(28 days)
The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to position the patient accurately according to the treatment plan for the delivery of various radiation therapy treatment procedures. The table can be controlled locally from the treatment room via the table interface or remotely from the linear accelerator control console.
The 550 TxT Treatment Table is a powered radiation therapy patient support assembly that is functionally equivalent to the previously cleared ZXT Treatment Table (K910971). The 550 TxT Treatment Table is to be used in conjunction with Siemens linear accelerator systems. The table provides six degrees of freedom including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions. The 550 TxT Treatment Table design improves the quality of treatment delivery by providing greater positioning accuracy and higher load capacity as compared to the ZXT Treatment Table. The patient can be positioned on the treatment table either manually with the free float function or smoothly by using the motorized movements.
This Siemens 510(k) submission for the 550 TxT Treatment Table is a traditional 510(k), where the primary purpose is to demonstrate substantial equivalence to a predicate device. It does not contain acceptance criteria or a study proving that the device meets those criteria, outside of indicating substantial equivalence through comparison to the predicate device ZXT Treatment Table (K910971).
The document describes the device, its intended use, and claims substantial equivalence to a previously cleared device. It does not present specific performance metrics or detailed studies, as these types of submissions often rely on the established performance of the predicate device and internal testing to confirm that the new device performs similarly.
Therefore, the requested information, particularly regarding specific acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in this 510(k) summary. The document is a regulatory approval notice based on substantial equivalence, not a detailed performance study report.
Here's a breakdown of why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states the device "improves the quality of treatment delivery by providing greater positioning accuracy and higher load capacity as compared to the ZXT Treatment Table," but no quantitative acceptance criteria or exact performance figures are given.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
- 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 such medical imaging or diagnostic study is described. The device is a treatment table, not a diagnostic AI.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 treatment table; it does not involve human readers interpreting images.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical treatment table, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. There is no AI algorithm being described that would require a training set.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
- Device Name: 550 TxT Treatment Table
- Predicate Device: ZXT Treatment Table (K910971)
- Claim of Performance Improvement: The 550 TxT Treatment Table "improves the quality of treatment delivery by providing greatent the SSU TXT Treatment Table dolgh Improved to the ZXT Treatment Table. The news positioning accuracy and higher load capacity as bompared to the treatment table." This is a qualitative statement, not a quantitative one with acceptance criteria.
- Substantial Equivalence: The FDA determined the device is substantially equivalent to the predicate device based on the information provided in the 510(k) submission, allowing it to be marketed. The substantiation for this usually comes from engineering tests that compare the new device's performance against the predicate, but the details of these tests are not present in this summary.
§ 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.