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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 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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da Vinci SP® Surgical System, Model SP1098:
The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist SPTM Instruments:
Intuitive Surgical® EndoWrist SP™ Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use 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 SP Surgical System, Model SP1098 is a software-controlled, electromechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instruments and Camera Instrument 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 Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of EndoWrist SP Instruments can be attached to and detached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instrument and up to three surgical instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an obturator, a seal, an entry guide, disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.

The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The EndoWrist SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y-Z movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The EndoWrist SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The EndoWrist SP Camera Instrument is a reusable endoscope that provides a stereo image of the surgical site. Like the instruments, the distal end includes multiple joints that provide the flexibility needed for use with a single-port system.

This document describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (referred to as "the device" or "SP1098 system") and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device (Model SP999) and that design output meets design input requirements. The "performance" is generally reported as successful completion of these tests, confirming the device's ability to operate as intended and safely.

Below is a summary of the performance studies conducted and the reported outcomes:

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

• Cadaver and Animal Performance Testing:

  • Cadaver Models: 6 cadaver procedures were performed.
  • Porcine Models: 3 porcine (live animal) procedures were performed.
  • Surgeons: 3 independent practicing surgeons participated. Each performed 7 urologic procedures in cadaver models and 5 representative and simulated procedures in porcine models, totaling 36 surgical procedures.
  • Data Provenance: Not explicitly stated, but cadaver and porcine models are used, generally implying controlled laboratory or surgical simulation environments. The participants are "independent practicing surgeons," suggesting their experience is relevant to real-world clinical practice, but the tests themselves were in simulated environments. It's a prospective study in the sense that the device was specifically tested in these models.

• Human Factors (HF) Performance Testing:

  • Participants: A total of 15 surgical teams (surgeon and patient-side assistant) and 15 prep teams (scrub tech and circulating nurse).
  • Data Provenance: The study was conducted in a "simulated operating room environment," involving controlled, prospective testing scenarios.

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

• Cadaver and Animal Performance Testing: The "ground truth" for the success criteria (e.g., "Anastomosis complete and deemed acceptable upon visual inspection," "Critical anatomy identified," "Hemostasis maintained") was implicitly established by the 3 independent practicing surgeons who performed the procedures and evaluated the outcomes. Their qualifications are stated as "independent practicing surgeons," implying they are qualified by their profession and experience to make these assessments.
• Human Factors Testing: The "usability risk analysis was developed with feedback from internal functional group experts." The qualifications of these internal experts are not specifically detailed (e.g., years of experience, specific certifications), but they are described as "functional group experts."

4. Adjudication Method for the Test Set

• Cadaver and Animal Performance Testing: The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the surgical outcomes. The success criteria imply a direct assessment by the performing surgeons. It might be assumed that for critical assessments like "acceptable upon visual inspection," the surgeons' professional judgment served as the "adjudication."
• Human Factors Testing: "The SP1098 usability risk analysis was updated throughout the design process as formative testing was conducted, system design was iterated, new use errors were identified, and new mitigations were implemented." This suggests an iterative process where identified issues were reviewed and addressed, but a specific "adjudication method" for individual use errors is not detailed. Objective performance data and subjective feedback were collected and presumably interpreted by human factors experts.

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 device is a surgical system, not an AI-assisted diagnostic or interpretation tool for "readers." The performance studies focused on the surgical system's ability to perform procedures, safety, and usability.

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

• Not applicable. The device is a surgical system that requires a human surgeon for operation (human-in-the-loop). It is not a standalone algorithm. The "standalone" aspect that could be considered is the system's electromechanical function and software control, which were tested via bench performance without direct human interaction for some aspects, but the overall product is user-dependent.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• For Cadaver and Animal Testing: The ground truth was based on the expert assessment and visual inspection of the surgical outcomes by "independent practicing surgeons" against predefined success criteria (e.g., "Anastomosis complete and deemed acceptable," "Kidney completely freed," "Hemostasis maintained"). No mention of pathology or long-term outcomes data for these specific tests.
• For Human Factors Testing: The ground truth for identifying usability issues and risks was based on observations of user performance (objective data) and user feedback (subjective data) during simulated scenarios, interpreted by human factors experts.

8. The Sample Size for the Training Set

• Not explicitly stated for an AI/algorithm context. This device is a robotic surgical system, not a machine learning model that undergoes "training" in the traditional sense with a distinct training dataset. Its development likely involved iterative design and testing using various models and prototypes, which could be seen as its "training" or development phase.

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

• Not applicable in the context of an AI training set for this type of medical device. The "ground truth" for the device's design and engineering development (analogous to a training set in ML) would have been established through engineering specifications, design input requirements, and previous historical data/knowledge from predicate devices (e.g., da Vinci SP999, da Vinci Xi IS4000). These requirements and the "truth" of their fulfillment were then verified through the detailed bench, cadaver, animal, and human factors testing described.

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The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.

The Human Extensions HX Device is a hand held powered laparoscopic device. The device enables, by its attached instruments grasper and needle holder, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension", enhancing maneuverability and control. The HX Device is electromechanically controlled and includes both hardware and software and comprises of two major parts, the Handpiece and the Instrument. The HX Device Handpiece consists of a reusable Control Interface (CI) handle held by the surgeon and a Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip (grasper/needle holder). Prior to use, a set of single use, disposable, sterile Power Cable, Arc, Finger Pads, and strap-adapting Spacer are assembled on the Handpiece and the CI unit. In addition, prior to use, the Handpiece is covered with a standard, sterile cover (e.g., endoscopic camera cover) of at least 8.5 cm inner diameter. The sterile cover is not provided with the HX device. After each use, the Handpiece is cleaned and disinfected according to the specifications detailed in the Instructions For Use.

The provided text describes the regulatory clearance for the HX Device, a handheld powered laparoscopic device. It details the device's intended use, comparison to predicate devices, and the performance data submitted to support its substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "All tests met the predefined acceptance criteria" for various bench tests and an animal study. However, the specific quantitative acceptance criteria values and the quantitative results of the device performance against these criteria are not explicitly stated in the provided text.

The text broadly lists the types of tests conducted and states their successful completion:

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

• Bench Testing: The text does not specify the exact sample sizes (number of devices, instruments, or tests) used for the various bench tests. It only states that these tests were conducted.
• Animal Study: The text does not specify the sample size (number of animals or procedures) used for the GLP animal study.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a regulatory submission for a new device, it's highly probable that the studies were prospective and conducted to generate data for this submission. The manufacturer, Human Extensions Ltd., is based in Israel, so the studies were likely conducted there or in a region that supports GLP standards.

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

• Bench Testing: Not applicable in the context of "ground truth" established by experts in the same way as clinical imagery interpretation. These tests evaluate quantifiable physical properties and performance.
• Animal Study: The text states, "GLP Animal Study was performed by several users." It then mentions, "Users were able to perform tissue manipulation tasks such as grasping different tissues, and to perform continues or interrupted sutures tasks." These "users" are implicitly the experts who performed the procedures and evaluated the device's performance, but their specific number or qualifications (e.g., "veterinarian with X years of experience," or "surgeon with Y years of experience") are not detailed.

4. Adjudication Method for the Test Set

• Bench Testing: Adjudication is not typically relevant here, as results are usually objective measurements against defined specifications.
• Animal Study: The text mentions that the study was performed by "several users" and that the "devices performed well without malfunction to users' satisfaction." This suggests a subjective assessment by the users, but no formal adjudication method (like 2+1 or 3+1 consensus) is described among these users.

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

• No MRMC study is mentioned or implied. The document focuses on demonstrating the device's basic performance, reliability, and safety attributes, and showing substantial equivalence to predicate devices, rather than a comparative effectiveness study involving human readers' diagnostic accuracy or changes in their performance with AI assistance. The HX Device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• This concept is not directly applicable. The HX Device is a physical, electromechanically controlled surgical instrument that is always "human-in-the-loop," as it is "controlled by the surgeon's hand." While it has software, its performance is intrinsically tied to human operation. The software validation mentioned is for the functionality of the device's embedded software, not for a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Bench Testing: Ground truth is established by the definitions of the physical and mechanical properties being measured and the predefined acceptance criteria for those measurements.
• Animal Study: The ground truth for the animal study appears to be defined by the successful completion of specified surgical tasks (tissue manipulation, grasping, suturing) without device malfunction, and the "satisfaction" of the users (operators). This is an observational and performance-based ground truth within a controlled preclinical setting. It does not rely on pathology or outcomes data in the sense of long-term patient follow-up, but rather on immediate operational success and device reliability during simulated procedures.

8. Sample Size for the Training Set

• The document addresses a regulatory submission for device performance and equivalence, not an AI model's training. Therefore, there is no mention of a "training set" in the context of machine learning. The device's design and engineering are based on principles of mechanical and electrical engineering, validated through the described tests.

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

• As there is no training set for an AI model mentioned, this question is not applicable.

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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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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 (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, 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 "gynecologic laparoscopic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Hysterectomy (Radical, Hysterectomy for Benign Disease 1), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions. 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, electromechanical 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.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device: da Vinci® Surgical System, Model IS4000

Acceptance Criteria and Reported Device Performance

The clinical studies for the da Vinci® Surgical System, Model IS4000, do not present a clear table of predefined numerical acceptance criteria. Instead, the studies demonstrate substantial equivalence by comparing the outcomes of da Vinci-assisted procedures to open and laparoscopic surgical procedures, focusing on comparable or superior safety and effectiveness metrics.

The reported device performance, in comparison to traditional methods (open and laparoscopic surgery), is summarized for "umbrella procedures" (Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy) across various publications:

The overall acceptance is based on the demonstration that the da Vinci-assisted procedures are associated with comparable or improved outcomes (fewer complications, less blood loss, shorter hospital stays) compared to traditional methods, despite potentially longer operative times in some cases. The increased operative time was deemed acceptable as it did not lead to increased complication rates.

Study Details

The provided document describes a labeling modification for the da Vinci Xi Surgical System (Model IS4000) to include additional specific gynecologic laparoscopic surgical procedures. The performance data presented is a summary of existing pre-clinical and clinical studies that have previously been used to support the clearance of the device.

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

   • Pre-Clinical Animal Study Data: Provided results from 7 evaluations in a total of 27 animals.
     • Provenance: Not specified, but implied to be prospective experimental data from animal studies.
   • Clinical Study Data: This refers to a review of 21 published clinical data publications. These publications included randomized controlled trials, meta-analyses, systematic reviews, Health Technology Assessments, and comparative studies.
     • Provenance: This is retrospective data analysis from various published clinical studies. The country of origin for these studies is not specified in this summary but would be diverse given the nature of published literature.

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

   • Pre-Clinical Animal Study Data: For the animal studies, the "ground truth" would be established by the researchers conducting the experiments and analyzing the physiological outcomes and histological findings. The number and qualifications of these experts are not specified in the summary.
   • Clinical Study Data: For the retrospective clinical data, the "ground truth" is derived from the reported outcomes and statistical analyses within the 21 identified publications. The experts involved would be the authors of those publications (surgeons, statisticians, researchers, etc.). The specific number and exact qualifications of these experts for all 21 publications are not provided in this summary. However, it's inherent that these would be medical professionals experienced in conducting and reporting clinical trials.

3. Adjudication method for the test set:

   • Pre-Clinical Animal Study Data: Not specified. Adjudication methods are typically outlined in the study protocols of animal research, but are not detailed here.
   • Clinical Study Data: For the aggregate of 21 publications, the adjudication method is essentially the peer-review process inherent to scientific publications. This submission itself represents an internal review and synthesis of these published findings by the manufacturer and the FDA. No specific external adjudication panel beyond this is mentioned for this particular 510(k) submission.

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 device (da Vinci Surgical System) is a surgical robot that assists human surgeons, not an AI diagnostic tool that human readers interpret. The studies compare robotic assistance (human with robot) versus traditional surgery (human without robot for the specific robotic tasks). Therefore, the concept of "human readers improving with AI vs without AI assistance" in the context of interpretation accuracy doesn't directly apply. The comparison is related to surgical outcomes.

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

   • No, a standalone study was not done because the da Vinci Surgical System is designed to be a human-in-the-loop system. It is a tool that enhances a surgeon's capabilities, not an autonomous system. The indication states: "It is intended to be used by trained physicians in an operating room environment."

6. The type of ground truth used:

   • Pre-Clinical Animal Study Data: Based on anatomical observations, physiological measurements, and histopathological findings in animals.
   • Clinical Study Data: Based on clinical outcomes data from human patients, including complications (e.g., adverse events), blood transfusions, length of hospital stay, operative time, and conversion rates, as reported in published peer-reviewed medical literature. This is essentially patient outcomes data.

7. The sample size for the training set:

   • Not applicable / Not specified in this context. This 510(k) is for a labeling modification and relies on previously submitted performance data and published literature. The da Vinci Surgical System is an electro-mechanical system controlled by a surgeon, not an AI algorithm that learns from a training set in the conventional sense of machine learning. The "training" for such a system would involve engineering development, testing, and validation against design specifications and performance requirements, rather than a data-driven machine learning training set. Surgeons are also "trained" to use the system.

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

   • Not applicable. As explained above, for this type of medical device, the concept of a "training set" with associated "ground truth" as typically defined for AI/ML algorithms does not directly apply. The development and validation of the device rely on engineering principles, verification, and validation testing, and clinical evaluations where "ground truth" is defined by standard medical endpoints and established surgical practices.

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The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery.

The intended use for the 12 mm & Stapler Accessories is unchanged from what was cleared in K140553 (EndoWrist Stapler 45, Stapler 45 Reloads). They are being submitted again in this 510(k) to clear them for use with the subject device, da Vinci® Xi (IS4000) 12 mm Endoscope.

The indications for use for the 12 mm Endoscope Sterilization Tray is a modification of the indication statement for the Endoscope Sterilization Tray (K133942). The model numbers for the 12 mm Endoscope have been added. Steris V-Pro was also validated and therefore added to the indication statement. Finally, the maximum weight of the tray and endoscope has been adjusted to reflect the weight of the modified subject devices. The resulting indications for use for the 12 mm Endoscope Sterilization Tray are as follows:

The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express cycle
• · STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

The Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories use the existing endoscopic imaging system submitted in K131861 (cleared March 28, 2014). The 12 mm rigid endoscopes come in both 0° and 30° angles for use through 12 mm ports.

Entry to the body cavity and maintenance of pneumoperitoneum are facilitated through the use of a12 mm & Stapler cannulae (both standard and long lengths), blunt obturators (also in standard and long lengths) and the 12 mm & Stapler Cannula Seal.

The Endoscope Sterilization Tray (an accessory to the 12 mm endoscope) is a thermoformed plastic tray with silicone inserts, a plastic lid, and a stainless steel cover. The tray, lid, and cover contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci 12 mm endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100S. STERRAD 100NX Express and Steris V-Pro sterilization systems.

The provided document is a 510(k) summary for the Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria for a new type of device. Therefore, the document does not contain a typical "acceptance criteria" table with specific performance thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic device) and reported device performance against those thresholds in the way one might expect for a diagnostic or AI-powered device.

Instead, the acceptance criteria for this device are implicitly tied to meeting the design requirements and demonstrating functionally acceptable performance and equivalence to predicate devices through various tests.

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

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

As mentioned, there isn't a table of explicit quantitative acceptance criteria with numerical performance metrics for the endoscope's primary function in the way you might see for a diagnostic device. The acceptance criteria are broadly defined by meeting design requirements and ensuring clinically acceptable performance. The reported performance is that all tests "PASSED," indicating the device met the predefined pass/fail criteria (which are not explicitly detailed numerically in this summary).

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

• Design Verification (12 mm Endoscope): Sample sizes up to six units were used.
• Design Verification (12 mm Endoscope Sterilization Tray): Sample sizes up to four units were used.
• Reliability (Life, 12 mm Endoscope): A sample size of nine was used.
• Animal Testing (Design Validation): Testing was conducted across three labs using three porcine.
• Animal Testing (Device Comparison): Two porcine were used in various setups (pelvic, upper GI, kidney).
• Animal Testing (Surgeon Evaluation): Testing was completed across three labs, utilizing canines or porcine.

Data Provenance: The document does not specify the country of origin of the data. The animal testing and usability studies appear to be prospective in nature, as they involve conducting new tests and evaluations on the device.

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)

• For the Animal Testing (Surgeon Evaluation), six independent, external surgeons served as evaluators to complete vision assessments. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary, but they are described as "independent, external surgeon evaluators."

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

The document does not explicitly state an adjudication method (like 2+1, 3+1) for establishing ground truth or resolving discrepancies in performance evaluations. The surgeon evaluations mention "All evaluators found each vision criteria clinically acceptable and safe for the subject device," suggesting a consensus or individual assessment against predefined criteria rather than a multi-reader adjudication process for a discrete '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, an MRMC comparative effectiveness study was not done. This document pertains to a surgical endoscope and its accessories, not an AI-assisted diagnostic or image interpretation device. There is no mention of AI or human readers improving with AI assistance.

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. This device is an endoscope for human surgeons, not an algorithm.

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

• For the performance tests, the "ground truth" seems to be established by predetermined "objective pass/fail criteria" defined in protocols, visual inspections, functional testing, and "clinically acceptable performance" as assessed by external surgeons (a form of expert consensus for clinical utility).
• For the animal studies, the "ground truth" for the device's performance against user needs and intended use was based on its ability to complete various surgical and visualization tasks.

8. The sample size for the training set

• This document describes performance testing for a physical medical device (an endoscope and its sterilization tray). It does not involve machine learning or AI algorithms with "training sets." Therefore, this question is not applicable.

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

• Not applicable, as there is no training set for an AI algorithm mentioned in this document.

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