(115 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization: Device must be sterile. | Sterilization validation was provided to support substantial equivalence. |
| Shelf Life: Device must maintain integrity and functionality over its specified shelf life, including transportation. | Shelf life testing including transportation simulation, package integrity, and device functionality testing was provided. |
| Biocompatibility: Device materials must be biocompatible (non-cytotoxic, non-irritating, non-sensitizing). | Biocompatibility testing including cytotoxicity per ISO 10993-5 and irritation and sensitization testing per ISO 10993-10 was provided. |
| Mechanical Performance: | |
| - Maintenance of Transvaginal Access: Device must effectively maintain transvaginal access. | Assessment of maintenance of transvaginal access was performed. |
| - Facilitation of Instrument Access: Device must facilitate instrument access to the surgical site. | Assessment of facilitation of instrument access to surgical site was performed. |
| - Device Removal: Device must be easily removable. | Assessment of device removal was performed. |
| - Device Retention: Device must remain securely in place during procedures. | Assessment of device retention was performed. |
| - Maintenance of Insufflation: Device must maintain insufflation (or pneumoperitoneum). | Assessment of maintenance of insufflation was performed. |
| Clinical Performance (Safety): Acceptable rates of peri- and post-operative complications. | Both clinical datasets (Baekelandt et al. (2018) and iNOTESs Society Registry) demonstrated acceptable rates of peri- and post-operative complications following use of the subject device. |
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.
§ 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.