(52 days)
The YJ-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The YJ-011S series is a mechanical wheelchair 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 bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
The provided text describes a 510(k) premarket notification for a reclining wheelchair, which is a Class I device. As such, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than a clinical study or AI/software validation. Therefore, many of the requested elements regarding acceptance criteria for AI performance, clinical study details, expert review, effect size, and training/test set specifics are not applicable or not present in this type of regulatory submission.
Applicable Information from the Submission:
This submission for the Zhenjiang Assure Medical Equipment Co., Ltd. Reclining Wheelchair (K232198) primarily relies on demonstrating compliance with recognized performance standards for mechanical wheelchairs and biocompatibility testing. The "acceptance criteria" are implied by the successful execution and results of these tests, showing the device meets the safety and performance benchmarks established by the standards and is comparable to the predicate device.
1. A table of acceptance criteria and the reported device performance
The submission does not present a formal "acceptance criteria" table with specific quantitative thresholds that would be typical for an AI/software device. Instead, acceptance is demonstrated by compliance with international standards for wheelchairs and biocompatibility. The "reported device performance" is that the device complied with these standards.
| Acceptance Criteria (Implied by Compliance with Standards) | Reported Device Performance |
|---|---|
| Mechanical Performance: | Complied with: |
| ISO 7176-1: Determination of static stability | ISO 7176-1:2014 |
| ISO 7176-3: Determination of effectiveness of brakes | ISO 7176-3:2012 |
| ISO 7176-5: Determination of overall dimensions, mass, and maneuvering space | ISO 7176-5:2008 |
| ISO 7176-7: Measurement of seating and wheel dimensions | ISO 7176-7:1998 |
| ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths | ISO 7176-8:2014 |
| ISO 7176-11: Test dummies | ISO 7176-11:2012 |
| ISO 7176-13: Determination of coefficient of friction of test surfaces | ISO 7176-13:1989 |
| ISO 7176-15: Requirements for information disclosure, documentation, and labeling | ISO 7176-15:1996 |
| ISO 7176-16: Resistance to ignition of postural support devices | ISO 7176-16:2012 |
| ISO 7176-22: Set-up procedures | ISO 7176-22:2014 |
| Biocompatibility: | Complied with: |
| Cytotoxicity (per ISO 10993-5) | Non-cytotoxic |
| Sensitization (per ISO 10993-10) | Non-sensitizing |
| Irritation (per ISO 10993-23) | Non-irritating |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The evaluations were non-clinical performance and biocompatibility tests of the physical device, not an assessment of software or AI performance on a data set. Therefore, there is no "test set" in the context of data or images, nor data provenance.
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)
This information is not applicable. There was no test set requiring expert ground truth establishment for this type of medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no test set requiring adjudication in this type of 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
This information is not applicable. This device is a mechanical wheelchair, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a mechanical wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the context of "ground truth" for AI/software. The "ground truth" for this device's performance is defined by the established criteria and methods within the referenced ISO standards for mechanical wheelchairs and biocompatibility.
8. The sample size for the training set
This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is a mechanical wheelchair and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.
§ 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).