(26 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The JAN MAO Wheelchair, JMC612-F18EPP is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
The provided submission describes a medical device, the JAN MAO Wheelchair, JMC612-F18EPP, and its substantial equivalence to a predicate device. However, it does not include information about AI algorithms or advanced performance studies typically associated with "acceptance criteria" and "device performance" in the context of AI/ML devices.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they relate to AI/ML device studies. The information available pertains to traditional medical device regulatory submissions.
Here's an analysis based on the provided text, focusing on the available information:
Analysis of the Provided Text:
The document describes a 510(k) premarket notification for a mechanical wheelchair. The primary method for demonstrating "device performance" and meeting "acceptance criteria" in this context is through compliance with recognized standards and comparison to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 | Meets applicable requirements |
| ISO 7176 Wheelchair Standards | Meets applicable requirements |
| California Technical Bulletin CAL 117 (Flame Retardant) | Upholstery meets standard |
| Overall dimensions similar to predicate device | Overall dimensions are similar |
| Same weight capacity as predicate device | Same weight capacity |
| Back upholstery material the same resistance ignitability fabric as predicate device | Back upholstery material is the same resistance-ignitability fabric |
Note: The specific numerical acceptance limits or detailed test results for ANSI/RESNA or ISO 7176 are not provided in this summary. The submission simply states that the device "meets the applicable performance requirements."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a mechanical device like a wheelchair, "test set" typically refers to the units produced for testing against engineering standards. The sample size and data provenance are not specified.
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 and not provided. "Ground truth" and "expert consensus" are terms primarily used in the context of AI/ML or diagnostic device studies. For a mechanical wheelchair, compliance with standards is typically verified through engineering tests, not expert consensus on ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for objective engineering tests of a mechanical device.
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 and not provided. MRMC studies and the concept of "human readers improving with AI" are specific to AI-assisted diagnostic or interpretive devices. This is a mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. There is no algorithm mentioned in the context of this mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. As mentioned previously, "ground truth" is not a concept typically applied to the performance assessment of a mechanical device like a wheelchair in a regulatory submission like this. Performance is largely determined by adherence to engineering specifications and safety standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" nor "ground truth" in the AI/ML sense for this device.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is performance testing against recognized national and international wheelchair standards.
- Study Name (Implied): Performance Testing of JAN MAO Wheelchair, JMC612-F18EPP
- Standards Used: ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. The upholstery fabric also met the California Technical Bulletin CAL 117 standard for flame retardant.
- Result: The device "meets the applicable performance requirements as specified" in these standards.
- Methodology (Implied): This type of testing typically involves a series of physical and mechanical tests specified by the standards, such as fatigue testing, static stability, braking efficacy, dimensional checks, and material flammability tests. The specifics of these tests are not detailed in the summary.
- Substantial Equivalence Comparison: The submission also relies on comparison to a legally marketed predicate device, the AVANTICARE Mechanical Wheelchair, MR-9000 (K050708), to demonstrate substantial equivalence. Key attributes compared include intended use, foldability, overall dimensions, weight capacity, and upholstery material. The differences (removable armrest and swing-away footrest) were deemed not to impact safety.
§ 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).