(129 days)
The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip- ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
The da Vinci Sinale-Site Instruments and Accessories are a new set of devices developed by Intuitive Surgical to enable single incision cholecystectorny using the IS3000 da Vinci Si Surgical System.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to provide arasping, cautery, cutting, clip ligation and suction/irrigation functions. The instruments are non-wristed (similar to the predicate, laparoscopic instruments).
The da Vinci Single-Site Instruments and Accessories are intended to be used with the existina IS3000 da Vinci Si Surgical System.
This document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a new performance claim. Therefore, much of the requested information about acceptance criteria and study details for meeting them is not present. This type of regulatory submission primarily relies on showing that the new device operates similarly to existing, already-approved devices, rather than proving a new, quantitative performance benchmark.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given document. The 510(k) summary states, "Bench, animal, and clinical data demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or efficacy as compared to the predicate devices."
This indicates that internal design input verification and validation were performed, and a comparison to predicate devices was made, but specific quantitative acceptance criteria or detailed performance metrics against those criteria are not publicly disclosed in this summary. The focus is on substantial equivalence rather than meeting specific statistical performance targets for a novel claim.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given document. The document vaguely mentions "Bench, animal, and clinical data," but does not specify sample sizes for these tests or the provenance of the data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given document. For a 510(k) demonstrating substantial equivalence, ground truth as typically understood in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not a primary focus. The "bench, animal, and clinical data" would likely involve surgical outcomes, device functionality, and safety assessments, rather than expert interpretation of a test set in the conventional sense.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given the nature of the device (surgical instruments) and the regulatory pathway (510(k) for substantial equivalence), a formal adjudication method for a "test set" in the context of diagnostic interpretation is not applicable or described.
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
This information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, an MRMC study comparing human performance with/without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable to this device. As explained above, this is a set of surgical instruments, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly detailed beyond the mention of "bench, animal, and clinical data." For surgical instruments, "ground truth" would generally relate to successful completion of surgical tasks, device functionality validation, and patient outcomes (e.g., absence of complications, effective tissue manipulation, etc.) as observed during animal and clinical trials. It would not be expert consensus on imaging or pathology reports in the context of diagnostic devices.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable to this device, as there is no "training set" for surgical instruments in this context.
§ 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.