(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.
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SIEMENS
Tab 1 510(k) Summary
| Submitter: | Siemens Medical Solutions USA, Inc.Oncology Care Systems Group4040 Nelson AvenueConcord, CA 94520 |
|---|---|
| Contact: | Ken NehmerSenior Manager of Regulatory Affairs |
| Phone:Fax:Email: | (925)602-8011(925)602-8008ken.nehmer@siemens.com |
| Proprietary Name: | 550 TxT Treatment Table |
| Common Name: | Couch, Radiation Therapy, Powered |
| Classification: | 892.5770 |
| Product Code: | JAI |
| Substantial Equivalence Claimed To: | ZXT Treatment TableK910971 cleared on May 3, 1991 |
Description:
The 550 TxT Treatment Table is a powered radiation therapy patient support assembly that is and The 550 TXT Treatment Table is a powered hadded the many fable (K910971). Refer to Table in the Sand equivalent in functionally as the providely the 550 TxT Treatments and specifications.
The 550 TxT Treatment Table is to be used in conjunction with Siemens linear accelerator systems. The I he 550 TXT Treatment Table is to be used information man Boss including isocentric rotation, column rotation, longitudinal, lateral, and vertical motions.
The 550 TxT Treatment Table design 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 either manually with the free float function or smoothly by using the motorized movements.
Intended Use:
The 550 TxT Treatment Table is to be used as an integral part of the Siemens linear accelerator systems to The 350 TXT Treathern Trable is to be dood to an integral or various radiation therapy treatment position the patient accurately according to the treatment room via the table interface or remotely from the linear accelerator control console.
Siemens Medical Solutions USA, Inc.
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Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
MAR 1 8 2005
Mr. Ken Nehmer Senior Manager of Regulatory Affairs Siemens Medical Solutions USA, Inc. Oncology Care Systems Group 4040 Nelson Avenue CONCORD CA 94520
Re: K050422
Trade/Device Name: 550 TxT Treatment Table Regulation Number: 21 CFR §892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: February 16, 2005 Received: February 18, 2005
Dear Ms. Dunbar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in above and nate to legally marketed predicate devices marketed in interstate commerce prior to the cholors and regard ment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approvisions of the Act. The general controls provisions provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I tease of advisou that your device complies with other requirements of the Act or any I Dri has made a acternations administered by other Federal agencies. You must comply with all the I caral batered ate 200 Act 3 requirements, moraling practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hanceinig your antial equivalence of your device to a legally premarket notification. The PDA Inding of Sacsantal organ mirice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regarded on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entition, "Thisoration on your responsibilities under the Act from the 807.97). You may outain other general meeticance at its toll-free number (800) Division of Sillan Manufacturers, Internet address http://www.fda.gov/cdrb/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: 550 TxT Treatment Table
Indications for Use:
The 550 TxT Treatment Table is to be used as an integral part of the Siements linear accelerator systems to The 550 TXT Treatment Table is to be used to an investiality of various radiation therapy treatment position the patient accurately according to the treatment plan for value interface or remotely from the linear accelerator control console.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K050422 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | ✓ |
| Over-the-Counter Use |
§ 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.