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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model ISS000) shall 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, gyneologic 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 myomectorny 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 Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients.

The Intuitive da Vinci® 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles:

• · STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles
• · STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles
• · STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · STERIS V-PRO 1 using the V-PRO/Lumen cycle

da Vinci Surgical System, Model IS5000:

The da Vinci Surgical System Model IS5000/Gen5 is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The da Vinci Surgical System Model IS5000/Gen5 is a modification to the da Vinci Xi Surgical System Model IS4000 with the same core features. The IS5000 System further integrates supporting surgical devices, such as an updated electrosurgical generator (E-200) and an integrated insufflator. The instruments and accessories compatible with the IS4000 System are also compatible with the IS5000 System, with an additional set of force feedback instruments designed specifically for the IS5000 System. These Force Feedback instruments (including Large Needle Driver, MegaSutureCut Needle Driver, Cadiere Graspers, Fenestrated Bipolar Forceps, and Maryland Bipolar Forceps) are similar to the Xi instruments with the addition of a sensor that translates directional forces at the instrument back to the surgeon through the hand controls on the Console.

da Vinci Insufflator

The da Vinci Insufflator is a pneumatic device, integrated into the system Tower, which connects to house or tank CO2 gas through the Tower insufflation manifold. It is operated through controls and indicators on each of the Tower, Console, or Robot touchscreens.

Endoscope Tray

The endoscope tray is a stainless steel sterilization tray to encase and protect da Vinci endoscopes during reprocessing.

Acceptance Criteria and Device Performance for da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray

This document describes the acceptance criteria and supporting studies for the Intuitive Surgical da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in a summary table. However, it outlines the types of testing conducted to demonstrate substantial equivalence to predicate devices and overall safety and effectiveness. Based on the "Performance Data" section, the implicit acceptance criteria are that the devices meet design input requirements, perform as intended, and are safe and effective for their intended uses.

• Devices perform as intended.
• Compatibility with existing instruments and accessories (for IS5000).
• Integrated features (e.g., insufflator, ESU) function correctly. | - Bench testing demonstrated that design output meets design input requirements and devices perform as intended.
• Mechanical and functional verification were conducted.
• Simulated use in animal and cadaver models showed intended performance.
• IS5000 compatible with a subset of IS4000 instruments and accessories.
• Force Feedback instruments are designed specifically for IS5000.
• IS5000 includes new integrated insufflator and ESU. |
  | Safety - Electrical & Electromagnetic | - Compliance with relevant electrical safety and electromagnetic compatibility standards. | - Electrical Safety and Electromagnetic Compatibility testing conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2, and IEC 60825-1. |
  | Software | - Software verification and validation performed following established processes and methodologies.
• Compliance with FDA guidance for device software functions.
• Cybersecurity compliance. | - Software verification and validation testing performed following the same processes and test methodology as for the predicate device.
• Software documentation classified as "Enhanced" and provided as recommended by FDA guidance.
• Cybersecurity information demonstrating compliance with Section 524B of the FD&C Act and FDA guidance was provided. |
  | Usability & Human Factors | - Safe and effective use by intended users (surgeons, OR staff) in intended use environments.
• No use errors leading to serious patient or user harm. | - Human Factors data assessed use-safety and effectiveness for intended uses, user groups, and environments.
• Surgeon and OR Staff participants safely completed simulated surgical tasks and high-risk use scenarios.
• Results showed no use errors resulting in serious patient or user harm.
• Confirmed safety, effectiveness, and usability for robotic-assisted surgical procedures. |
  | Clinical Performance (Safety & Effectiveness) | - Comparable safety and performance to predicate device in a clinical setting.
• Acceptable adverse event rates.
• No remarkable differences in outcomes compared to predicate (except for specific contraindication).
• Specific finding: Acknowledge and address any identified risks, such as increased unplanned hospital readmission due to vaginal bleeding with force feedback needle driver in specific procedures. | - Clinical Investigation: 53 subjects across 4 specialties followed for 30 days.
• Qualitatively compared to a retrospective review of robotic cases using the predicate device.
• Identified increase in unplanned hospital readmission due to vaginal bleeding when using the force feedback needle driver in hysterectomy and myomectomy (leading to a contraindication).
• No other remarkable differences between the data from the two groups were observed.
• Clinical results show low numbers of adverse events, conversions, deaths, readmissions (2 in gynecology, related to vaginal bleeding), and re-operations. |
  | Sterilization (for Endoscope Tray) | - Ability to encase and protect compatible endoscopes for sterilization in specified sterilization machines and cycles.
• Compatibility with specific sterilization wraps. | - Intended for use with STERRAD 100NX (Flex, Express, DUO cycles) and STERIS V-PRO maX 2, maX, and 1 Plus/1 (Non Lumen, Flexible, or Lumen cycles).
• Intended to be used with legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap.
• Maximum product load: one da Vinci 5 endoscope.
• Maximum weight of tray and endoscope: 13 lbs. |

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

The primary clinical test set information is from a prospective, multi-center, single-arm confirmatory clinical investigation.

• Sample Size: 53 subjects.
  • General Surgery: 20 subjects
  • Thoracic: 6 subjects
  • Urology: 6 subjects
  • Gynecology: 21 subjects
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission, it is likely the data was collected in the United States, but this is not explicitly confirmed. The study was prospective, as stated.
• Bench and Pre-clinical studies: Involved animal (canine or porcine) and cadaver models, but specific sample sizes for these are not detailed.

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

The document does not explicitly provide details on the number or qualifications of experts used to establish a "ground truth" for the clinical test set in the sense of independent adjudication of outcomes.

For the pre-clinical surgical equivalence studies, veterinary pathologists were involved in the review of histology from excised tissue. Their specific qualifications (e.g., years of experience) are not mentioned.

For the human factors study, Surgeon and OR Staff participants were observed, implying their expertise was leveraged, but they were the users being studied, not necessarily establishing a separate "ground truth".

The clinical investigation involved surgeons with a range of experience performing procedures, and outcomes were tracked. The document doesn't indicate a separate panel of experts for post-hoc ground truth establishment for clinical events. Adverse events, readmissions, etc., would typically be derived directly from patient records and assessed by the study investigators/clinicians.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth for the clinical outcomes. Adverse events, readmissions, surgeries, etc., appear to be directly measured results from the clinical investigation. The document mentions "clinical assessments" and "qualitative comparison" to retrospective data, suggesting a direct observation and comparison approach rather than a multi-expert adjudication of each case for a specific "ground truth."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done based on the provided text. The device described, the da Vinci Surgical System, Insufflator, and Endoscope Tray, are surgical tools, not AI-driven diagnostic or assistive technologies that would typically involve "human readers" to interpret data (like images) with or without AI assistance. The clinical study compares the new system to a predicate system (IS4000) based on surgical outcomes.

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

This question is not applicable to the device described. The da Vinci Surgical System is an instrument control system that assists surgeons; it is not a standalone algorithm performing tasks independently. While it is software-controlled, its performance is always in conjunction with a human surgeon. Bench testing and pre-clinical studies evaluate the device's technical performance and safety aspects without direct human patient involvement, which could be considered "standalone" in that context, but this isn't an "algorithm-only" performance evaluation.

7. The Type of Ground Truth Used

• Clinical Investigation: Clinical outcomes (e.g., adverse events, conversions, deaths, readmissions, re-operations) observed directly from patient follow-up data. The identified issue with the force feedback needle driver in specific procedures resulting in vaginal bleeding was likely a direct observation within the study data.
• Pre-clinical Studies: Veterinary pathologists' review of histology from excised tissue to assess surgical safety and performance in animal models.
• Bench Testing: Engineering measurements, mechanical and functional verification against design input requirements.
• Human Factors: Observation of user performance and subjective feedback from surgeons and OR staff.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models being developed for the device's core functionality. The da Vinci Surgical System as described is a robotic surgical platform, not an AI diagnostic or predictive tool that would undergo a typical machine learning training and testing paradigm. "Training set" might refer to data used during software development, but it's not specified.

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

As there is no explicit mention of an "AI training set" for the device's core surgical assistance function, the method for establishing its ground truth is not provided. Any software development would rely on traditional software verification and validation processes against specified requirements, rather than a machine learning ground truth establishment.

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