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The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

Based on the provided FDA 510(k) clearance letter and summary for the "Vessel Sealer Curved" device, it is important to note that this document pertains to a surgical instrument (hardware), not a medical device with an AI/software component that would involve "acceptance criteria" and "studies" as typically understood for AI-based diagnostic or prognostic devices.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission. The 510(k) summary clearly outlines the types of testing performed: mechanical, reliability, software (presumably related to the electrosurgical generator and da Vinci system, not AI), biocompatibility, shelf-life, transit, and animal studies focusing on functional performance like burst pressure and thermal spread.

Therefore, I cannot extract the information requested in the format provided because the device and its clearance process do not involve AI performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and preclinical validation tests detailed in Section VI "Performance Data" (Design Verification, Shelf-Life, Transit, Biocompatibility, Design Validation via animal testing).

Here's how to address the prompt given the nature of the device:

Acknowledgement of Device Type:
The Vessel Sealer Curved is a physical surgical instrument (bipolar electrosurgical instrument) used with a compatible da Vinci Surgical System and an electrosurgical generator. It is not an AI/software-based diagnostic or imaging device.

Why the Requested Information is Not Applicable:
The majority of the questions in the prompt (e.g., acceptance criteria for AI, sample sizes for test/training sets for AI, expert ground truth, MRMC studies, standalone AI performance) are relevant to the regulatory pathway for AI/Machine Learning-enabled medical devices. Since the Vessel Sealer Curved is a hardware device focused on mechanical and electrosurgical performance, these metrics are not part of its 510(k) submission.

Information that is relevant and can be inferred from the document:

The acceptance criteria for a device like this would be tied to its functional performance, safety, and substantial equivalence to a predicate device.

• Overall Goal: To demonstrate substantial equivalence to the predicate device (Vessel Sealer Extend K183107) in terms of intended use, technological characteristics, safety, and performance.

• Key Performance Indicators (Acceptance Criteria): While not explicitly stated in a table format with specific percentages for AI performance, the document implies the following types of performance criteria based on the tests conducted:

  • Mechanical Integrity: The device must withstand expected forces and remain functional (e.g., ability to grasp, dissect, and transect tissue).
  • Reliability: Consistent performance over its intended lifespan/usage.
  • Sealing Effectiveness: Ability to seal vessels up to 7mm effectively, preventing burst at a certain pressure (Burst Pressure Testing).
  • Controlled Thermal Spread: Minimizing unintended thermal damage to surrounding tissue (Thermal Spread on Vessels).
  • Compatibility: Seamless function with the da Vinci Surgical System and E-200 electrosurgical generator.
  • Biocompatibility: No adverse biological reactions when in contact with tissues.
  • Shelf-Life and Transit Stability: Maintaining sterility and functional integrity throughout its shelf-life and during shipping.

Study Proving Device Meets Criteria (Based on Document):

The performance data listed in Section VI outlines the studies conducted:

• Design Verification:
  • Mechanical bench testing
  • Reliability Testing
  • Force to Jaw Failure
  • Software Verification (likely for the control system, not AI)
  • Testing in accordance with IEC60601-1 and IEC60601-1-2 (electrical safety)
  • Usability Testing
• Shelf-Life Verification: In accordance with ASTM F1980.
• Transit Verification: In accordance with ASTM D4169-16.
• Biocompatibility: In accordance with ISO 10993-1 and FDA guidance.
• Design Validation (Animal Testing):
  • Burst Pressure Testing
  • Thermal Spread on Vessels
  • Chronic Animal Study

Addressing Specific Prompt Questions (as far as applicable):

1. A table of acceptance criteria and the reported device performance:

   • As explained, specific quantitative acceptance criteria for AI performance are not relevant here. The acceptance criteria would be successful completion of the listed engineering and preclinical tests, demonstrating that the device's functional outputs meet design inputs and that it performs safely and effectively comparable to the predicate. The document states, "The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs."

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for bench or animal testing in this summary and would vary by test (e.g., number of units tested mechanically, number of animals in the design validation study, number of vessels sealed).
   • Data Provenance: Not specified regarding country of origin. The studies are described as engineering bench tests and animal studies. These are prospective experiments conducted to validate the device.

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

   • Not applicable in the AI sense. Ground truth for a surgical instrument would be established through direct measurement of physical performance (e.g., pressure at which a seal bursts, precise measurements of thermal spread, visual inspection for mechanical integrity), and observation of physiological effects in animal models by veterinary or surgical experts. These wouldn't be "experts establishing ground truth for an AI assessment."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as it's not an AI-based diagnostic assessment. Performance is measured objectively.

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 applicable. This is for evaluating AI assistance in diagnostic tasks, which is not the function of this device.

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

   • Not applicable. This device is a surgical instrument operated by a human surgeon via the da Vinci system. Its "performance" is inherently tied to human use.

7. The type of ground truth used:

   • The "ground truth" for this device's performance is based on direct physical measurements (e.g., force, pressure, temperature, electrical parameters), observational data from preclinical animal studies (e.g., successful vessel sealing, lack of adverse tissue reactions, long-term tissue response in chronic studies), and adherence to established engineering and biocompatibility standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI model that undergoes "training."

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

   • Not applicable.

In summary, the provided document details the regulatory clearance for a conventional surgical instrument, not an AI-enabled device. Therefore, the performance criteria and validation methods are entirely different from those required for AI software.

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