(122 days)
da Vinci SP Surgical System, Model SP1098:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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.
da Vinci SP Instruments:
Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. 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 da Vinci SP Surgical System, Model SP1098, is a software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.
The provided FDA 510(k) Clearance Letter for the da Vinci SP Surgical System (K251324) does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.
This document is for a robotic surgical system, not an AI/ML software device for diagnostic or analytical purposes. The clearance focuses on hardware, software for controlling the hardware, and human factors related to the physical use of the surgical system.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics for an AI/ML algorithm or corresponding acceptance criteria.
- Sample sizes used for the test set and the data provenance: No test set, data provenance, or sample sizes related to an AI/ML model are mentioned.
- Number of experts used to establish the ground truth... and qualifications: Not applicable as there's no AI/ML model for which ground truth would be established by experts for performance evaluation.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes human factors evaluation related to the usability of the surgical system, not diagnostic performance with AI assistance.
- Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no standalone AI algorithm being cleared.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document mentions "Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject devices continue to meet design requirements and user needs" and "Human Factors Evaluation including usability validation has been conducted to demonstrate safety and effectiveness." These are general statements about software and usability testing for a medical device, but they do not detail the specific performance metrics, acceptance criteria, or study designs typically used for AI/ML devices as requested in the prompt.
§ 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.