(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.
§ 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).