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The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular 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 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.

This special 510(k) is being submitted for an additional EndoWrist® instrument, the Cardiac Probe Grasper, to be utilized with probes and catheters used endoscopically during cardiac ablation procedures. This submission also includes the related minor labeling changes / clarifications on the da Vinci® Surgical Systems and EndoWrist Instruments. There are no changes in the technology, materials, manufacturing, performance, design, specifications or method of use for the da Vinci Surgical System or the CryoCath SurgiFrost Surgical CryoAblation System.

The da Vinci Surgical Systems consist of two integrated subsystems as follows: Intuitive Surgical® Endoscopic Instrument Control System: This sub-system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon is able to view the surgical field and control critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within that field. Movements are controlled by the surgeon through use of Master Tool Manipulators (MTMs), two hand-operated mechanisms residing within the Surgeon Console. The EndoWrist® endoscopic instruments, stereo endoscope and camera attach to surgical arms located on the Patient Side Cart (PSC). The endoscopic instruments attach to arms known as Patient Side Manipulators (PSM). Another arm, known as the Endoscope Camera Manipulator (ECM), holds the stereo endoscope and camera. Commands from the Surgeon Console are relayed to the PSC, located adjacent to the patient, via various cables. Instrument and endoscope insertions, removals and exchanges are performed by another member of the surgical team positioned adjacent to the PSC. Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as the InSite® Vision System, consists of a stereo endoscope, endoscopic camera, and accessories including a light source and light guides. The InSite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D) image of the surgical field. Additional monitors may be supplied by the user to allow other members of the surgical team to view the procedure.

Here's a breakdown of the acceptance criteria and the study details for the Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments and the Intuitive Surgical® EndoWrist® Cardiac Probe Grasper, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" aspect is addressed by confirming that the new instrument maintains the basic functional characteristics of existing, cleared instruments within the da Vinci system.

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

The document only mentions "bench testing" and "design analysis and comparison." It does not provide specific details about a "test set" with a defined sample size for clinical or real-world performance evaluation.

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely laboratory-based (bench testing). The regulatory submission is for a medical device in the US, so the "country of origin" of the data is implicitly internal to the manufacturer's testing or US-based contract labs. The study is presumed to be prospective as it's part of a pre-market submission, involving new tests on the Cardiac Probe Grasper.

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

Not applicable. The document does not describe the establishment of a "ground truth" using experts in the context of the bench testing or design analysis mentioned. The evaluation is based on engineering principles and comparison to existing products.

4. Adjudication Method for the Test Set

Not applicable, as no expert-based ground truth establishment or adjudication process is described for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not mentioned in the document. The device is a surgical instrument and system, not an imaging AI or diagnostic algorithm that would typically undergo an MRMC study.

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

Not applicable. This device is a surgical instrument and system that inherently requires human-in-the-loop operation. It is not an algorithm that operates autonomously.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, outcomes data) is not directly applicable here. For this surgical instrument, the "ground truth" for its performance is derived from its ability to meet design input requirements and demonstrate functional equivalence and compatibility with the existing da Vinci Surgical System, which is already legally marketed and established as safe and effective for its intended uses. This is verified through:

• Design analysis and comparison: Engineering review against predicate devices.
• Bench testing: Laboratory tests to confirm functional characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument and system, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The Intuitive Surgical® da Vinci® Surgical System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular 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 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.

This 510(k) is being submitted for an expansion of the Indications for Use to include pediatric use. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this premarket notification.

The da Vinci Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System, seeking to expand its Indications for Use to include pediatric use. It asserts that there are no changes to the device itself, only to its intended use population.

Here's a breakdown of the acceptance criteria and study information, based on the provided document:

Acceptance Criteria and Device Performance

There are no explicit, quantifiable acceptance criteria or reported device performance metrics in the provided document. The submission is based on the premise that the device (da Vinci Surgical System) is already cleared for a wide array of surgical tasks in adults and that its use in pediatrics would not introduce new safety or effectiveness concerns.

The core argument for the expanded indication is based on:

• Substantial Equivalence: The device is technologically identical to the predicate device cleared for adult use.
• Risk Analysis and Assessment: This was conducted to confirm that basic functional characteristics are substantially equivalent to the predicate device without introducing new safety or effectiveness issues.
• Review of Field Experience and Published Literature: This was performed to validate that there are no new issues of safety or effectiveness for performing surgical tasks in representative pediatric surgical procedures.

Therefore, the "acceptance criteria" appear to be:

Study Details

The provided document does not describe a traditional clinical study with a test set, ground truth, or statistical analysis of performance metrics. Instead, it relies on a comparison to existing clearances, risk analysis, and a review of external data.

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

   • Sample Size: Not applicable. No specific "test set" of patients or cases is mentioned.
   • Data Provenance: Not applicable in the context of a prospective or retrospective study specific to this submission. The "review of field experience and published literature" would encompass data from various sources and potentially countries, but this is not detailed.

2. 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 "ground truth" was established for a specific test set within the scope of this 510(k) submission. The assessment relies on the existing safety and effectiveness profile of the device in adults and the broader medical literature/field experience concerning pediatric surgical procedures using similar technology.

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

   • Not applicable. There was no specific test set requiring adjudication.

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:

   • Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool for "human readers." No MRMC study was mentioned.

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

   • Not applicable. This device is a human-controlled surgical system.

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

   • The "ground truth" for the expanded pediatric indication appears to be based on a combination of:
     • Historical performance/safety data of the da Vinci system in adults (as cleared under previous 510(k)s).
     • Risk analysis and assessment of potential differences in pediatric use.
     • Published medical literature and field experience regarding robotic surgery in pediatric populations.
     • Expert opinion from the submitter that the existing device can be safely and effectively used in pediatrics.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a training set in the conventional sense. The "training" for safe and effective use refers to physician training, as stated in the Indications for Use: "It is intended for use by trained physicians..."

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

   • Not applicable, as there is no training set for an algorithm.

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The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. This 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.

This 510(k) is being submitted for an expansion of the Indications for Use to include gynecologic laparoscopic surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this pre-market notification.

The da Vinci Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables, Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System, specifically for an expansion of its indications for use to include gynecologic laparoscopic surgical procedures. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically find for a new diagnostic AI device or a device requiring new performance claims.

Instead, the submission argues for substantial equivalence based on the existing device's proven performance in other surgical specialties and a comparison of surgical tasks.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission argues for substantial equivalence based on the device's existing clearance for a "full array of surgical tasks across multidisciplinary surgical specialties" and a "comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures."

Essentially, the "acceptance criteria" here implicitly refer to the established safety and effectiveness of the existing da Vinci system, and the "reported device performance" is its proven ability to perform surgical tasks in general. The document asserts that no new safety or effectiveness issues arise from extending its use to gynecologic procedures.

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

This information is not provided. The submission relies on a "design analysis and comparison" and "design validation" rather than a clinical trial with a distinct test set of patient data to evaluate performance for the new indication.

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

This information is not provided. As there's no clinical test set in the traditional sense, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. This type of study is more common for diagnostic devices measuring human reader performance. The da Vinci system is a surgical tool, and the submission focuses on its mechanical and functional equivalence for surgical tasks.

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

N/A. The da Vinci Surgical System is explicitly a "human-in-the-loop" device, as surgeons control the instruments. The concept of "standalone" performance without the human surgeon is not applicable here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the established safety and effectiveness profile of the da Vinci Surgical System in its already cleared indications, and the similarity of surgical tasks in gynecologic laparoscopic procedures to those where the device is already cleared. The document states:

• "a comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures with the system."
• "design analysis and comparison, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and design validation confirm that there are no new issues of safety or effectiveness for performing surgical tasks in gynecologic laparoscopic surgical procedures."

This is a form of "comparison to predicate" and "design validation" based on expert surgical knowledge and engineering principles, rather than a quantifiable ground truth derived from pathology or outcomes data in a new clinical study for this specific indication.

8. The Sample Size for the Training Set

This information is not provided. The da Vinci system is a robotic surgery system, not a machine learning algorithm that is "trained" on a dataset in the typical AI sense for image analysis or diagnosis. Its "training" would be more akin to engineering development and refinement based on extensive R&D and clinical experience in other surgical fields.

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

This information is not provided, as the concept of a "training set" and "ground truth" in the AI sense does not directly apply to the approval process described here for a surgical robotic system's expanded indication for use. Its operational "ground truth" is defined by its engineering specifications, safety parameters, and successful performance in prior surgical applications.

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The Intuitive Surgical® Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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.

This 510(k) is being submitted for a labeling change / clarification on the da Vinci ® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System. The only change is an updated indication statement to clarify use in broad urologic surgical procedures.

The da Vinci ® Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical® Endoscopic Instrument Control System: This sub-Device system is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the operative field. Endoscopic instrument and camera movements, within the patient, are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided text is a 510(k) summary for a labeling change to the Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments. It explicitly states: "There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System." The only change is an updated indication statement.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The submission is based on the substantial equivalence principle, where the updated device is compared to previously cleared predicate devices, arguing that the change (labeling/indication clarification) does not alter its safety or effectiveness.

Due to the nature of this 510(k) submission, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance data or acceptance criteria are presented for a modified or new device.
2. Sample size used for the test set and the data provenance: No test set was used for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth was used.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is a surgical system, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") 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, stabilizers, 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 ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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 special 510(k) is being submitted for a minor labeling change / clarification on the da Vinci® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System or the Guidant Flex 10 ablation probe and Microwave Ablation System. The only change is an updated indication statement and addendum user manual sheet for the da Vinci® Surgical System.

The da Vinci® Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided 510(k) summary (K043153) describes a "Special 510(k)" for a minor labeling change/clarification for the Intuitive Surgical® da Vinci® Surgical System. Crucially, this submission explicitly states that there are no changes in the device's design, technology, materials, manufacturing, performance, specifications, and method of use.

Therefore, there is no new study or performance data presented in this specific 510(k) to prove the device meets acceptance criteria related to its performance. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices (K990144, K002489, K011002, K013416, K021036, K022574, K040237 for the da Vinci® system itself, and K013946, K041340 for the Guidant Microwave Ablation System).

Here's an analysis based on the document's content:

1. Table of acceptance criteria and the reported device performance:

Since this is a special 510(k) for a labeling change, no new specific performance acceptance criteria or reported device performance for the device itself is presented. The document asserts that "design analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." However, the exact acceptance criteria for these past tests are not detailed in this document.

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

Not applicable. No new test set data is presented for performance evaluation of the device. The "bench testing" mentioned is to confirm substantial equivalence, not to demonstrate new performance metrics.

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

Not applicable. No new test set requiring expert ground truth is described.

4. Adjudication method for the test set:

Not applicable. No new test set requiring adjudication is described.

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. This device is not an AI/CAD device for image interpretation, and no MRMC study is mentioned.

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

Not applicable. This device is a surgical system with human-in-the-loop control, not a standalone algorithm.

7. The type of ground truth used:

Not applicable. No new performance study requiring ground truth is described in this document. For previous clearances, the ground truth would have been established through a combination of engineering specifications, clinical outcomes, and expert assessment for safety and effectiveness in surgical procedures.

8. The sample size for the training set:

Not applicable. This document pertains to a labeling change for an existing device, not the development or training of a new algorithm.

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

Not applicable.

In summary, for K043153:

The "acceptance criteria" for this specific submission relate to the administrative requirements of a Special 510(k) – specifically, demonstrating that the labeling update and the intended use clarification do not alter the fundamental safety and effectiveness of the device as previously cleared. The "study that proves the device meets the acceptance criteria" is the assertion of substantial equivalence to previously cleared predicate devices and the internal checks (design analysis and comparison, bench testing) to confirm that the labeling change has no impact on the underlying device performance. The performance of the da Vinci® Surgical System itself was established in prior 510(k) submissions, which are not detailed in this document.

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