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

The HexaPOD consists of two platforms, which are connected by six linear, rigid but 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.

Here's a breakdown of the acceptance criteria and study information for the HexaPOD RT Couch Top device, based on the provided document:

Acceptance Criteria and Device Performance

Important Note: 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, detailed quantitative performance metrics or specific studies demonstrating device acceptance criteria are not provided in this document. The acceptance is based on demonstrating substantial equivalence to a predicate device, and the modifications being benign in terms of safety and effectiveness.

Study Information

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

   • Not Applicable. The document states that "No performance data is required..." and therefore no specific test set data is presented. The submission relies on demonstrating substantial equivalence to a predicate device.

2. 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. As no specific performance studies or test sets were mandated or performed for this submission, there's no mention of experts establishing ground truth for a test set.

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

   • Not Applicable. No test set or independent performance study was conducted or presented.

4. 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 mechanical patient support system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

   • Not Applicable. This device is a mechanical patient support system, not an algorithm.

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

   • Not Applicable. Since no performance data or test sets were required or presented, no specific ground truth was established for the device itself in this submission. The "ground truth" for its acceptance is its demonstrated substantial equivalence to the predicate device, which implies the predicate device's performance characteristics are the standard.

7. The sample size for the training set

   • Not Applicable. This device is a mechanical patient support system, not an AI or machine learning model that would require a training set.

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

   • Not Applicable. No training set was used.

Ask a specific question about this device

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

The HexaPOD consists of two platforms, which are connected by six linear, rigid but 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 document is a 510(k) Premarket Notification for a medical device called the HexaPOD™ RT Couch Top. It outlines the device's description, 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 the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because no such studies were required or performed for this specific device submission.

The 510(k) submission for the HexaPOD™ RT Couch Top focuses on demonstrating substantial equivalence to a previously legally marketed device (Medical Intelligence's "HexaPOD RT Couch Top") rather than proving novel performance against specific acceptance criteria through new clinical or performance studies. The modifications made were evolutionary hardware changes and implementing additional safety functions, which did not trigger a requirement for new performance data.

Ask a specific question about this device