(63 days)
The intended use of the Model STS Pediatric powered wheelchair is to provide mobility to children and young adults, weighing up to 150 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Not Found
This is a 510(k) premarket notification for a medical device called the "Innovative Products Pediatric Sit to Stand Wheelchair." This document is not a study report, but rather an FDA clearance letter. Therefore, it does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in clinical trial reports or performance evaluation summaries for AI/ML devices.
The information provided in this document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device.
However, based on the context of a 510(k) submission, we can infer some general aspects and state that the specific details you requested are not present in this document.
Here's an attempt to answer your questions based on what can be inferred or is explicitly missing from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. For a physical medical device like a wheelchair, acceptance criteria would typically involve engineering specifications, safety standards (e.g., ISO standards for wheelchairs), durability tests, and performance metrics related to mobility, standing function, and control.
- Reported Device Performance: Not detailed in this document. The FDA letter confirms that the device is "substantially equivalent" to a legally marketed predicate device for its stated indications for use. This implies that its performance, as demonstrated by the manufacturer in their full 510(k) submission, was deemed comparable to the predicate.
2. Sample sized 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 FDA clearance letter. For a physical device, this would typically refer to the number of units tested, the types of users involved in any user testing, and the methodology of such 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 information is not applicable or provided in this document. "Ground truth" and expert reviews are more relevant for diagnostic or AI/ML-based devices. For a physical device, "ground truth" would be established through objective measurements against engineering specifications and safety standards, rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., medical images).
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 information is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant to AI/ML-based diagnostic devices, not a physical pediatric sit-to-stand wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a physical wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- As mentioned in point 3, the concept of "ground truth" in this context would refer to objective validation against engineering standards, safety regulations, and functional performance metrics (e.g., weight capacity, stability, maneuverability). The specific type of "ground truth" used for testing the wheelchair is not detailed in this FDA letter.
8. The sample size for the training set
- This information is not applicable or provided. "Training set" refers to data used to train AI/ML algorithms. For a physical device, there isn't a "training set" in this sense. Design and development are based on engineering principles and iterative testing.
9. How the ground truth for the training set was established
- This information is not applicable.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for a physical medical device (Pediatric Sit to Stand Wheelchair). It confirms that the device is "substantially equivalent" to a legally marketed predicate device. This letter does not contain the detailed information about acceptance criteria and study results in the manner requested, as those details would be found within the full 510(k) submission, not the clearance letter itself. The questions you posed are largely relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a physical device like a wheelchair.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JUL 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innovative Products, Inc. % Mr. Jim Steinke President 830 South 48th Street Grand Forks, North Dakota 58201-9985
Re: K071390
Trade/Device Name: Innovative Products Pediatric Sit to Stand Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: June 2, 2007 Received: July 9, 2007
Dear Dr. Steinke:
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 - Mr. Jim Steinke
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark A. Miller
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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Indications for Use Statement
510K number:
Device Name: Innovative Products Pediatric Sit to Stand Wheelchair
Indications for Use: The intended use of the Model STS Pediatric powered wheelchair is to provide mobility to children and young adults, weighing up to 150 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BEL、V THIS LANE-CONTINUE ON ANOTHER PAGE IF NEEDED) ﯿﺎ ﮨﮯ
Concurrence of CDRH/ Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K08351 |
|---|---|
| --------------- | -------- |
7
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).