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The GelPOINT Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopic assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

The GelPOINT Transvaginal Access Platform is a sterile, single use instrument that allows access to the vagina to perform laparoscopic assisted hysterectomy. The device consists of a cannula with suture ties, and a cap made of a flexible gel-like material. The gel cap has two stopcocks that can be used for insufflation or smoke evacuation. Four trocars are included and may be placed through the gel cap. The trocars allow insertion of standard laparoscopic instruments into the vagina. Construction materials include various polymers, silicone and stainless steel.

Packaging consists of a PTEG tray that is placed in a Tyvek/Mylar pouch and shipped in a carton. Sterilization is via Gamma irradiation; sterility assurance level is 10°.

This document describes the GelPOINT Transvaginal Access Platform, Models: C2A00, C2A01, C2A02, and its substantial equivalence to a predicate device. However, the provided text does not contain the specific acceptance criteria, detailed study results, or information about the study design typically requested for a detailed AI device evaluation.

The document focuses on the regulatory submission (510(k)) for a medical device that facilitates laparoscopic hysterectomies and specimen extraction. The performance data presented is for biocompatibility and mechanical testing of the physical device, not for an AI algorithm.

Therefore, I cannot populate the requested table and sections with information about AI acceptance criteria, device performance, sample sizes, expert involvement, or ground truth for an AI algorithm, as this information is not present in the provided text.

Here's what can be extracted and what is missing, based on your request and the provided text:

Information based on the provided text (for a physical medical device, not an AI):

Study that Proves the Device Meets Acceptance Criteria (as described in the text):

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

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

• Sample Size for Testing: Not explicitly stated in terms of number of devices tested for biocompatibility or mechanical performance.
• Data Provenance: The biocompatibility testing leveraged data from a "reference device (K133393), which is identical in materials and composition to the subject device." This suggests prior testing on a similar product. The origin of the actual test data (e.g., country of origin, retrospective/prospective) is not specified.

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

• This information is not applicable to the type of device testing described (biocompatibility and mechanical). No "ground truth" established by human experts is mentioned for these physical device tests.

4. Adjudication method for the test set:

• Not applicable to the type of device testing described.

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 is not an AI device, so an MRMC study related to AI performance is not applicable and was not performed.

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

• This is not an AI device, so standalone algorithm performance is not applicable.

7. The type of ground truth used:

• For Biocompatibility: Compliance with established international standards (ISO 10993-1) and FDA guidance (G95-1), which define acceptable biological responses. This is a scientific and regulatory standard-based "ground truth."
• For Mechanical Testing: Performance relative to design specifications and comparison to a predicate device, based on dedicated internal test methods. The "ground truth" here is the functional requirement of sealing and fixation set by the manufacturer and deemed equivalent to the predicate.

8. The sample size for the training set:

• Not applicable as this is not an AI device with a training set.

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

• Not applicable as this is not an AI device.

Summary of Missing Information in the context of an AI device:

The provided document is a 510(k) clearance letter for a physical medical device (GelPOINT Transvaginal Access Platform), not an AI/ML-driven device. As such, it does not include any of the specified details related to AI performance evaluation, such as:

• Specific numerical acceptance criteria for AI metrics (e.g., sensitivity, specificity, AUC).
• Detailed quantitative performance data (metrics, confidence intervals) for any AI component.
• Information on AI test sets (size, provenance of data).
• Details on expert readers, ground truth establishment, or adjudication for AI performance.
• Any mention of MRMC studies or standalone AI performance.
• Information about AI training sets.

If you are looking for evaluation details pertinent to an AI-powered medical device, this document would not be the correct source.

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