(291 days)
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.
§ 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.