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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 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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