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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 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 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 pediatic use. It is intended to be used by tramed physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The EndoWrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.

The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS4000 da Vinci Xi Surgical System or IS4200 da Vinci X Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

This is a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document asserts substantial equivalence to a predicate device (K131861). As such, it does not detail new clinical studies with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a novel AI/ML device submission might. This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering analysis, bench testing, and potentially some animal studies if there are significant differences.

Here's a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:

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

Since this is a submission for an electrosurgical instrument (scissors) and not a diagnostic AI/ML device, the "acceptance criteria" discussed are primarily related to engineering performance specifications and safety, not diagnostic accuracy metrics like sensitivity, specificity, or AUC. The document does not provide a table with specific numerical acceptance criteria and reported device performance for these types of metrics. Instead, it states that:

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

This information is typically not applicable to submissions for electrosurgical instruments like these scissors, which are evaluated primarily through bench and design verification/validation testing. The document does not mention "test sets" in the context of clinical data, as it describes engineering performance data rather than clinical outcomes or diagnostic accuracy.

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 is not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the type of device and testing described (electrosurgical instrument performance).

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

This is not applicable for the reasons stated above.

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 is not applicable. The device is an electrosurgical instrument, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

This is not applicable. The device is a surgical instrument and does not involve an algorithm or standalone performance in the context of AI/ML.

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

This is not applicable. The "ground truth" for the performance of an electrosurgical instrument is its ability to perform its intended mechanical and electrical functions reliably, safely, and biocompatibly, which is assessed through engineering tests, not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for this type of medical device submission.

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

This is not applicable for the reasons stated above.

In summary:

The provided document describes a 510(k) submission for a surgical instrument, the 8mm Monopolar Curved Scissors, asserting substantial equivalence to an existing predicate device based on engineering and biocompatibility testing. The "acceptance criteria" and "performance" discussed relate to mechanical, electrical, and material properties, as opposed to clinical diagnostic accuracy or AI/ML performance metrics. Therefore, many of the specific questions geared towards AI/ML device evaluation are not applicable to this submission.

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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 Surgical System, Model 184000) 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.

This 510(k) is for expansion of the representative, specific procedures via labeling modification, to include the following additional representative, specific procedures under the previously cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861) and the da Vinci X Surgical System (K171294) : Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy);- Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems 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 is a 510(k) summary for the da Vinci Surgical System, Model IS4000 and IS4200. This submission seeks to expand the "general laparoscopic surgical procedures" indication to include specific additional procedures. The core of the submission revolves around demonstrating substantial equivalence to predicate devices, focusing on clinical outcomes from existing literature rather than new device performance testing.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for device performance as would be seen in a typical medical device study. Instead, it relies on demonstrating comparable outcomes to existing surgical methods (open and laparoscopic) for the new indications. The "reported device performance" is the aggregated clinical outcomes from published literature for the da Vinci-assisted procedures (specifically LAR/TME and ISR), compared against open and laparoscopic procedures. The acceptance criterion is essentially that the da Vinci system should at least be comparable to or better than the existing methods across various clinical metrics.

Acceptance Criteria/Clinical Outcomes for Comparison:

Note: The tables (1A, 1B, 2A, 2B) provide detailed numerical data from various publications supporting these summary findings. For instance, in LAR/TME, operative times for da Vinci systems ranged from 191 to 337.9 minutes, while open procedures were 124 to 273.8 minutes and laparoscopic were 158.1 to 298.8 minutes, showing the reported "increased operative times" for da Vinci. Similarly, mortality rates were largely comparable across modalities.

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

The document does not describe a single "test set" in the traditional sense of a prospective clinical trial for algorithm validation. Instead, it relies on a literature review of published clinical studies.

• Sample Sizes (for "Umbrella" Procedures):

  • Low Anterior Resection/Total Mesorectal Excision (LAR/TME): Data from 11 publications. The sample sizes within these publications varied significantly, with "da Vinci" cohorts ranging from 25 to 1217 patients, "Open" cohorts from 25 to 4403 patients, and "Laparoscopic" cohorts from 156 to 5935 patients (as seen in Tables 1A and 1B).
  • Intersphincteric Resection (ISR): Data from 2 publications. Sample sizes for "da Vinci" cohorts were 40 and 108 patients; for "Open" cohorts, 114 patients; and for "Laparoscopic" cohorts, 40 patients (as seen in Tables 2A and 2B).

• Data Provenance: The data comes from published clinical studies. While specific countries are not mentioned, published literature tends to be international in scope, potentially including data from various countries. The types of studies included a prospective randomized controlled trial, meta-analyses, systematic reviews, and large database comparative studies. This indicates a mix of retrospective and prospective studies, predominantly observational or comparative in nature.

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

The concept of "experts used to establish ground truth" is not directly applicable here. This is because:

• The device being assessed (da Vinci Surgical System) is a surgical tool, not an AI or diagnostic imaging device that produces classifications requiring expert labeling.
• The "performance data" is derived from clinical outcomes published in medical literature. The "ground truth" for these outcomes (e.g., mortality, complications, length of stay, surgical margins) was established by the original research teams and clinical record-keeping within those studies, performed by trained medical professionals (surgeons, pathologists, nurses, etc.) according to their respective clinical practices.
• The FDA review team evaluates the submitted evidence, but they do not create ground truth for the performance assessment.

4. Adjudication Method for the Test Set

Since there isn't a "test set" or a direct human-in-the-loop diagnostic process in this context, an adjudication method for establishing ground truth is not described or relevant. The "adjudication" in this case would be the critical review of the scientific literature by the sponsor and subsequently by the FDA to determine if the presented evidence supports 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 MRMC study was done, nor would it be relevant for this type of medical device submission. The da Vinci Surgical System is a robotic surgical platform, not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists, pathologists). Its purpose is to assist surgeons during procedures, not to interpret medical images or data. The study focuses on clinical outcomes of using the system versus traditional surgical methods.

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 system is inherently a human-in-the-loop system, as it is controlled by a surgeon. It is a surgical instrument, not an autonomous algorithm. The "performance data" describes the clinical outcomes when used by a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission consists of clinical outcomes data from published literature. This includes:

• Mortality rates
• Blood transfusion rates and estimated blood loss (EBL)
• Length of hospital stay
• Post-operative and intra-operative complication rates
• Rates of positive surgical margins (PSM)
• Anastomotic leak rates
• Erectile dysfunction (ED) rates
• Urologic function scores
• Conversion rates (from da Vinci to open or laparoscopic)
• Number of lymph nodes harvested/retrieved
• Circumferential Resection Margin (CRM) / Distal Resection Margin (DRM) involvement
• Fecal continence rates (for ISR)

These outcomes are generally established through clinical follow-up, pathology reports, and patient questionnaires in the original studies.

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of machine learning or AI. The da Vinci Surgical System is a hardware/software system, and its "training" per se would involve engineering development and rigorous testing, not data-driven machine learning in the conventional sense. The "performance data" presented is clinical evidence of its use in patients, not data used to train a model. Therefore, a training set size is not applicable to this 510(k) submission.

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

As there is no "training set" in the context of this 510(k) submission, the method for establishing its ground truth is not applicable. The device's "ground truth" development would be tied to its design specifications, engineering verification, and validation testing during its product development lifecycle, prior to clinical use and regulatory submission. The clinical data presented here is evidence of its performance, not its training.

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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, 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 IS3000) is intended to r no multive accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp assist in the 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 approximation against, orceral procedures, general laparoscopic surgical procedures, gynecologic probos and acoussent anning actrage tal otolaryngology surgical procedures restricted to benign and malignant itumors classified as T1 and T2, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy rumors clasmed as 1 x and 12, gateda adjunctive mediastinotomy to perform coronary anastomosis during procedurer The system is indicated for adult and pediatric use. It is intended to be used by trained earchies 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.

The da Vinci Surgical Systems (Models IS3000, IS4000 and IS4200) are software-controlled, electromechanical systems designed for surgeons to perform minimally invasive surgery. The da Vinci 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 is a 510(k) summary for the da Vinci Surgical System, focusing on a labeling change rather than a study proving performance against acceptance criteria for a new device or significant modification.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. This 510(k) is specifically for a minor administrative change (a labeling update to contraindications), not a clinical performance study.

Here's an explanation of what can and cannot be answered based on the provided text:

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

• Not applicable / Not provided. The document describes a change to labeling (contraindications) for existing devices already on the market, not a new device or a performance enhancement that would require a study with acceptance criteria.

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

• Not applicable / Not provided. No test set or clinical study data is presented as this submission is for a labeling change.

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 / Not provided. No ground truth establishment is described as there is no clinical study.

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

• Not applicable / Not provided. No test set or adjudication process is mentioned.

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 / Not provided. This device is a surgical system, not an AI-assisted diagnostic tool or an "AI" in the typical sense that would involve human "readers" or an MRMC study comparing AI assistance.

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

• Not applicable / Not provided. The da Vinci system is a human-controlled surgical system. There is no standalone "algorithm-only" performance to evaluate in this context.

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

• Not applicable / Not provided. No ground truth is established as there is no performance study.

8. The sample size for the training set

• Not applicable / Not provided. No new algorithm or trainable component is described in this 510(k) submission that would require a training set.

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

• Not applicable / Not provided. No training set is involved.

Summary of the document:

This 510(k) submission (K171699) by Intuitive Surgical, Inc. is a Special 510(k) for their da Vinci Surgical Systems (Models IS3000, IS4000, IS4200). A Special 510(k) is typically used for well-defined modifications to a manufacturer's own legally marketed device that do not affect the indications for use or alter the fundamental scientific technology of the device, and for which the risk of the modification can be adequately assessed by the manufacturer's design controls.

In this specific case, the modification is a labeling change to the "General Warnings and Cautions" section in the User Manuals, specifically concerning the endoscopic contraindication statement. The submitter argues that this change:

• Does not change device usage or the patient population.
• Does not change the risk profile of the devices.
• Adequately instructs the user.

Therefore, the submission concludes that the modified devices (with the updated labeling) are substantially equivalent to the predicate devices because the labeling modification has no impact on the safety or effectiveness of the da Vinci Surgical Systems themselves. This type of submission does not involve clinical studies or performance data against specific acceptance criteria for a new or significantly modified device function.

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