(52 days)
The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.
This document is a 510(k) premarket notification for a mechanical wheelchair, specifically the Pride Mobility Products Corporation Kids ROCK 3 Chair. It demonstrates the device's substantial equivalence to a predicate device through non-clinical testing. It does not describe a study to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML-based medical devices.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) are not applicable to the provided document.
Here's a summary of the information that is available in the document, formatted to address your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/RESNA WC19 (Wheelchairs Used as Seats in Motor Vehicles) | Compliant |
| ISO 7176-19 (Wheeled Mobility Devices for Use in Motor Vehicles) | Compliant |
| ISO 7176-15 (Requirements for information disclosure, documentation, and labeling) | Compliant |
| ISO 7176-8 (Requirements and test methods for static, impact, and fatigue strengths) | Compliant |
| ISO 7176-1 (Determination of static stability) | Compliant |
| ISO 7176-7 (Measurement of seating and wheel dimensions) | Compliant |
| ISO 7176-5 (Determination of overall dimensions, mass, and turning space) | Compliant |
| ISO 7176-3 (Determination of efficiency of brake) | Compliant |
| Fabric and Foam Testing | Compliant |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical product subjected to engineering and material tests according to international standards. The document doesn't provide specific sample sizes (e.g., number of wheelchairs tested) for these non-clinical tests, nor does it refer to "data provenance" in the context of medical imaging or AI/ML data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and mechanical testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth for interpretation. Compliance with standards is typically determined by testing against predefined physical criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.
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: No. This document describes a mechanical wheelchair, not an AI/ML device, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This document describes a mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering and safety standards (e.g., ISO, ANSI/RESNA) through non-clinical physical testing.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and good manufacturing practices.
Summary:
This document is a 510(k) summary for a mechanical wheelchair, which is a traditional medical device. The "acceptance criteria" discussed are compliance with established international and national standards for wheelchair safety, performance, and durability. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed against these standards. It does not involve clinical studies or the type of performance evaluation (e.g., sensitivity, specificity, AUC) typically associated with AI/ML devices, and hence, many of the requested details are not relevant to this submission. The device was deemed substantially equivalent to a predicate device (Litestream 500E, K042444) based on similar intended use and technological characteristics, and compliance with the relevant standards.
§ 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).