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The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.

Device Description

The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

AI/ML Overview

This document is a 510(k) summary for the GelPOINT® V-Path Vaginal Access System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document describes functional testing but doesn't explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. Instead, it describes general successful outcomes.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance (Summary of results)
Ability to maintain transvaginal access.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments.
Ability to facilitate instrument access to the surgical site.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to establish and maintain a path of entry for minimally invasive instruments.
Ability to allow for device removal.	The studies confirm that the GelPOINT V-Path Vaginal Access System has the ability to allow for device removal. (Inferred from "Device removal" being an assessed function).
Ability to maintain device retention/anchoring.	The studies confirm that the GelPOINT V-Path Vaginal Access System can remain anchored in the patient while withstanding conditions under normal clinical use.
Ability to maintain insufflation.	The studies confirm that the integrity and sealing capability of the device system are adequate to maintain insufflation as a means to provide visualization of the surgical space.
Biocompatibility (non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, non-pyrogenic).	The biocompatibility test results demonstrate the GelPOINT V-Path Vaginal Access System is biocompatible and has met the criteria to be classified as non-cytotoxic, non-sensitizer, non-irritant, non-systemically toxic, and non-pyrogenic.
Shelf-life of 3 years.	Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration of 3 years.

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

Sample Size for Test Set: The document mentions "bench testing" and "Functional bench testing" but does not provide specific sample sizes (e.g., number of devices tested, number of trials).
Data Provenance: The studies were internal company studies ("A protocol was developed by Applied Medical"). There is no mention of country of origin of data, and these are laboratory bench tests, not patient data, so the retrospective/prospective distinction is not applicable in the usual sense for clinical data.

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

This information is not provided in the document. The studies are described as functional bench tests, suggesting engineering or quality assurance personnel would evaluate the performance rather than clinical experts establishing a ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

This information is not provided. Given the nature of bench testing, it's unlikely an adjudication method like 2+1 or 3+1 (typically used for clinical imaging assessments) would be applied.

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:

MRMC Study: No.
AI Assistance: The document describes a medical device for surgical access, not an AI-powered diagnostic or assistive tool. Therefore, a study on human readers improving with AI assistance is not applicable and was not conducted.

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

No. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not applicable.

7. The type of ground truth used:

For the functional tests, the "ground truth" would be the successful demonstration of the device's intended functions (e.g., maintaining an open pathway, retaining its position, maintaining insufflation). For biocompatibility, the ground truth is established by meeting the pass/fail criteria outlined in the referenced ISO standards and USP . For shelf-life, the ground truth is the device maintaining specifications after accelerated aging.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating the substantial equivalence of a physical surgical access device through functional bench testing, biocompatibility testing, and shelf-life studies. It does not involve clinical studies with patient data, expert review of images, or artificial intelligence algorithms. Therefore, many of your requested points related to AI performance, reader studies, and large-scale data sets are not relevant to this type of device submission.

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