Search Results

KleenSpec® Single Use Vaginal Speculum

The disposable vaginal speculum 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 vaginal speculum can be used with or without the illuminator.

KleenSpec® 790 Series Cordless Illuminator

When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.

The illuminator can be used independent of the speculum as a general-purpose light source.

This product is available for sale only upon the order of a physician or licensed health care professional.

The subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data.

Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.

The provided text is a 510(k) Summary for a medical device: the KleenSpec® Single Use Vaginal Speculum. It describes a modification to an existing device (the addition of an extra small size) and explicitly states that no clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data.

Therefore, the device's acceptance criteria are not based on clinical performance metrics, but rather on its substantial equivalence to a predicate device. The study that proves the device meets acceptance criteria is non-clinical bench testing and adherence to design control procedures.

Here's a breakdown of the requested information based on the provided document:

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

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

• Sample size for test set: Not applicable (N/A) – No clinical test set was used. The evaluation was based on non-clinical bench testing.
• Data provenance: Not applicable (N/A) – No clinical data (from a country of origin, retrospective or prospective) was used. Testing was conducted internally by Welch Allyn.

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)

• Not applicable (N/A) – No clinical test set requiring expert ground truth was utilized. The assessment was based on engineering design validation and verification.

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

• Not applicable (N/A) – No clinical test set requiring adjudication was utilized.

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

• Not applicable (N/A) – This device is a physical medical instrument (vaginal speculum), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

• Not applicable (N/A) – This device is a physical medical instrument, not an algorithm.

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

• Not applicable (N/A) – No clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for this regulatory submission was established through engineering design specifications, material specifications, and performance testing against those specifications, implicitly confirming the device's functional integrity and safety characteristics are equivalent to the predicate.

8. The sample size for the training set

• Not applicable (N/A) – No training set was used. This is not an AI/machine learning device.

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

• Not applicable (N/A) – No training set or associated ground truth was established for this device.

Ask a specific question about this device