Search Results

The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence.

Not Found

The provided text is a 510(k) premarket notification decision letter from the FDA regarding the KegelMaster™ 2000. This document primarily focuses on the regulatory aspects of device approval based on substantial equivalence to a predicate device, rather than detailing specific acceptance criteria and the results of a scientific study proving those criteria were met for this particular device.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving those criteria were met. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a summary of performance data from a specific study against predefined acceptance criteria for the KegelMaster™ 2000 itself.

The document includes:

• Regulatory information: Device name, regulation number, regulatory class, product code, and the FDA's determination of substantial equivalence.
• Indications for Use: "The Kegelmaster 2000 is intended to assist women in performing Kegel Exercises, which may help control stress urinary incontinence."

However, it lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results from a standalone algorithm performance study.
7. Type of ground truth used in a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Without a detailed study report, which is not part of this 510(k) clearance letter, I cannot provide the requested information.

Ask a specific question about this device