(196 days)
The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.
The Motion Composites APEX Manual Wheelchair is manually operated, user propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The Apex wheelchairs are traditional rigid wheelchairs. They are made of aluminum alloy or carbon fiber. The frame which utilizes a standard geometry that creates a cantilever like rigid assembly. Upon the outside of this framework, and to the rear, are assembled two aluminum axle plates. Wheels of varying size and type are connected to the carbon fiber camber tube via stainless steel axles. On the front end of the frame are assembled two aluminum caster mount. Caster forks are mounted to these mounts via steel axles. A variety of caster wheels and tires are then connected to the fork based on user preference.
The Motion Composites APEX Manual Wheelchair is a mechanical wheelchair, which is a Class I device. As such, it does not require a demonstration of clinical efficacy through extensive human studies. The primary acceptance criteria for this device are related to its mechanical performance and compliance with recognized standards for manual wheelchairs to ensure safety and basic functionality.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 7176-1:1999 Determination of Static Stability | The APEX Manual Wheelchair has been tested to and complies with this standard. (Implies satisfactory static stability for safe use.) |
| ISO 7176-3:2012 Determination of Effectiveness of Brakes | The APEX Manual Wheelchair has been tested to and complies with this standard. Specifically, the "push-to-lock" and "Graid-Aid" brakes passed the new standard. The "pull-to-lock" parking brakes failed the new standard (ISO 7176-8 2nd Edition 2014-12-15) and are therefore not offered, indicating an improved safety option. |
| ISO 7176-5:2008 Determination of Overall Dimensions, Mass and Maneuvering Space | The APEX Manual Wheelchair has been tested to and complies with this standard. (Ensures that the physical characteristics and maneuverability meet defined criteria.) |
| ISO 7176-7:1998 Determination of Seating and Wheel Dimensions | The APEX Manual Wheelchair has been tested to and complies with this standard. (Ensures proper dimensions for user seating and wheel configuration.) |
| ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength | The APEX Manual Wheelchair has been tested to and complies with this standard. (Demonstrates durability and structural integrity under static impact and fatigue conditions.) |
| ISO 7176-15 Requirements for Information Disclosure, Documentation and Labeling | The APEX Manual Wheelchair has been tested to and complies with this standard. (Ensures clear and accurate information is provided to users and for regulatory purposes.) |
| FDA Guidance Document for the Preparation of Premarket Notification [(510(k)] Applications Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles | The APEX Manual Wheelchair meets or addresses the various safety and performance requirements outlined in this guidance document, which serves as a basis for substantial equivalence to its predicate. (Implies general safety and performance aligned with regulatory expectations for the device type.) |
| Predicate Device Weight Limit Comparability | The APEX has a weight limit of 250 lbs, which is similar to the predicate Helio C2 (250 lbs) and within 15 lbs of the Quickie Q7 (265 lbs). This is clearly stated in the proposed device labeling. (Demonstrates safe load-bearing capacity comparable to existing devices.) |
| Caster Effectiveness | The APEX casters offer the same effectiveness as predicate devices, as per the APEX successfully obtaining its ISO certification. (Implies that the steering and turning functionality of the casters is robust and comparable.) |
| Parking Brake Effectiveness (Safer Option) | The APEX's push-to-lock and Graid-Aid brakes pass the new ISO 7176-8 (2nd Edition 2014-12-15) standard, offering a safer parking brake option compared to the predicate's older standard with a previously failing pull-to-lock option (which the APEX does not offer). (Indicates improved safety in parking brake design and performance over a predicate's specific failing option.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "the APEX Manual Wheelchairs" as having been tested, suggesting that multiple units or configurations were likely tested for each standard. However, specific numbers are not provided.
- Data Provenance: The testing was performed on the APEX Manual Wheelchair itself. The location of the testing facility or specific country of origin for the data is not specified, but the applicant (Motion Composites) is based in Quebec, Canada. The studies are prospective in the sense that the APEX device was specifically subjected to these tests to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This type of information (experts establishing ground truth for a test set) is typically relevant for interpretational or diagnostic AI/software devices.
- For a mechanical device like a wheelchair, "ground truth" is established by adherence to engineering standards and objective measurements. The "experts" would be the engineers and technicians performing the tests and the bodies (e.g., ISO) that set the standards. Their qualifications would be in mechanical engineering, quality assurance, and adherence to testing protocols for medical devices. The document does not specify the number or specific qualifications of these individuals, as it's implied by compliance with the standards.
4. Adjudication Method for the Test Set:
- Adjudication methods like 2+1 or 3+1 consensus are not applicable to the type of testing described (mechanical performance against standards). The results of these tests are objective measurements (e.g., whether a brake holds a certain force, whether a frame withstands a certain impact). The "adjudication" is inherent in whether the measured values fall within the parameters defined by the ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers (e.g., radiologists) with and without AI assistance, typically for diagnostic tasks. Given that the APEX Manual Wheelchair is a mechanical mobility device, such a study design is entirely irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
- No, a standalone (algorithm only) study was not done. This concept applies to AI/software as a medical device (SaMD) where the algorithm performs a task independently. The APEX is a physical mechanical device; its "performance" is its physical function and durability, not an algorithm's output.
7. The Type of Ground Truth Used:
- The "ground truth" for the APEX Manual Wheelchair's performance is defined by the international standards (ISO 7176 series) for wheelchairs and by the safety and performance requirements outlined in FDA guidance documents for manual wheelchairs. These standards provide objective metrics and test methods against which the device's physical and functional properties are measured. Essentially, the "ground truth" is compliance with these established engineering and safety benchmarks.
8. The Sample Size for the Training Set:
- Not applicable. The APEX Manual Wheelchair is a mechanical device, not an AI/machine learning model that requires a "training set" of data. Its design and manufacturing process are based on engineering principles and materials science, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the concept of a "training set" does not apply to this device, neither does the method for establishing its ground truth.
§ 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).