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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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The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:

• . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
• . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm

This document describes the 510(k) summary for the TransEnterix Senhance Surgical System, focusing on the acceptance criteria and study proving its substantial equivalence to a predicate device. This is primarily a regulatory submission, so instead of typical "AI/ML model" performance metrics, the "acceptance criteria" here refer to meeting performance standards that demonstrate safety and effectiveness for a medical device, particularly in comparison to a previously cleared device.

Given the nature of the provided document, which is a 510(k) summary for a surgical instrument, many typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not applicable. The device is a surgical instrument system, not an AI diagnostic algorithm.

Here's an interpretation of the requested information based on the provided text:

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

Since this is a 510(k) for new instruments within an existing surgical system, the acceptance criteria are generally to demonstrate that the new instruments (3mm bipolar) perform as intended, are safe and effective, and do not raise new questions of safety or effectiveness compared to predicate devices. The performance is reported in terms of successful completion of various tests.

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

• Sample size: The document does not specify a numerical sample size for individual tests like mechanical testing or ESU compatibility, but indicates "testing" was conducted. For "Design Validation," it states "a porcine model" was used, implying more than one animal or multiple procedures within one animal, but no specific count is provided.
• Data Provenance: The origin of the data is from in-house testing conducted by TransEnterix, Inc. The studies appear to be prospective for the purpose of this 510(k) submission, specifically designed to test the new 3mm bipolar instruments.

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

This is not applicable in the context of this device and study type. The "ground truth" here is established by engineering and medical device performance standards (e.g., successful mechanical function, proper sterilization, electrical safety compliance) rather than expert interpretation of medical images or diagnoses. The "Design Validation" involved simulating use, implying evaluation by qualified personnel, but "experts" in the sense of clinical reviewers for ground truth is not relevant.

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

Not applicable. This type of adjudication method is common in studies involving human interpretation (e.g., radiology reads), not for performance testing of a surgical instrument.

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 a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. The device isn't an algorithm. Its performance is inherent to its mechanical, electrical, and material properties, and its interaction with the Senhance Surgical System.

7. The type of ground truth used:

The "ground truth" is based on:

• Engineering specifications and performance standards (e.g., force measurements, voltage ratings, mechanical integrity).
• Validated regulatory standards (e.g., IEC 60601-2-2 for electrical safety, established SAL for sterilization).
• Demonstrated functionality in a simulated use environment (porcine model) comparing to the established performance of predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model that requires a "training set."

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

Not applicable. No training set for an AI/ML model.

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The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

The Senhance "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.

The provided text describes performance testing for new instruments and adapters for the TransEnterix Senhance Surgical System to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain an acceptance criteria table with reported device performance in the format requested, nor does it detail a study that proves the device meets such criteria as an AI-enabled medical device would typically require. The document focuses on demonstrating that new accessories do not raise new safety or effectiveness concerns compared to existing cleared devices.

However, I can extract the relevant information from the document that addresses some of your points. The "acceptance criteria" are implied by the summary statements of each test, confirming the devices "perform as intended", "met requirements", "demonstrated compatibility", or "fulfilled all applicable requirements".

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with numerical performance data. Instead, for each test, it provides a summary statement indicating that the device met the requirements or performed as intended.

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

• Sample Size for Test Set: Not explicitly stated with a specific number of cases or samples for each test. The descriptions imply various tests were conducted on the "Additional instruments and adapters" as a group.
• Data Provenance: The design validation was conducted in a porcine model, simulating key human anatomy. This indicates animal data. The other bench tests and compatibility tests would likely be conducted in a laboratory setting. There is no mention of human clinical data or geographical origin.

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

• This information is not provided in the document. The tests described are primarily engineering, mechanical, electrical, software, and biological safety tests, not diagnostic performance evaluations that would typically involve human expert consensus for "ground truth". The "design validation" involved a porcine model, but the role or number of experts involved in evaluating its success is not detailed.

4. Adjudication Method for the Test Set:

• This information is not provided. The nature of the tests (bench, biocompatibility, sterilization, electrical, software) does not typically involve an adjudication method in the way a diagnostic study with human readers would.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary." The study is focused on demonstrating substantial equivalence of accessories, not evaluating the effectiveness of human readers with vs. without AI assistance.

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

• This document describes physical surgical instruments and adapters for a robotic surgical system, not a standalone AI algorithm. Therefore, this question is not applicable. The "software" section refers to the existing system's software continuing to operate reliably with the new instruments, not a new algorithm's standalone performance.

7. The type of ground truth used:

• Ground Truth varies by test type:
  • Bench Testing: Engineering specifications, physical measurements (e.g., force, voltage), statistical comparisons (for clip applier).
  • Biocompatibility: ISO 10993-1 standards (e.g., cytotoxicity, sensitization levels).
  • Reprocessing/Cleaning: Effectiveness against established microbial or soil removal standards.
  • Sterilization: Sterility Assurance Level (SAL) of 10^-6.
  • Electrical Safety: IEC 60601-2-2:2017 standard compliance.
  • Software: Expected software behavior and functionality without errors or unexpected changes.
  • Design Validation: Performance within a simulated use environment (porcine model) against defined user needs and intended uses.

8. The sample size for the training set:

• This document is about physical devices and their compatibility/safety, not an AI model that requires a training set. Therefore, this question is not applicable.

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

• As this document is not about an AI model with a training set, this question is not applicable.

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