(53 days)
The intended use of the eLexus(MP3C-1) is to provide mobility to persons limited to a seated position t are capable of operating a powered wheelchair.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Primechair" (later referred to as eLexus(MP3C-1)), a powered wheelchair. It is a regulatory approval document and not a scientific study report. Therefore, it does not contain information about acceptance criteria for an AI/device's performance or a study proving that the device meets such criteria in the way you've outlined.
The information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in clinical study reports or scientific publications for AI/medical device performance evaluation, not in 510(k) clearance letters for powered wheelchairs.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance characteristics evaluated in the context you're asking about for AI systems.
Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
NOV - 6 2007
Will Ridgway Sales Manager Dalton Medical Corporation 1103 Venture Ct. Carrollton, Texas 75006
Re: K052496 Trade/Device name: Primechair
Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 30, 2005 Received: October 25, 2005
Dear Mr. Ridgway:
This letter corrects our substantially equivalent letter of November 4, 2005.
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 (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.
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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.
This letter will allow you to continue 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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Protesting and Promoting Public Health
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Indications for Use
510(k) Number (if known): K052496
Device Name: ELexus(MP3C-1)
Indications For Use: The intended use of the eLexus(MP3C-1) is to provide mobility to persons limited to a seated position t are capable of operating a powered wheelchair.
i resoription Use (Part 21 CFR 801 Subpad D) AND/ DR
Over-The-Counter Use_xx_______________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II 网|【 DED)
Concurrence of CDRH, Off ce of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOSZ496
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).