(14 days)
Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.
The AIR, Inc. Model "Flight" mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The device can be easily folded for transport.
The provided 510(k) summary for the "Flight" mechanical wheelchair describes a performance study aimed at demonstrating substantial equivalence to a predicate device. This is largely based on compliance with voluntary standards rather than a typical clinical performance study for an AI-powered diagnostic device.
Here's an analysis of the acceptance criteria and the study, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Voluntary Standards (Performance) | ANSI/RESNA WC Vol 1: Applicable standards for mechanical wheelchairs | Meets applicable ANSI/RESNA standards | This is a general statement that the device meets the relevant standards. Specific numerical values for the standards are not provided in this document. |
| Voluntary Standards (Safety/Flammability) | ANSI/RESNA WC Vol 1, Section 16: Determination of flammability | Upholstery meets ANSI/RESNA WC Vol 1, Section 16 | Confirms compliance with a specific safety standard related to upholstery flammability. |
| Intended Use Equivalence | Same intended use as predicate device | "Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position." (Matches predicate) | The primary indication for use is identical to that of the predicate device, demonstrating functional equivalence. |
| Physical Characteristics Equivalence | Comparable weight bearing capacity | "Both devices have the same weight bearing capacity" | Directly states equivalence in a key performance aspect. |
| Functionality Equivalence | Foldable for transportation/stowage | "both devices are foldable for transportation or stowage" | Directly states equivalence in a key functional aspect. |
| Dimensional Similarity | Overall dimensions similar to predicate | "The overall dimensions are similar." | A qualitative assessment of similarity. |
| Safety Differences | Differences between new device and predicate are not safety-related | "The differences between the new device and the predicate are chiefly in the frame materials and in overall dimensions. These differences are not safety related" | A critical assertion for demonstrating substantial equivalence. |
Note: This 510(k) summary is for a mechanical wheelchair, not an AI/diagnostic device. Therefore, the concept of "device performance" here relates to meeting engineering and safety standards, and functional equivalence, rather than diagnostic accuracy metrics like sensitivity or specificity.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k). The "performance testing" described refers to engineering tests against specified standards rather than a clinical trial with a "test set" of patient data. The device itself (one or more units of the Flight wheelchair) would be the "test subject" for these engineering tests.
- Data Provenance: Not applicable. The "data" comes from engineering tests performed on the physical device, not from patient populations or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in the context of a diagnostic device, typically refers to a definitive diagnosis or outcome. For a mechanical wheelchair, the "ground truth" for its performance is determined by whether it physically meets the specified engineering standards (e.g., strength, durability, flammability under controlled test conditions). This doesn't involve human expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretation of clinical data. Since this involves engineering tests rather than clinical data interpretation, adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices to assess the impact of a new technology (like AI) on physician performance. The "Flight" wheelchair is a mechanical device, and its evaluation focuses on engineering compliance and functional equivalence, not on improving human reader performance.
- Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" evaluation was done. The "Flight" mechanical wheelchair was tested on its own to determine if it met the specified ANSI/RESNA standards. This is an evaluation of the device's inherent physical performance characteristics, independent of human interaction beyond operating the test equipment.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of the "Flight" mechanical wheelchair is based on engineering standards and specifications. The device is tested against predefined metrics and procedures outlined in documents like ANSI/RESNA WC Volume 1, Section 16 (for flammability) and other applicable standards for mechanical wheelchairs. Successful completion of these tests, demonstrating compliance with the numerical and qualitative requirements of the standards, constitutes the "ground truth" that the device performs as intended and meets safety requirements.
8. The Sample Size for the Training Set
Not applicable. The "Flight" mechanical wheelchair is a physical product, not an AI algorithm that requires a "training set" of data to learn from. Its design and manufacturing are based on engineering principles and material science, not machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 890.3850 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).