Search Results

The Gynescope™ System is intended for the examination of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated.

The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.

The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.

The Gynescope™ System is a colposcope platform for physicians to perform examinations of the vagina, cervix and external genitalia. The Gynescope™ System consists of the following components:

• Gynescope™ Image Acquisition System (IAS)
• Gynescope™ System Console
• Gynescope™ Single Use Vaginal Speculum

The IAS is a handheld colposcope that includes imaging optics and provides white and green illumination using both centered and side illumination techniques. The IAS also includes color and monochrome sensors. The color sensor is used for standard examinations under white or green illumination, while the monochrome sensor is only used for imaging target tissues under green illumination. Key functions of the device (e.g., magnification, illumination, light source, image capture, etc.) can be operated using a built-in keypad on the IAS. A cable connects the IAS to the Gynescope™ System Console.

During use, the IAS is attached to the Gynescope™ Single Use Vaginal Speculum to form a single body. When combined, the Gynescope™ Single Use Vaginal Speculum provides access to the vaginal cavity and prevents direct contact of the IAS with the patient. This component also includes a separate opening for instruments if needed during an examination. The Gynescope™ Single Use Vaginal Speculum is non-sterile, made of polycarbonate, and is provided in four sizes.

The Gynescope™ System Console is responsible for data processing, storage and display of information to the user. In addition, the Gynescope™ System Console can be used to control functions of the IAS (e.g., magnification, illumination, light source, image capture, etc.). User's interact with the Gynescope™ System Console via a 12.2-inch touchscreen interface. This component also includes a video output connection that allows connection to a peripheral video device (e.g., monitor). A cradle is also mounted on the Gynescope™ System Console that is used to hold and protect the IAS between uses.

The provided text describes a 510(k) summary for the Gynescope™ System, a colposcope. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm's performance. The "Summary of Performance Testing" section details various engineering and safety tests (electrical safety, EMC, software, cybersecurity, imaging evaluation, biocompatibility, mechanical testing of the speculum) but does not present a clinical study with specific acceptance criteria related to a device's diagnostic performance against a ground truth, especially not involving AI.

Therefore, **I cannot extract the requested information based on the provided text, as it does not contain details about:

1. A table of acceptance criteria and reported device performance for a diagnostic task.
2. Sample sizes for a test set or its provenance for such a diagnostic study.
3. Number of experts or their qualifications for establishing ground truth for a diagnostic test set.
4. Adjudication methods for a diagnostic test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance without human-in-the-loop.
7. Type of ground truth (expert consensus, pathology, outcomes data) for a diagnostic task.
8. Sample size for a training set (indicating the absence of an AI component being evaluated here).
9. How ground truth for a training set was established.**

The document primarily focuses on the device's technical specifications, safety, and functional equivalence to a predicate colposcope, not on the performance of a diagnostic algorithm or AI system.

Ask a specific question about this device