(67 days)
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, 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.
Remote Software Update is a software enabled feature that performs software update downloads and installations without the need of a service engineer to be physically at the user's site. Remote Software Update utilizes the OnSite functions of the da Vincio Xi™ Surgical System to facilitate and manage software updates.
The software update is downloaded over a network connection using secure communication protocols. Once the software update package is downloaded and cryptographically verified with a digital signature, metadata inside the package determines the type of installation required and if necessary guides the user through all of the steps required to complete the software update.
The provided text is a 510(k) summary for the da Vinci Xi Surgical System with a Remote Software Update feature. It states that the device is substantially equivalent to a previously cleared predicate device (K131861). The document does not describe specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) or a study that quantitatively measures the device's performance against such criteria. Instead, it focuses on demonstrating substantial equivalence based on technological characteristics and performance data related to software functionality.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth details) are not directly applicable or available in this document, as the submission is for a software update feature rather than a diagnostic or AI-driven decision-making tool.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The document describes the "Performance Data" in a general sense, stating that it demonstrates substantial equivalence and that the design output meets design input requirements. The explicit acceptance criteria and corresponding reported performance are not presented in a quantitative table for metrics commonly associated with AI/diagnostic devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Functionality: | Software Testing: |
| - Ability to perform software update downloads securely | - Software update downloaded over a network connection using secure communication protocols. |
| - Ability to cryptographically verify downloaded software package | - Software update package is cryptographically verified with a digital signature. |
| - Ability to determine installation type and guide user | - Metadata inside the package determines the type of installation required and guides the user through steps. |
| - No adverse impact on the existing device's intended use or indications for use. | - Performance test data demonstrate substantial equivalence. |
| - Design output meets design input requirements | - Design output meets design input requirements. |
| Equivalence to Predicate Device: | Substantial Equivalence Demonstrated: |
| - Equivalent in intended use, indications for use, and technological characteristics. | - "da Vinci Xi Surgical System with Remote Software Update is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861." |
Additional Information based on the document:
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Sample size used for the test set and the data provenance:
- The document mentions "Software testing was conducted to support this modification," including user interface, algorithm, and software verification testing. However, it does not specify the sample size of the test set (e.g., number of software updates tested, number of simulated scenarios).
- Data Provenance: Not specified, but given it's software testing for a medical device feature, it's typically internal testing by the manufacturer (Intuitive Surgical, Inc.). The document does not indicate country of origin for test data or whether it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing described is primarily software verification and validation, not clinical performance against a medical ground truth involving expert review of patient data.
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Adjudication method for the test set:
- Not applicable for software verification testing as described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not conducted according to this document. The submission is for a software update feature, not for a diagnostic or AI-assisted interpretation tool that would benefit from MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Remote Software Update" is an algorithmic feature designed to function primarily without direct human intervention in the download and verification steps. The description points to "algorithm, and software verification testing," which implies standalone testing of this automated process. However, explicit details of a "standalone performance study" in terms of clinical metrics for the surgical system itself are not provided as this submission is for the software update mechanism.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For software testing, the "ground truth" would be the expected behavior and outcomes defined by the software requirements and specifications (e.g., successful download, correct verification, appropriate installation guidance). It's not a clinical "ground truth" in the sense of pathology or outcomes.
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The sample size for the training set:
- Not applicable. This document describes a software update feature for an existing device, not a machine learning or AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for machine learning.
§ 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.