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The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site

The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke

The provided text describes a 510(k) premarket notification for the AFS Medical Sterile Single-Use Access Port System. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility testing, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories in your prompt are not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and testing results:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Non-Clinical Performance Tests: Sample sizes are not explicitly stated for individual tests. The data provenance is internal testing performed by the manufacturer, likely in a laboratory setting.
• Clinical Testing: "Real-world data was collected from two independent clinical sites in Austria." The number of procedures or patients is not specified. This is prospective data collection.

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

• Non-Clinical Performance Tests: Not applicable, as these are objective engineering and material tests, not reliant on expert interpretation for "ground truth."
• Clinical Testing: The text mentions "multiple clinicians reported no adverse events related to the device and assessed performance of all key attributes as acceptable." The exact number or qualifications of these clinicians are not specified beyond their role in performing procedures at clinical sites.

4. Adjudication method for the test set

• Non-Clinical Performance Tests: Not applicable as these are objective tests.
• Clinical Testing: Not specified, beyond the general statement that "multiple clinicians" assessed performance. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a surgical access port system, not a diagnostic AI device that would utilize such a study design.

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

Not applicable. This device is a manual surgical tool, not an algorithm or an AI-powered system designed for standalone performance.

7. The type of ground truth used

• Non-Clinical Performance Tests: Objective measurements against engineering and materials standards (e.g., force measurements, light intensity, leakage rates, compliance with IEC standards).
• Biocompatibility Testing: Laboratory results from standardized biological tests (ISO 10993 series).
• Clinical Testing: Clinician assessment of device performance and adverse event reporting based on real-world use during surgical procedures.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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