(195 days)
The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectorny with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.
The da Vinci Xi Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device: da Vinci Xi Single-Site Instruments and Accessories. This document does not pertain to an AI/ML device, and therefore the acceptance criteria and study information outlined in the request (specifically regarding AI/ML performance metrics, ground truth, expert adjudication, MRMC studies, and training/test sets) are not applicable.
The document discusses the substantial equivalence of the new device to a predicate device (da Vinci Si Single-Site Instruments and Accessories) and outlines the design verification and validation processes conducted to ensure safety and effectiveness.
Here’s a breakdown of the information relevant to the device, formatted as requested where possible, but with clear indications where the requested AI/ML specific information is not available:
Device: da Vinci Xi Single-Site Instruments and Accessories
1. Table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way it might for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly tied to meeting design input requirements, ensuring safety and effectiveness, and demonstrating substantial equivalence to the predicate device.
The "Performance Data" section describes categories of testing performed, which serve as evidence of the device meeting its design requirements and thus implicitly its acceptance criteria.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary of Testing) |
|---|---|
| Design Verification | Bench testing performed with an IS4000 da Vinci Surgical System covering: |
- Instruments: Physical specifications (size, weight, shape); Mechanical requirements (axes torques, loading, range of motion, accuracy, grip forces, needle handling, tip alignment); Electrical requirements; User interface; Equipment interfaces (cannula, sterile adapter, RFID, Universal Surgical Manipulator, Patient Side Manipulator).
- Accessories: Physical specifications (size, shape, finish, materials); Mechanical requirements (forces, loading, insufflation, flow rate, cannula insertion, port insertion/removal); Compatibility (instruments, seals, cannulae); Markings; System Recognition (magnets).
- Other: Software compatibility testing and instrument data verification testing to confirm intended function. |
| Design Validation | Validated general, functional, and interaction (compatibility) requirements. Assessed safety and efficacy in representative simulated clinical settings. Testing utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst-case clinical use. Representative tissue types were used as appropriate. The validation aimed to address how the features of each device meet user needs and intended use as documented in product requirements documents. |
| Substantial Equivalence | Demonstrated by showing the subject device has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device (da Vinci® SiTM Single-Site Instruments and Accessories in K122532). The distal tips (jaws, blades, cautery-tips, and clevis) are identical to the predicate. Modifications to the back ends were for compatibility with the IS4000 Surgical System. Performance data detailed above supported this claim. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of a "test set" sample size for a quantitative performance metric. The validation involved using porcine (in vivo) and cadaveric tissue models. The number of such models or specific tests performed is not quantified.
- Data Provenance: Not applicable as this is not a data-driven AI/ML study. The "data" comes from physical, mechanical, electrical, and simulated clinical performance testing, primarily bench tests and tissue model evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from a test set of images or patient data. The "ground truth" for this device's performance would be engineering specifications and successful execution of surgical tasks on tissue models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication method for a test set of data is mentioned, as this is not an AI/ML study.
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
- Not applicable. This is not an AI-assisted device in the context of diagnostic interpretation by human readers. It is a surgical instrument system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a set of physical surgical instruments and accessories. Its performance is always "human-in-the-loop" as it's designed to be used by trained physicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly used for the design verification and validation testing would be adherence to engineering specifications, functional requirements, and successful simulated surgical outcomes on tissue models as determined by qualified engineers/testers and potentially surgeons participating in the validation. It is not expert consensus on medical images or pathology results.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of AI/ML. Its design and development would have involved iterative prototyping and testing, but these are not "training sets" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, there is no ground truth established for it.
§ 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.