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The medi Bulter is indicated for use as an accessory to medical support stockings. The medi Butler is a lightweight steel frame aid for the application of medical support stockings. The medi Butler is suitable for all compression stocking sizes.

The Butler is a lightweight steel frame application aid that solves the often difficult problem of applying compression stockings. The application aid is suitable for all compression stocking sizes.

The provided text is a 510(k) summary for the medi Butler, an application aid for medical support stockings. It focuses on the device's general information, intended use, and technological characteristics compared to a predicate device.

There is no acceptance criteria or study data presented in the provided document.

The document states that the medi Butler is substantially equivalent to a legally marketed predicate device (Jobst Stocking Donner, a Class I 510(k) exempt device). For Class I 510(k) exempt devices, the regulatory pathway generally relies on demonstrating substantial equivalence to a legally marketed device without the need for extensive clinical studies to prove performance against specific acceptance criteria. This process is typically less rigorous than for Class II or Class III devices that may require clinical trials or more detailed performance data.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. This device is a physical aid, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document essentially states that the medi Butler is similar in construction and intended use to existing devices, and thus is substantially equivalent, negating the need for the types of studies and acceptance criteria typically associated with more complex or novel medical devices.

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