(49 days)
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The provided FDA 510(k) summary is for a Manual Wheelchair (MW18), a Class I, reserved medical device. This type of device does not typically involve AI components or require the complex statistical studies, multi-reader multi-case studies, and expert ground truth establishment that are common for AI/ML-driven diagnostic devices.
Instead, the acceptance criteria for a manual wheelchair primarily focus on functional performance, safety, and compliance with established industry standards. The study proving the device meets these criteria is a series of non-clinical performance tests conducted in accordance with international standards for wheelchairs.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document lists the ISO standards that the device complies with, which effectively serve as the acceptance criteria. The "reported device performance" is the statement of compliance with these standards.
| Acceptance Criteria (ISO Standard & Description) | Reported Device Performance |
|---|---|
| ISO 7176-1:2014: Wheelchairs - Part 1: Determination of static stability | Complies with the standard |
| ISO 7176-3:2012: Wheelchairs - Part 3: Determination of effectiveness of brakes | Complies with the standard |
| ISO 7176-5:2008: Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space | Complies with the standard |
| ISO 7176-7:1998: Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Complies with the standard |
| ISO 7176-8:2014: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength | Complies with the standard |
| ISO 7176-11:2012: Wheelchairs -- Part 11: Test dummies | Complies with the standard (used for testing) |
| ISO 7176-13:1989: Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. | Complies with the standard |
| ISO 7176-15:1996: Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling. | Complies with the standard |
| ISO 16840-10:2021: Wheelchair seating - Part 10: Resistance to ignition of postural support devices | Complies with the standard |
| ISO 7176-22: 2014: Wheelchairs - Part 22: Set-up procedures | Complies with the standard (used for testing) |
| ISO 10993-5: Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity | Complies with the standard (for biocompatibility) |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies with the standard (for biocompatibility) |
| ISO 10993-23: Biological evaluation of medical devices - Part 23: Tests for irritation | Complies with the standard (for biocompatibility, though noted "not applicable" seemingly by mistake for this standard as well as others in the provided text as the biocompatibility tests were conducted) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data, as this is a mechanical device. The "test set" refers to the physical units of the Manual Wheelchair (MW18) that were subjected to the non-clinical tests. The document does not explicitly state the number of sample units used for these tests. Data provenance is not applicable in the context of patient data as it's not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this device. "Ground truth" in the context of AI/ML performance is not relevant for a mechanical manual wheelchair. The "truth" is established by the ability of the device to meet the defined performance specifications and safety standards through physical testing.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation, not for mechanical device testing. Compliance with standards is typically assessed by conformity to predefined pass/fail criteria for each test.
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
This is not applicable. An MRMC study is designed for evaluating the performance of diagnostic algorithms, often with human readers in the loop. This device is a manual wheelchair, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is the compliance with established international performance and safety standards (ISO standards) for manual wheelchairs. This is determined through objective, quantifiable physical tests, rather than expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices.
8. The sample size for the training set
This is not applicable. There is no "training set" for a mechanical device like a manual wheelchair.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or "ground truth for a 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).