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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 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):

Acceptance Criteria Interpretation: The "acceptance criteria" here are implied by the substantial equivalence argument: the da Vinci system performance for these new indications should be comparable to or better than traditional laparoscopic methods, without raising new questions of safety or effectiveness. The p-values are used to assess statistical differences between the robotic and laparoscopic cohorts. While the robotic operative time is significantly longer (p < 0.001), some key safety outcomes (conversion to open, transfusion, intraoperative complications, and mortality) show no significant difference or favorable trends for robotic assistance (e.g., lower reoperation rate and readmission rate in the PS matched data). The submission concludes that the RWE demonstrates the safety and effectiveness of robotic-assisted duodenal switch bariatric surgical procedures and that da Vinci-assisted procedures are substantially equivalent to laparoscopic procedures based on these outcomes.

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

• Sample Size (Test Set):
  • Unmatched: 1,878 patients in total (377 robotic-assisted, 1501 laparoscopic).
  • Propensity Score Matched: 628 patients (314 robotic-assisted, 314 laparoscopic).
• Data Provenance:
  • Country of Origin: USA.
  • Nature of Data: Retrospective Real World Evidence (RWE) from the Premier Health Database (PHD). The data covers the period from 2016 to 2020.

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

The document does not describe a process of individual expert ground truth establishment for each case. Instead, the "ground truth" is derived from real-world clinical outcomes recorded in the Premier Health Database using ICD-10 and CPT codes. This implicitly relies on the medical professionals (e.g., surgeons, diagnosticians, hospital staff) who documented these codes and outcomes in clinical practice, rather than a separate panel of experts being convened to review the data for the purpose of this study.

4. Adjudication method for the test set

There is no mention of an adjudication method in the context of expert review for ground truth, as the data provenance is real-world clinical records rather than expert interpretation of medical images or other subjective assessments. The "adjudication" in this context is the inherent process of medical documentation and coding within the healthcare system.

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 study compares the outcomes of robotic-assisted surgery (where the surgeon uses the da Vinci system) versus traditional laparoscopic surgery. It is not comparing human readers' performance with and without AI assistance in reading or diagnosis. The da Vinci system is a surgical tool, not an AI diagnostic assistant. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report here.

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

No, a standalone (algorithm only) performance was not done. The da Vinci system is an "Endoscopic Instrument Control System" that "is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments." It is fundamentally a human-in-the-loop system, where the surgeon controls the robotic arms. The study evaluates the outcomes of surgery performed by surgeons with the assistance of the da Vinci system, not an autonomous algorithm.

7. The type of ground truth used

The ground truth is based on outcomes data and clinical diagnoses/procedures (documented via ICD-10 and CPT codes) from real-world patient records in the Premier Health Database. These outcomes include operative times, length of hospital stays, conversion rates, various complication rates, readmission rates, reoperation rates, and mortality rates.

8. The sample size for the training set

The document does not mention a separate "training set" in the context of an AI/machine learning model being developed or trained. This submission is for a labeling modification of an existing surgical system, not the initial clearance of a new AI algorithm. The real-world evidence presented is used to support the safety and effectiveness of the existing device for new labeled uses, but not to train a model in the typical sense.

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

As there is no mention of a "training set" for an AI model, this question is not applicable to the provided document. The real-world data itself serves as the basis for demonstrating equivalence for the new indications, not as data for training an algorithm where ground truth needs to be established by experts.

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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, 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 da Vinci X Surgical System, Model IS4200 is a modification to the Patient Side Cart of the da Vinci Xi Surgical System, Model IS4000, cleared under K131861. The arms of the IS4000 have been grafted onto the setup structure of the da Vinci Si Surgical System Patient Cart (K081137). The da Vinci X Patient Cart utilizes the same electronics as the da Vinci Xi Patient Cart with some minor modifications. The da Vinci X Patient Cart is run by the same software and is to be used with the Surgeon Console and Vision Cart of the da Vinci Xi Surgical System. All of the da Vinci Xi instruments and accessories, including advanced instruments (e.g., Single Site, Vessel Sealer, Stapler, etc.), are compatible with the da Vinci X Surgical System.

The da Vinci X Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The da Vinci X Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes the supporting electronic and video processing equipment for the system.

The Patient Side Cart is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system. The da Vinci X Surgical System Patient Cart has the same arms as the da Vinci Xi Surgical System Patient Cart and is compatible with all of the base, Single-Site, and advanced instruments and accessories (with the exception of the column drape) cleared for use with the da Vinci Xi Surgical System (K131861).

The provided FDA document describes the da Vinci X Surgical System (Model IS4200), a modification to the da Vinci Xi Surgical System. It primarily focuses on demonstrating substantial equivalence to a predicate device (da Vinci Xi Surgical System, K131861) rather than presenting a study with explicit acceptance criteria and corresponding performance metrics for a novel AI algorithm.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted as it is not the focus of this 510(k) summary.

However, based on the provided text, I can infer and summarize what is available regarding performance data and the nature of the "study" (verification and validation testing) conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or objective performance measures in a table format that are typically associated with AI algorithm validation (e.g., sensitivity, specificity, accuracy). Instead, the performance data focused on demonstrating that the modified device functions as intended and is safe and effective when compared to the predicate.

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

• Sample Size: The document does not specify exact sample sizes for hardware verification, human factors testing, preclinical validation, or software testing.
• Data Provenance: Not explicitly stated. The testing would have been conducted by Intuitive Surgical, Inc. as part of their device development and submission process. The nature of these tests (hardware, software, human factors, preclinical) suggests they were likely controlled, prospective tests designed to evaluate the modified system.

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

This information is not provided in the document. For a surgical system modification, "ground truth" might refer to the successful completion of surgical tasks in preclinical settings. The "experts" would likely be the engineering and clinical teams at Intuitive Surgical, and potentially surgeons participating in preclinical validation, but specific numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the device (a surgical system modification), adjudication methods in the context of diagnostic AI might not be directly applicable. Instead, the validation would involve successful execution of procedures and verification against design specifications.

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

A multi-reader multi-case (MRMC) comparative effectiveness study and the effect size of human improvement with AI assistance are not applicable and therefore not mentioned. The da Vinci X Surgical System is an instrument control system, not an AI diagnostic tool designed to assist human "readers" in interpreting medical images or data. It enhances a surgeon's ability to perform surgery, but not through an "AI assistance" model in the way typically discussed for diagnostic algorithms.

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

The concept of a "standalone" performance for the da Vinci X Surgical System is not applicable. This device is fundamentally a human-in-the-loop system designed to assist surgeons. Its core function is to translate a surgeon's hand movements into precise instrument movements within the patient's body. The "algorithm" component (software) is integral to this human-driven control.

7. The Type of Ground Truth Used:

For this type of device (a surgical system modification), "ground truth" would likely be established through:

• Design Specifications: Ensuring the system meets its engineering and functional requirements.
• Preclinical Validation: Successful completion of surgical tasks on models or animal subjects by trained operators.
• Safety and Effectiveness Benchmarks: Demonstrating that the modified system performs at least as safely and effectively as the predicate device.

8. The Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning is not applicable as described in this document. The da Vinci X Surgical System is not an AI algorithm that learns from a dataset for a specific diagnostic or predictive task. It is a robotic surgical system that translates user input. The "software testing" mentioned would relate to verification and validation of deterministic software functionality, not machine learning model training.

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

This information is not applicable as there is no "training set" in the machine learning sense for this device.

In summary: The provided document is a 510(k) submission for a modification to an existing surgical robot. It focuses on demonstrating substantial equivalence through various engineering, hardware, software, and human factors verification and validation, rather than the performance of a novel AI diagnostic algorithm. Therefore, many of the requested specific details regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment in an AI context are not present.

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