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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 VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared 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, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared 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.

[VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200]
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

[VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR]
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.

[HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[TELESCOPE IR/ULTRA WAIR500A,WAIR530A,WAIR100A,WAIR130A]
These endoscopes are intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.

The subject devices OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB were cleared in 510(k) K190449. After clearances, no technological modification for the subject devices were made. Therefore, the above devices have been omitted from the device description in this pre-market notification.

CLV-S200-IR: This device consists of the source circuit, the control circuit, the illumination lamp, and the optical filter. The control circuit connects to the diaphragm to regulate the light intensity, the source circuit supplies the power to the illumination lamp, the operation panel and the rear panel. By switching on the illumination lamp, this device provides the light for endoscopic observation. This device regulates the endoscopic image brightness constantly from the video system center. The observation mode can be switched by the optical filter extracting the specific wavelengths.

WAIR100A, WAIR130A, WAIR500A, WAIR530A: The "IR" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "IR" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before the first and each subsequent use of the device, it must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "IR" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).

This document describes the VISERA ELITE II Infrared Imaging System components (Xenon Light Source, Telescopes, Video System Center, and Camera Heads). There is no explicit "device" (like an AI algorithm) for which acceptance criteria and a study proving the device meets those criteria are directly provided in the format you described.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device meets specific performance acceptance criteria for a new function. Therefore, much of the requested information regarding an AI study or specific performance metrics linked to acceptance criteria is not present.

However, I can extract information related to the device's validation and compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several types of performance testing and compliance with standards. It does not provide a table with quantitative acceptance criteria and corresponding reported performance values for a specific device feature that would typically be seen in an AI performance study (e.g., sensitivity, specificity for disease detection). Instead, it lists validation activities.

The subsequent points (2-9) are generally applicable to studies for AI/CADe devices and are not fully addressed by this document, which pertains to a general surgical imaging system rather than a specific AI-driven diagnostic or assistive tool.

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

• Test Set Sample Size: Not applicable. The document describes an animal study but does not specify a "test set" in the context of an AI algorithm evaluation. For the animal study, it mentions "canines and swines" but does not give a specific number of animals.
• Data Provenance: The animal study involved "canines and swines." It's a prospective study as it involved taking videos to validate performance. Country of origin is not specified.

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

• For the animal study videos, evaluation was done by an "independent Health Care Professional." The number of professionals and their specific qualifications (e.g., radiologist with X years of experience) are not detailed.

4. Adjudication method for the test set:

• Not specified. It only mentions evaluation by "an independent Health Care Professional."

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

• No MRMC or comparative effectiveness study involving human readers with and without AI assistance was described. This document is not for an AI-assisted device in that context.

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

• Not applicable. This device is an imaging system, not an AI algorithm. Its performance is demonstrated as an imaging tool used by surgeons.

7. The type of ground truth used:

• For the animal study, the "ground truth" for demonstrating substantial equivalence in IR observation was based on the performance observed and evaluated by a healthcare professional in a simulated body environment. This is closer to expert assessment/observation in a controlled animal setting, rather than pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary:

This 510(k) pertains to an endoscopic imaging system. It demonstrates substantial equivalence to predicate devices through various engineering, safety, and limited performance tests (bench and animal study). It does not involve a software-based AI algorithm for image interpretation or diagnosis that would typically require validation against a test set with established ground truth by multiple experts. Therefore, many of the requested points related to AI device evaluation are not applicable or cannot be extracted from this document.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

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 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 da Vinci Xi 8 mm Endoscope was originally cleared under K131861 on March 28, 2014, for use with the da Vinci® Surgical System, Model IS4000. Additional features and indications were cleared under K141077 on August 12, 2014, to add the da Vincio Firefly" Imaging System. The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the endoscope submitted in the original 510(k) K131861 for high definition (HD) visible light imaging and near-infrared fluorescence imaging during minimally invasive surgery.

This document is a 510(k) premarket notification for a medical device, specifically the da Vinci Xi 8mm Endoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than proving a new device's independent safety and effectiveness through clinical trials with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the information requested in your prompt (acceptance criteria for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment) is not present in this regulatory document. This document primarily describes design verification and validation for physical and functional characteristics of an endoscopic device, not an AI/ML diagnostic or prognostic tool.

The "Performance Data" section (page 4) lists general categories of bench testing performed:

• Optical
• Illumination
• Mechanical
• Temperature
• Electrical
• Hardware/software compatibility
• Functional
• Reliability/life
• Labeling

It states that "Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use." And "Design Validation Testing was performed to confirm that the design modifications to the predicate device do not raise new questions of safety and effectiveness."

In summary, this document does not contain the type of AI/ML performance data, acceptance criteria, or study design details that your prompt is asking for. It's a regulatory submission for an updated surgical endoscope, not an AI-powered diagnostic device.

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