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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.

Endo Wrist SP Instruments:

Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 turnors 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 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.

This 510(k) is for a labeling modification only, to add "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It primarily discusses a labeling modification to add "simple prostatectomy" as a representative procedure and the justification for this change. The document does not describe acceptance criteria for a device performance study in the typical sense of a new device validation with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing performance data from literature for different prostatectomy approaches.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance (as inferred from the provided text):

The "acceptance criteria" here are not explicitly stated numerical thresholds for performance. Instead, the inherent acceptance criterion is that the new procedure ("transvesical prostatectomy" for both simple and radical cases) performed with the da Vinci SP Surgical System demonstrates similar clinical outcomes to previously cleared prostatectomy approaches (extraperitoneal and transabdominal radical prostatectomy) performed with the same device. This demonstrates "substantial equivalence" and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Description: The "test set" here is composed of peer-reviewed literature and a cadaver study.
  • Literature Review: 11 primary publications for transvesical prostatectomy (8 for TVSP, 3 for TVRP) with a total of ~428 patients (247 for TVSP, 181 for TVRP).
  • Comparison Literature: 10 publications for extraperitoneal radical prostatectomy (EPRP) with ~1,259 patients and 7 publications for transabdominal radical prostatectomy (TARP) with ~649 patients.
• Data Provenance: Retrospective, collected from peer-reviewed scientific literature published between January 1, 2018, and January 7, 2023. The countries of origin are not specified, but peer-reviewed literature typically encompasses international data.
• Cadaver Study: One male cadaver was used. This was a prospective study to confirm instrument access and motion.

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

• Cadaver Study: The document states that "Design validation testing was performed... Evaluation of the ability to provide robotic and laparoscopic instrument access... was confirmed and an assessment of instrument motion... was performed." It doesn't explicitly state the number or qualifications of the experts performing this evaluation for the cadaver study, but it implies trained medical professionals (likely surgeons or surgical engineers) would conduct such validation.
• Literature Review: The ground truth for the literature review is based on reported clinical outcomes from published studies. The "experts" in this context are the authors of the peer-reviewed articles, who are typically surgeons specializing in urology and robotic surgery. Their qualifications and number are variable across the 28 referenced publications.

4. Adjudication Method for the Test Set:

• Literature Review: The method involved systematic searching of Scopus, Embase, and PubMed databases, followed by systematic literature screening. For comparative effectiveness, "all primary publications reporting relevant clinical outcomes for transvesical simple/radical prostatectomy performed using the da Vinci SP Surgical System were included." For the predicate approaches, publications with "50 or more patients in at least one study arm were included." This suggests a criteria-based inclusion/exclusion process for publications, but a formal "adjudication method" beyond standard systematic review practices (e.g., dual review and consensus) is not explicitly detailed.
• Cadaver Study: No adjudication method is described beyond the inherent observation and confirmation by the performing team.

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

No, an MRMC comparative effectiveness study was not done. The study relies on comparing aggregated historical clinical outcomes from published literature and a single cadaver study, not on human readers interpreting cases with or without AI assistance. The device is a surgical system, not an AI diagnostic or assistive tool in the traditional sense of image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The "da Vinci SP Surgical System" is a robotic surgical platform; it is a human-in-the-loop device by its very nature (a surgeon controls the system). Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable or relevant to this device.

7. The Type of Ground Truth Used:

• Cadaver Study: Direct observation and confirmation of instrument access, motion, and robustness within a cadaveric model.
• Literature Review: Clinical outcomes data reported in peer-reviewed publications. This includes various metrics collected by the original study authors, such as operative time, estimated blood loss (EBL), complication rates (intraoperative, 30-day postoperative, major), length of stay, readmission rate, urinary retention, continence rate, catheterization time, positive surgical margins, and mortality. These are patient outcomes, representing a form of "ground truth" for clinical performance.

8. The Sample Size for the Training Set:

The 510(k) summary does not describe any "training set" in the context of an AI/ML algorithm development. The device is a surgical system, not an AI algorithm that learns from data. The prior clinical experience with the da Vinci SP System and its predicate devices, as well as general surgical knowledge, would constitute the underlying "knowledge base" for its design and intended use, but not a formally defined "training set" for an algorithm.

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

Not applicable, as there is no described AI training set.

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