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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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The GelPOINT® Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

GelPOINT Path is inserted into the anal canal to establish access to the rectum and lower sigmoid colon in preparation for transanal endoscopic surgery. The access channel lumen may be closed off with an airtight cap. The cap allows for insufflation of the surgical site. The cap is constructed of a gel material through which multiple sleeves may be placed. These sleeves establish ports that allow passage of a laparoscope and laparoscopic instruments without loss of insufflation. GelPOINT Path was previously cleared in access channel lengths ranging from 4.5cm to 15cm. The proposed clearance for the access channel length is 3.5cm to 15cm.

This document is a 510(k) summary for the GelPOINT® Path Transanal Access Platform, a medical device. It's a regulatory submission to the FDA, not a study report that details acceptance criteria and performance data in the typical sense of a clinical trial.

Therefore, many of the requested categories simply do not apply to this type of document because it describes a line extension of an already cleared device, not a new device requiring extensive de novo performance testing. The main argument for substantial equivalence is based on the lack of impact of the new feature (shorter access channel length) on already established safety and effectiveness.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable:

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

This document does not provide a table of acceptance criteria or reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. This is because the submission is for a line extension of an already cleared device (K110792 and K133393). The argument is that the proposed change (shorter access channel length) does not impact the performance specifications already established for the predicate devices.

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

Not applicable. This submission is for a line extension of a device. It refers to performance testing done for the predicate devices (K110792 and K133393) but does not provide details on their sample sizes or data provenance. No new testing of this nature was conducted or reported for this specific submission (K171701).

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. This type of information is not relevant to a 510(k) submission for a line extension of an existing mechanical device. There is no "ground truth" to establish through expert review in the context of diagnostic accuracy for this device.

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

Not applicable. There was no test set requiring adjudication in the context of this 510(k) submission.

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 device is a transanal access platform, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is a transanal access platform, not an AI algorithm.

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

Not applicable. There is no concept of "ground truth" in the context of diagnostic accuracy for this mechanical device's 510(k) submission. Safety and effectiveness would be established through performance testing related to its mechanical function, biocompatibility, sterility, etc. (as mentioned for the predicate devices), not through comparison to a diagnostic ground truth.

8. The sample size for the training set

Not applicable. This device is a transanal access platform; there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set for this mechanical device, there is no ground truth to establish for it.

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