(312 days)
Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time. The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion and back are made from flame retardant Nylon and/or Polyester fabric. The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device): Put a suitable seat cushion on the wheelchair seat. Put your foot into the pedal and attach the foot strap to stabilize foot. When riding use both legs to pedal for forward movement. To stop use the brake mounted in the control lever. For parking or getting on/off the wheelchair lock the brakes. In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.
The provided document is a 510(k) summary for the Profhand Pedal Wheelchair Model HM-10. It describes the device's technical specifications, intended use, and claims substantial equivalence to a predicate device. However, it does not include acceptance criteria or a study that evaluates the device's performance against specific clinical metrics as typically seen for AI/ML-driven devices.
Instead, the document focuses on compliance with established international standards and FDA guidance documents for mechanical wheelchairs. This type of submission relies on demonstrating adherence to safety and performance benchmarks already defined for similar mechanical devices, rather than novel clinical performance metrics.
Therefore, many of the typical AI/ML-related questions cannot be answered from this document. I will answer what is available and clarify what information is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176-1: 1999 Determination of static stability | Profhand pedal wheelchair passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motonzed Three-Wheeled Vehicles. |
| The document states: "Profhand pedal wheelchair/Model HM-10 have been designed, manufactured and tested for conformance to the relevant FDA recognized ISO standards for mechanical wheelchair as referenced in this submission." | |
| Specifically, it states compliance with ISO 7176-1: 1999. | |
| ISO 7176-3: 2003 Determination of effectiveness of brake | Compliant |
| ISO 7176-5: 2008 Determination of overall dimensions, mass, and maneuvering space | Compliant |
| ISO 7176-11: 1992 Test dummies | Compliant |
| ISO 7176-13: 1989 Determination of coefficient of friction of test surface | Compliant |
| ISO 7176-15: 1996 Requirement for information disclosure, documentation and labeling | Compliant |
| ISO 7176-16: 1997 Resistance to ignition of upholstered parts | Compliant |
| ISO 10993-1: 2009- Guidance on selection of biocompatibility tests | Compliant |
| ISO 10993-5: 2009- Biocompatibility tests for cytotoxicity in vitro method | Compliant |
| ISO 10993-10: 2009 Biological tests for irritation and delayed-type hypersensitivity | Compliant |
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 document. The testing described refers to compliance with ISO standards for mechanical wheelchairs, which typically involves physical testing of the device itself and its components, rather than a clinical "test set" of patient data as might be relevant for AI/ML devices.
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 and therefore not provided. The ground truth for this type of mechanical device is compliance with engineering and safety standards, which is determined through laboratory testing and verification against the specific requirements outlined in the ISO standards, not by expert medical review of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are relevant for subjective interpretations of data (e.g., medical image reads) to establish ground truth. For mechanical device testing against ISO standards, the results are typically objective measurements and observations, not requiring adjudication in the clinical sense.
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 and therefore not provided. MRMC studies are designed to evaluate the performance of AI/ML systems in a clinical context, often with human readers. The Profhand Pedal Wheelchair is a mechanical device, not an AI/ML system, and therefore such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through its conformance to recognized international standards (ISO standards) and FDA guidance documents for mechanical wheelchairs. This involves objective testing against predefined parameters for stability, braking, dimensions, material properties (e.g., flammability, biocompatibility), etc. It is not based on expert consensus, pathology, or outcomes data related to disease diagnosis or patient treatment in a clinical sense.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As there is no AI/ML model or training set, there is no ground truth to establish for such a set.
§ 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).