(99 days)
The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.
The Renegade is designed to offer the user the option of conventional hand-to-wheel propulsion, or the use of pushbar levers which provide thrust by way of a gear and chain system. Each wheel has multiple gears and independent brakes, providing versatility and control. The wheelchair is fitted with accessory holders to provide a means to carry sports and recreational equipment.
The provided text is a 510(k) summary for the Alpha One Renegade Wheelchair. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document is a traditional 510(k) submission for a mechanical wheelchair, not a medical imaging or AI-enabled device.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and AI performance metrics is not applicable to this type of submission. Traditional 510(k)s for mechanical devices primarily focus on demonstrating substantial equivalence to legally marketed predicate devices in terms of material composition, technical characteristics, and intended use, often relying on engineering specifications, performance testing (e.g., durability, stability), and comparisons of features, rather than clinical study data with statistical measures like sensitivity, specificity, or reader performance.
Here's an attempt to address the applicable points based only on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the way one would expect for an AI/imaging device. The overall "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit for a 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Stryker Sorano Wheelchair K051369, Poirier S.A. Arnas Wheelchair K840631) | "This device, with respect to material composition, technical characteristics, and intended use, is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For a mechanical wheelchair, clinical "test sets" in the context of diagnostic performance are not typically used. Testing would likely involve engineering and performance benchmarks, not patient data.
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 information is not provided and is not applicable for a traditional mechanical wheelchair 510(k). "Ground truth" in this context would relate to engineering specifications and performance standards, not diagnostic interpretations by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for a traditional mechanical wheelchair 510(k).
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
An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically understood in AI/imaging studies (e.g., pathology, clinical outcomes) is not applicable here. For a mechanical device, performance is evaluated against engineering standards and safety requirements. The "truth" is whether the device meets its design specifications and performs safely and effectively according to its intended use and comparison to the predicate.
8. The sample size for the training set
This information is not provided and is not applicable. There is no AI training set for a mechanical device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable. There is no AI training set for a mechanical device.
In summary: The provided document is a 510(k) summary for a mechanical wheelchair. It demonstrates substantial equivalence to predicate devices based on design and intended use. The questions posed are primarily relevant to AI/imaging devices, and therefore, most of the requested information cannot be extracted from this particular submission.
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Submitter: Alpha One Renegade Wheelchair Traditional 510(k)
510(k) SUMMARY- Renegade Wheelchair
Submitter Name: Submitter Address: Alpha One 127 Main Street Portland, Maine 04106
Brad Strause
207-767-2189
207-799-8346
IOR and IQC
Contact Person:
Phone Number: Fax Number:
Date Prepared:
September 24, 2008
Renegade Wheelchair
Device Trade Name:
Mechanical special grade wheelchair
Name: Classification
Device Common
Numbers: Classification Names:
Product Codes:
Predicate Devices:
Statement of Intended
Device Description:
Use:
Stryker Sorano Wheelchair (K051369)
21 CFR 890.3850 and 21 CFR 890.3880
Poirier S.A. Arnas Wheelchair (K840631)
The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.
Wheelchair, Mechanical and Wheelchair, Special Grade
The Renegade is designed to offer the user the option of conventional hand-to-wheel propulsion, or the use of pushbar levers which provide thrust by way of a gear and chain system. Each wheel has multiple gears and independent brakes, providing versatility and control. The wheelchair is fitted with accessory holders to provide a means to carry sports and recreational equipment.
Comparison to the This device, with respect to material composition, technical Predicate Devices: characteristics, and intended use, is substantially equivalent to the predicate devices.
JAN - 6 2009
Section 5.0
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha One % Trisler Consulting, LLC Ms. Pastv J. Trisler 5600 Wisconsin Ave, Suite 509 Chevy Chase, Maryland 20815
Re: K082857
Trade Name: Renegade Wheelchair Regulation Number: 21 CFR 890.3880 Regulation Names: Special grade wheelchair Regulatory Class: II Product Code: IOC Dated: December 10, 2008 Received: December 12, 2008
Dear Ms. Trisler:
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.
JAN - 6 2009
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 -- Ms. Pasty J. Trisler
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Submitter: Alpha One
510(k) Number (if known):
Device Name:
Renegade Wheelchair
Indications for Use:
The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082857
. .
§ 890.3880 Special grade wheelchair.
(a)
Identification. A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.(b)
Classification. Class II (performance standards).