(329 days)
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):
| Criterion | Description |
|---|---|
| Device Name | GelPOINT Transvaginal Access Platform, Models: C2A00, C2A01, C2A02 |
| Indications for Use | Intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining pneumoperitoneum during laparoscopic hysterectomy. Indicated for use in laparoscopic assisted vaginal hysterectomies. Also a conduit for the extraction of specimens. |
| Biocompatibility Testing | Followed ISO 10993-1 and FDA General Program Memorandum G95-1. Tests included: Cytotoxicity, Sensitization, and Irritation. Passed. |
| Mechanical Testing | Dedicated test method created by Applied Medical, focused on: 1. Sealing against insufflation pressure, with and without instruments in place. 2. Fixation in the vagina. |
Study that Proves the Device Meets Acceptance Criteria (as described in the text):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for the physical device based on this document) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 and FDA G95-1 requirements for external communicating devices (contacting tissue/bone/dentin |
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.