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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and 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.

This 510(k) is for a labeling modification only, to include "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as an additional representative, specific procedure under the previously cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use for the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294).

There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

This FDA 510(k) clearance letter pertains to a labeling modification for the da Vinci Xi and X Surgical Systems, adding "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as a specific procedure under the existing General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Indications for Use. Since this is a labeling modification and not a change to the technological characteristics of the device, the traditional acceptance criteria and study data typical for a new device clearance are not provided in the same way. The primary evidence presented is Real World Evidence (RWE) demonstrating substantial equivalence for this new indication.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined numerical thresholds for a new device's performance. Instead, the study aims to demonstrate substantial equivalence for the robotic new indication (Robotic-assisted Tracheobronchoplasty, R-TBP) compared to the currently accepted method (Open Tracheobronchoplasty, O-TBP) based on a comparison of safety and effectiveness outcomes. The "reported device performance" are the R-TBP outcomes from the Premier Health Database (PHD) compared against O-TBP outcomes from a systematic literature review (SLR).

Table of Performance Outcomes (Implicit Acceptance Criteria and Reported Performance)

The implicit acceptance criteria are that the robotic-assisted procedure's outcomes should be comparable to or better than the open procedure's outcomes, without introducing new safety or effectiveness issues.

Conclusion from Data: The presented data suggests that robotic-assisted tracheobronchoplasty generally shows comparable or improved safety and effectiveness outcomes across most metrics when compared to open tracheobronchoplasty, supporting the claim of substantial equivalence.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Robotic-assisted Tracheobronchoplasty (R-TBP): 124 patients identified in the Premier Health Database (PHD) that underwent tracheobronchoplasty procedures.
   • Open Tracheobronchoplasty (O-TBP): Approximately 278 patients, derived from a systematic literature review of 3 publications.
   • Data Provenance (R-TBP): Retrospective, from the Premier Health Database (PHD) in the USA, covering data from 2013 to 2023, across 6 hospitals.
   • Data Provenance (O-TBP): Retrospective, from published literature covering Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center (BIDMC) in the USA, from 2000 to 2023.

2. 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 RWE study. The "ground truth" (i.e., patient outcomes) is derived directly from medical records (PHD) and published study data (SLR). There wasn't an independent panel of experts establishing ground truth for individual cases.

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

   • Not described, as the data collection relies on existing medical records and published literature. No explicit adjudication method for the test set is mentioned.

4. 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, an MRMC comparative effectiveness study was not done. This is not an AI/software diagnostic device that involves human "readers." The device is a surgical system; the study compares surgical outcomes with and without the device's assistance in a specific procedure (R-TBP vs O-TBP). The comparison is between the robotic approach (device-assisted human surgeon) and the open approach (human surgeon without robotic assistance).

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

   • No. The da Vinci Surgical System is a tool used by a human surgeon ("human-in-the-loop"). The performance inherently involves the human surgeon's skill in operating the system.

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

   • Outcomes data derived from retrospective medical records (for R-TBP) and published literature (for O-TBP). The outcomes reported include: operative time, length of stay, complication rates, mortality rates, readmission rates, reoperation rates, and discharge disposition.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the context of needing a "training set" for model development. The robotic surgical system itself is a mature technology; this submission is for a labeling expansion based on existing clinical use (RWE).

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

   • Not applicable, as there is no "training set" in the context of an AI/ML algorithm development.

Summary of Key Takeaways from the document relevant to the request:

• Device Type: Surgical Robotic System (da Vinci Xi/X)
• Submission Type: Labeling modification for an additional procedure (tracheobronchoplasty).
• Proof: Real-world evidence (RWE) from a database (Premier Health Database) for robotic procedures compared to a systematic literature review for open procedures.
• Primary Goal: Demonstrate substantial equivalence of the robotic-assisted procedure's outcomes to the established open procedure.
• Test Set (Robotic): 124 patients from US hospitals (retrospective, 2013-2023).
• Test Set (Open Comparator): ~278 patients from US hospitals (retrospective, 2000-2023) via literature review.
• Ground Truth: Patient outcomes data (safety and effectiveness metrics) extracted from clinical records/literature.
• No ML/AI Algorithm Validation: The study does not involve evaluating an AI model; thus, concepts like training sets, experts for ground truth, or MRMC studies for reader improvement with AI assistance are not applicable.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi and X Surgical Systems, Models IS4000 and 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.

Intended Use: To assist in the accurate control of endoscopic instruments in minimally invasive surgery.

The da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, are software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.

The basis for this submission is the modification of the da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, cleared in K240723. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network, including customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.

The provided FDA 510(k) clearance letter pertains to the da Vinci Xi/X Surgical Systems (IS4000/IS4200). This document primarily focuses on a software modification, specifically the "Networked Central Configuration Management" feature, and does not describe a clinical study comparing device performance against specific acceptance criteria in the manner typically seen for diagnostic or AI-driven devices.

Here's a breakdown of the requested information based on the provided text:

Key Takeaway: The submission is for a software modification to an already cleared device, not a new device requiring extensive clinical performance studies against defined acceptance criteria. Therefore, many of the requested data points (like sample size for test sets, expert consensus, MRMC studies, standalone performance with ground truth) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as described for clinical performance. This submission is for a software modification to an existing, already cleared device. The "performance data" discussed relates to software and cybersecurity testing, not clinical outcomes against specific performance metrics for diagnosis or treatment efficacy in patients compared to a predicate or ground truth.

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

Not applicable. The document describes software and cybersecurity testing, not a clinical test set with patient data for performance evaluation. Therefore, there is no mention of a sample size for a test set or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth in the context of clinical performance is not relevant for a software update related to configuration management and cybersecurity. Software testing would involve software engineers and cybersecurity experts, but their roles are not defined as "establishing ground truth" in the clinical sense.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among experts in establishing ground truth. This is not mentioned as it's a software modification submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. The document does not mention any clinical studies, and therefore no MRMC comparative effectiveness study was performed to evaluate human reader improvement with or without AI assistance. The da Vinci system is a surgical robot, not an AI diagnostic tool for image interpretation or similar tasks that would typically involve MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The da Vinci Xi/X Surgical Systems are surgical robots intended to be used with human surgeons (human-in-the-loop). A standalone performance evaluation in the absence of human involvement would not be relevant for this device. The software update is for configuration management, not an autonomous function.

7. Type of Ground Truth Used

Not applicable in the clinical sense. The "ground truth" for software testing would be the predefined functional requirements and specifications, and for cybersecurity, it would be adherence to security protocols and protection against identified threats. This is different from clinical ground truth such as pathology, expert consensus on imaging, or patient outcomes data.

8. Sample Size for the Training Set

Not applicable. The document refers to software modifications and testing for an existing device. There is no mention of a "training set" in the context of machine learning or AI model development which would require such a set. The "training" implied is for the system's internal functions, not for a learning algorithm.

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

Not applicable. As there is no mention of a training set for an AI/machine learning model, the method for establishing its ground truth is not discussed.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and 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 revasoularization. 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.

This premarket notification is for a labeling modification only, to revise the Precaution for Representative Uses statement so that it does not apply to radical prostatectomy performed using the subject devices. This labeling change is supported by real-world evidence (RWE). There are no changes to the technological characteristics or the indications for use of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text describes a 510(k) premarket notification for a labeling modification to the da Vinci Xi and X Surgical Systems. The modification aims to remove a precaution statement regarding outcomes related to cancer treatment, specifically radical prostatectomy (RP), since this procedure was evaluated for overall survival. The submission relies on Real-World Evidence (RWE) from a retrospective cohort study to demonstrate the non-inferiority of robotic-assisted surgical device (RASD) radical prostatectomy compared to non-RASD RP concerning overall survival.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to 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, 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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Appendectomy" under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

This document, a 510(k) summary, details a labeling modification for the da Vinci Xi and X Surgical Systems to include "Appendectomy" under their cleared "general laparoscopic surgical procedures" indications for use. It is not a study demonstrating device performance or meeting acceptance criteria in the typical sense of a new device or a new algorithmic feature.

Therefore, many of the requested fields are not applicable in this context. This submission is for a procedural labeling change based on the existing safety and effectiveness of the device for similar procedures.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria or reported device performance in the form of metrics (e.g., accuracy, sensitivity, precision) because it's a labeling modification for an existing device. Instead, the "acceptance criteria" here relate to demonstrating that appendectomy is equivalent in safety and effectiveness to already cleared procedures for the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No new test set or data was used because this submission is for a labeling modification based on the substantial equivalence of the procedure to already cleared procedures. The submission argues that appendectomy is covered under existing cleared procedures (LAR/TME and Colectomy) for which the device has already demonstrated safety and effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new ground truth was established for a test set. The claim is based on the inherent surgical similarities between procedures already approved for the device.

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

Not applicable. No adjudication method was used as there was no new test set requiring expert review.

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. No MRMC comparative effectiveness study was done. This device is a surgical system, not an AI-assisted diagnostic or interpretative tool for human readers.

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

Not applicable. This device is a surgical system that assists in controlling instruments. It is not an algorithm performing a task without human intervention. The submission focuses on the human surgeon using the device for a new procedure within its established capabilities.

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

The "ground truth," in a conceptual sense for this submission, is the established surgical knowledge and practice regarding the equivalence of appendectomy to other laparoscopic procedures (LAR/TME and Colectomy) already cleared for the da Vinci systems. This is implicitly based on expert surgical opinion on procedural steps, required instruments, anatomical structures, and associated risks. No formal new "ground truth" for a study was established for this submission.

8. The sample size for the training set:

Not applicable. There is no training set in the context of this submission. The device itself has undergone extensive training (development and testing) prior to its initial clearance. This submission solely re-evaluates the scope of its cleared indications.

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

Not applicable. As there is no training set for this labeling modification, there is no ground truth established for it. The original "ground truth" for the device's development would have been established through a rigorous process of engineering, preclinical testing, and clinical trials for its initial clearance and prior modifications.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X 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, 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. Itis 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 Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to 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, 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. Itis 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 Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi and X Surgical Systems, not a study to prove a device meets acceptance criteria regarding active performance metrics. The submission asserts substantial equivalence based on the current device's performance being equivalent to predicate devices for new labeled uses.

Here's an analysis of the provided information, focusing on how the request's points relate to the document:

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

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for device performance. Instead, it aims to demonstrate substantial equivalence for new labeled uses by comparing the real-world performance of the da Vinci systems (robotic-assisted, "R") with traditional laparoscopic procedures ("L") for duodenal switch bariatric surgeries. This comparison functions as the "performance" data.

Table of Device Performance (from the document, Table 1):

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X 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, 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. Itis 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 Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to 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, 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. Itis 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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Hepatectomy/Liver Resection" under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi Surgical System (Model IS4000) and the da Vinci X Surgical System (Model IS4200) to include "Hepatectomy/Liver Resection" as a representative specific procedure under the existing Indications for Use. The submission argues for substantial equivalence based on clinical data from published literature.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., "mortality rate must be less than X%"). Instead, it presents a comparative effectiveness study showing that the da Vinci-assisted procedures for Hepatectomy/Liver Resection are "substantially equivalent" to minimally invasive/laparoscopic procedures based on several clinical endpoints. The acceptance criterion is implicitly that the robotic-assisted procedure's performance on these endpoints isnot worse than the comparator procedures.

The reported device performance is presented in Tables 1A and 1B: da Vinci vs. Minimally Invasive/Laparoscopic Hepatectomy/Liver Resection Procedures. These tables detail various clinical outcomes from 32 retrospective studies, 5 database studies, and 1 prospective study comparing robotic-assisted and laparoscopic/minimally invasive approaches for hepatectomy/liver resection.

Table of Performance Comparison (Derived from Tables 1A and 1B and supporting text):

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

The "test set" in this context refers to the published clinical studies analyzed.

• Sample size: The study identified 38 publications. Within these publications, individual study sizes (N) for both Robotic and Laparoscopic cohorts vary widely, as shown in Tables 1A and 1B. For example, some studies have N as low as 9 (Berber 2010 Robotic) or 10, while others are significantly larger, such as Lap 6186 (Stewart 2019) or Robotic 354 (Stewart 2019). The total number of patients across all 38 studies is not aggregated but is certainly substantial.
• Data provenance: The data is retrospective and prospective clinical data from published literature.
  • One (1) prospective study (LOE 2b)
  • Five (5) database studies (LOE 2c)
  • Thirty-two (32) retrospective studies (LOE 3b)
    The country of origin is not specified in the provided text, but it's international clinical literature.

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

The ground truth for the outcomes reported in the individual studies (e.g., mortality, complications, EBL) would have been established by the clinical teams involved in those primary studies. This submission is a literature review, not a primary clinical study establishing new ground truth. Therefore, the "ground truth" here is derived from the aggregated findings of numerous published studies conducted by various clinical experts worldwide. The submission itself doesn't mention specific experts establishing a ground truth for its own analysis, but rather synthesizes existing expert-derived clinical data.

4. Adjudication method for the test set

Not applicable in the conventional sense. This is a review of published literature. The outcomes of the individual studies would have been adjudicated according to the methods of those respective studies. The selection of the studies for this submission was based on specific search criteria and filters as outlined in Figure A, implying a systematic review process rather than expert adjudication of individual cases for ground truth.

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 is not an AI/imaging device. It's a surgical system where human surgeons directly control the robotic instruments. The comparative effectiveness study referenced is between human surgeons using the da Vinci system versus human surgeons using traditional minimally invasive/laparoscopic techniques. There is no mention of "human readers" or "AI assistance" in the context of improving diagnostic/interpretive tasks.

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

No. The da Vinci system is a robotically-assisted surgical tool that requires a human surgeon in the loop. It is not an autonomous algorithm.

7. The type of ground truth used

The "ground truth" in this context is the clinical outcome data (e.g., mortality, complications, blood loss, length of stay, resection margins) reported in published peer-reviewed clinical studies. These outcomes are established through standard clinical practice, surgical records, patient follow-up, and, where applicable, pathology reports for resection margins.

8. The sample size for the training set

Not applicable. This device is a surgical system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for this device is the training of surgeons to use the system, which is mentioned in the Indications for Use: "It is intended to be used by trained physicians."

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

Not applicable. As above, there is no "training set" in the context of an AI algorithm. The training of surgeons involves established surgical curricula, proctoring, and credentialing processes within medical institutions, based on clinical experience and outcomes.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X 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, 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 Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to 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, 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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific foregut procedures under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication and Toupet Fundoplication. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The document describes a 510(k) premarket notification for a labeling modification to the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200). The modification seeks to include additional "foregut" procedures (Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication, and Toupet Fundoplication) under the already cleared "general laparoscopic surgical procedures" Indications for Use. The submission states that there are no changes to the technological characteristics of the device, implying that the device itself is not being changed, only its listed indications for use. Therefore, standard acceptance criteria for device performance (e.g., accuracy, precision, safety) in a new or modified device submission are not applicable here in the typical sense. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence for the expanded indications.

The study that proves the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence for the new indications) is a clinical literature review comparing the da Vinci-assisted procedures to minimally invasive/laparoscopic procedures for the "foregut" procedures.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a labeling modification only, with no technological changes to the device, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence for the expanded indications through clinical outcomes. The device performance is reported by comparing outcomes of da Vinci-assisted procedures to standard minimally invasive/laparoscopic procedures.

• Mortality Rates
• Estimated Blood Loss (EBL) Volumes
• Lengths of Hospital Stay (LOS)
• Intraoperative Complication Rates
• Post/Peri-Operative Complication Rates
• Conversion Rates
• Readmission Rates
• Perforation Rates
• Operative Times

(See Table 1A for detailed study-specific data, e.g., Ali (2019): Robotic EBL Not Reported, Lap EBL Not Reported. Overall, across studies, these metrics were reported and determined to be comparable or equivalent.) |
| - Mortality Rates | |
| - Estimated Blood Loss (EBL) Volumes | |
| - Lengths of Hospital Stay (LOS) | |
| - Intraoperative Complication Rates | |
| - Post/Peri-Operative Complication Rates | |
| - Conversion Rates | |
| - Readmission Rates | |
| - Perforation Rates | |
| - Operative Times | |
| For Hiatal/Paraesophageal/Sliding Hernia Repair ("Umbrella Procedure #2"): Substantially equivalent rates for: | Hiatal/Paraesophageal/Sliding Hernia Repair: Findings from publications demonstrate substantial equivalence based on:

• Mortality Rates
• Estimated Blood Loss (EBL) Volumes
• Blood Transfusion Rates
• Lengths of Hospital Stay (LOS)
• Intraoperative Complication Rates
• Postoperative Complication Rates
• Conversion Rates
• Reoperation Rates
• Readmission Rates
• Operative Times

(See Table 1B for detailed study-specific data, e.g., Gehrig (2013): Robotic Op Time 172±31 min, Lap Op Time 168±42 min. Overall, across studies, these metrics were reported and determined to be comparable or equivalent.) |
| - Mortality Rates | |
| - Estimated Blood Loss (EBL) Volumes | |
| - Blood Transfusion Rates | |
| - Lengths of Hospital Stay (LOS) | |
| - Intraoperative Complication Rates | |
| - Postoperative Complication Rates | |
| - Conversion Rates | |
| - Reoperation Rates | |
| - Readmission Rates | |
| - Operative Times | |

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

• Sample Size (Test Set): The sample sizes vary by study within the literature review. For Heller Myotomy, the combined robotic cases across the 8 studies in Table 1A total 1043 patients. The combined laparoscopic cases total 5787 patients. For Hiatal/Paraesophageal/Sliding Hernia Repair, the combined robotic cases across the 7 studies in Table 1B total 1878 patients. The combined laparoscopic cases total 7085 patients.
• Data Provenance: The data provenance is from published clinical literature. The document states that "Fifteen (15) publications were identified...used in three (3) databases: PubMed, Scopus and Embase." These studies would encompass various countries and healthcare systems depending on the authors' affiliations. The study types include two (2) systematic reviews/meta-analyses, one (1) prospective study, two (2) database studies, and ten (10) retrospective studies.

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

The ground truth for the test set (the clinical outcomes reported in the literature) was established by the physicians and researchers who conducted the original studies. The document does not specify the number or specific qualifications of these original researchers, but it can be inferred that they are medical professionals and researchers in the field of surgery, as their work was published in peer-reviewed journals and structured as systematic reviews, prospective, database, and retrospective studies.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set in the context of the 510(k) submission. Instead, the "adjudication" of the clinical data comes from:

• The peer-review process of the scientific journals where the original 15 papers were published.
• The methodology of systematic reviews and meta-analyses included, which involve rigorous evaluation of study quality and results.
• The FDA's own review of these publications to determine if they support substantial equivalence.

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. An MRMC comparative effectiveness study was not done. This submission is for a surgical system and its indications, not an AI-powered diagnostic or interpretive tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between different surgical approaches (da Vinci-assisted vs. conventional laparoscopic), not between human performance with and without AI.

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

Given that the device is a surgical system (the da Vinci Xi and X Surgical Systems), which involves a human surgeon operating the robot, a "standalone algorithm only" performance study is not applicable or relevant to this device. This device is inherently "human-in-the-loop."

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data reported in published medical literature. These outcomes include objective measures such as mortality rates, estimated blood loss, length of hospital stay, complication rates (intraoperative and postoperative), conversion rates, readmission rates, perforation rates, reoperation rates, and operative times. This data is the direct result of actual surgical procedures.

8. The Sample Size for the Training Set

Not applicable. The submission describes a labeling modification for an existing surgical system. As there are no changes to the technological characteristics of the device and no new algorithm is being deployed, there is no "training set" in the context of machine learning or AI algorithms. The system's "training" for surgeons occurs through professional instruction and practice, not through a data-driven training set in the AI sense.

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

Not applicable, as there is no training set in the AI/ML context. If interpreted metaphorically, the "ground truth" for training surgeons on how to use the da Vinci system is established through medical education, surgical training programs, professional instructions for use, and clinical experience, guided by established surgical best practices and outcomes. However, this is not a ground truth for a machine learning training set as typically inquired.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000 and da Vinci X 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 modifications to the da Vinci Xi and X Surgical Systems adds a hardware component called the Advanced Processor (AP4000) as well software components, both on the Advanced Processor and a separate iOS app, to the surgical system.

These modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events). This allows surgeons to initiate and control video recordings as well as capture endoscopic images. These modifications also allow OR staff and others present in the OR to pair their iOS mobile devices with the Advanced Processor in order to view the live endoscopic video.

This FDA 510(k) summary describes modifications to the da Vinci Xi and X Surgical Systems, not a new AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies and acceptance criteria is not applicable to this document. The document focuses on regulatory clearance for hardware and software modifications that enhance existing functionalities of a robotic surgical system, rather than an AI-driven diagnostic or treatment recommendation system requiring clinical performance studies against a ground truth.

Specifically, the modifications enable:

• Video recording/Image capture.
• WiFi pairing of iOS devices with an Advanced Processor.
• An iOS app to view live endoscopic video.
• Data logging (stereo endoscopic video, kinematics, real-time events).

The submission asserts that these modifications do not affect the substantial equivalence of the device to its predicate because "verification and validation testing have established there are no new issues of safety or effectiveness."

Here's an attempt to answer the questions based on the provided document, highlighting what is not applicable due to the nature of the submission:

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

Since this is a submission for modifications to an existing device, and not a new diagnostic or prognostic AI/ML device, there are no specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) reported in this document. The "acceptance criteria" for these modifications appear to be successful completion of verification and validation testing, and compliance with relevant standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes verification and validation testing of software and hardware modifications for a robotic surgical system, not a clinical study involving a test set of patient data for an AI/ML diagnostic or prognostic algorithm. The testing would involve engineering and software validation tests, not clinical data sets in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth establishment by experts is relevant for AI/ML algorithms performing tasks like diagnosis or detection. The current submission focuses on verifying the functionality and safety of video recording, streaming, and data logging features.

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

This information is not applicable for the same reasons as #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

This information is not applicable. The device provides tools for surgeons (video recording, streaming), but it is not an AI assistant meant to improve human reader performance in interpreting medical images or data.

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

This information is not applicable. The modifications are for a human-controlled surgical system, enhancing its capabilities rather than introducing a standalone AI algorithm.

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

This information is not applicable. The "ground truth" for the verification and validation of these modifications would be the functional specifications and safety requirements met through engineering and software testing.

8. The sample size for the training set

This information is not applicable. This document does not pertain to the development or validation of an AI/ML algorithm that would require a training set.

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

This information is not applicable. As no AI/ML training set is mentioned or implied, the method for establishing its ground truth is irrelevant to this submission.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) 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 Intuitive Surgical Endoscopic Instrument Control System (da Vinci X 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, 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 subject of this 510(k) submission are software modifications to the da Vinci Xi Surgical System (Model IS4000) and da Vinci X Surgical System (Model IS4200). These modifications allow Intuitive Surgical to offer cloud-based features to the IS4000 and IS4200 systems such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.

• . Surgeon Cloud Accounts – Enable surgeons to log in to multiple IS4000 systems and access their personal IS4000 system settings (vision, ergonomic, motion scaling, and energy) by storing user preferences in a cloud-based central Intuitive data server.
• . Procedure List – Enable surgeons/OR staff to select a surgical procedure they intend to perform from the surgeon console touchscreen before the start of surgery.
• . Central Configuration – Enable authorized Intuitive Surgical employees to remotely configure features of one or more IS4000 systems simultaneously.

The provided text describes a 510(k) premarket notification for software modifications to the da Vinci Xi Surgical System and da Vinci X Surgical System. The modifications allow for cloud-based features such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.

However, the document does not contain any information regarding clinical performance studies, acceptance criteria, sample sizes for test or training sets, expert review processes for ground truth establishment, or multi-reader multi-case (MRMC) studies.

The "Performance Data" section explicitly states:

"Using an ISO 14971 compliant risk management process, a comprehensive hazard analysis of the software was performed, and impacted risks assessed, mitigations were evaluated and tested to be acceptable through verification and validation testing. The software development process based on ISO 62304 ensured that the software changes were appropriately documented, risk assessed and tested. Design verification tests were performed to verify the proposed software modifications performed as intended. The testing also verified the modifications to the da Vinci system software and server infrastructure did not raise new questions of safety and effectiveness. In addition, the pre and postmarket FDA guidance documents regarding cybersecurity were followed to document, risk assess and verify that the cybersecurity controls performed as expected in the event of an exploitation of a cybersecurity vulnerability. Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. None of the software modifications impact the intended use or indications for use of the da Vinci X/Xi Systems."

This indicates that the performance data for this 510(k) submission primarily consists of design verification and validation testing, hazard analysis, and cybersecurity assessment, rather than a clinical study measuring diagnostic or treatment outcome performance against specific acceptance criteria. The claim of "substantial equivalence" is based on these engineering and software system evaluations, and the fact that the modifications do not alter the intended use of the device.

Therefore, I cannot populate the requested table or answer most of the questions regarding acceptance criteria, study design, and ground truth, as this information is not present in the provided text.

However, I can extract the following relevant non-clinical information:

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

• Acceptance Criteria: Based on the text, the acceptance criteria are implicitly tied to the successful completion of design verification and validation testing, hazard analysis per ISO 14971, and cybersecurity control verification per FDA guidance. The overall goal is to demonstrate that the software modifications perform as intended and do not raise new questions of safety and effectiveness, thus maintaining substantial equivalence to the predicate device.
• Reported Device Performance:
  • Software modifications performed as intended.
  • Modifications did not raise new questions of safety and effectiveness.
  • Cybersecurity controls performed as expected.
  • Design output meets design input requirements.
  • No impact on the intended use or indications for use.

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

• Not applicable/Not provided. The "test set" here refers to engineering and software validation, not a clinical data set.

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

• Not applicable/Not provided. Ground truth in a clinical sense (e.g., diagnosis, pathology) was not established for this type of submission.

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

• Not applicable/Not provided.

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 MRMC study was done. This submission is for software modifications that add cloud-based functionality, not for AI assistance in diagnosis or treatment.

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

• Not applicable/Not provided. The device is a surgical system requiring human operation. The software modifications are infrastructure and user preference-related, not a standalone diagnostic algorithm.

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

• Not applicable. The "ground truth" for this submission would be defined by engineering specifications and functional requirements, against which the software was verified and validated.

8. The sample size for the training set:

• Not applicable/Not provided. No machine learning training set is mentioned in the context of this 510(k) for software modifications.

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

• Not applicable/Not provided.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to 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, 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 Intuitive Surgical Endoscopic Instrument Control System (da Vinci X 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, 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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294) and the associated labeling claims: Gastrectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided document describes a 510(k) submission for a labeling modification of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) to include "Gastrectomy" as a recognized procedure under the existing "general laparoscopic surgical procedures" indication for use. This is explicitly stated as a labeling modification only, with no changes to the technological characteristics of the cleared devices. As such, the "acceptance criteria" and "device performance" in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity) for a novel device or AI algorithm are not applicable here.

Instead, the study aims to demonstrate that adding "Gastrectomy" to the labeling does not introduce new safety or effectiveness concerns compared to the already cleared general laparoscopic indications, and that the da Vinci systems are substantially equivalent for this new labeled use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a labeling modification and not a new device or AI algorithm with specific performance metrics like accuracy, sensitivity, or specificity, there are no predefined numerical acceptance criteria or typical "device performance" values.

Instead, the "acceptance criteria" can be inferred as demonstration of comparable safety and effectiveness outcomes for Gastrectomy procedures performed with the da Vinci system when compared to laparoscopic and/or open procedures, based on literature review.

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

• Sample Size for the Test Set:
  The study is a literature review, not a primary clinical trial with a "test set" in the traditional sense of a prospectively collected cohort. The sample sizes are derived from the N values reported in the individual studies included in the meta-analysis/systematic review. For example, some studies reviewed had sample sizes for Robotic Gastrectomy ranging from 53 to 1830 patients, for Laparoscopic Gastrectomy from 61 to 4123 patients, and for Open Gastrectomy from 145 to 8585 patients.
• Data Provenance: The data provenance is stated as "Published clinical data from literature." The document extensively cites 16 publications. No specific countries of origin are mentioned, but based on typical medical literature, these would likely be international. The studies cited include:
  • Two (2) randomized controlled trials (level 1b evidence)
  • Ten (10) systematic reviews/meta-analysis (level 2a evidence)
  • Four (4) database studies (level 2c evidence)
    The nature of these studies (e.g., retrospective database analyses, prospective RCTs within the included literature) would vary.

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

This type of study does not involve "experts establishing ground truth" for individual cases in a test set. The "ground truth" here is the aggregated clinical outcomes reported in published studies, which are considered evidence-based medical conclusions. The experts involved would be the authors of the 16 published clinical studies (surgeons, statisticians, researchers, etc.) who conducted the original research and established their findings. Their specific qualifications are not detailed in this 510(k) summary, but are implicitly assumed based on the peer-reviewed nature of the published literature.

4. Adjudication Method for the Test Set

No adjudication method is applicable here as this is a review of published literature, not a study involving individual case assessments by reviewers. The "adjudication" is inherent in the peer-review process of the published articles and the methodology of systematic reviews and meta-analyses.

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 MRMC comparative effectiveness study was done. This submission is for a surgical system, not an AI diagnostic/interpretive tool requiring human reader performance evaluation.

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

No standalone algorithm performance study was done. The da Vinci Xi and X Surgical Systems are electro-mechanical systems intended to assist surgeons (human-in-the-loop), not standalone algorithms. The submission explicitly states "The Intuitive Surgical Endoscopic Instrument Control System...is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments...It is intended to be used by trained physicians in an operating room environment..."

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data (e.g., mortality, EBL, LOS, complication rates, reoperation rates, etc.) collected and analyzed in previously published clinical studies (Randomized Controlled Trials, Systematic Reviews/Meta-analyses, and Database Studies).

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of an AI/ML algorithm. The "training data" for making the determination about substantial equivalence for the new indication are the 16 published clinical studies. The sum of patients across all studies' da Vinci cohorts, laparoscopic cohorts, and open cohorts constitutes the entirety of the evidence base reviewed. These numbers are substantial, with individual studies reporting hundreds to thousands of patients (e.g., Robotic 1830, Lap 4123, Open 8585 in some studies).

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

Since there is no "training set" in the AI/ML sense, the question refers to how the evidence for the labeling modification was established. The "ground truth" (i.e., the clinical outcomes and conclusions) in the selected 16 publications was established through:

• Clinical Research Methodologies: Randomized controlled trials, systematic reviews, meta-analyses, and database studies.
• Data Collection: Gathering patient data on various clinical outcomes (e.g., EBL, LOS, complications, mortality) from surgical procedures.
• Statistical Analysis: Rigorous statistical methods applied by the authors of the original publications to analyze and interpret the collected data, leading to the reported conclusions regarding comparability or differences in outcomes between da Vinci, laparoscopic, and open surgical approaches.
• Peer Review: The scientific rigor of these publications being accepted into peer-reviewed journals.

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