(295 days)
The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. It is designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
The SMOOV O10 drive unit is attached and detached to rigid wheelchairs via a bracket or alternatively to a foldable wheelchair with an optional adapter. The SMOOV 010 converts the user´s manual wheelchair, when needed, in a partly motorized wheelchair to extend the mobility and flexibility of the wheelchair user. To extend functionality an optional Smartphone App is available. The user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.
This document describes the 510(k) Summary for the SMOOV O10 add-on drive for wheelchairs (K192016). This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative performance and compliance with relevant standards, rather than a standalone clinical study with acceptance criteria and reported device performance in the format typically seen for novel diagnostics or treatments.
Here's an attempt to structure the available information based on your request, acknowledging the limitations of a 510(k) summary in providing all requested details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial for a diagnostic device. Instead, substantial equivalence is demonstrated by comparing the subject device (SMOOV O10) to a predicate device (SmartDrive MX2+ K151199) across various technical specifications and intended uses, and by demonstrating conformity to recognized international standards for safety and performance in powered wheelchairs.
The "acceptance criteria" are implied by compliance with these standards and comparable specifications to the predicate device. The "reported device performance" is largely presented through these specifications and the claim of meeting the standards.
| Feature / Standard Compliance | Acceptance Criterion (Implied by Standard/Predicate) | Reported Device Performance (SMOOV O10) |
|---|---|---|
| Intended Use | Auxiliary power to manual wheelchairs to reduce pushing power for active users physically and mentally able to safely control a manual wheelchair. | Matches predicate, provides auxiliary power to manual wheelchairs to reduce pushing power for active users who are physically and mentally able to safely control a manual wheelchair. |
| User Weight | Up to 150 kg (Predicate) | Up to 140 kg |
| Nominal Power of Engine | 250 W (Predicate) | 250 W |
| Max. Assisted Speed | 6-8.9 km/h (Predicate) | 6 km/h (Standard), 10 km/h (Optional) |
| Nominal Range | 19.8 km (Predicate) | Up to 20 km (as per ISO 7176-4) |
| System Weight | 6 kg (Predicate) | 7.2 kg (Drive unit only) |
| Wireless Communication Encryption | Effective mitigation of SweynTooth vulnerabilities (Implied) | All wireless communication is encrypted. Firmware updates performed on affected devices to address vulnerabilities. |
| Safety in case of successful attack (SweynTooth) | Device enters safe state, no unintended movements. | Motor stops, driving support stops (auxiliary power provision ceases). Unintended movements are impossible. |
| General Safety and Performance | Conforms to recognized standards (e.g., ISO 7176 series for wheelchairs, IEC for batteries, ISO 14971 for risk management, biological evaluation standards). | Declared conformity with all listed standards (refer to full list in document). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study with human subjects. The evaluation for this 510(k) relies on:
- Comparison to a predicate device: MaxMobility GmbH SmartDrive (MX2+) (K151199).
- Conformity to recognized international standards: A comprehensive list of ISO and IEC standards related to wheelchairs, batteries, biological evaluation, electromagnetic compatibility, and risk management is provided.
- Engineering bench testing: Implied by conformity to standards, but specific sample sizes for these tests are not detailed in this summary.
Data Provenance: Not applicable in the context of a "test set" from a clinical study. The data is largely derived from the technical specifications, design documents, and test reports supporting compliance with the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there was no "test set" requiring expert ground truth in the clinical sense. The "ground truth" for the device's acceptable performance is established by its adherence to internationally recognized consensus standards and its substantial equivalence to a legally marketed predicate device, as assessed by the manufacturer and reviewed by the FDA.
4. Adjudication method for the test set
Not applicable, as no external clinical test set requiring expert adjudication is described in this 510(k) summary.
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
Not applicable. The SMOOV O10 is an assistive powered wheelchair attachment, not a diagnostic or AI-assisted image analysis tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The SMOOV O10 is a physical medical device (an add-on drive for wheelchairs) with a human user always "in-the-loop" for control and operation. It is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of the SMOOV O10 for this 510(k) is primarily established through:
- Compliance with recognized international standards: These standards define measurable performance and safety criteria accepted by experts in the field of medical devices and assistive technology.
- Comparison to a legally marketed predicate device: Demonstrating that the subject device's design, materials, intended use, and performance are substantially equivalent to a device already deemed safe and effective.
8. The sample size for the training set
Not applicable. The SMOOV O10 is a physical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).