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510(k) Data Aggregation
(155 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter. Models: W3331. has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The provided text is a 510(k) summary for a Mobility Scooter (Model W3331). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study design for AI models, and performance metrics for AI assistance is not applicable.
However, I can extract the general acceptance criteria and the methods used to prove the device meets these criteria as described in the document.
Device: Mobility Scooter (W3331)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily derived from various ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance | Remark |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) & ISO 10993-10: 2010 (Irritation & Skin Sensitization) requirements for user directly contacting materials | All user directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements. | S.E. (Substantially Equivalent) to predicate |
| Electromagnetic Compatibility (EMC) | ||
| ISO 7176-21: 2009 & IEC 60601-1-2 requirements | EMC performance results meet the requirements of ISO 7176-21. | S.E. to predicate |
| Performance (ISO 7176 series) | ||
| ISO 7176-1: 2014 (Static Stability) | Static stability determined and meets design specification. | S.E. to predicate. Proposed device: Dynamic Stability: 6 degree, Static Stability: 8 degree. Predicate: 9 degree (This indicates a slight performance difference, but considered SE based on the full scope of testing). |
| ISO 7176-2: 2017 (Dynamic Stability) | Dynamic stability determined and meets design specification. | S.E. to predicate |
| ISO 7176-3: 2012 (Effectiveness of Brakes) | Effectiveness of brakes determined and meets design specification. | S.E. to predicate. Proposed device: Time to brake < 1 s, Brake Distance (Normal operation, Horizontal, Forward, Max speed) ≤1.3m. Predicate: Time to brake < 1 s, Brake Distance ≤1.5m. |
| ISO 7176-4: 2008 (Energy consumption/Theoretical Distance Range) | Theoretical distance range determined and meets design specification. | S.E. to predicate. Proposed device: 15 km/9.32 Miles. Predicate: 15 km/9.32 Miles. |
| ISO 7176-5: 2008 (Overall Dimensions, Mass, Maneuvering Space) | Dimensions, mass determined. | S.E. to predicate. Differences in overall dimension, ground clearance, turn radius, front/rear wheel size noted, but considered SE. |
| ISO 7176-6: 2018 (Max speed, acceleration, deceleration) | Dimensions, mass determined (appears to be a copy-paste error in the document, likely refers to speed metrics). | S.E. to predicate. Proposed device: 4.25mph (6.83km/h). Predicate: 6 km/h. |
| ISO 7176-7 (Seating and wheel dimensions) | Seating and wheel dimensions determined. | S.E. to predicate. Differences in armrest distance noted, but considered SE. |
| ISO 7176-8: 2014 (Static, Impact, Fatigue Strengths) | All test results meet requirements in Clause 4 of ISO 7176-8. | S.E. to predicate |
| ISO 7176-9: 2009 (Climatic Tests) | Device continues to function according to manufacturer's specification after climatic tests. | S.E. to predicate |
| ISO 7176-10: 2008 (Obstacle-climbing ability) | Obstacle-climbing ability determined. | S.E. to predicate |
| ISO 7176-11: 2012 (Test dummies) | Test dummies used meet requirements of ISO 7176-11. | S.E. to predicate |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Coefficient of friction of test surfaces determined. | S.E. to predicate |
| ISO 7176-14: 2008 (Power and control systems) | All test results meet requirements in Clauses 7-17 of ISO 7176-14. | S.E. to predicate |
| ISO 7176-15: 1996 (Information disclosure, documentation, labeling) | Information disclosure, documentation, and labeling meet requirements of ISO 7176-15. | S.E. to predicate |
| ISO 16840-10: 2021 (Resistance to ignition of postural support devices) | Performance of resistance to ignition meets requirements of ISO 16840-10:2021. | S.E. to predicate (predicate used ISO 7176-16) |
| ISO 7176-25: 2013 (Batteries and chargers) | Performance of batteries and charger meets requirements in Clause 5 and 6 of ISO 7176-25. | S.E. to predicate |
| Labeling | ||
| Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory. | S.E. to predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests conducted on the device itself (Mobility Scooter Model W3331) to evaluate its performance against engineering standards. This is not a study involving patient data, test sets, or populations. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically applied to AI/ML or clinical studies is not applicable. The "test set" in this context refers to the physical device being tested against various standard requirements.
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 as the document describes physical device testing against established engineering standards (ISO 7176, ISO 10993) rather than an AI/ML model where expert ground truth is typically assessed. The "ground truth" here is the pass/fail criteria defined by the ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human adjudication process described for establishing ground truth in this non-clinical engineering testing. The compliance is determined by measurements against standard specifications.
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 as the device is a physical mobility scooter, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical mobility scooter and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance specifications and acceptance criteria defined by international engineering standards (ISO 7176 series and ISO 10993 series). The device's performance is measured against these objective, predefined values.
8. The sample size for the training set
This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.
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