(144 days)
The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.
The IOGYN Endoscope is a rigid multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel, and two fluid channels. The body consists of an outer and an inner tube of surgical steel. The light fibers, rod-lens optical system, and two fluid channels are sandwiched between these tubes. The inner tube serves as a working channel to provide access for resection/coagulation instruments. The fluid channels are intended to move fluid. At the proximal end, the endoscope is provided with a light post that is compatible with standard endoscopic light sources, and with an eyepiece intended for visualization. The IOGYN Endoscope is dimensionally compatible with the IOGYN System.
The provided text describes the 510(k) submission for the IOGYN Endoscope. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, especially in the context of AI performance. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with quantitative metrics for AI or human performance.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported device performance for an AI-powered device. Instead, it indicates that "Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate device. The IOGYN Endoscope met all specified design and performance requirements."
This statement is very general and does not provide specific metrics or acceptance criteria as would be expected for an AI device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing mentioned (thermal and simulated use) does not appear to involve a "test set" of patient data in the context of an AI study.
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 document describes a medical device (endoscope), not an AI system that would require expert-established ground truth on a test set.
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
This information is not provided in the document. The document describes an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical endoscope, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. The "ground truth" for the device's performance would likely relate to its mechanical and optical functionality, not diagnostic accuracy based on medical imaging.
8. The sample size for the training set
This information is not provided in the document. AI training sets are not relevant to the approval of this physical endoscope.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope 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 hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.