(59 days)
The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.
The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.
MED-TEC 6 degree axis couch
The provided document is a 510(k) cleared by the FDA for the "MED-TEC 6 degree axis couch." This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for performance studies.
Therefore, most of the information you've requested regarding acceptance criteria, a specific study proving those criteria, sample sizes, expert involvement, and ground truth types is not available within this 510(k clearance letter and its attached "Indications For Use" statement.
The 510(k) process for a Class II device like this couch generally involves submitting information about the device's design, intended use, materials, manufacturing processes, and how it compares to a legally marketed predicate device. The "acceptance criteria" here are typically tied to the device's ability to perform its intended function safely and effectively, similar to the predicate, and to comply with general controls and any special controls applicable to its device class.
Here's what can be inferred or stated based on the provided text, and where your requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics within this document. The implicit acceptance criteria are that the device performs its intended function (patient support and positioning during radiation therapy and other medical procedures) safely and effectively, and is substantially equivalent to a predicate device. This would typically involve demonstrating mechanical stability, range of motion, load bearing capacity, and safety features in testing, but these specific criteria and their target values are not detailed here.
- Reported Device Performance: The document states the device "supports and aids in positioning a patient during radiologic, radiation therapy, and other medical procedures" and that the "6 degree axis couch adds Pitch and Roll to the normal X, Y, Z, and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table." This describes the functionality and benefit of the device but doesn't provide quantitative performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not available. The document does not describe a clinical or performance "test set" in the context of, for example, image analysis or diagnostic accuracy. For a device like a patient support assembly, testing would likely involve engineering and bench testing rather than human subject testing in the traditional sense of a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available. There is no mention of "experts" establishing "ground truth" for a test set in this 510(k documentation, as it's not a study involving expert assessment of data (e.g., medical images).
4. Adjudication method for the test set
- Not applicable/Not available. No test set or adjudication method is described.
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 mechanical patient support assembly, not an AI-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
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 assembly and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not available. Ground truth, in the context of the type of studies implied by your questions, is not relevant to this mechanical device's 510(k. The "truth" for this device would be its mechanical specifications, safety, and functionality conforming to engineering standards and its intended use.
8. The sample size for the training set
- Not applicable/Not available. There is no "training set" relevant for a mechanical device like this couch.
9. How the ground truth for the training set was established
- Not applicable/Not available. As there is no training set, this question is not applicable.
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Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three curved lines extending from its head, resembling wings or feathers. The logo is black and white and appears to be a seal or emblem.
Public Health Service
AUG 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald Francis Riibe Regulatory Affairs MED-TEC. Inc. P.O. Box 320 1401 8th Street S.E. ORANGE CITY IA 51041-0320 Re: K031866 Trade/Device Name: MED-TEC 6 degree axis couch Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: 90 JAI Dated: June 6, 2003 Received: June 18, 2003
Dear Mr. Riibe:
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 the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment 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 device, subject to the general controls provisions of the Act. The general controls 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 (PMA), it may be subject to 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
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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MED-TEC, INC.
Traditional 510(k)
Attachment... E-3.4
Page 1 of of le
510(k) Number (if known): __
Device Name: __ MED-TEC 6 degree axis couch
Indications For Use:
The intended use of this device is to support a patient during radiation therapy; or The intended use of the MED-TEC 6 degree axis couch is to support and aid in positioning a patient during radiologic, radiation therapy, and other medical procedures.
The 6 degree axis couch adds Pitch and Roll to the normal X, Y, Z. and Yaw motions. The additional Pitch and Roll make patient alignment simpler without the need to manually move the patent on the table.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sayre
(Division Sign-Off Division of Reproductive and Radiological D 510k) Num
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter USE
(Optional Format 1-2-96)
TR
Traditional 510(k)
June 6, 2003
§ 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.