(32 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The WU'S SCOOTER WT-M4A is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text is a 510(k) summary for the WU'S 4-WHEELED NEO SCOOTER, WT-M4A. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not describe a study that uses acceptance criteria for an AI/ML device. Instead, it outlines performance testing against established standards for mobility devices and compares the new device to a predicate device.
Therefore, I cannot directly extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them from the provided text. The questions seem to be tailored for AI/ML device submissions, which this document is not.
However, I can interpret the available information in the context of the general principles of device evaluation for substantial equivalence:
Interpretation of the provided information as an analogy to acceptance criteria for non-AI devices:
In this context, the "acceptance criteria" are not for an AI model's performance metrics (like sensitivity, specificity, etc.) but rather for the overall safety and effectiveness of the medical device (the scooter). The "study" is the performance testing and comparison to a predicate device to demonstrate substantial equivalence.
Here's how the provided information relates to the spirit of your request, even if not directly answering for an AI/ML device:
1. Table of "Acceptance Criteria" and Reported Device Performance (interpreted for a medical scooter):
| Acceptance Criteria Category (Implied by Regulation/Standards) | Reported Device Performance (WT-M4A) |
|---|---|
| Safety and Effectiveness | Demonstrated via compliance with EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 standards. |
| Strength and Fatigue of Mainframes | Mainframes materials meet strength and fatigue tests; similar to predicate device WT-M4. |
| Electronic Systems Safety | Same suppliers as predicate device, UL certified for electronic controller, batteries, motors, and recharge. Ensures same safety level. |
| Weight Capability | 205 kgs (New device WT-M4A) |
| Cruising Range per Charge | 10-15 miles (New device WT-M4A). (Predicate WT-M4: 19 miles) |
| Incline Angle | 8 degrees (New device WT-M4A). (Predicate WT-M4: 12 degrees) |
| Components Similarity | Uses same suspension of cross brace, same size of wheels, same type of armrest, footplate, wheel lock, same warranty as predicate WT-M4. |
| Back Upholstery Materials | Same fabric as predicate device, passed resistance ignition test. |
| Intended Use | Same as predicate device: "to provide mobility to persons restricted to a seated position." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of individual scooters. The "test set" here refers to the device itself (WT-M4A) being tested against the stated standards and compared to the predicate device (WT-M4). Typically, this involves testing representative units.
- Data Provenance: The testing was conducted against international and national standards (ANSI / RESNA, CISPR, EN, IEC). The manufacturer is WU's TECH CO., LTD. in China (Taiwan). The report date is August 6, 2007. This suggests the testing data originates from the manufacturer's testing or accredited labs. It is a prospective evaluation of the new device's performance against established benchmarks.
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):
- This question is not applicable to this type of device submission. There is no "ground truth" to be established by experts in the sense of an AI/ML diagnostic task (e.g., diagnosing a condition from an image).
- Instead, the "ground truth" for a device like a scooter is defined by engineering specifications, safety standards, and performance test protocols established by regulatory bodies and industry associations (e.g., ANSI / RESNA). The "experts" would be the engineers and technicians conducting the tests according to these pre-defined standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert review processes, particularly for AI/ML models where there might be disagreement on ground truth labeling.
- For a medical scooter, tests are typically objective and quantitative, conducted according to established procedures. The results are compared directly to the specified limits within the standards.
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:
- This question is not applicable. MRMC studies are specifically designed for evaluating the impact of AI assistance on human reader performance in diagnostic tasks (e.g., how AI helps radiologists detect diseases). This document pertains to a physical mobility device, not a diagnostic AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. There is no "algorithm" in the sense of an AI/ML model for this device. The device itself is a standalone physical product. Its performance is measured directly against physical and electrical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As mentioned in point 3, the "ground truth" for this device is defined by established engineering and safety standards and performance test protocols (e.g., the safety limits for EMC, the strength requirements for materials, explicit performance criteria for weight capacity, cruising range, and incline angle). These are objective, measurable criteria, not subjective interpretations or clinical diagnoses.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" for an AI/ML model described in this document. This refers to the data used to train an AI algorithm.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
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NO. 225, YUAN-PIER ST., HSIN CA TEL: 886-3-5382105 FAX: 886-3-53821 Homepage: www.wustech.com.tw Email: wustis@ms45.hinet.net
11 V V 221936 L
SEP 2 1 2007
66 510(k) SUMMARY "
Submitter's Name: WU'S TECH CO., LTD.
NO. 225, YUAN-PIER ST., HSIN CHU CITY, 30093, CHINA (TAIWAN)
Date summary prepared:
August 6, 2007
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
WU'S 4-WHEELED NEO SCOOTER, WT-M4A SCOOTER MOTORIZED 3-WHEELED VEHICLE, Class II, 21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The WU'S SCOOTER WT-M4A is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison: WU'S SCOOTER WT-M4 (K023166)
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Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are fixed. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices use the same suspension of cross brace, same size of wheels, and same type of armrest, footplate, wheel lock, and same warranty. Besides, the back upholstery materials are also the same fabric and passed the resistance ignition test.
Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motors, Thus the same safety level for the two devices is assured. and recharge.
Owing to the new device WT-M4A is huger than the predicate device WT-M4 that means the weight capability of the new device is 205kgs and the predicate device is Thus the major differences exiting the two devices are the cruising range 130kgs. per charge and incline angle. This means the cruising range of the new device is 10-15 miles and the incline angle is 8 degrees, and the predicate device is 19 miles and 12 degrees for the incline angle. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
SEP 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
WU'S TECH Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Jen, Ke-Min No. 58. Fu-Chiun St. Hsin-Chu City, 30067, Taiwan, ROC
Re: K072337
Trade/Device Name: Neo Scooter WT-M4A Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 6, 2007 Received: August 20, 2007
Dear Dr. Jen, Ke-Min:
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 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 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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Page 2 - Dr. Jen, Ke-Min
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 (240) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
9/21/0
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________ K
Device Name: WU'S NEO SCOOTER, WT-M4A
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of C Office of Device Evaluation (ODE) (Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number
of l
Page
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).