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510(k) Data Aggregation
(186 days)
The device is a motor drive, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disable or elderly person limited to a seated position.
The EQ 20C scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an on-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
This 510(k) submission is for a mobility scooter, which is a medical device. The information provided heavily relies on a comparison to a predicate device rather than a comprehensive study with acceptance criteria in the way one might analyze a diagnostic or AI device. Therefore, many of the requested fields are not directly applicable or cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a motorized three-wheeled vehicle), "acceptance criteria" are generally established through adherence to recognized national and international standards for safety and performance, and demonstrating substantial equivalence to a legally marketed predicate device. The performance is then related to how the device meets these standards and compares to the predicate.
| Acceptance Criteria (based on standards & predicate comparison) | Reported Device Performance (KYMCO EQ 20C scooter) |
|---|---|
| Intended Use: Provide mobility to a disabled or elderly person limited to a seated position. | Same as predicate (EQ 30) |
| Compliance with ANSI/RESNA WC Vol. 1 Sec. 7 & 8 | Complied with requirements |
| Compliance with ANSI/RESNA WC Vol. 2 Sec. 21 | Complied with requirements |
| Compliance with ISO 7176 series (e.g., -1, -2, -3, etc.) | Complied with requirements |
| Compliance with ISO 10993 series (e.g., -1, -5, -10) | Complied with requirements (Biocompatibility) |
| Compliance with ISO 14971 | Complied with requirements (Risk Management) |
| Compliance with EN 61000-4 series (e.g., -2, -3, -8) & CISPR 11 | Complied with requirements (EMC) |
| Substantial Equivalence to Predicate Device (KYMCO EQ 30 - K072630) for: | |
| - Maximum load capacity | 127 kg (280 lbs) (Predicate: 150 kg / 330 lbs) - Lower but acceptable difference |
| - Overall dimensions (Height, Length, Width) | 921 mm (36.3"), 1080 mm (43.5"), 520 mm (20.5") (Predicate: 1250 mm, 1240 mm, 560 mm) - Differences noted but not deemed to alter intended use |
| - Seat dimensions (Height, Width, Depth) | 550 mm (21.7"), 427 mm (16.8"), 350 mm (13.8") (Predicate: 756 mm, 455 mm, 400 mm) - Differences noted but not deemed to alter intended use |
| - Motor Rated power | 250 W (Predicate: 350 W) - Lower but not deemed to alter intended use |
| - Braking distance | Forward: 1.0 m (39.4") at max speed (Predicate: 1.24 m / 48.8") - Better braking distance reported |
| - Net weight with battery | 55.5 kg (122 lbs) (Predicate: 84.4 kg / 185.7 lbs) - Lighter |
| - Slope grade ability | 8 degree (Predicate: 10 degree) - Lower but not deemed to alter intended use |
| - Per-charge distance | Up to 21 km (13 miles) (Predicate: Up to 37 km / 23.1 miles) - Lower but not deemed to alter intended use |
| - Maximum speed | Up to 6.5 km/h (4.1 mph), variable (Predicate: Up to 8 km/hr / 4.7 mph), variable) - Lower but not deemed to alter intended use |
| - Turning Radius | 1200 mm (47.2") (Predicate: 1565 mm / 61.6") - Smaller turning radius (better) |
| - Maximum curb height | 50 mm (2") (Predicate: 80 mm / 3.14") - Lower but not deemed to alter intended use |
| - Other features (Lights, Horn, Anti-tip wheels, Operation mode, Armrest) | Similar functions, some stylistic differences or presence/absence of certain features (e.g., headrest, suspension) - Differences noted but not deemed to alter intended use |
Note: The "acceptance criteria" here are implicitly whether the device meets the safety and performance requirements of the cited standards and whether any differences from the predicate device are determined by the FDA to not raise new questions of safety or effectiveness, thus maintaining substantial equivalence. The document doesn't explicitly state quantitative thresholds for each parameter as "acceptance criteria," but rather demonstrates compliance with standards and compares specifications to the predicate.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this submission. The "test" here refers to compliance with international standards and a comparison of specifications with a predicate device. There is no "test set" of patient data or algorithm performance data as would be used for AI/diagnostics.
- Data Provenance: The data comes from the manufacturer's own testing against the listed standards and their internal comparison of the EQ 20C with their predicate device, the EQ 30. No external patient data or clinical trial data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in this context. The "truth" is established by adherence to engineering and safety standards and the direct measurement of device specifications.
4. Adjudication method for the test set
- Not applicable. There is no adjudication method described. Compliance with standards typically involves testing by qualified personnel (either internal or third-party labs) and documenting results against standard requirements.
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 is a physical mobility device, not an AI or diagnostic imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. Refer to point 5.
7. The type of ground truth used
- The "ground truth" in this context is the established engineering and safety standards (e.g., ANSI/RESNA, ISO, EN, CISPR) and the specifications of the legally marketed predicate device (KYMCO EQ 30). Device performance is evaluated against these standards and compared to the predicate to establish substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. Refer to point 8.
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