(241 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.
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, 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 subject of this 510(k) submission are software modifications to the da Vinci Xi Surgical System (Model IS4000) and da Vinci X Surgical System (Model IS4200). These modifications allow Intuitive Surgical to offer cloud-based features to the IS4000 and IS4200 systems such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.
- . Surgeon Cloud Accounts – Enable surgeons to log in to multiple IS4000 systems and access their personal IS4000 system settings (vision, ergonomic, motion scaling, and energy) by storing user preferences in a cloud-based central Intuitive data server.
- . Procedure List – Enable surgeons/OR staff to select a surgical procedure they intend to perform from the surgeon console touchscreen before the start of surgery.
- . Central Configuration – Enable authorized Intuitive Surgical employees to remotely configure features of one or more IS4000 systems simultaneously.
The provided text describes a 510(k) premarket notification for software modifications to the da Vinci Xi Surgical System and da Vinci X Surgical System. The modifications allow for cloud-based features such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.
However, the document does not contain any information regarding clinical performance studies, acceptance criteria, sample sizes for test or training sets, expert review processes for ground truth establishment, or multi-reader multi-case (MRMC) studies.
The "Performance Data" section explicitly states:
"Using an ISO 14971 compliant risk management process, a comprehensive hazard analysis of the software was performed, and impacted risks assessed, mitigations were evaluated and tested to be acceptable through verification and validation testing. The software development process based on ISO 62304 ensured that the software changes were appropriately documented, risk assessed and tested. Design verification tests were performed to verify the proposed software modifications performed as intended. The testing also verified the modifications to the da Vinci system software and server infrastructure did not raise new questions of safety and effectiveness. In addition, the pre and postmarket FDA guidance documents regarding cybersecurity were followed to document, risk assess and verify that the cybersecurity controls performed as expected in the event of an exploitation of a cybersecurity vulnerability. 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. None of the software modifications impact the intended use or indications for use of the da Vinci X/Xi Systems."
This indicates that the performance data for this 510(k) submission primarily consists of design verification and validation testing, hazard analysis, and cybersecurity assessment, rather than a clinical study measuring diagnostic or treatment outcome performance against specific acceptance criteria. The claim of "substantial equivalence" is based on these engineering and software system evaluations, and the fact that the modifications do not alter the intended use of the device.
Therefore, I cannot populate the requested table or answer most of the questions regarding acceptance criteria, study design, and ground truth, as this information is not present in the provided text.
However, I can extract the following relevant non-clinical information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Based on the text, the acceptance criteria are implicitly tied to the successful completion of design verification and validation testing, hazard analysis per ISO 14971, and cybersecurity control verification per FDA guidance. The overall goal is to demonstrate that the software modifications perform as intended and do not raise new questions of safety and effectiveness, thus maintaining substantial equivalence to the predicate device.
- Reported Device Performance:
- Software modifications performed as intended.
- Modifications did not raise new questions of safety and effectiveness.
- Cybersecurity controls performed as expected.
- Design output meets design input requirements.
- No impact on the intended use or indications for use.
2. Sample sized used for the test set and the data provenance:
- Not applicable/Not provided. The "test set" here refers to engineering and software validation, not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth in a clinical sense (e.g., diagnosis, pathology) was not established for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/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 MRMC study was done. This submission is for software modifications that add cloud-based functionality, not for AI assistance in diagnosis or treatment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a surgical system requiring human operation. The software modifications are infrastructure and user preference-related, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this submission would be defined by engineering specifications and functional requirements, against which the software was verified and validated.
8. The sample size for the training set:
- Not applicable/Not provided. No machine learning training set is mentioned in the context of this 510(k) for software modifications.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.