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The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.

The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.

This K021017 document is a 510(k) summary for a medical device called the LeeSpec™ Disposable Vaginal Speculum. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.

Therefore, the "acceptance criteria" for this device are primarily based on its substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the 510(k) summary itself, which highlights the similarities to the predicate device.

Here's an analysis of the provided information relative to your requested categories:

1. A table of acceptance criteria and the reported device performance

For a 510(k) of this nature, the "acceptance criteria" are not performance metrics in the way one might think of a diagnostic test (e.g., sensitivity, specificity). Instead, they are the criteria for substantial equivalence to the predicate device. The "reported device performance" is the statement that the characteristics of the new device match those criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• This 510(k) summary does not describe an analytical or clinical study with a "test set" in the traditional sense of evaluating performance metrics. It's a comparison to a predicate device.
• Therefore, there is no sample size for a test set, no data provenance, and no retrospective or prospective study mentioned in this document. The "data" here is the descriptive information of the device and its comparison to the predicate.

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)

• As there is no traditional "test set" or clinical study, there are no experts mentioned in this document as being used to establish ground truth. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• None mentioned, as there was no formal "test set" requiring adjudication.

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. This device is a physical speculum and does not involve AI or human readers in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a manual medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For this type of device and 510(k) submission, the "ground truth" for performance is the established safety and effectiveness of the legally marketed predicate device (Medisul Disposable Vaginal Speculum K000414), which serves as the benchmark against which the new device is compared. The expectation is that because the new device is substantially equivalent in its design, materials, and intended use, it will have similar performance characteristics to the predicate.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an algorithm being developed or a clinical trial in the sense of patient enrollment for a new treatment.

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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