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Depalt Vaginal Speculum is used for the purposes of visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.

Depalt Lighting System provides the light necessary to illuminate the field during procedures/examinations.

Depalt Vaginal Speculum is a nonmetal, single use (disposable) medical device used to expose the interior of the vagina. The vaginal speculum may be used with or without the Depalt Lighting System.

Depalt Lighting System provides the light necessary to illuminate during procedures and examinations.

This submission K072762 is for a medical device (Depalt Vaginal Speculum and Depalt Lighting System), not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) does not apply.

The FDA 510(k) submission for this device focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of:

• Intended Use: Visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures/examinations.
• Technological Characteristics:
  • Speculum: Nonmetal, single-use (disposable), made of Polystyrene.
  • Lighting System: Provides illumination during procedures and examinations.
• Material: Polystyrene for the speculum.

The substantiation for this type of device typically involves:

• Bench Testing: To ensure mechanical integrity, material compatibility, and light output specifications (for the lighting system). This is often compared against industry standards or the performance of predicate devices.
• Biocompatibility Testing: To ensure the materials used are safe for patient contact.
• Sterilization Validation: If the device is supplied sterile.
• Labeling Review: To ensure appropriate instructions for use and warnings.

Since this is not an AI/ML device, the following points from your request are not applicable:

• A table of acceptance criteria and the reported device performance (in the context of AI metrics).
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The FDA's review for this 510(k) focuses on safety and effectiveness through substantial equivalence, primarily based on the listed technical characteristics and intended use, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy.

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