(29 days)
To provide mobility to persons limited to a sitting position.
The ORION II Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".
The provided text describes a 510(k) summary for a medical device, specifically a modified manual wheelchair (ORION II Heavy Duty). It focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, design characteristics, and compliance with recognized standards.
However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/algorithm-driven device. The submission is for a mechanical wheelchair, and the "study" referred to is the demonstration of compliance with ISO 7176 standards for wheelchairs.
Therefore, most of the requested information regarding AI/algorithm performance (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Compliance) | Reported Device Performance |
|---|---|
| Similar Indications for Use | Provides mobility to persons limited to a sitting position (Same as predicate) |
| Similar Key Design Technical Characteristics | Mechanical wheelchair with tilt and recline capabilities, adjustable back angle, similar performance (Similar to predicate) |
| Withstand higher weight capacities | Modified with wider frames and reinforced design to withstand 350lbs (for 21"-24" widths) and 500lbs (for 24"-32" widths). This is an improvement over the original 250lbs capacity. |
| Compliance with ISO 7176 standards | Developed and concluded to be safe and effective in accordance with ISO 7176, parts 1, 5, 7, 8, and 11. |
| Substantial Equivalence to Predicate Device | Determined substantially equivalent to the ORION II Wheelchair (K061010) (FDA-reviewed). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a mechanical wheelchair, not an AI/algorithm-driven device that would typically have a "test set" in the context of data evaluation. The "test" involved demonstrating compliance with ISO standards through engineering design and potentially physical testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of expert consensus is not relevant for this mechanical device submission. Compliance with ISO standards likely involves engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are not relevant for this type of device submission.
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. This is a mechanical device, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For compliance with ISO 7176 standards, the "ground truth" would be the engineering specifications, test protocols, and performance requirements outlined in those standards. The device's performance is measured against these established benchmarks.
8. The sample size for the training set
- Not applicable. This is a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical device.
Summary of the "Study" (Compliance Demonstration):
The "study" or demonstration of the device meeting acceptance criteria for this mechanical wheelchair involves:
- Engineering Design and Analysis: The modifications to the ORION II (wider frames, reinforced design) were specifically engineered to allow for higher weight capacities (350lbs and 500lbs) compared to the predicate device's 250lbs.
- Compliance with Recognized Standards: The core of the demonstration is the declaration that the device was "developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." These are international standards for wheelchairs that specify requirements and test methods for aspects such as:
- ISO 7176-1: Determination of static stability
- ISO 7176-5: Determination of dimensions, mass, and manoeuvring space
- ISO 7176-7: Seating and wheel dimensions
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11: Test dummies
This compliance indicates that the wheelchair underwent various tests (e.g., static stability, strength, fatigue) and met the specified performance criteria outlined in these standards for its stated weight capacities.
- Substantial Equivalence Argument: The entire submission serves as a "study" to prove substantial equivalence to the predicate device (ORION II Wheelchair K061010) by comparing indications for use, technological characteristics, and demonstrating that any differences (like increased weight capacity) do not raise new questions of safety or effectiveness, particularly given the compliance with relevant ISO standards.
In essence, the "study" for this mechanical device is a combination of design validation, engineering testing, and adherence to established international performance and safety standards, rather than a clinical trial or algorithmic performance evaluation.
§ 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).