(90 days)
The Mechanical Wheelchairs are intended to provide mobility to persons restricted to a sitting position.
Not Found
This document is a 510(k) clearance letter from the FDA for several models of mechanical wheelchairs. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices involving AI or image analysis. This type of clearance (510(k)) is based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer based on the available information, noting what cannot be found:
1. A table of acceptance criteria and the reported device performance
The document does not specify performance-based acceptance criteria in terms of numerical metrics (e.g., sensitivity, specificity, accuracy) like those found in studies for diagnostic devices. The acceptance is based on "substantial equivalence" to predicate devices. The device performance is implicitly considered to be equivalent to safely and effectively marketed predicate mechanical wheelchairs.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices for the stated Indications for Use (providing mobility to persons restricted to a sitting position). | Reviewed and determined to be substantially equivalent to predicate devices marketed interstate prior to May 28, 1976, or to lawfully reclassified devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) clearance for mechanical wheelchairs, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic algorithms. The clearance is based on design and safety characteristics compared to existing devices.
3. 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. There is no mention of "experts" establishing ground truth for a test set in this document. The FDA's review involves assessing the device's design, materials, and intended use against regulatory requirements and predicate devices, which is performed by FDA reviewers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described in this document.
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 document pertains to mechanical wheelchairs, not AI-assisted reading or diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" in the context of performance studies for diagnostic or AI devices does not apply here. The "truth" in this context is whether the wheelchairs meet safety and performance standards equivalent to predicate devices.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm mentioned in this document.
9. How the ground truth for the training set was established
Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Foshan Shunde Jaeyong Hardware Co., Ltd. % Regulatory Insight; Inc. Mr. Kevin Walls, RAC Principal Consultant 5401 South Cottonwood Court Greenwood Village, Colorado 80121
OCT 2 6 2010
Re: K102110
Trade/Device Name: 24" Widen Wheelchair (JY/CT-H28)
18" Reclining Wheelchair (JY/260) 18" Light Weight Wheelchair (JY/CT-H06)
18" Aluminum Commode Wheelchair (JY/CT-H02A)
20" Comfort Wheelchair (JY-280)
Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 20, 2010 Received: August 25, 2010
Dear Mr. Walls:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
For
Mark N. Melkerson DEP DR
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102117
Device Name:
- 24" Widen Wheelchair (JY/CT-H28) a!
- b. 18" Reclining Wheelchair (JY-260)
- 18" Light Weight Wheelchair (JY/CT-H06) C.
- d. 18" Aluminum Commode Wheelchair (JY/CT-H02A)
- e. 20" Comfort Wheelchair (JY-280)
Indications for Use: The Mechanical Wheelchairs are intended to provide mobility to persons restricted to a sitting position.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Gevice Evaluation (ODE)
(Division (Division Sign-cical, Orthopedic. Dry Restorative Devices
510(k) Number K102110
Page 1 of 1
OCT 2 6 2010
§ 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).