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The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.

The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.

The provided document is a 510(k) premarket notification for the Intuitive Surgical da Vinci Xi Hasson Cone. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the format requested.

The document states that "Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." It lists the types of testing conducted but does not provide specific numerical acceptance criteria or the reported device performance against those criteria.

Therefore, I cannot populate the table or provide detailed answers to many of the questions as the information is not present in the provided text. I will indicate where the information is not available.

Description of the Acceptance Criteria and Study:

The document broadly states that performance data (bench and animal testing) demonstrated that the da Vinci Xi Hasson Cone is substantially equivalent to a predicate device and that its design output meets design input requirements. The testing included:

• Dimensional measurements
• Mechanical and functional verification
• Simulated use in animal models
• Human factors assessment

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified in the document. The document mentions "animal and cadaveric models" for design validation testing but does not provide quantities.
• Data provenance: Not specified. Testing was described as "bench" and "animal and cadaveric models," suggesting prospective
  testing, but detailed provenance (e.g., country of origin) is not mentioned.

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 applicable/Not specified. The context of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus on images) does not directly apply to the mechanical and functional device testing described. The "experts" would likely be the engineers and perhaps surgeons involved in the animal validation, but their number and specific qualifications are not detailed.

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

• Not applicable/Not specified. This is typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. For device performance testing, the "adjudication" would be based on meeting predefined engineering specifications and functional outcomes.

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

• No. The document describes a medical device (Hasson cone) used in laparoscopic surgery, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Not applicable. This device is a physical surgical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device testing is adherence to engineering specifications, functional performance in simulated environments (bench testing), and successful operation within animal/cadaveric models. It's based on objective measurements and observed physical outcomes rather than expert interpretation of diagnostic data or pathology.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

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