(31 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The AVANTICARE Transport Wheelchair, MT-3000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
The provided text is a 510(k) Summary for the LERADO AVANTICARE Transport Wheelchair, MT-3000. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria in the way typically expected for an AI-powered diagnostic device.
The "Performance Testing" section states: "AVANTICARE Transport Wheelchair, MT-3000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards."
This indicates that compliance with these established industry standards serves as the "acceptance criteria" and the "study" is the testing performed against these standards. Unfortunately, the document does not provide the specific numerical acceptance criteria, the detailed results, or the methodology of this performance testing.
Therefore, I cannot fully complete the requested table and answer all questions in the requested format for an AI/diagnostic device, as the provided content pertains to a mechanical wheelchair and not a software or AI-based medical device.
However, I can extract what is provided related to performance and create a table based on the type of information that would be in an acceptance criteria table, even if specific numerical values are not given in this document.
Here's an attempt to answer based only on the provided text, acknowledging its limitations for an AI/diagnostic context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Wheelchair Standards Compliance | Meet applicable requirements of ANSI/RESNA WC vol. 1 | "Meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1" |
| Wheelchair Standards Compliance | Meet applicable requirements of ISO 7176 | "Meets the applicable performance requirements as specified in ISO 7176" |
| Material Flame Retardancy | Upholstery fabric meets California Technical Bulletin CAL 117 standard | "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. It refers to the testing of "the device" (singular), implying a representative unit or units.
- Data Provenance: Not specified. The device manufacturer is in Taiwan, ROC, so testing would likely have occurred there or with a certified lab. The study type (e.g., retrospective or prospective) is not applicable or specified for this type of mechanical device testing.
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 is not applicable to the performance testing of a mechanical wheelchair against engineering standards. "Ground truth" in this context would be the objective measurements and adherence to the specified technical parameters of the standards, not expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions related to diagnostic interpretation. The wheelchair testing would involve objective measurements and pass/fail criteria based on engineering specifications.
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 is for AI-assisted diagnostic devices, not mechanical wheelchairs.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for AI algorithms, not mechanical wheelchairs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of the wheelchair would be the objective measurements of the device's characteristics and performance parameters (e.g., strength, stability, dimensions, durability, flame retardancy of materials) as defined and evaluated against the specific, quantifiable criteria within the ANSI/RESNA WC vol. 1 and ISO 7176 standards, and California Technical Bulletin CAL 117.
8. The sample size for the training set
Not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is used for this device.
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Image /page/0/Picture/0 description: The image shows a logo for Lerado Group. The logo consists of the word "LERADO" in large, bold letters, with a triangle in place of the "A". Below the word "LERADO" is the text "LERADO GROUP" in smaller letters. Below that is Chinese text.
VERSEA LTD. TWN BRANCH(BVD No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475520 Fax. 886-5-2379672 E-mail edwardL(@mail lerado.com http:// www.lerado.com
APR 1 8 2005
દ દ 510(k) SUMMARY "
Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI) No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Hsien, 612, Taiwan, ROC.
Date summary prepared:
Device Name:
Proprietary Name:
LERADO .
Common or Usual Name: Classification Name:
AVANTICARE Transport Wheelchair, MT-3000 Mechanical Wheelchair Mechanica! Wheelchair, Class I, 21 CFR 890.3850
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 AVANTICARE Transport Wheelchair, MT-3000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
AVANTICARE Transport Wheelchair, MT-3000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
A VANTICARE Mechanical Wheelchair, MS-8000 ( K050290 )
1/2
March 12, 2005
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Image /page/1/Picture/0 description: The image contains the text "K050707 2/2" in the upper left corner. Below this text is the logo for LERADO Group. The logo features the word "LERADO" in large, bold letters, with a triangle above the "A". Below the word "LERADO" is the text "LERADO GROUP" in smaller letters. Below this text is some Chinese characters.
LERADO OVERSEA LTD. TWN BRANCH(BVI) LENADO OVERSERIA Chia Yi Hsien, Taiwan, ROC Fax: 886-5-2379672 Tel: 886-5-2475520 http:// www.lerado.com E-mail.edwardl.@mail.lerado.com
Summary for substantial equivalence comparison:
The intended use between the new device MT-3000 and predicate device MS-8000 Mainframes of two devices are foldable. The overall dimensions are the same. are the Same. - Triannames -- 17 Mannumer -- 12 March - 1gnitability fabric are similar. Hack upholoty in a Technical Bulletin CAL 117 standard for flame The major differences existing are the overall dimension, tire size i retardant. felardant. - The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a symbol representing health and human services.
APR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerado Oversea Ltd. TWN Branch (BVI) C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 58, Fu- Chiun Street Hsin-Chu City China (Taiwan) ROC 300
Re: K050707
K050707
Trade/Device Name: Lerado Avanticare Transport Wheelchair, MT-3000 Regulation Number: 21 CRF 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 12, 2005 Received: March 18, 2005
Dear Dr. Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premaince insubstantially equivalent (for the indications referenced above and nave uccemined we asketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manatical provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, me encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAN devices that have been reciassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval issu and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, sayest to the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the rectments reading, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (35c above) into e. Existing major regulations affecting your device. EDA it may be subject to such additional controls: Existing high one of to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 89 and can be lound in the Code of Featur Regulation in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a successful other requirements of the Act
that FDA has made a determination that your device complies with onlyg that FDA has made a delerimiation all. Jour access by other Federal agencies. You must or any Federal Statures and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, more and many of the discles desires as set CFR Part 807); labeling (21 CFR Part 800); good frances (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000); 11 CFR 1000 1050 forth in the quality Systems (QD) regalates) (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 – Dr. Ke-Min Jen
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article quivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale the nermits premarket notification. The PDA Intamg of backand. - 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
rs of the may on any 10, 2019 - Alam alone note the reculation entitled If you desire specific advice for your aconce on one one the regulation entitled, the regulation entitled, the may obtain contact the Office of Compliance at (216) 276 - 17 (215 Part 807.97). You may obtain "Misbranding by relerence to premarket nothleadon" (= : 02 stct from the Division of Small other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to himl Manufacturers, International and Consumer Assistance aroved cdrh/industry/support/index.html.
Sincerely yours,
A. Hype Kurda
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ): K
Device Name: LERADO, AVANTICARE Transport Wheelchair, MT-3000
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use AND/OR
510(k) Number_KO SO?O ?
Over-The-Counter Use
F1
(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 CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
§ 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).