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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 and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. 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.

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 port. The system is indicated for urologic and general thoracoscopic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. 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 is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

This document is a 510(k) summary for the da Vinci SP Surgical System. It details the device's indications for use and presents performance data to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria (Performance Endpoints) and Reported Device Performance

The acceptance criteria for the clinical study were primarily based on safety and performance endpoints demonstrated by the incidence of adverse events and the rate of conversion to other surgical methods. While specific numerical acceptance thresholds are not explicitly stated as "acceptance criteria" in a table format, the study's success is defined by these metrics. The performance data presented indicates that the device met these implicit criteria by demonstrating favorable outcomes.

Note on "Acceptance Criteria": The document does not explicitly present a pre-defined table of numerical acceptance criteria. Instead, it describes the demonstration of safety and performance (low adverse event rates, zero conversions) and then performs a comparison to published literature for the predicate device, showing that the 95% confidence intervals overlap. This indicates that performance was considered acceptable if it was similar to that of the already-cleared multiport robotic systems.

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

• Clinical Study Test Set (Prospective, Multicenter, Single-Arm):

  • Total Subjects: 32 subjects
  • Thymectomy Cohort: 13 subjects
  • Lobectomy Cohort: 19 subjects
  • Data Provenance: United States (6 institutions), prospective.

• Pre-clinical Study Test Set (Cadaver and Animal Performance Testing):

  • Subjects: 3 independent practicing surgeons
  • Procedures: 18 surgical procedures total (5 procedures per surgeon in a cadaver model, 1 procedure per surgeon in a porcine model).
  • Data Provenance: Not explicitly stated, but typically conducted in a controlled lab/testing environment.

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

• Clinical Study: The ground truth for the clinical study was established by the clinical outcomes observed in patients undergoing surgery using the da Vinci SP Surgical System. This includes intra-operative observations and post-operative follow-up (30-day). The data was collected by the treating physicians and study staff at 6 institutions in the United States. The qualifications of these clinicians are not explicitly detailed, but they are implied to be "trained physicians" in an "operating room environment" as per the Indications for Use.
• Pre-clinical Study: "Three (3) independent practicing surgeons participated" in this study. Their specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "independent practicing surgeons." The "success criteria" for each procedure were "deemed surgically acceptable upon visual inspection" - implying these surgeons assessed the outcome as part of establishing the ground truth for this phase.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The study was a "single-arm" study. Adverse events were reported, and it's mentioned that none were "deemed to be device related." This suggests some level of medical review or adjudication, likely by the study investigators or a clinical events committee, but the specific process (e.g., 2+1, 3+1) is not detailed.
• Pre-clinical Study: The surgeons performed the procedures and assessed completion/acceptability. No independent adjudication method is described beyond the surgeons performing the procedures and judging the outcomes.

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

No MRMC study was performed. The device is a surgical system, not an AI-assisted diagnostic or image interpretation tool for "human readers." Therefore, this section is not applicable. The comparison was between the da Vinci SP system and existing multiport robotic systems (literature comparison) or traditional open/VATS procedures in terms of surgical outcomes.

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

This is not applicable. The da Vinci SP Surgical System is a robotic surgical platform that requires human operation (surgeon-in-the-loop). It is not an algorithm performing a task autonomously.

7. The Type of Ground Truth Used

• Clinical Study:
  • Safety Ground Truth: Real-world clinical outcomes in patients (intra-operative and post-operative adverse events, complications, readmissions, reoperations, mortality).
  • Performance Ground Truth: Successful completion of surgical procedures without conversion, operative metrics (time, blood loss), and critical clinical parameters like positive surgical margins.
• Pre-clinical Study: Surgical outcomes in cadaver and porcine models assessed by surgeons based on defined procedure completion criteria (e.g., "complete dissection," "sufficient lymph node dissection," "hemostasis maintained," "critical anatomy identified").

8. The Sample Size for the Training Set

No specific "training set" for an AI model is mentioned as this device is a surgical system, not an AI/ML algorithm. The development and validation of such a complex system would involve extensive engineering, bench testing, pre-clinical trials (as described), and then clinical studies. The design and validation relied on established medical device development processes and prior knowledge from the predicate device (da Vinci Xi Surgical System).

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

Not applicable, as there is no mention of an AI/ML training set in the context of this device's submission. The "ground truth" for the device's design verification and validation would have been established through engineering specifications, biomechanical principles, surgical anatomical knowledge, and established clinical practices, leading to the performance criteria tested in the pre-clinical and clinical studies.

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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 (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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