(26 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 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 pediatic use. It is intended to be used by tramed physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The EndoWrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.
The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS4000 da Vinci Xi Surgical System or IS4200 da Vinci X Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.
This is a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document asserts substantial equivalence to a predicate device (K131861). As such, it does not detail new clinical studies with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a novel AI/ML device submission might. This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering analysis, bench testing, and potentially some animal studies if there are significant differences.
Here's a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for an electrosurgical instrument (scissors) and not a diagnostic AI/ML device, the "acceptance criteria" discussed are primarily related to engineering performance specifications and safety, not diagnostic accuracy metrics like sensitivity, specificity, or AUC. The document does not provide a table with specific numerical acceptance criteria and reported device performance for these types of metrics. Instead, it states that:
| Acceptance Criteria Category | Reported Device Performance Summary (as described in the document) |
|---|---|
| Instrument Reliability & Durability | Verified through bench testing. |
| Leakage | Verified through bench testing. |
| Electrical Safety | Verified through bench testing. |
| General & Physical Requirements | Verified through bench testing to ensure compatibility with the system and tip cover accessory. |
| Functional & Interaction (Compatibility) | Validated to meet user needs and intended use as documented in the product requirements. |
| Biocompatibility | Met requirements of recognized biocompatibility standards (ISO 10993-1:2018 and ASTM standards) based on toxicological assessment. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically not applicable to submissions for electrosurgical instruments like these scissors, which are evaluated primarily through bench and design verification/validation testing. The document does not mention "test sets" in the context of clinical data, as it describes engineering performance data rather than clinical outcomes or diagnostic accuracy.
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)
This is not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the type of device and testing described (electrosurgical instrument performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
This is not applicable. The device is an electrosurgical instrument, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a surgical instrument and does not involve an algorithm or standalone performance in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for the performance of an electrosurgical instrument is its ability to perform its intended mechanical and electrical functions reliably, safely, and biocompatibly, which is assessed through engineering tests, not clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" for this type of medical device submission.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
In summary:
The provided document describes a 510(k) submission for a surgical instrument, the 8mm Monopolar Curved Scissors, asserting substantial equivalence to an existing predicate device based on engineering and biocompatibility testing. The "acceptance criteria" and "performance" discussed relate to mechanical, electrical, and material properties, as opposed to clinical diagnostic accuracy or AI/ML performance metrics. Therefore, many of the specific questions geared towards AI/ML device evaluation are not applicable to this submission.
§ 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.