imaging System is a fully-integrated, adjunct endoscopic imaging system for the da Vinci X Surgical Systems. The da Vinci Firefly Imaging System consists of enhanced, existing components of the da Vinci X Surgical Systems: an 8 mm endoscope (0 degree) optimized for NIR fluorescence imaging, the fluorescence-capable Endoscope Controller, and supporting software functions. There are no changes being made to the described components from the previouslycleared version of the device (K141077).

There are two changes being made between the subject devices. The two changes are equivalent for both the da Vinci Fluorescence Imaging Vision System and the da Vinci First change is that a Fluorescence Imaging Kit will no longer be included with the subject devices, this Fluorescence lmaging Kit includes cross-labeled indocyanine green (ICG) fluorescence imaging agent, and syringe trays. Historically, the ICG labeling by itself has not included indications for use with an imaging medical device. Therefore, as a part of the previous 510(k) clearances for the da Vinci Fluorescence Imaging Vision System (K124031) and the da Vinci Firefly Imaging System (K141077), ICG was cross-labeled by Intuitive to include indications for use with the predicate devices. The labeling of the imaging agent ICG (trade name SP) AGENT GREEN), as published on the FDALabel Database, now includes indications for use with a fluorescence imaging device.

The second change is that the user manuals for both devices have been revised. The fluorescence imaging-related content in the subject devices user manuals has been updated to remove references to the Fluorescence lmaging Kit, for consistency with the expanded ICG imaging agent indications for use.

The provided text is a 510(k) summary for the da Vinci Fluorescence Imaging Vision System and the da Vinci Firefly Imaging System. It describes the device, its intended use, and the changes made in this particular submission.

However, the summary explicitly states:
"Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The information required by this section is not applicable. The changes in this 510(k) are limited to the removal of the Fluorescence Imaging Kit and revised labeling. Based on the risk management assessment of these changes, no design verification or validation testing is required to ensure safe and effective performance of the subject devices."

This means that this specific 510(k) submission does not contain new studies or data to prove the device meets acceptance criteria. The submission is focused on minor administrative changes (removal of a kit and label revisions) to previously cleared devices. Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets them from this document.

To answer your request, I would need access to the original 510(k) submissions (K124031 for the da Vinci Fluorescence Imaging Vision System and/or K141077 for the da Vinci Firefly Imaging System) where the initial performance data and acceptance criteria would have been established.

Based on the provided text, I can only state that no new studies were conducted or reported for this particular 510(k) submission (K210918).

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The do Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The do Vinc® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the do Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The Intuitive Surgical da Vinci Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible light and near-infrared fluorescence imaging during minimally invasive surgery. The Intuitive Surgical do Vinci Fluorescence Imaging Vision System consists of the following elements in addition to the standard components of the IS3000 da Vinci SI Surgical System:

• . 12mm and 8.5 mm endoscopes (0 degree) optimized for NIR fluorescence imaging in addition to VIS imaging,
• . A 3D High Definition stereoscopic camera head optimized for NIR fluorescence imaging in addition to VIS imaging,
• . An illuminator for use with the video processor unit, and
• . A Fluorescence Imaging Kit [IndoCyanine Green (ICG) fluorescence imaging agent, aqueous solvent, and syringe trays]

Here's a breakdown of the acceptance criteria and study information for the Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document focuses on supporting an expanded indication for use—specifically, the visualization of extrahepatic biliary ducts. Therefore, the acceptance criteria are implicitly tied to the ability to visualize these ducts effectively and safely.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

• Prospective Study: 72 subjects undergoing robotic cholecystectomy procedures. A subset of 55 cases from this study was assessed by an independent reviewer. The country of origin is not explicitly stated. Given the submitter's location (Sunnyvale, CA) and the mention of a "single center US study," it's highly probable that the prospective study and its subset are U.S.-based. This was a prospective study.
• Published Literature: 96 subjects from three (3) different centers. The country of origin is not specified but could be international given "different centers." This would likely be a retrospective analysis of published data.
• Single Center US Study: 154 consecutive robotic-assisted cholecystectomy cases. This was a retrospective study from the U.S.

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

• Prospective Study: The operating surgeons identified the biliary ducts in the 72 subjects. For a subset of 55 cases, an "independent reviewer" performed an assessment. The exact number of operating surgeons or the independent reviewer's qualifications are not specified beyond "independent reviewer."
• Published Literature/Single Center US Study: The method of ground truth establishment and expert involvement for these datasets is not detailed in the summary, other than "demonstrated consistent visualization."

4. Adjudication Method

• For the prospective study, the primary assessment was by the operating surgeons. For a subset, an "independent reviewer assessment" was performed. It's unclear if there was a formal adjudication process (e.g., 2+1, 3+1 consensus) between these assessments or if the independent reviewer's assessment was a separate, singular evaluation. No explicit adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The summary does compare the device's performance to standard white light visualization, stating: "Fluorescence imaging enabled visualization of all three (3) ducts in a significantly higher percentage of cases as compared to standard white light visualization."
• However, it does not explicitly describe a formal MRMC study comparing human readers with AI assistance versus without AI assistance. The comparison is between two imaging modalities (fluorescence vs. white light), both interpreted by human surgeons.
• Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" cannot be determined from this text, as the device is an imaging system, not an AI for image interpretation. The device provides information to human readers.

6. Standalone (Algorithm Only) Performance

• No, a standalone (algorithm only) performance study was not done.
• The device is an imaging system intended for use by surgeons for real-time visualization. The summary explicitly states: "The device is not intended for standalone use for biliary duct visualization." and "The da Vinci Fluorescence Imaging Vision System is intended for adjunctive use only in conjunction with standard white light and, when indicated, intraoperative cholangiography (IOC) for extrahepatic biliary duct visualization."

7. Type of Ground Truth Used

• The ground truth for the test sets (prospective study, published literature, single-center study) was primarily based on expert visual identification of biliary ducts during surgery (by operating surgeons or independent reviewers), likely correlated with surgical findings and potentially intraoperative cholangiography (IOC) mentioned as a standard of care. There is no explicit mention of pathology or long-term outcomes data being used as ground truth for detection in this context.

8. Sample Size for the Training Set

• The summary does not mention a training set in the context of a machine learning algorithm. This device is an imaging system, not an AI-driven diagnostic or interpretative algorithm that typically requires a training set. The data presented are for evaluating the performance of the imaging system itself in visualizing structures in a clinical setting.

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

• As no training set is discussed or implied for an AI algorithm, this question is not applicable based on the provided text.

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The da Vinci® Fluorescence Imaging Vision System is intended to provide realtime endoscopic visible and near-infrared fluorescence imaging. The da Vinci® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging.

The Intultive Surgical da Vinci® Fluorescence Imaging Vision System is an endoscopic imaging system for high definition (HD) visible ilght and near-Infrared fluorescence Imaging during minimally invasive surgery. The Intuittve Surgical da Vincl® Fluorescence Imaging Vision System is a variation of the Intultive Surgical da Vincle SI Surgical System: Model IS3000 (K081137) with the following modified/additional components:

• 12mm endoscopes (0 degree or 30 degree) optimized for NIR . fluorescence Imaging In addition to VIS Imaging,
• A 3D High Definition stereoscopic camera head optimized for NIR . fluorescence imaging In addition to VIS Imaging,
• A new illuminator for use with the existing video processor unit, and ◆
• A Fluorescence Imaging Klt (IndoCyanine Green (ICG) fluorescence ● Imaging agent, aqueous solvent, and syringe trays)

The provided text describes the Intuitive Surgical da Vinci® Fluorescence Imaging Vision System, its intended use, and its equivalence to predicate devices, but it does not contain specific acceptance criteria or detailed study results beyond a general statement of verification and validation. Therefore, most of the requested information cannot be extracted directly from the given document snippets.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document states that "The results of verification and validation tests demonstrate that the da Vinci® Fluorescence Imaging Vision System components met their design and performance criteria and are substantially equivalent to the predicate devices." However, it does not specify what those criteria were nor does it report specific performance metrics (e.g., sensitivity, specificity, accuracy, or any quantitative measurements related to image quality or vessel visualization).

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

• Cannot be provided. The document mentions "verification and validation tests" but does not provide any details about the sample sizes, data provenance, or whether the tests were retrospective or prospective.

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)

• Cannot be provided. The document does not describe any studies involving human experts to establish ground truth for a test set. The validation seems to be focused on meeting technical design and performance specifications rather than clinical performance evaluated by experts.

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

• Cannot be provided. As no studies involving human experts or ground truth establishment are detailed, no adjudication method is mentioned.

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

• Cannot be provided. The document describes a medical device, not an AI or deep learning system that provides assistance to human readers in the traditional sense. It's a fluorescence imaging system. There is no mention of an MRMC study or AI assistance.

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

• Cannot be provided clearly. The device itself is an imaging system used by surgeons. Its "performance" would inherently involve a human surgeon viewing the images. The document states "The da Vinci® Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging." This implies human interpretation is part of its intended use. There's no mention of an "algorithm only" performance evaluation as typically understood for AI-driven diagnostic tools.

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

• Cannot be provided. There is no information about the type of ground truth used for performance evaluation, as detailed clinical validation studies are not described in the provided text. The "ground truth" for this device's validation appears to be its stated design and performance criteria, verified through technical tests, rather than a clinical ground truth like pathology for diagnostic accuracy.

8. The sample size for the training set

• Cannot be provided. The document describes a hardware and imaging system, not a machine learning or AI model that requires a training set.

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

• Cannot be provided. As there is no mention of a training set, this question is not applicable.

Summary of what the document does provide:

• Device Name: Intuitive Surgical da Vinci® Fluorescence Imaging Vision System
• Intended Use/Indications for Use: To provide real-time endoscopic visible and near-infrared fluorescence imaging. It enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infra-red imaging.
• Performance Data Statement: "The results of verification and validation tests demonstrate that the da Vinci® Fluorescence Imaging Vision System components met their design and performance criteria and are substantially equivalent to the predicate devices."
• Predicate Devices: Intuitive Surgical da Vinci® SI Surgical System: Model IS3000 (K081137) and Novadaq Spy Scope Intra-operative Operating System (KO91515).
• Conclusion: The device is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices based on design, technological characteristics, and a high-level summary of verification and validation that confirm the device meets its own design requirements and specifications. It does not usually include detailed clinical study protocols, acceptance criteria, or performance metrics in the way these questions are posed, especially for a device that is an imaging system and not an AI diagnostic algorithm.

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