The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) 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, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, 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, gynecologic laparosopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. 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 Professional Instructions for Use.

Device Description

The subject da Vincio Xi™ Surgical System (Model IS4000) with the Integrated ESU (IESU) feature has the same design and components as the predicate da Vincio Xi™ Surgical System, with a software modification to enable communication between the Surgeon Console (Model SS4000) and the ERBE ESU Model VIO dV mounted on the Vision Cart. Software changes to the ERBE ESU Model VIO dV that enable communication with the da Vinci Xi Surgical System (Model IS4000) have been submitted to FDA under K150364.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "da Vinci Xi Surgical System" with an Integrated ESU (IESU) feature. While it discusses performance data in a general sense, it does not provide specific acceptance criteria or a detailed study report with quantitative results. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an attempt to answer your questions based on the available information, noting where information is explicitly not present:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary states "Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet the design input requirements and that the subject device is safe and effective for its intended use." However, it does not specify what those design input requirements (acceptance criteria) were or the quantitative performance results against them.

2. Sample size used for the test set and the data provenance

The document mentions "test cases specific to the software-enabled Integrated ESU control" and "a tissue model" for design validation. It also refers to a "summative usability validation study."

Sample size for the test set: Not explicitly stated.
Data provenance: The testing was conducted by Intuitive Surgical, Inc. on their device. It can be inferred that the data is prospective as it was generated specifically for this submission. The country of origin is the US, where Intuitive Surgical is based.

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. The document states that a "tissue model" was used for design validation and a "summative usability validation study" was conducted. It refers to "intended users" in the human factors study.

Number of experts: Not provided.
Qualifications of experts: Not provided. For human factors, it generally implies surgeons or operating room personnel who are "intended users."

4. Adjudication method for the test set

This information is not provided.

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

No, a multi-reader multi-case comparative effectiveness study is not mentioned. This submission is for a surgical system, not an AI-assisted diagnostic tool for "human readers." The "AI" in this context refers to the software controlling the surgical instruments and the integrated ESU. The human factors study evaluates the safety and effectiveness of the device when used by humans, not the improvement of human performance with the AI in a comparative sense, but rather the usability of the system itself.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable in the traditional sense of a diagnostic algorithm. The device, the "da Vinci Xi Surgical System," is inherently a human-in-the-loop system. The software modifications are for controlling the ESU from the surgeon console, which is part of the human-controlled surgical system. Therefore, a "standalone algorithm only" performance study would not be relevant or possible for this type of device.

7. The type of ground truth used

For the design validation related to ESU control, a "tissue model" was used. For the human factors study, the "intended use environments and in the foreseeable use scenarios" imply evaluating the actual use of the system by "intended users" (surgeons/OR staff).

Tissue model: This would likely involve observing the effect of the electrical current on biological tissue, implying a form of empirical observation or experimental outcome.
Human Factors: The "ground truth" for human factors is typically the successful and safe execution of tasks by users in simulated or real-world scenarios according to predefined safety and efficacy criteria. This is based on expert consensus of what constitutes safe and effective use.

8. The sample size for the training set

This information is not provided and likely not applicable in the AI/ML sense. The "training set" for the software in this context refers to the development and testing of the software itself rather than a machine learning model that is "trained" on a large dataset of patient images or outcomes. It's a traditional software development and verification process.

9. How the ground truth for the training set was established

This information is not provided and likely not applicable in the AI/ML sense. The ground truth for software development usually refers to the functional requirements and specifications that the code is designed to meet, established through engineering design processes.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Intuitive Surgical Ms. Crystal Ong Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K152892

Trade/Device Name: da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: March 29, 2016 Received: March 30, 2016

Dear Ms. Ong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152892

Device Name da Vinci Xi Surgical System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Crystal OngRegulatory AffairsPhone Number: 408-523-8636Fax Number: 408-523-8907Email: crystal.ong@intusurg.com
Date Summary Prepared:	April 29, 2016
Trade Name:	da Vinci® Xi Surgical System
Common Name:	System, Surgical, Computer Controlled Instrument
Classification:	Class II - 21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY, GCJ
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	K131861 – da Vinci® Xi Surgical System

Device Description

Intended Use/Indications for Use:

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laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. 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 Professional Instructions for Use.

Substantial Equivalence:

The subject device, da Vinci Xi Surgical System with the Integrated ESU feature, has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The only technological difference is that the subject device can now control the settings on the ERBE ESU Model VIO dV instead of requiring the Patient Side Assistant to change the settings on the ESU.

Performance Data:

In accordance with Intuitive Surgical's Design Control process, risk analysis was conducted to evaluate the impact of the modification to the predicate device. Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet the design input requirements and that the subject device is safe and effective for its intended use.

Design Verification:

Software verification testing was performed for the Surgeon Side Cart (SSC) - Vision Cart (VSC) user interface and for the integrated instrument function control sub-system to confirm that the subject da Vinci Xi Surgical System with the Integrated ESU feature functions as intended.

Design Validation:

The design validation testing was performed to confirm that the da Vinci Xi Surgical System, Model IS4000 with P4 system software met the user needs and intended use as documented in the Product Requirements document. Included as part of that evaluation were test cases specific to the software-enabled Integrated ESU control. The portion of testing that evaluated control of the Integrated ESU was evaluated using a tissue model.

Human Factors

A comprehensive human factors engineering (HFE) process was followed for the development of the da Vinci Xi Surgical System with the Integrated ESU feature. A summative usability validation study was conducted to demonstrate that the device can be used to perform essential functions and is safe and effective for its intended use. The validation study and the other elements of the HFE program provide evidence that changing IESU settings from the

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surgeon console is safe and effective when used by the intended users in the intended use environments and in the foreseeable use scenarios.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Xi Surgical System with the Integrated ESU feature is substantially equivalent to the predicate da Vinci Xi Surgical System cleared in K131861.

Image /page/5/Picture/5 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with a registered trademark symbol to the right of the word.

Regulation Number and Section

§ 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.