(119 days)
The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Shengguang Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistanceignitability fabric.
The provided text is a 510(k) summary for a manual wheelchair, which is a Class I medical device. For such devices, the regulatory pathway relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than extensive clinical studies that measure specific performance metrics against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment is typically not part of a 510(k) submission for a manual wheelchair.
However, based on the provided text, I can infer the acceptance criteria are adherence to recognized standards for wheelchair performance and safety, along with demonstrating similarity to predicate devices. The "study" that proves the device meets these criteria is the non-clinical testing described in the submission, along with the substantial equivalence comparison.
Here's an attempt to answer your questions based on the available information, noting where specific details are not provided due to the nature of the device and regulatory submission:
1. Table of acceptance criteria and the reported device performance
Given the nature of a manual wheelchair and a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily established by conformity to recognized industry standards and direct comparison of features and performance to legally marketed predicate devices. The device "performance" is implicitly demonstrated by passing these tests and showing equivalence.
| Acceptance Criteria Category | Specific Criteria / Standard Applied | Reported Device Performance | Comments / Context |
|---|---|---|---|
| Safety & Performance Standards | ANSI/RESNA WC-1:2009 Section 1: Determination of static stability | Compliance demonstrated. | Device passed this standard. |
| ANSI/RESNA WC-1:2009 Section 3: Determination of effectiveness of brakes | Compliance demonstrated. | Device passed this standard. | |
| ANSI/RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space | Compliance demonstrated. | Device passed this standard. | |
| ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions | Compliance demonstrated. | Device passed this standard. | |
| ANSI/RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strengths | Compliance demonstrated. | Device passed this standard. | |
| ANSI/RESNA WC-1:2009 Section 11: Test dummies | Compliance demonstrated. | This section likely refers to the use of standardized test dummies during testing. | |
| ANSI/RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces | Compliance demonstrated. | Device passed this standard. | |
| ANSI/RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling | Compliance demonstrated. | Device passed this standard. | |
| Material Flammability | California Technical Bulletin 117 Section E Part 1 (Upholstery material) | Shown to be Class 1 - normal flammability. | Applies to SG-LY-001001/ SG-LY-001016 and SG-LY-001017/SG-LY-001018 series. |
| California Technical Bulletin 117 Section A Part 1 and Section D Part 2 (Seat cushion foam material) | Shown to meet performance standards. | Demonstrated compliance with flammability standards for foam. | |
| Biocompatibility | FDA Guidance G95-1 | Meets biocompatibility requirements. | Based on using same materials, chemical composition, and manufacturing processes as predicate devices for patient-contacting components. |
| Substantial Equivalence to Predicate Devices | Same intended use, similar specifications, functions, and performance as predicate devices. | The Shengguang Manual Wheelchair is substantially equivalent. | Differences in weight of wheelchair, style of backrest height, and armrest did not affect safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a 510(k) for a basic manual wheelchair. The "test set" here refers to the actual physical device models manufactured by Shengguang. The standards (ANSI/RESNA WC-1:2009) define the specific number of test pieces required (e.g., how many chairs are subjected to durability tests), but this detail isn't explicitly stated in the summary.
- Data Provenance: The testing was "Non-clinical testing performed on the Shengguang Manual Wheelchair." The country of origin for the testing is not explicitly stated, but it would have been conducted by or for Pingdingshan Shenxing Healthcare Technology Co., Ltd. in China. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.
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 question is not applicable to this type of device and submission. "Ground truth" and expert consensus are concepts typically relevant to diagnostic or AI-driven devices where human interpretation or expert labeling is needed. For a manual wheelchair, compliance with engineering standards and material properties is objectively measured, not subjectively interpreted by experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies where subjective assessments (e.g., lesion detection, disease staging) require resolution of discrepancies among multiple reviewers. For mechanical device testing against standards, the results are typically objective measurements.
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 device is a manual wheelchair, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and concepts of human readers or AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/algorithm performance. The Shengguang Manual Wheelchair is a mechanical device and does not involve any algorithms or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- As explained in point 3, the concept of "ground truth" as typically defined for diagnostic or AI devices does not apply here. The "truth" for this device's performance is established by objective measurements and adherence to recognized international and national consensus standards (ANSI/RESNA WC-1:2009) for mechanical properties, safety, and flammability. Material properties are verified against specifications and predicate device equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" for a manual wheelchair. This term refers to data used to train machine learning models.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set (see point 8), there's no ground truth to establish for it.
In summary: The K131529 submission for the Shengguang Manual Wheelchair demonstrates substantial equivalence primarily through adherence to established performance and safety standards for wheelchairs and direct comparison of its design and components to previously cleared predicate devices. The specific types of studies, ground truth, and expert involvement described in your prompt are characteristic of submissions for more complex, often software-driven or diagnostic, medical devices, and do not apply to this Class I manual wheelchair.
§ 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).