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The intended use of the device is to support and aid in positioning a patient during radiation therapy.

The HexaPOD evo consists of two platforms, which are connected by six length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.

The provided text is a 510(k) summary for the HexaPOD™ evo RT Couch Top, which is a powered radiation therapy patient support assembly. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as such data was not required or provided in this 510(k) submission.

Here's a breakdown of why the specific questions cannot be answered based on the input:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document states no performance data was required or requested.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No performance data or testing on a test set was mentioned.
• 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. No performance data or ground truth establishment was mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance data or adjudication was mentioned.
• 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. The device is a physical patient support assembly, not an AI or imaging interpretation device. MRMC studies are not relevant.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical patient support assembly, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance data or ground truth establishment was mentioned.
• 8. The sample size for the training set: Not applicable. As no performance data from a study was required, there's no mention of a training set.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment was mentioned.

In summary, the 510(k) submission for the HexaPOD™ evo RT Couch Top focuses on its substantial equivalence to a predicate device due to minor hardware changes, and explicitly states that no performance data was required or requested.

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