(11 days)
To assist the mobility of the elderly, sick, injured and disabled persons at an affordable price.
Mechanical Wheelchair
This document is a 510(k) premarket notification decision letter from the FDA for a mechanical wheelchair, specifically models TX312 and TX368, manufactured by Texin Industrial (International) Limited.
Based on the provided document, the following information can be extracted regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance:
The document is an FDA clearance letter based on substantial equivalence. It does not contain a table of acceptance criteria or reported device performance metrics. The FDA determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This typically means the device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed device. Performance data, if submitted, would have been reviewed during the substantial equivalence determination but are not detailed in this type of letter.
2. Sample size used for the test set and the data provenance:
The document does not specify any sample size for a test set, nor does it mention data provenance (country of origin, retrospective/prospective). This letter is a regulatory decision, not a scientific study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention any experts used to establish ground truth or their qualifications. Ground truth establishment is typically part of a performance study, which is not described here.
4. Adjudication method for the test set:
The document does not describe any adjudication method.
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:
The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a mechanical wheelchair.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document does not describe any standalone algorithm performance. The device is a mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not specify any type of ground truth used.
8. The sample size for the training set:
The document does not specify any sample size for a training set.
9. How the ground truth for the training set was established:
The document does not describe how ground truth was established for a training set.
In summary:
This document is a regulatory clearance letter, not a detailed study report. It states that the device (mechanical wheelchair) was found substantially equivalent to a predicate device. Information regarding specific performance criteria, study methodologies, sample sizes, expert involvement, or any form of AI evaluation is not present in this document. The FDA's determination of substantial equivalence implies that the device is as safe and effective as a legally marketed predicate device, but the specifics of how that equivalence was demonstrated (through testing and data) are not detailed here.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1997
SEP 26 1997
Texin Industrial (International) Limited ·c/o Ms. Carole Stamp 510(k) Program Manager TUV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
K973473 Re : ASLI, Models TX312 and TX368 Requlatory Class: I Product Code: IOR September 11, 1997 Dated: September 15, 1997 Received:
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Carole Stamp
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Mechanical Wheelchair evice Name:
Indications For Use:
To assist the mobility of the elderly, sick, injured and disabled persons at an affordable price.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative Devices
510(k) Number K973473
Prescription Use r 21 CFR 801.109) Over-The-Counter Use
Optional Format 1-2-96
OR
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).