(28 days)
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
This is a 510(k) summary for a manual wheelchair and as such, it does not fit the typical format for studies and acceptance criteria as described in your request, which usually applies to more complex medical devices, especially those involving AI or diagnostic interpretations.
However, I can extract the relevant information regarding performance and acceptance criteria from the provided document as best as possible within the context of a mechanical device.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Shanghai Wheelchair Factory's Manual Wheelchair Series
The acceptance criteria for this manual wheelchair series are based on compliance with an international standard for wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance/Statement of Compliance |
|---|---|---|
| Mechanical Performance | ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs" (specifically Part 8) | "The Manual Wheelchair Series meet the applicable requirements specified in part 8 of the ISO Standard ISO 7176: 1993(E)" |
Note on "Power and Control Systems of Electric Wheelchairs": The document explicitly states the manual wheelchair meets requirements specified in part 8 of ISO 7176:1993(E), which is titled "Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." This appears to be a clerical error in the submission, as a manual wheelchair does not have "power and control systems of electric wheelchairs." It is highly probable that the submission intended to reference a part of ISO 7176 (or a different ISO standard for manual wheelchairs) that covers mechanical integrity, stability, durability, or other relevant aspects for manual wheelchairs. However, based strictly on the provided text, this is the standard cited. For the purpose of this analysis, I will proceed with what is written in the document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size used for the test set. It merely states that the "Manual Wheelchair Series" meets the requirements, implying that the tested units (likely representative samples of the different models in the series) passed the specified tests.
Data provenance (country of origin, retrospective/prospective) is also not mentioned. The testing would have been conducted by the manufacturer or a third-party testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and therefore not provided in the document. For a mechanical device like a wheelchair, "ground truth" is established through standardized physical tests (e.g., fatigue testing, static strength testing, dynamic testing, etc.) outlined in the ISO standard, not through expert consensus or interpretation of data. The results of these tests (e.g., whether a component broke, how much force was sustained, etc.) are objective measurements against specified thresholds.
4. Adjudication Method for the Test Set
This is not applicable and therefore not provided in the document. As mentioned above, mechanical testing involves objective measurements against predefined acceptance criteria from the standard, not an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable to a manual wheelchair. MRMC studies are used for diagnostic or interpretive devices, often involving AI, where human performance in reading or interpreting data is being evaluated. A manual wheelchair is a mechanical mobility aid and does not involve "human readers" or "AI assistance" in its direct function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to a manual wheelchair. Standalone performance refers to the performance of an algorithm or AI system without human intervention, which is not relevant for this device.
7. The Type of Ground Truth Used
The "ground truth" (or more accurately, the validation method) used is compliance with an international standard: ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs" (specifically Part 8). The standard defines objective test methods and performance criteria.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. "Training set" refers to data used to train machine learning models, which are not involved in the design or validation of a purely mechanical device like a manual wheelchair.
9. How the Ground Truth for the Training Set Was Established
This is not applicable to a manual wheelchair, as there is no "training set" in the context of mechanical device validation.
In summary, the provided 510(k) summary for the manual wheelchair primarily demonstrates substantial equivalence by stating compliance with a recognized international mechanical standard, rather than through complex clinical studies often associated with diagnostic or AI-powered devices.
§ 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).