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The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel 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 laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Acceptance Criteria and supporting study information are derived from the "Discussion of Performance Data" and "Comparison with the Predicate Device" sections of the provided text.

Here's a breakdown of the requested information:

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

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

• Sample Size:
  • Baekelandt et al. (2018) study: n=70
  • iNOTESs Society Registry data: n=906
• Data Provenance: The document does not specify the country of origin for either dataset.
  • Baekelandt et al. (2018): Randomized, single-center, single-blinded trial (Prospective).
  • iNOTESs Society Registry data: Registry data (Likely prospective, though details aren't fully specified).

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)

This information is not provided in the document. The studies report "acceptable rates of peri- and post-operative complications," implying clinical assessment, but the number or qualifications of experts involved in determining these outcomes are not detailed.

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

This information is not provided in the document.

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

• No MRMC study was done that involved AI vs. human readers. The studies described (Baekelandt et al. and iNOTESs Registry) are clinical performance studies of a medical device (Transvaginal Access Platform), not an AI diagnostic tool. They compare different surgical approaches or document outcomes with the device.

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

• Not applicable. The device is a physical surgical access platform, not an algorithm. Therefore, no standalone algorithm performance study was performed.

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

• The ground truth for the clinical performance criteria ("acceptable rates of peri- and post-operative complications") appears to be clinical outcomes data, likely assessed by healthcare professionals involved in the care of the patients. This would include direct observation, patient follow-up, and review of medical records for complications.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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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:

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