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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.

The basis for this submission is a modification to the reprocessing instructions, in addition to an increase in the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instrument family as listed in Table 1, which Intuitive intends to introduce into interstate commerce in accordance with 21 CFR Section 807.81.

The provided document is an FDA 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes to reprocessing instructions and increasing the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instruments.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing conducted to support the changes. While it doesn't explicitly state "acceptance criteria" with numerical thresholds, it details the types of tests performed and implies that passing these tests demonstrates acceptable performance. The "reported device performance" is generally stated as "All testing passed and supports the subject device changes."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each of the performance tests (Cleaning Validation, Reliability Verification, Dielectric Strength Testing, Jaw Force to Failure Verification). It generally refers to "instruments" being subjected to tests.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The testing appears to be internal validation performed by the manufacturer, Intuitive Surgical, Inc., located in Sunnyvale, California.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document describes engineering-based performance testing rather than studies involving human interpretation or expert ground truth establishment in the traditional sense (e.g., for diagnostic algorithms). The "ground truth" for these tests would be the established engineering specifications and regulatory standards. Therefore, the concept of a "number of experts" establishing ground truth in this context is not directly applicable. The experts involved would be the engineers and regulatory specialists who designed and conducted the tests and interpreted the results against established standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is engineering performance testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes benchtop and laboratory testing of the instruments' physical and functional performance, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device, the da Vinci Force Feedback Instruments, is a physical surgical instrument that assists a human surgeon. It is not an AI algorithm in the standalone sense. The performance tests are for the instruments themselves, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is based on engineering specifications, regulatory standards, and established industry guidelines. For example:

• Cleaning validation against ANSI/AAMI ST98.
• Dielectric strength testing against IEC 60601-2-2.
• Jaw force to failure verification against FDA guidance.
• Reliability (life) verification against internal design life specifications.

8. The Sample Size for the Training Set:

Not applicable. This document is about a physical medical device (surgical instruments) undergoing performance validation, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no machine learning model or training set involved.

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