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To shape the beam from a low energy radiation therapy source up to 50kVp.

The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT). The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm. The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.

The provided document, a 510(k) summary for the Axxent® FlexiShield Mini, is primarily an administrative submission to the FDA demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way one would typically find for a new diagnostic imaging AI algorithm.

The Axxent® FlexiShield Mini is a radiation therapy beam-shaping block, which is a physical medical device, not an AI algorithm or a diagnostic tool. Therefore, the questions regarding AI study design (sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not addressed in the document.

The "study" in this context is a demonstration of substantial equivalence to a legally marketed predicate device.

Here's the relevant information that can be extracted from the provided text:

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

The document does not specify "acceptance criteria" in a quantitative, performance-based manner typically associated with clinical trials or AI algorithm validation. Instead, the primary "acceptance criterion" for 510(k) clearance is substantial equivalence to a predicate device.

2. Sample size(s) used for the test set and the data provenance:

Not applicable. This is a physical medical device, so there is no "test set" of data or "data provenance" in the context of an AI algorithm or diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "ground truth established by experts" for this type of device's 510(k) submission.

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 is not an AI-assisted 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.

In summary: The provided document is a 510(k) summary for a physical medical device used in radiation therapy. It establishes equivalence to a predicate device based on design, materials, principles of operation, and product specifications. The questions posed in your request are primarily relevant to the evaluation of AI algorithms or diagnostic tools, which is not the nature of the Axxent® FlexiShield Mini.

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