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The Smith & Nephew HandPort System is intended to provide abdominal access to the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery. The retractor may also be used independently to provide incision retraction and to protect the wound from contamination.

The Smith & Nephew HandPort System is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens.

The HandPort System provides access to the abdominal cavity while maintaining pneumoperitoneum; the laparoscopic surgeon regains the tactile sense and feedback along with the increased hand-eye and instrumentation manipulation capacity of open surgery.
The standard HandPort System device consists of the following components:

1. Base retractor,
2. Sleeve,
3. Bracelet,
4. Retractor Cap, with or without Instrument Portal, and
5. Sterile Lubricant

The provided text describes a 510(k) summary for the Smith & Nephew HandPort System, but it does not contain specific acceptance criteria or a detailed study report with performance metrics. The summary focuses on demonstrating substantial equivalence to a predicate device and briefly mentions three types of testing without providing detailed results or how those results meet specific criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.

However, I can extract the available information regarding the studies mentioned:

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

• Acceptance Criteria: Not explicitly stated in the provided document.
• Reported Device Performance:
  • Bench Testing: "confirmed that the HandPort System reliably maintains pneumoperitoneum under simulated use conditions."
  • Simulated Use Testing (Animal Series): "confirmed that the HandPort System provides sufficient hand access to anatomical structures while maintaining pneumoperitoneum for the duration of the surgical procedure."
  • Prospective, Multicenter Clinical Trial: "confirmed the capability of the HandPort System in facilitating hand-assisted surgery in a range of surgical procedures."

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

• Bench Testing: Sample size not specified.
• Simulated Use Testing (Animal Series): Sample size not specified. Data provenance: Animal series (details like species or number of animals not provided).
• Prospective, Multicenter Clinical Trial: Sample size not specified. Data provenance: Prospective, multicenter clinical trial. Country of origin not specified.

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

• Not specified for any of the mentioned tests. The clinical trial involved "surgeons," but their number or specific qualifications (e.g., years of experience) are not detailed.

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

• Not specified for any of the mentioned tests.

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

• This device is a surgical access system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The clinical trial focused on the device's capability in facilitating hand-assisted surgery.

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

• This device is a physical surgical tool, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

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

• The document implies clinical observation and assessment by surgeons for the clinical trial, assessing the "capability of the HandPort System in facilitating hand-assisted surgery." For bench and animal testing, the "ground truth" would be direct measurement of pneumoperitoneum maintenance and assessment of hand access to anatomical structures.

8. The sample size for the training set

• This device is a non-AI surgical tool; thus, the concept of a "training set" in the context of machine learning is not applicable.

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

• As per point 8, this is not applicable.

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