(24 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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, 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, 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.
The da Vinci X Surgical System, Model IS4200 is a modification to the Patient Side Cart of the da Vinci Xi Surgical System, Model IS4000, cleared under K131861. The arms of the IS4000 have been grafted onto the setup structure of the da Vinci Si Surgical System Patient Cart (K081137). The da Vinci X Patient Cart utilizes the same electronics as the da Vinci Xi Patient Cart with some minor modifications. The da Vinci X Patient Cart is run by the same software and is to be used with the Surgeon Console and Vision Cart of the da Vinci Xi Surgical System. All of the da Vinci Xi instruments and accessories, including advanced instruments (e.g., Single Site, Vessel Sealer, Stapler, etc.), are compatible with the da Vinci X Surgical System.
The da Vinci X Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The da Vinci X Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an Endoscope, EndoWrist Instruments, and Accessories.
The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes the supporting electronic and video processing equipment for the system.
The Patient Side Cart is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system. The da Vinci X Surgical System Patient Cart has the same arms as the da Vinci Xi Surgical System Patient Cart and is compatible with all of the base, Single-Site, and advanced instruments and accessories (with the exception of the column drape) cleared for use with the da Vinci Xi Surgical System (K131861).
The provided FDA document describes the da Vinci X Surgical System (Model IS4200), a modification to the da Vinci Xi Surgical System. It primarily focuses on demonstrating substantial equivalence to a predicate device (da Vinci Xi Surgical System, K131861) rather than presenting a study with explicit acceptance criteria and corresponding performance metrics for a novel AI algorithm.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted as it is not the focus of this 510(k) summary.
However, based on the provided text, I can infer and summarize what is available regarding performance data and the nature of the "study" (verification and validation testing) conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or objective performance measures in a table format that are typically associated with AI algorithm validation (e.g., sensitivity, specificity, accuracy). Instead, the performance data focused on demonstrating that the modified device functions as intended and is safe and effective when compared to the predicate.
| Acceptance Criteria (Inferred from device modification context) | Reported Device Performance (Summary of testing) |
|---|---|
| Device functions as intended and is safe/effective | Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. |
| Hardware functions correctly | Hardware verification was performed. |
| Human factors related to the new configuration are acceptable | Human factors testing was performed. |
| Device is suitable for preclinical use | Preclinical validation testing was performed. |
| Software functions correctly and reliably | Software testing was conducted, including user interface, algorithm, and software verification/validation testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for hardware verification, human factors testing, preclinical validation, or software testing.
- Data Provenance: Not explicitly stated. The testing would have been conducted by Intuitive Surgical, Inc. as part of their device development and submission process. The nature of these tests (hardware, software, human factors, preclinical) suggests they were likely controlled, prospective tests designed to evaluate the modified system.
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 document. For a surgical system modification, "ground truth" might refer to the successful completion of surgical tasks in preclinical settings. The "experts" would likely be the engineering and clinical teams at Intuitive Surgical, and potentially surgeons participating in preclinical validation, but specific numbers and qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the device (a surgical system modification), adjudication methods in the context of diagnostic AI might not be directly applicable. Instead, the validation would involve successful execution of procedures and verification against design specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study and the effect size of human improvement with AI assistance are not applicable and therefore not mentioned. The da Vinci X Surgical System is an instrument control system, not an AI diagnostic tool designed to assist human "readers" in interpreting medical images or data. It enhances a surgeon's ability to perform surgery, but not through an "AI assistance" model in the way typically discussed for diagnostic algorithms.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of a "standalone" performance for the da Vinci X Surgical System is not applicable. This device is fundamentally a human-in-the-loop system designed to assist surgeons. Its core function is to translate a surgeon's hand movements into precise instrument movements within the patient's body. The "algorithm" component (software) is integral to this human-driven control.
7. The Type of Ground Truth Used:
For this type of device (a surgical system modification), "ground truth" would likely be established through:
- Design Specifications: Ensuring the system meets its engineering and functional requirements.
- Preclinical Validation: Successful completion of surgical tasks on models or animal subjects by trained operators.
- Safety and Effectiveness Benchmarks: Demonstrating that the modified system performs at least as safely and effectively as the predicate device.
8. The Sample Size for the Training Set:
The concept of a "training set" in the context of machine learning is not applicable as described in this document. The da Vinci X Surgical System is not an AI algorithm that learns from a dataset for a specific diagnostic or predictive task. It is a robotic surgical system that translates user input. The "software testing" mentioned would relate to verification and validation of deterministic software functionality, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the machine learning sense for this device.
In summary: The provided document is a 510(k) submission for a modification to an existing surgical robot. It focuses on demonstrating substantial equivalence through various engineering, hardware, software, and human factors verification and validation, rather than the performance of a novel AI diagnostic algorithm. Therefore, many of the requested specific details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment in an AI context are not present.
§ 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.