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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 da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic 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.

da Vinci SP Instruments:
Intuitive Surgical da Vinci 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, colorectal, and general thoracoscopic 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 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 "transanal local excision (TALE)" as a new representative, specific procedure in the Professional Instructions for Use.

The provided FDA 510(k) clearance letter and summary do not contain acceptance criteria or performance data for an AI-powered device. Instead, the document describes the clearance of the da Vinci SP Surgical System (SP1098), which is a robot-assisted surgical system, for an expanded indication: "transanal local excision (TALE)".

The performance data presented focuses on clinical performance and substantial equivalence of this surgical system for the new indication, not on the performance of a separate AI algorithm or its acceptance criteria.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set data) are not applicable or cannot be extracted from this document as they pertain to AI/ML device evaluations.

However, I can extract information related to the performance study conducted to support the new indication for the da Vinci SP Surgical System as described in the summary:

Study Proving Device Meets Acceptance Criteria (for the expanded indication)

The device in question, the da Vinci SP Surgical System (SP1098), is a robot-assisted surgical system. The 510(k) application (K243714) is for a labeling modification only, specifically to add "transanal local excision (TALE)" as a new representative, specific procedure. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the system, as modified by this labeling change, remains safe and effective for the new procedure, and is substantially equivalent to existing methods.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a labeling modification for a surgical system and not an AI/ML device with specific quantitative performance metrics like sensitivity/specificity, the "acceptance criteria" are implied by demonstrating substantial equivalence and satisfactory clinical performance through a combination of bench testing and literature review. The reported "performance" relates to clinical outcomes when using the da Vinci SP system for TALE compared to hand-held devices.

Implied Acceptance Criteria & Reported Device Performance for TALE Procedure:

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

• Bench Performance Testing (Cadaver Study):

  • Sample Size: Two complete TALE procedures were performed in one male cadaver.
  • Data Provenance: Not explicitly stated, but implies a prospective experimental setting. Location (country of origin) not specified beyond "in a male cadaver."

• Published Clinical Data Review:

  • SP Transanal Local Excision (TALE):
    • Sample Size: 4 publications reviewed, covering a total of 81 patients (43 from two publications on full/partial-thickness resection, and 38 from two publications on partial-thickness resection only).
    • Data Provenance: Peer-reviewed literature published globally (implied by journal names like "Dis Colon Rectum," "ANZ J Surg," "Annals of surgery"). The studies themselves are prospective/retrospective clinical studies.
  • Transanal Procedures with Hand-held Devices (TEM/TEO/TAMIS):
    • Sample Size: 42 publications reviewed, covering approximately 21,121 patients.
    • Data Provenance: Peer-reviewed literature published globally (various international journals listed). The studies themselves encompass Prospective, Retrospective, and Meta-analysis types.

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

• Bench Performance Testing: The cadaver study was performed to "confirm the clinical performance" and "assess instrument motion... and ability to reach targeted anatomy and complete the procedure." This implies evaluation by trained personnel (likely surgeons experienced with the da Vinci system and TALE procedures), but the exact "number of experts" or their specific "qualifications" for establishing ground truth are not detailed in this summary. The design validation was to confirm clinical performance, implying expert judgment during the procedure.
• Published Clinical Data: The "ground truth" for the clinical data came from the clinical outcomes reported in the original peer-reviewed studies themselves. These studies inherently involve practicing surgeons and pathologists establishing diagnoses, procedure success, and complications. The review process for the 510(k) would involve regulatory and clinical experts from the manufacturer analyzing and summarizing this previously established clinical data.

4. Adjudication method for the test set

• Bench Performance Testing: No explicit adjudication method is described beyond the conduct of the procedures and confirmation of performance. It was a direct observation and assessment of the system's ability to perform the TALE procedure.
• Published Clinical Data: For the literature review, a systematic search and screening were performed, and inclusion/exclusion criteria were applied to identify relevant publications. This implies a form of "adjudication" or selection process performed by the submitter's team to determine which studies were suitable for comparison, but not an independent adjudication of patient data for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, an MRMC study was not conducted or referenced. MRMC studies are typically used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., distinguishing cancerous from non-cancerous lesions). This 510(k) is for a robot-assisted surgical system, and the performance evaluation is based on the system's ability to facilitate a surgical procedure and its clinical outcomes, not on radiologists' diagnostic performance.

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

This question is not applicable. The da Vinci SP system is a surgical robot that is intended for human-in-the-loop performance (i.e., controlled by a trained physician). There is no "standalone" performance for such a device in the context of surgery. The "performance" is inherently a human-robot collaboration.

7. The type of ground truth used

• Bench Performance Testing: "Ground truth" was established by the physical and functional performance of the da Vinci SP Surgical System in a cadaver model as assessed by the operators (surgeons/engineers) conducting the procedures (e.g., ability to access rectum, manipulate instruments, complete the procedure).
• Published Clinical Data: "Ground truth" for clinical outcomes (e.g., operative time, complication rates, negative surgical margins) was derived from the data reported in the peer-reviewed clinical studies. This data would have been established by the clinicians, pathologists, and other medical professionals involved in the original studies based on patient diagnosis, surgical intervention, and follow-up. For example, tumor staging and lesion types were confirmed by pathology.

8. The sample size for the training set

This question is not applicable. The da Vinci SP Surgical System is a robotic system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development. The system's design and engineering principles are based on established robotics and surgical mechanics, verified and validated through a combination of engineering tests and clinical experience.

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

This question is not applicable, as there is no "training set" for an AI/ML algorithm for this device.

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