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The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic 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, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2. 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 (except for transoral otolaryngology surgical procedures). 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 to request an expansion of the Indications for Use to include transoral otolaryngology surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, or method of use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification. The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) consists of two integrated sub-systems as follows: A Surgeon Console and a 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. The 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), which is 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 individual positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical Systems, 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 surgeon located at 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 (K090993) is for an expansion of the Indications for Use for the Intuitive Surgical da Vinci Surgical Systems to include transoral otolaryngology surgical procedures. Since this is an expansion of indication for an existing device, the study is focused on demonstrating substantial equivalence rather than meeting specific performance criteria.

Therefore, the structure for acceptance criteria and device performance table, and sections related to algorithm performance, training data, ground truth establishment, and MRMC studies are not directly applicable in the conventional sense for this submission. The 510(k) summary focuses on comparing the surgical tasks involved in the new indication to those already cleared for the device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this 510(k) is for an expansion of indications for an already cleared device (Intuitive Surgical da Vinci Surgical Systems), the acceptance criteria are not in the form of numerical performance metrics for an AI algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing treatment methods and the lack of new safety or effectiveness issues.

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

• Test Set Sample Size: Not explicitly stated as a numerical value within the 510(k) summary. It refers to a "multicenter retrospective clinical study" that included "transoral otolaryngology surgical patients." The exact number of patients or cases is not provided.
• Data Provenance:
  • Country of Origin: Not specified in the summary.
  • Retrospective or Prospective: Retrospective.

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

This submission does not involve an AI algorithm with a defined "ground truth" established by experts in the typical sense. The clinical study's "ground truth" would be derived from patient outcomes, surgical observations, and comparison to standard treatments.

• Number of Experts: Not applicable/not specified. The study involved a clinical assessment implicitly by the treating physicians and researchers.
• Qualifications of Experts: The study was conducted by "trained physicians in an operating room environment," as indicated in the Intended Use statement common to the da Vinci system.

4. Adjudication Method for the Test Set

Not applicable as this is a clinical outcomes study for an existing surgical device's indication expansion, not a diagnostic or AI performance study requiring expert adjudication of image annotations or classifications.

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

Not applicable. This is not a study measuring the effectiveness of human readers with or without AI assistance. It's a clinical study to support an expanded indication for a surgical robot.

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

Not applicable. The da Vinci Surgical System is a human-controlled robotic surgical system; it's not an autonomous algorithm. The study assesses the system's performance with a human surgeon.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the clinical outcomes and observations from the surgical procedures performed using the da Vinci system.

• Type of Ground Truth: Clinical outcomes (feasibility, efficacy, safety, functional assessment) from actual patient surgeries, compared to historical controls for alternative treatment methods (Open surgery, transoral surgery, and chemoradiation treatment).

8. Sample Size for the Training Set

Not applicable. The da Vinci Surgical System is a physical device, and this submission is for an expanded indication, not an AI algorithm that requires a training set in the machine learning sense. The device itself has been developed and refined over many years and multiple previous 510(k) clearances.

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

Not applicable for the reasons stated above.

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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, scissors, 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 and suturing during general laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. 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 Instructions for Use.

The working ends and elements of the Intuitive Surgical® da Vinci™ Surgical System, Endoscopic Instruments and Accessories are essentially identical in function, size and shape to the predicate devices referenced. They represent standard embodiments of standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.

This 510(k) summary describes a traditional medical device (surgical instruments), not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML performance acceptance criteria, such as "Sample size used for the test set and the data provenance", "Number of experts used to establish the ground truth for the test set", "Adjudication method", "MRMC comparative effectiveness study", and "Sample size for the training set", are not applicable to this submission.

The acceptance criteria and evaluation method for this device are based on proving "substantial equivalence" to predicate devices through design analysis and in vitro testing, focusing on functional characteristics.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. Performance was evaluated through design analysis and in vitro testing, not a clinical study with a "test set" in the context of AI/ML.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance claims are based on engineering analysis and in vitro testing, not expert consensus on a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/ML device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense for AI/ML. The "ground truth" for substantial equivalence was based on predefined functional, size, and shape characteristics of existing predicate devices, against which the new device aspects were compared.

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Intuitive Surgical™ Endoscopic Instrument Control System (hcreinafter 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, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.

Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels, forceps/pickups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing .

The working ends and elements of the Intuitive Surgical™ Endoscopic Instruments and Accessories are essentially identical in size and shape to the predicate devices referenced and represent standard embodiments of standard surgical tools modified for use with the Intuitive Surgical™ Endoscopic Instrument Control System.

The provided text describes a 510(k) submission for the Intuitive Surgical™ Endoscopic Instrument Control System and Endoscopic Instruments. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study to meet specific quantitative acceptance criteria for device performance. Therefore, many of the requested sections about quantitative acceptance criteria, detailed study design, and advanced statistical analyses (like MRMC) are not explicitly present in the provided document.

Here's an attempt to extract and infer the information based on the given context:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or numerical reported device performance metrics. The core of the submission is based on demonstrating "substantial equivalence" to predicate devices, which is a qualitative assessment rather than a quantitative one against predefined statistical targets.

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

The document states an "extensive prospectively randomized and concurrently controlled clinical study was performed." However, it does not provide the specific sample size for this clinical study or details on the data provenance (e.g., country of origin). The study is prospective, as indicated by "prospectively randomized."

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

This information is not provided in the document. As the study focuses on safety and effectiveness compared to predicate devices in surgical procedures, the "ground truth" would likely be based on clinical outcomes assessed by the operating surgeons and medical staff, rather than a separate panel of experts establishing a ground truth for a diagnostic task.

4. Adjudication method for the test set

This information is not provided.

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

The document describes a "prospectively randomized and concurrently controlled clinical study" to demonstrate substantial equivalence in terms of safety and effectiveness. However, it does not explicitly state that this was an MRMC comparative effectiveness study focused on comparing human readers' performance with and without AI assistance. The Intuitive Surgical Endoscopic Instrument Control System is a surgical robotic system, not a diagnostic AI system, so the concept of "human readers" improving with "AI assistance" in the typical diagnostic sense does not directly apply here. The study would have compared clinical outcomes with the new device versus predicate devices.

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

No, this device is explicitly described as an "Endoscopic Instrument Control System" intended "to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments." It is an assistive surgical tool, inherently designed for human-in-the-loop performance, not a standalone algorithm.

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

Given it's a clinical study for a surgical instrument, the "ground truth" for safety and effectiveness would implicitly be based on clinical outcomes data (e.g., successful procedure completion, complication rates, recovery times, surgeon's assessment of ease of use and tissue effect) observed and documented during the "prospectively randomized and concurrently controlled clinical study."

8. The sample size for the training set

This information is not applicable and not provided. The device is a surgical instrument control system, not an AI model that requires a training set in the conventional machine learning sense. The "design analysis and comparison" and "in vitro testing" would be validated against engineering specifications and functional requirements, not a training set.

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

This information is not applicable and not provided, as there is no mention of a training set for an AI model.

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