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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 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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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 "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. 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 provided document, K173585, describes the a 510(k) premarket notification for a labeling modification to include "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System (Model IS4000) and the da Vinci X Surgical System (Model IS4200). The document does not describe the acceptance criteria and study proving a device's performance against acceptance criteria in the manner typically seen for AI/ML-enabled devices. Instead, it focuses on demonstrating the substantial equivalence of adding VHR procedures to the existing robotic surgical systems by comparing the outcomes of robotic-assisted VHR to traditional open and laparoscopic VHR.

Therefore, many of the specific questions about acceptance criteria for an AI/ML device's performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, and standalone algorithm performance, as requested in the prompt, are not applicable or directly addressed by this document. This document is about a surgical system, not an AI/ML diagnostic or prognostic tool.

However, I can extract information related to the clinical study data used to support the labeling modification, which serves a similar purpose to a performance study for a new indication.

Here's the information as it relates to the provided document:

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

The document doesn't define explicit numerical "acceptance criteria" in the way one would for an AI/ML device (e.g., "sensitivity must be >X%"). Instead, it demonstrates comparability and, in some cases, superiority of the robotic-assisted VHR to existing surgical methods across several clinical outcomes and measures. The "acceptance" for this 510(k) is based on demonstrating substantial equivalence and safety and effectiveness for the new indication compared to existing methods.

The tables provided (Tables 1, 2, 3, and 4a) present the "reported device performance" in terms of clinical outcomes for robotic-assisted VHR procedures compared to open and laparoscopic VHR. Below is a summary of the key findings, which serve as the "performance" data used to support the new indication.

Summary of Device Performance (Robotic-Assisted VHR vs. Comparators)

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The Intuitive Surgical Endoscopic Instrument Control 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 thoracoscopical 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 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 procedures 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): Gastric Bypass (Roux-en-Y) and Gastric Sleeve. 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.

This document is a 510(k) summary for a labeling modification of the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200). It focuses on adding specific gastric procedures (Gastric Bypass and Gastric Sleeve) to the "general laparoscopic surgical procedures" indication for use. Therefore, the acceptance criteria and supporting studies are related to the safety and effectiveness of the device for these additional procedures, primarily against existing surgical methods (open and laparoscopic).

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices and established surgical practices (open and laparoscopic) by showing comparable or improved outcomes in various metrics. The acceptance is implicitly based on these comparisons showing non-inferiority or superiority in critical safety and effectiveness parameters.

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

• Test Set Description: The "test set" in this context refers to the published clinical data analyzed for Gastric Bypass (Roux-en-Y), which served as the "umbrella procedure" to support both Gastric Bypass and Gastric Sleeve.
• Sample Size (for Gastric Bypass umbrella procedure): The clinical data summarized in Table 1A involved 10 publications. The total number of patients included across these studies is:
  • da Vinci (Robotic) Cohort: 172 + 61 + 100 + 100 + 100 + 125 + 100 + 65 + 388 + 143 = 1,354 patients
  • Laparoscopic (Lap) Cohort: 173 + 46 + 100 + 100 + 100 + 121 + 100 + 54 + 389 + 323 = 1,506 patients
  • Open Cohort: 95 + 524 = 619 patients
• Data Provenance: The data are from published clinical studies. The specific countries of origin are not mentioned, but clinical literature is generally international. The studies include both non-randomized, controlled, prospective studies (2 studies) and retrospective cohort studies (8 studies).

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

• This information is not provided in the given text. The "ground truth" for these clinical outcome studies is inherent in the reported patient outcomes and surgical metrics gathered and published by the original study authors. There is no mention of independent experts establishing a ground truth for a test set for the purpose of this 510(k) submission. The FDA's review process inherently involves medical experts, but they are assessing the submitted evidence, not establishing a new ground truth.

4. Adjudication Method for the Test Set

• This information is not provided. The text describes a review of published clinical data. Adjudication methods (like 2+1 or 3+1 consensus) are typically associated with image-based diagnostic studies or clinical trials where expert review of individual cases is part of the study design. For a meta-analysis or review of published literature on surgical outcomes, the "adjudication" is primarily how each original study defined and reported its outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of a device (often imaging-based AI) by comparing how multiple readers perform with and without the device. This submission is for a surgical system and its labeled indications, and the performance evaluation relies on real-world surgical outcomes and peer-reviewed literature, not diagnostic reader performance.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as it's not an MRMC study.

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

• No, a standalone (algorithm-only) performance study was not done. The da Vinci system is a surgical assistance system, inherently involving a human surgeon (human-in-the-loop). Its "performance" is evaluated by the outcomes of surgeries performed with the system assisting the surgeon, compared to traditional methods.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical performance evaluation is based on patient outcomes and surgical metrics reported in peer-reviewed clinical literature (e.g., mortality, complication rates, length of stay, operative time, reoperation rate, etc.). This is essentially outcomes data collected and documented in clinical studies.

8. The Sample Size for the Training Set

• This information is not applicable in the conventional sense for this type of submission. The da Vinci system is an electro-mechanical surgical system, not an AI/ML algorithm that undergoes a distinct "training" phase on a dataset of cases to learn to perform a task. The "experience" or "learning" of the system happens through engineering design, software development, preclinical testing, and extensive clinical validation over many years.
• However, if one were to consider the continuous development and refinement of the system's design and software, it would be based on an enormous "dataset" of engineering principles, surgical knowledge, user feedback, and prior clinical experience.

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

• As explained above, a "training set" with established ground truth in the context of machine learning is not directly applicable here. The development of the surgical system relies on established surgical practices, engineering standards, and medical knowledge. Pre-clinical animal studies (mentioned as 6 evaluations in 24 animals) contribute to the developmental understanding and validation of the system's design, but this isn't a "training set" in the AI sense.
• The "ground truth" for surgical device development is rooted in the safety and effectiveness principles derived from surgical anatomy, physiology, surgical techniques, and clinical outcomes, primarily established by expert surgeons and medical researchers over decades.

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The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) 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 laparosopic 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 Surgical System, Model 184200) 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 laparosopic 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 procedures 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): Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy. 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 provided text describes a 510(k) premarket notification for a labeling modification of the da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200. This modification adds specific representative procedures (Pancreatectomy, Pancreaticoduodenectomy, Splenectomy, and Cholecystectomy) under the existing "general laparoscopic surgical procedures" indication for use.

Crucially, the submission states that there are no changes to the technological characteristics of the device. Therefore, the "device" in question (the da Vinci surgical system itself) is already cleared, and the performance data presented is to establish substantial equivalence for the expanded indications for use, not to prove the fundamental performance of the surgical robot. The acceptance criteria and "device performance" in this context refer to the clinical outcomes of procedures performed using the da Vinci system compared to traditional open or laparoscopic methods, demonstrating that the new indications are safe and effective.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to demonstrate that da Vinci Xi/X-assisted procedures for the newly added indications are comparable or superior to existing open or laparoscopic surgical procedures across a range of clinical outcomes.

The "reported device performance" is derived from the clinical literature review for the "umbrella procedures" (Pancreatectomy and Pancreaticoduodenectomy), which are considered representative of the more complex/higher-risk operations. The less complex/lower-risk "covered procedures" (Splenectomy and Cholecystectomy) were supported by inference from the umbrella procedures.

Below is a summary of the findings, which implicitly serve as the "acceptance criteria" and "reported performance" through comparative equivalence:

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

• Sample Size for Clinical Studies (Test Set):

  • Pancreatectomy (Umbrella Procedure #1): Eleven (11) publications were identified. The sample sizes within these publications varied significantly. For example, in Table 1A, individual study cohorts ranged from 22 to 3743 patients for da Vinci, laparoscopic, and open procedures. The largest single cohort for da Vinci was 258 (Zureikat, 2017) and for open was 3743 (Zureikat, 2017).
  • Pancreaticoduodenectomy (Umbrella Procedure #2): Eight (8) publications were identified. Individual study cohorts ranged from 102 to 3743 patients. The largest single cohort for da Vinci was 476 (Pedziwiatr, 2017) and for open was 3743 (Zureikat, 2017).
  • Covered Procedures (Splenectomy and Cholecystectomy): No specific clinical studies were provided for these procedures; their clearance was supported by the data from the umbrella procedures.

• Data Provenance: The data are derived from published clinical literature, including:

  • Prospective randomized controlled trials
  • Meta-analyses
  • Systematic reviews
  • Large database comparative studies

  The specific countries of origin are not specified, but peer-reviewed medical literature typically encompasses international data. The studies are retrospective and prospective, depending on the nature of the individual publications included in the literature review.

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

This is not applicable in the traditional sense for this submission. The "ground truth" for the clinical effectiveness and safety of the da Vinci system for these procedures is established by the peer-reviewed published clinical literature, which is generated by numerous clinical researchers and practicing surgeons. The FDA review process itself involves experts (e.g., "Director, Division of Surgical Devices, Office of Device Evaluation") who evaluate the scientific rigor and conclusions of the submitted literature review.

4. Adjudication Method for the Test Set

Not directly applicable in the terms of human reader adjudication of images. The "adjudication" in this context is the consensus reached through the scientific and statistical analysis presented in the peer-reviewed meta-analyses, systematic reviews, and comparative studies. The FDA then adjudicates the strength of this evidence for the purpose of granting substantial equivalence.

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

No, an MRMC comparative effectiveness study was not done. The submission relies on a literature review comparing clinical outcomes of different surgical approaches (da Vinci, laparoscopic, open).

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

This question is not applicable. The da Vinci Surgical System is a human-in-the-loop device; it is controlled by a surgeon. The "performance" being evaluated is the outcome of surgical procedures when performed using the da Vinci system (with a human surgeon operating it), compared to other surgical methods. This is not an AI algorithm performing a task autonomously.

7. The Type of Ground Truth Used

The "ground truth" for the clinical performance claims is based on patient outcomes data reported in published clinical trials and studies. These outcomes include:

• Mortality rates
• Estimated blood loss
• Length of hospital stay
• Postoperative complication rates
• Spleen preservation rates (for pancreatectomy)
• Gastric emptying rates
• Reoperation rates
• Readmission rates
• Pancreatic fistula rates
• Operative time
• Conversion rates
• R0/R1 resection rates
• Lymph node yield

8. The Sample Size for the Training Set

No explicit "training set" for an AI algorithm is mentioned as this device is not presented as an AI-driven autonomous system in this submission. The performance data is for the surgical system itself. The publications reviewed in the submission can be considered the evidence base that informs the regulatory decision, rather than a training set for an AI model.

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

As no training set for an AI algorithm is mentioned, this question is not applicable. The clinical "ground truth" for the effectiveness of the surgical system is established through the standard methodologies of clinical research (e.g., prospective trials, retrospective analyses, meta-analyses) that generated the published literature.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic 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 laparossopic 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 pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci Xi Surgical System, Model IS4000, is a softwarecontrolled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

It appears that the provided text is a 510(k) summary for a medical device (da Vinci Xi Surgical System) and focuses on a labeling modification rather than presenting a performance study of the device itself against specific acceptance criteria for a new algorithmic feature. The submission is to include "Inguinal Hernia Repair" procedures under an already cleared "general laparoscopic surgical procedures" indication.

Therefore, the information I can extract to directly answer your request about device acceptance criteria and a study proving it meets them for a specific performance metric (like algorithm accuracy) is limited, as this is primarily a procedural and comparative effectiveness submission for a surgical procedure, not an AI algorithm.

However, I can reframe the "acceptance criteria" based on the comparative effectiveness study presented for the procedure performed with the device. The study aims to demonstrate that robotic-assisted inguinal hernia repair is "safe and effective" and compares several clinical outcomes to open surgery and laparoscopic procedures.

Here's the closest I can get to your request based on the provided document:

Acceptance Criteria and Study for da Vinci Xi Surgical System (for Inguinal Hernia Repair Procedure Labeling)

The acceptance criteria are not explicitly stated in terms of a quantifiable threshold for a device's performance (e.g., AUC > 0.90 for an AI algorithm). Instead, the study aims to demonstrate that performing Inguinal Hernia Repair with the da Vinci Xi Surgical System is safe and effective and comparable or superior in key clinical outcomes to existing standard-of-care procedures (open and traditional laparoscopic surgery).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Study Data):

  • Robotic-assisted cohort: 652 subjects
  • Open cohort: 602 subjects
  • Laparoscopic cohort: Variable N from 20 to 3,457 (derived from 11 published studies for comparison)
  • Data Provenance: Retrospective, multi-center, non-randomized controlled clinical study conducted at six (6) investigational sites in the United States. The laparoscopic comparison data is from published literature (Bittner, et al., 2015).

• Training Set: Not applicable as this is not a machine learning model being trained and tested. This is a post-market clinical study for a labeling modification of an existing surgical system.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• The "ground truth" for the clinical study is the actual clinical outcomes observed in patients undergoing the procedures (e.g., actual complications, readmissions, reoperations, length of stay, mortality). These are objective clinical endpoints, not subjective interpretations by experts. Therefore, the concept of "experts establishing ground truth" as it applies to an image interpretation AI model does not fit here. The study involved practicing surgeons and medical staff at the investigational sites who collected the data.

4. Adjudication Method for the Test Set

• The document does not describe a formal "adjudication method" for the clinical endpoints in the same way one would for an AI model's output. Clinical data collection would typically follow standard protocols at each investigational site, potentially with source data verification, but not an "adjudication" of the data itself by independent experts in the context of resolving disagreements on results. The data are quantitative clinical outcomes.

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

• No, a MRMC study was not done. This study is a clinical comparative effectiveness study comparing surgical approaches (robotic-assisted vs. open vs. laparoscopic) for a specific procedure. It does not involve multiple human readers interpreting images with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone study was not done. The da Vinci Xi Surgical System is a surgical robotic system with human-in-the-loop (the surgeon). The study evaluates the performance of the procedure when performed with this system, not an isolated algorithm. The submission is for a labeling modification to include a new procedure, not a new algorithm or AI functionality.

7. Type of Ground Truth Used

• The ground truth used for the clinical study was clinical outcomes data collected from patient records (e.g., hospital discharge records, patient follow-ups). These include objective metrics like length of stay, occurrence of complications, reoperations, readmissions, and mortality.

8. Sample Size for the Training Set

• Not applicable; see point 2.

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

• Not applicable; see point 2.

Summary for this specific 510(k) context:

This 510(k) is about expanding the indications for use of an existing surgical robotic system to include Inguinal Hernia Repair. The "study" here is a clinical comparative effectiveness study demonstrating that the procedure performed with the device is safe and effective and compares favorably or acceptably to existing surgical methods. It is not an AI/algorithm performance study on a test set, so many of the requested items (like expert ground truth for interpretation, MRMC, standalone algorithm performance, or specific AI training/test set details) are not directly addressed in the provided text.

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The Intuitive Surgical Endoscopic Instrument Control 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, 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 laparosopic 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 procedures under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text describes a 510(k) premarket notification for the Da Vinci Xi Surgical System, focusing on a labeling modification to include additional specific procedures under existing general indications for use. This involves demonstrating substantial equivalence to predicate devices, rather than establishing entirely new performance criteria for a novel device. Therefore, the information typically requested regarding acceptance criteria and a study proving a new device meets those criteria is not directly applicable in this context as new performance metrics are not being established.

However, I can extract and structure the available information about the demonstration of suitability for the expanded indications, which functions as the system's "acceptance" for these new procedures.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly demonstrating that the da Vinci Xi Surgical System, when used for the expanded "umbrella" and "covered" procedures, shows comparable or improved patient outcomes (mortality, complications, blood loss, length of stay, operative time) compared to established surgical methods (Open and VATS procedures).

• Complications: Comparable.
• Blood Transfusion Rates: Comparable or lower.
• Length of Hospital Stay: Comparable or shorter.
• Operative Times: Comparable or shorter (5 studies), or increased (13 studies) (but no correlation with increased mortality).
• Conversion Rates: Comparable or lower compared to VATS. |
  | Mediastinal Mass Resection | - Mortality Rates: Comparable.
• Operative Times: Comparable.
• Complication Rates: Comparable or lower.
• Length of Hospital Stay: Comparable or shorter compared to open surgical procedures.
• Single-arm studies: No reports of mortality, low complication rates (intraoperative

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