(259 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance (Proxies) |
|---|---|
| Visualize at least one extrahepatic biliary duct. | At least one (1) biliary duct identified with fluorescence imaging in 100% (72/72) of subjects in the prospective study. |
| Acceptable identification rate by an independent reviewer. | At least one extrahepatic biliary duct identified in 98.2% (54/55) of subjects by an independent reviewer in a subset of the prospective study cases. |
| Superiority/Consistency over White Light for Bile Duct Viz. | Fluorescence imaging enabled visualization of all three (3) ducts in a significantly higher percentage of cases compared to standard white light visualization. |
| Comparable Safety Profile. | Comparable safety profile for extrahepatic biliary duct visualization compared to white light visualization. |
| Substantial Equivalence to General Vessel Visualization. | Data supports substantial equivalence of "extrahepatic biliary duct visualization" to the cleared general indications for "visual assessment of vessels." |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.