(92 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes. blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection 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 (except for transoral otolaryngology robotic surgical procedures). 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 EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System or IS3000 da Vinci Si 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.
The provided text describes a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the format requested.
Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.
However, I can extract information related to the device description, testing methods, and the general statement of equivalence.
Here's a breakdown of what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and specific numerical performance results. Instead, it lists the types of tests performed to ensure the device meets design requirements.
Inferred "Acceptance Criteria" (based on tests performed):
| Acceptance Criteria Type | Reported Device Performance (as inferred from tests) |
|---|---|
| Instrument Reliability | Verified through Design Verification tests |
| Instrument Durability | Verified through Design Verification tests |
| Leakage | Verified through Design Verification tests |
| Range of Motion (Roll, Pitch, Yaw) | Verified through Design Verification tests |
| Jaw Close and Open Positions | Verified through Design Verification tests |
| Friction | Verified through Design Verification tests |
| Electrical Safety | Verified through Design Verification tests |
| Instrument Labeling | Verified through Design Verification tests |
| Compatibility with Tip Cover Accessory | Verified through Design Verification tests |
| Compatibility with System Software | Verified through Design Verification tests |
| Functional Requirements | Validated through Design Validation tests in simulated clinical settings (porcine model) |
| Interaction (Compatibility) Requirements | Validated through Design Validation tests in simulated clinical settings (porcine model) |
| Safety | Assessed in representative simulated clinical settings (porcine model) |
| Efficacy | Assessed in representative simulated clinical settings (porcine model) |
2. Sample sized used for the test set and the data provenance
- Sample size used for the test set: Not explicitly stated. The document mentions "Design verification and design validation testing were conducted on the subject device." It does not specify the number of units tested.
- Data provenance: The tests were conducted internally by Intuitive Surgical, Inc. on a "porcine model" for design validation. This suggests a prospective assessment of the device's performance in a controlled, simulated clinical environment. The country of origin is not specified but the company is based in Sunnyvale, California.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical instrument, not an AI/diagnostic tool requiring expert-established ground truth for its performance evaluation in this context. Its evaluation focuses on mechanical, electrical, and functional performance.
4. Adjudication method for the test set
Not applicable. See point 3.
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 diagnostic device, but a surgical instrument. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical instrument that is always used with a human-in-the-loop (a trained physician). Standalone performance of an algorithm is irrelevant.
7. The type of ground truth used
For the design validation, the "ground truth" was established by the physical and functional outcomes observed in a porcine model under "normal and expected worst case clinical use" scenarios. The evaluation aimed to confirm that "the features of the instrument meet the user needs and intended use."
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of available information from the document:
The 8mm Monopolar Curved Scissors is a reusable surgical instrument used with the Intuitive Surgical da Vinci S and Si Surgical Systems. It performs cutting, cauterizing, coagulation, manipulation, and blunt dissection of tissue.
To demonstrate substantial equivalence to its predicate device, Intuitive Surgical performed:
- Design Verification: Bench testing on an IS3000 da Vinci Si Surgical System to verify mechanical and labeling requirements, including reliability, durability, leakage, range of motion, jaw positions, friction, electrical safety, labeling, and compatibility with accessories and software.
- Design Validation: Testing in representative simulated clinical settings utilizing a porcine model to evaluate functional and interaction requirements, as well as the safety and efficacy of the instrument under normal and worst-case clinical use. This ensured the instrument met user needs and intended use.
The document concludes that based on the intended use, indications for use, technological characteristics, and performance data from these tests, the device is substantially equivalent to the predicate device.
§ 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.