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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 nearinfrared 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 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 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 Firefly Imaging System provides visualization in two modes: standard, visible-light imaging mode and a near-infrared fluorescence imaging mode, consisting of either a black-and-white surgical image or completely black background with the nearinfrared fluorescence depicted in a color overlay. For near-infrared fluorescence imaging, indocyanine green (ICG) fluorescence imaging agent is required.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size for the test set used in the "Delta validation testing" or "Delta design verification testing."

The data provenance is also not explicitly detailed. It can be inferred that the testing was conducted internally by Intuitive Surgical, Inc. as part of their design verification and validation processes. There is no mention of country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The provided text does not provide information regarding the number of experts used or their specific qualifications for establishing ground truth within these tests. The tests are described as "validation testing" and "design verification testing" against "design requirements and specifications" and "clinical applications test cases," suggesting an internal product-centric validation rather than a clinical ground truth established by external experts in an MRMC study.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method like 2+1 or 3+1. The description of testing ("met the acceptance criteria for all of the design requirements and specifications") implies a direct assessment against predefined engineering or performance metrics rather than a consensus-based review of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an imaging system (da Vinci Firefly Imaging System), not an AI-assisted diagnostic tool that directly aids human readers in interpretation. The filing describes a modification to an existing imaging system (change in excitation wavelength from 805nm to 785nm), and the testing focused on verifying the performance of this modified system against its design specifications and maintaining substantial equivalence. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system used during surgery, and its functionality involves providing real-time visible and near-infrared fluorescence imaging to surgeons. It is inherently a human-in-the-loop device as it provides visual information for a surgeon to interpret and act upon. The text does not describe any standalone algorithmic performance without human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the testing described appears to be based on engineering design requirements and specifications for the imaging system's performance, particularly related to the 785nm fluorescence system, illumination, and compatibility. It also references "Firefly Clinical Applications test cases," which suggests scenarios designed to evaluate the system's performance in clinical contexts, likely validated against anticipated imaging results or known technical benchmarks. It does not mention expert consensus, pathology, or outcomes data as the primary ground truth for this particular submission.

8. The Sample Size for the Training Set

The provided text does not mention a training set because this submission describes a modification to a medical device (an imaging system, specifically a change in laser wavelength) and not an AI/ML algorithm that would typically require a training set. The testing performed was for verification and validation of the hardware change.

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

Since there is no mention of a training set, the method for establishing its ground truth is not applicable to this document.

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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 da Vincil Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeous to perform minimally invasive suggedy 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), wing near infrared imaging.

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

The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the existing endoscopic imaging system as submitted in K131861 (cleared March 28, 2014) for high definition (HD) visible light and near-infrared fluorescence imaging during minimally invasive surgery. The da Vincie Firefly™ Imaging System utilizes the following existing components of the da Vinci Xi Surgical System:

• 8 mm 0° and 30° endoscopes (PNs 470026 and 470027) .
• Endoscope Controller (PN 372601) .

For near-infrared fluorescence imaging, the Fluorescence Imaging Kit is also required. The kits will be provided to the end user in an identical manner to the current supply and distribution chain for the predicate device. The kit is unchanged from K101077 (February 4, 2011)/K124031 (September 13, 2013).

• Fluorescence Imaging Kit (PN 950156) [Includes IndoCyanine Green (ICG) fluorescence . imaging agent, aqueous solvent, and syringe trays]

This document (K141077) describes the da Vinci® Firefly™ Imaging System, which is intended for real-time endoscopic visible and near-infrared fluorescence imaging during minimally invasive surgery. It allows for visual assessment of vessels, blood flow, related tissue perfusion, and major extra-hepatic bile ducts using near-infrared imaging. It is intended for use with standard white light and intraoperative cholangiography, but not for standalone use for biliary duct visualization.

Here's a breakdown of the acceptance criteria and supporting studies as presented in the document:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity/specificity/accuracy for the imaging system's clinical performance. Instead, it focuses on demonstrating that the device meets safety and effectiveness requirements through various tests. The acceptance criteria are implicitly that the device performs as intended, meets design requirements, and is substantially equivalent to predicate devices.

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

• Bench Testing: Sample sizes "up to 5 units" were used for design verification tests (Optical, Illumination, Mechanical, Environmental, Labeling). Data provenance is not explicitly stated but implies internal laboratory testing.
• Animal Testing:
  • Design Validation: Two labs were used, with one canine and one porcine.
  • Device Comparison: Two porcines were used.
  • Surgeon Evaluation: Four labs were used, utilizing canines or porcines.
  • Data provenance is from animal models (canine and porcine) in a simulated clinical setting. This is prospective testing.
• Human Factors and Usability Testing: 16 teams of users (surgeons and operating room staff) were involved. The study was conducted in a simulated operating room, which is a prospective test setting.

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

• The document mentions "independent, external surgeon evaluators" were used for the Animal Testing (Surgeon Evaluation) section. Four such surgeons served as evaluators.
• Their specific qualifications (e.g., years of experience) are not detailed other than being "independent, external surgeons".
• For bench and animal testing, "objective pass/fail criteria were defined in the protocol and used," implying internal expert definition, but specific numbers and qualifications are not provided.
• For human factors, 16 "teams of users (surgeons and operating room staff)" participated. Their specific qualifications are not detailed beyond their roles.

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

• The document does not explicitly describe an adjudication method like 2+1 or 3+1 for any of the testing.
• For the surgeon evaluations, it states "All evaluators completed at least one Firefly application to assess the various Firefly vision parameters." This suggests individual assessments, but no process for resolving discrepancies among the four evaluators is detailed. For other tests, "objective pass/fail criteria" were defined, implying a predetermined standard rather than expert adjudication of subjective outcomes.

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 involving human readers with AI assistance versus without AI assistance was not mentioned or performed.
• The device described is an imaging system, not an AI diagnostic tool. The "Firefly" system provides near-infrared fluorescence imaging. The "Device Comparison" in animal testing was a side-by-side comparison of image quality between the new device and a predicate device, not a comparison of human reader performance with and without AI assistance.

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

• The device is an imaging system used by surgeons in real-time. It is not an algorithm-only device that operates without human interaction.
• The product description explicitly states, "The device is not intended for standalone use for biliary duct visualization," meaning it's always used with human surgical intervention and standard white light. Therefore, no standalone (algorithm-only) performance testing would be relevant or performed.

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

• Bench Testing: Ground truth was based on pre-defined technical specifications and objective pass/fail criteria for dimensional, mechanical, functional, and electrical requirements.
• Animal Testing (Design Validation, Device Comparison, Surgeon Evaluation): Ground truth was based on:
  • Pre-defined test procedures and objective pass/fail criteria.
  • User needs and intended use documented in product requirements.
  • Comparison to the predicate device (IS3000 Firefly mode) for image quality.
  • Assessments by independent, external surgeon evaluators regarding clinically acceptable performance.
  • While not explicitly stated as "pathology" for, e.g., identifying bile ducts, the clinical assessment by surgeons in an animal model serves as the practical ground truth for the imaging system's utility in visualizing these structures in a surgical context.
• Human Factors and Usability Testing: Ground truth was based on whether the system allowed for "safe and effective use" during "typical workflow scenarios" and "troubleshooting scenarios related to safety-critical tasks" in a simulated environment, as assessed by observing user teams.

8. The sample size for the training set:

• The document describes performance testing for a medical device (an imaging system), not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable to this submission. The tests performed are for design verification and validation of hardware and integrated software.

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

• As noted above, this device does not involve a "training set" in the context of AI/ML. All ground truth establishment described (e.g., objective pass/fail criteria, surgeon assessments) pertains to testing and validation, not to the training of a machine learning model.

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