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The Tagg Vaginal Speculum is intended for use in retracting or cxposing the interior of the vagina during the routine/general gynecological, diagnostic and therapeutic obstetrical procedures. After the use of the speculum it is to be disposed of as medical waste.

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This document is a 510(k) clearance letter from the FDA for a disposable vaginal speculum. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria related to AI/ML performance. The device in question is a physical medical instrument (a vaginal speculum), not an AI/ML-driven diagnostic or therapeutic device.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The 510(k) clearance for this device is based on demonstrating substantial equivalence to a predicate device, likely through performance testing relevant to its mechanical and material properties, rather than AI/ML performance metrics.

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