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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:

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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.

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 all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera imansional (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 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 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 subject device changes are limited software, specifically modifications to the surgical instrument control algorithms. Two new functions are being added: instrument compensation under load and instrument grip compensation. The instrument control algorithm changes are being made to provide more consistent performance in specific situations. There are no labeling or user interface changes associated with the enhanced instrument control algorithms.

The provided text is a 510(k) summary for the da Vinci SP Surgical System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the text states: "Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate of or regression test cases. Additional new test cases within the algorithm the new instrument control algorithm risk mitigations are effective at reducing new risks to acceptable risk levels. Therefore, the test results device is substantially equivalent to its predicate device."

While this confirms that testing was done and acceptance criteria were met, it does not provide:

1. A specific table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a surgical system, not typically an AI-driven image analysis tool, so MRMC studies might not be applicable here.
6. Information on a standalone (algorithm only) performance study. Again, this is a surgical system, not a diagnostic algorithm.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fully complete the table and answer all your questions based on the provided document.

However, I can extract what is stated about the testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not Available in the Provided Text):

• Specific quantitative acceptance criteria (e.g., maximum force, precision of movement, control latency).
• Detailed quantitative performance results for each criterion.
• The exact "regression test cases" and "new test cases" mentioned.

Regarding the other points you requested:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
• 3. 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 provided in the document. Given it's a surgical system, "ground truth" would likely relate to objective performance metrics in simulated or cadaveric settings, or possibly clinical outcomes for predicate devices, rather than expert interpretation of medical images.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
• 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: Not provided in the document, and likely not applicable. The da Vinci SP Surgical System is a robotic surgical system that assists surgeons in performing procedures, not a diagnostic AI system meant to assist human "readers" (like radiologists). Its "AI" component refers to instrument control algorithms, not interpretative intelligence.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided in the document. The device is inherently "human-in-the-loop" as it is controlled by a surgeon. The software modifications are for "instrument compensation under load and instrument grip compensation," enhancing the existing human-controlled system.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. For a surgical system, "ground truth" for performance would likely involve objective measurements in engineering tests (e.g., force feedback accuracy, range of motion, vibration reduction), and potentially clinical performance metrics from prior human use (for comparison).
• 8. The sample size for the training set: Not provided in the document. The software changes are described as "modifications to the surgical instrument control algorithms" adding "instrument compensation under load and instrument grip compensation." This implies an engineering/control systems approach rather than a machine learning model requiring a large "training set" in the traditional sense of AI for image analysis.
• 9. How the ground truth for the training set was established: Not provided in the document. Similarly, if it's an algorithm modification, "training set ground truth" might refer to performance targets or parameters derived from engineering principles and existing operational data.

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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 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, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation 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 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, additional labeling, and additional hardware used to connect the device to a remote Intuitive server. These changes are being made to facilitate remote technical support and servicing of the device.

The information provided focuses on the regulatory clearance of the da Vinci SP Surgical System. It details the device's description, indications for use, comparison with a predicate device, and performance data related to modifications for remote technical support and servicing. However, it does not contain the specific acceptance criteria and detailed study information (like sample sizes for test/training sets, experts' qualifications, adjudication methods, or MRMC study results) typically associated with establishing the diagnostic performance or clinical effectiveness of a medical device in detecting a condition or influencing clinical outcomes.

Instead, the document highlights testing related to:

• System software changes: Verification of risk mitigations, requirements, and specifications related to networking.
• Cybersecurity-related testing: Alignment with FDA Draft Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
• Safety and EMC standards: Evaluation against IEC 60601-1-2.
• Networking hardware testing: Manual bench testing for physical installation, security of ports, dimensions, connectivity, and startup/shutdown.
• Wireless coexistence testing: To validate suitability of the Wireless Bridge in a simulated use environment against RF interference, ensuring accurate detection of instruments and endoscopes.

The conclusion states that no issues of safety or effectiveness and no new risks were identified from these modifications, and the device is substantially equivalent to the predicate. This suggests the performance data presented is focused on validating the modifications to the system (networking, software updates for remote access) rather than its core surgical performance (which would have been established during the predicate device's clearance).

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of a diagnostic or therapeutic clinical trial, nor can I provide details on sample sizes for test sets, expert qualifications, or comparative effectiveness studies of human readers with/without AI assistance, as these are not discussed in the provided text.

The closest analogue to "acceptance criteria" for the modifications described would be the successful completion of the various tests (cybersecurity, EMC, wireless coexistence, hardware bench testing) without identifying new safety or effectiveness concerns. The "study" proving this is the sum of these verification and validation activities.

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