(159 days)
The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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 Instructions for Use.
The working ends and elements of the Intuitive Surgical® da Vinci™ Surgical System, Endoscopic Instruments and Accessories are essentially identical in function, size and shape to the predicate devices referenced. They represent standard embodiments of standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
Device Acceptance and Study Information Summary
This 510(k) submission for the Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System and Endoscopic Instruments focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct acceptance criteria through a specific performance study against defined metrics.
The primary method of demonstrating equivalence is through "Design analysis and comparison" and "in vitro testing." No specific reported device performance values are provided for quantitative acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, formal acceptance criteria with numerical performance targets and reported device performance values are not explicitly stated. The core of the acceptance is based on demonstrating "substantial equivalence" to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in function, size, shape, and tissue effect to predicate devices for endoscopic procedures. | Confirmed through design analysis, comparison, and in vitro testing. |
| Intended Use as outlined for general laparoscopic, non-cardiovascular thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis. | The device meets the intended use as specified in the submission. |
2. Sample size used for the test set and the data provenance
The document states that "in vitro testing" was performed, but does not specify the sample size used for this testing. It also does not specify the data provenance in terms of country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The submission relies on "Design analysis and comparison" and "in vitro testing" rather than a clinical study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the submission focuses on in vitro testing and design comparison, adjudication methods typically associated with human interpretation of results (e.g., in imaging studies) are not applicable or 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. The device is a surgical control system and instruments, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The concept of "standalone" algorithm performance is not applicable to this device. The da Vinci™ System is an instrument control system intended to be used with human operators (trained physicians). It is not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since the primary method of evaluation was "design analysis and comparison as well as in vitro testing," the "ground truth" would likely be based on:
- Engineering specifications and performance standards: For the mechanical, electrical, and functional aspects validated during in vitro testing.
- Comparison to predicate device characteristics: The known performance and characteristics of the cited predicate devices served as a baseline for "substantial equivalence."
There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the "test set" in the context of this submission.
8. The sample size for the training set
This information is not applicable and not provided. The device is an instrument control system and instruments, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for this type of device.
§ 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.