Search Results

Da Vinci SP Surgical System, Model SP1098:

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 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.

EndoWrist SP Instruments:

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 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 table 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.

The design modifications included in this submission are limited to updated system software, specifically changes to the control algorithms to damp system structural vibrations.

The provided document is an FDA 510(k) clearance letter for the da Vinci SP Surgical System. It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to a predicate device. The document mentions "verification and validation testing" but does not provide specific details about the acceptance criteria or results of a study that proves the device meets specific performance criteria in a quantitative manner as would typically be seen in a clinical study for an AI/ML device.

This document refers to a surgical system (a robotic surgical device), not an AI/ML device for diagnosis or prognosis that relies on analyzing medical images or data. Therefore, many of the requested details about acceptance criteria, ground truth, sample size for test/training sets, expert adjudication, and MRMC studies, which are standard for the assessment of AI/ML devices, are not explicitly provided or relevant in the context of this traditional medical device clearance.

However, based on the information provided, here's an attempt to address the prompt, highlighting what is (and isn't) present in the text:

The document details the FDA 510(k) clearance for the da Vinci SP Surgical System (SP1098). The core of this clearance is the demonstration of substantial equivalence to a previously cleared predicate device (da Vinci SP Surgical System, K202968). The primary modification in this submission relates to updated system software, specifically changes to control algorithms designed to damp system structural vibrations.

There is no detailed study described in this document that explicitly proves the device meets quantitative acceptance criteria in the manner typically expected for an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, AUC). Instead, the focus is on demonstrating that the software changes do not adversely affect safety or effectiveness and that the modified device maintains performance comparable to its predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The subject device met the same acceptance criteria as the predicate device." However, it does not provide a specific table of these acceptance criteria or quantitative performance metrics. The general implied acceptance criteria for this software update are that the system continues to operate safely and effectively, and that the "dampening" of vibrations improves the surgeon's experience (faster stabilization) without negatively impacting control or patient safety.

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

The document mentions validation testing using an "animal model."

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin). The phrase "animal model" suggests prospective testing, but details are absent. The nature of the device (surgical robot) means the "test set" here refers to real-world performance testing, rather than an image dataset for AI.

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

Not applicable or specified in this document. For a robotic surgical system, "ground truth" would be related to the device's mechanical and software performance, often assessed against engineering specifications and validated through simulated or animal studies, and observed by engineers and potentially surgeons, rather than through expert consensus on diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable or specified. This concept is for diagnostic interpretation, not for evaluating a surgical robot's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC study was not conducted as described. This type of study is specific to evaluating AI in diagnostic image interpretation where multiple human readers interpret cases with and without AI assistance. The document refers to the effect of the software change as: "The enhanced control algorithms decrease the settling time of the surgeon transitions between control modes, so that the endoscope view and instruments stabilize more quickly after moving." This describes an improvement in user experience/system responsiveness, not an effect size quantifiable in an MRMC study.

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

The software changes involve control algorithms that directly influence the physical operation of the surgical system, which is inherently a human-in-the-loop device. While "unit testing" of algorithms was performed, it's not a standalone diagnostic performance evaluation in the usual AI/ML sense. The performance is tied to the integrated system and surgeon interaction.

7. The Type of Ground Truth Used:

For system control algorithms, "ground truth" would be derived from engineering specifications, sensor data, and observed mechanical stability/responsiveness. The document mentions:

• "System control algorithms were verified by unit testing" (likely against predefined specifications).
• "Verification of surgeon control mode accuracy and fault distances" (against engineering tolerances).
• "Verification of joint controller performance" (against design specifications).
• "Validation testing using an animal model" (real-world performance observed by experts).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that learns from a "training set" of data in the conventional sense (e.g., image datasets). The software updates are based on control engineering principles, not machine learning from a large dataset.

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

Not applicable. There is no training set in the context of this device's software.

In summary, this FDA clearance document describes a software update for a robotic surgical system. The review process is focused on demonstrating that the changes maintain the safety and effectiveness of the device and its substantial equivalence to a predicate, rather than detailing the performance of an AI/ML algorithm against a diagnostic ground truth dataset.

Ask a specific question about this device