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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 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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