(303 days)
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical da Vinci Si Surgical System, model IS3000 (also known as the Endoscopic Instrument Control System) is a modification of the existing da Vinci S Surgical System, model IS2000. Essentially, the IS3000 is an updated and enhanced version of the existing IS2000 device. The new IS3000 provides a more intuitive user interface and improved ease-of-use. Overall, the model IS3000 is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The IS3000 consists of the following 3 main components: Surgeon Console (model SS3000), Patient Cart (model PS3000), and Vision System Cart (model VS3000).
The provided 510(k) summary for the Intuitive Surgical da Vinci Si Surgical System (Model IS3000) does not contain information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics in the way typically expected for AI/ML-based medical devices or diagnostic tools.
Instead, this submission is for an updated version of an existing surgical system, establishing substantial equivalence to a predicate device (da Vinci S Endoscopic Instrument Control System, Model IS2000). The focus is on demonstrating that the new model (IS3000) does not raise new safety or effectiveness issues and is substantially equivalent to legally marketed devices.
Therefore, many of the requested categories for AI/ML device evaluations are not applicable or not provided in this regulatory document.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety and Effectiveness Equivalence: The device does not raise any new safety or effectiveness issues compared to the predicate device. | "The Intuitive Surgical da Vinci Si Surgical System (model IS3000) does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed computer-controlled surgical instrument systems..." |
| "All testing yielded acceptable results and was comparable to the predicate device." | |
| Compliance with Technical Standards: The device meets applicable technical and FDA-recognized consensus standards. | The IS3000 complies with applicable portions of: |
- UL/IEC 60601-1:1988, Amendment A1: 1991-11, Amendment A2: 1995 (Medical Electrical Equipment - Part 1: General requirements for safety)
- IEC 60601-1-1:2000 (Medical Electrical Equipment - Part 1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems)
- IEC 60601-1-2:2001 (Medical Electrical Equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility - requirements and tests)
- IEC 60601-1-4:2000 (Medical Electrical Equipment - Part 1: General requirements for safety; Collateral standard: Programmable electrical medical systems)
- IEC 60601-2-2:1998 (Medical Electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment)
- IEC 60601-2-18:1996, Amendment A1: 2000 (Medical Electrical Equipment - Part 2: Particular requirements for the safety of endoscopic equipment) |
| Functional Equivalence: Improvements in user interface and ease-of-use do not compromise the fundamental function or safety of the device and its components (Surgeon Console, Patient Cart, Vision System Cart, EndoWrist Instruments). | The IS3000 is described as "an updated and enhanced version of the existing IS2000 device" with "a more intuitive user interface and improved ease-of-use." The components serve the same fundamental purpose as the predicate. "There are no changes to the EndoWrist Instruments in this submission." |
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 mentions "Performance (bench) testing was conducted on the IS3000." However, it does not provide details on the sample size used for this testing, the specific test cases, or the provenance of any data (as it's a surgical system, not a data-driven diagnostic in the AI/ML sense). It's bench testing, implying laboratory-based functional assessments rather than patient data.
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. Ground truth, in the context of an AI/ML diagnostic's test set, is not a concept relevant to the type of bench testing described for this surgical system. The "truth" would be determined by engineering specifications and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication of results or images.
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. This is a surgical control system, not an AI-assisted diagnostic or image interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a surgical system designed for human-in-the-loop operation by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for bench testing typically refers to engineering specifications, design requirements, and established performance parameters of the predicate device (IS2000). Compliance with these, and with technical standards, would form the basis of the "truth."
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI/ML algorithm that is "trained" on a dataset. The "training" for such a system would involve engineering design, development, and iterative testing.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML algorithm with a traditional training set.
§ 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.