(15 days)
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 teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
The provided document is limited to the HexaPOD™ RT CouchTop, a medical device designed to support and position patients during radiation therapy. It is a 510(k) submission to the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than new clinical trials for safety and effectiveness.
As such, the document does not contain the detailed information required to fill out most of the points in your request. Specifically, it states:
- "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
This means there was no specific study conducted to prove the device meets acceptance criteria in the way you've outlined for performance metrics (sensitivity, specificity, accuracy, F1 score). The 510(k) process for this device relies on demonstrating that its technological characteristics are "substantially equivalent" to predicate devices, and therefore it is considered safe and effective for its intended use without new clinical performance studies.
Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I provide information on sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth for the training set.
Here's what can be extracted from the document based on your request, with the understanding that performance data as typically defined for AI/diagnostic devices is not applicable here:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission, the primary acceptance criterion is substantial equivalence to legally marketed predicate devices. This means the device must have the same intended use and either the same technological characteristics or, if different, those differences must not raise new questions of safety or effectiveness. The document asserts that the HexaPOD does not have technological characteristics that raise additional types of questions related to safety and effectiveness.
- Reported Device Performance: 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, there are no reported performance metrics like sensitivity, specificity, or accuracy in the context of diagnostic or AI-driven decision-making. The "performance" in this context is implicitly deemed acceptable by virtue of its substantial equivalence to predicate devices, which are already on the market.
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Substantial Equivalence to Predicate Devices (Med-Tec Inc.'s "Med-Tec 6 Degree Axis Couch" and Elekta Instrument Inc.'s "Elekta Oncology Systems Precise™ Treatment Table") in terms of: | The HexaPOD is determined to be "substantially equivalent" to the identified predicate devices. |
| - Intended Use: Support and aid in positioning a patient during radiation therapy. | The HexaPOD's intended use is identical: "to support and aid in positioning a patient during radiation therapy." |
| - Technological Characteristics (not raising new questions of safety/effectiveness). | "It is our opinion that the HexaPOD does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness." |
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: The document states that no performance data was required or requested. Therefore, there was no "test set" in the context of evaluating performance metrics.
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 test set that would require expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No performance data or test set 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: This device is a patient support assembly, not an AI or diagnostic tool. No MRMC study was conducted or mentioned.
6. 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. It does not have an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth in the context of disease detection, diagnosis, or outcome prediction was established or used, as this is a mechanical patient positioning device.
8. The sample size for the training set
- Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable: There is no mention of a training set or ground truth for such a set.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.