(140 days)
The Invacare® AVIVA FX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
The subject device is a front wheel drive version of the existing previously cleared Invacare TDX SP2 (Center Wheel Drive) Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The subject version of the Invacare TDX SP2 Power Wheelchair consists of the following changes: Alternative Front Wheel Drive Base, Seating Brackets to connect the Ultra Low Maxx Seating System to the base, Wiring Harness to connect the LiNX controller, the AVIVA FX base and the Ultra Low Maxx Seating System. The Invacare® AVIVA FX Power Wheelchair is a 24V DC battery-powered, motor-driven wheelchair, utilizing the predicate device LiNX® Control System and Ultra Low Maxx Seating System. The subject device consists of a rigid or "non-folding" type power wheelchair base with front wheel drive with 2 casters in the rear and two anti-tippers in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
This document describes the Invacare® AVIVA FX Power Wheelchair (Model: IFX-20MP), a front-wheel-drive version of the previously cleared Invacare TDX SP2 Power Wheelchair, with LiNX Electronics and Ultra Low Maxx Seating System.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on demonstrating substantial equivalence to a predicate device (Invacare TDX SP2 Power Wheelchair, K170507) and adherence to recognized international and national standards for safety and performance. The acceptance criteria are implicitly derived from these standards and the characteristics of the predicate device.
| Acceptance Criteria Category | Specific Criteria (from standards/predicate) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Indications for Use | Provide mobility and positioning to persons limited to a sitting position (same as predicate). | Met (subject device shares the same Indications for Use as the predicate). |
| Material Composition | Same as predicate device. | Met (subject device utilizes the same material composition). |
| Technological Characteristics | Similar to predicate device, with differences not raising new questions of safety/effectiveness. | Met (differences, primarily the front-wheel-drive base, were evaluated and found not to raise new safety/effectiveness concerns). |
| Static Stability | Adherence to ISO 7176-1:2014. | Demonstrated compliance through non-clinical testing. |
| Dynamic Stability | Adherence to ISO 7176-2:2017. | Demonstrated compliance through non-clinical testing. |
| Effectiveness of Brakes | Adherence to ISO 7176-3:2012. | Demonstrated compliance through non-clinical testing. |
| Energy Consumption (Theoretical Distance Range) | Adherence to ISO 7176-4:2008. | Demonstrated compliance through non-clinical testing. |
| Dimensions, Mass, Maneuvering Space | Adherence to ISO 7176-5:2008 / -7:1998. | Demonstrated compliance through non-clinical testing. |
| Maximum Speed, Acceleration, Deceleration | Adherence to ISO 7176-6:2018. | Demonstrated compliance through non-clinical testing (Maximum Speed 6.25mph, predicate 5mph/5.8mph). |
| Static, Impact, Fatigue Strengths | Adherence to ISO 7176-8:2014. | Demonstrated compliance through non-clinical testing. |
| Climatic Tests | Adherence to ISO 7176-9:2009. | Demonstrated compliance through non-clinical testing. |
| Obstacle Climbing Ability | Adherence to ISO 7176-10:2008. | Demonstrated compliance through non-clinical testing. |
| Power and Control Systems | Adherence to ISO 7176-14:2008. | Demonstrated compliance through non-clinical testing. |
| Information Disclosure, Documentation, Labeling | Adherence to ISO 7176-15:1996. | Demonstrated compliance through non-clinical testing. |
| Resistance to Ignition of Postural Support Devices | Adherence to ISO 7176-16:2012. | Demonstrated compliance through non-clinical testing. |
| Wheeled Mobility Devices for Use as Seats in Motor Vehicles | Adherence to ISO 7176-19:2008. | Demonstrated compliance through non-clinical testing. |
| Electromagnetic Compatibility (EMC) | Adherence to ISO 7176-21:2008. | Demonstrated compliance through non-clinical testing. |
| Batteries and Chargers | Adherence to ISO 7176-25:2013. | Demonstrated compliance through non-clinical testing. |
| Software Life Cycle | Adherence to IEC 62304:2006. | Software Verification Testing performed. |
| Flammability | Adherence to CAL117:2013, Section 1 and EN 1021-2:2014. | Demonstrated compliance through non-clinical testing. |
| Wireless Coexistence | Adherence to ANSI C63.27. | Demonstrated compliance through non-clinical testing. |
| Biocompatibility | Adherence to AAMI/ANSI/ISO 10993-5:2009 (Cytotoxicity) and AAMI/ANSI/ISO 10993-10:2010 (Irritation). | Demonstrated compliance through non-clinical testing. |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical laboratory testing. For such tests, the "test set" typically refers to the devices or components manufactured and tested according to the specified standards. The document doesn't explicitly state the exact number of units tested for each standard, but it implies that tests were conducted on the subject device (Invacare® AVIVA FX Power Wheelchair).
- Sample Size: Not explicitly stated as a number of devices, but testing was performed on the "subject Invacare® AVIVA FX Power Wheelchair" (singular/representative unit for engineering testing).
- Data Provenance: Non-clinical laboratory data generated to specifically evaluate the subject device against recognized standards. It is prospective testing designed to confirm compliance. The country of origin of the data is not specified but would typically be from accredited testing laboratories, likely within the manufacturer's region or designated by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a powered wheelchair and its evaluation primarily relies on engineering and performance standards, not on interpretation of images or clinical diagnoses by human experts to establish "ground truth" in the medical imaging sense. Therefore, the concept of "experts establishing ground truth" as typically seen in AI/diagnostic device submissions using a test set of patient data, is not directly applicable here.
Instead, the "ground truth" for the performance criteria is derived from:
- The requirements set forth in the international and national standards (e.g., ISO, IEC, CAL, ANSI).
- The published specifications and validated performance of the predicate device.
The "experts" involved would be:
- Engineers and quality assurance personnel from Invacare Corporation responsible for design, manufacturing, and internal testing.
- Personnel at accredited testing laboratories who perform the tests according to the standards and provide certified results. These individuals would have expertise in mechanical engineering, electronics, software validation, biocompatibility, etc., relevant to the specific test being conducted. Their qualifications are inherent in their accreditation to perform such tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus "ground truth." This is not relevant for the non-clinical performance and engineering tests described for this powered wheelchair.
For the non-clinical tests, the "adjudication" is essentially:
- Direct measurement and observation: The device either meets the quantitative specification (e.g., a stability angle, a speed, a dimension) or it does not.
- Compliance to a specified test protocol: The testing laboratory follows a defined protocol from the standard, and the results are reported as compliant or non-compliant. Deviations and failures would be investigated and resolved by the manufacturer to achieve compliance.
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. An MRMC comparative effectiveness study is not mentioned and would not be applicable to a powered wheelchair. Such studies are typically conducted for diagnostic devices (e.g., AI in medical imaging) to assess how AI assistance impacts human reader performance. This submission focuses on the mechanical and electrical safety and performance of the wheelchair as a standalone mobility device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" for an "algorithm only" device is not directly applicable here in the same way it would be for an AI diagnostic algorithm. While the wheelchair does incorporate the LiNX Control System (which has software and control algorithms), its performance is evaluated as an integrated system (device + software) through the various ISO, IEC, CAL, and ANSI standards. The software verification testing (IEC 62304:2006) ensures the software itself functions correctly and safely within the device's overall design. The overall device's performance is tested, essentially, "without human-in-the-loop" in the sense that the tests are designed to objectively measure the device's inherent capabilities against a standard, rather than evaluating a human operator's improved performance with the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the evaluation of this powered wheelchair is primarily:
- Industry and regulatory performance standards: International (ISO, IEC) and national (CAL, ANSI) standards define acceptable performance limits, test methods, and safety requirements.
- Predicate device characteristics: The specifications and previously cleared performance of the Invacare TDX SP2 Power Wheelchair (K170507) serve as a benchmark for substantial equivalence.
- Engineering specifications and design verification: Internal technical requirements define the expected operating parameters and safety features.
8. The sample size for the training set:
Not applicable. This submission is for a physical medical device (powered wheelchair), not an AI 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," there is no "ground truth for the training set."
§ 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).