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The Endo Wrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X Surgical System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000 and da Vinci 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, 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 da Vinci X/Xi 8 mm monopolar scissors instrument (470179) is used in conjunction with its intended surgical robot for cutting, cauterizing, coagulation, manipulating and blunt dissue. This instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axis of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

Endo Wrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision in a minimally invasive environment. EndoWrist instruments, in conjunction with the applicable surgical robot, are designed to support rapid and precise suturing, dissection, and tissue manipulation in surgical procedures.

The design, materials, and intended use of the Reusable Surgical Instruments, after an additional ten (10) reuse cycles, are substantially equivalent to the predicate device in form, fit, and function. The reusable device is identical to the predicate device in that the same standard mechanicals, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.

The provided text is a 510(k) premarket notification for a medical device: an 8mm Monopolar Curved Scissors (470179) for use with the da Vinci Xi/X Surgical System. The notification states that the device is a remanufactured/reprocessed version of an existing device, increasing its usability from 10 to 20 cycles through a refurbishment process.

The document discusses acceptance criteria and testing, but not in the context of an AI-powered diagnostic or assistive technology. Instead, the acceptance criteria and study described relate to the safety and effectiveness of the remanufactured physical surgical instrument itself.

Therefore, most of the requested information regarding AI device performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) is not applicable to this submission.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document refers to "design verification and design validation testing." This typically involves testing a representative number of units, but the specific count is not provided.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The data comes from laboratory and engineering testing of the physical remanufactured surgical instruments. The country of origin of the data is not specified, but it would be from the manufacturer's testing facilities. The tests are prospective in nature, as they are conducted on the remanufactured devices to prove their performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is objective physical and electrical properties, and biological safety, measured through standardized tests, not expert interpretation of medical images or data. Engineering and quality control personnel would be involved in conducting and evaluating these tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods like 2+1 are used for expert consensus on subjective assessments. The tests described are objective and rely on measurement against predefined specifications.

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. This device is a physical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a remanufactured physical surgical tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" used for this device's acceptance is based on predefined engineering specifications, material properties, electrical safety standards, and biocompatibility requirements, as well as the performance characteristics of the predicate device. It's objective, measurable criteria from a combination of regulatory standards and the original device's design.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/machine learning device.

In summary: The provided FDA submission for the 8mm Monopolar Curved Scissors focuses on demonstrating the substantial equivalence and safety/effectiveness of a remanufactured physical surgical instrument. The acceptance criteria and studies are related to the physical, electrical, and biological performance of this instrument, not to the performance of an AI algorithm.

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