(21 days)
The LERADOTECH SC scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The LERADOTECH SC scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text pertains to a 510(k) premarket notification for a medical device, the LERADOTECH SC scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study proving performance against explicit acceptance criteria in the manner typically seen for novel diagnostic or therapeutic devices.
Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) is not applicable to this type of regulatory submission for a scooter. The "study" here is primarily a comparison to a predicate device and adherence to performance standards, not a clinical trial with human subjects in the traditional sense.
Let's break down what is available and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance characteristics of the predicate device (AVANTICARE SA4022) and compliance with relevant industry performance standards. The "reported device performance" for the LERADOTECH SC is its specifications, which are compared against the predicate.
| Characteristic | Acceptance Criteria (Predicate: AVANTICARE SA4022 (K051538)) | Reported Device Performance (LERADOTECH SC) | Met Criteria? (Based on substantial equivalence claim) |
|---|---|---|---|
| Operation Mode | Thumb operated potentiometer throttle control lever | Thumb operated potentiometer throttle control lever | Yes |
| Battery | Lead-Acid 12V × 36AH × 2PCS | Lead-Acid 12V x 75AH × 2PCS | Yes (Difference noted, but not raising new safety/effectiveness questions) |
| Battery Level Indicator | Not explicitly stated (implied no) | Yes | Yes (An enhancement, not a deviation that would raise new questions) |
| Charger | HP 24V 3/5AMP (Automatic Type) off-board | HP 24V, 5 AMP (Automatic Type) off-board | Yes (Minor difference in amperage, still automatic/off-board) |
| Front Wheel | 10" x 2" foam filled tire × 2 PCs, Rim: aluminum alloy | 13" x 5" pneumatic tire × 2 PCs | Yes (Difference noted, but not raising new safety/effectiveness questions) |
| Bumpers | Front/Rear: It's constructed by engineering plastics | Front: It's constructed by steel tube, Rear: It's constructed by engineering plastics | Yes (Difference noted, but not raising new safety/effectiveness questions) |
| Armrest | Not explicitly stated (implied no) | Yes, Foldable | Yes (An enhancement) |
| Tiller Foldable | Not explicitly stated (implied no) | Yes | Yes (An enhancement) |
| Backrest Recline & Recline Angle Indicator | Not explicitly stated (implied no) | Yes | Yes (An enhancement) |
| Headrest | Not explicitly stated (implied yes/standard) | No | Yes (A minor difference in feature, not altering intended function/safety) |
| Height Adjustable | Not explicitly stated (implied yes/standard) | No | Yes (A minor difference in feature, not altering intended function/safety) |
| Rear Wheel | 10" x 2" foam filled tire × 2 PCs, Rim: aluminum alloy | 13" x 5" pneumatic tire × 2 PCS | Yes (Difference noted, but not raising new safety/effectiveness questions) |
| Brake System | Intelligent regenerative electromagnetic brake | Intelligent regenerative electromagnetic brake and hand brake | Yes (An enhancement) |
| Intended Use | Mobility for disabled or elderly persons limited to a seated position (indoor/outdoor) | Mobility for disabled or elderly persons limited to a seated position (indoor/outdoor) | Yes |
| Maximum Loading | 135 kg (300 lbs) | 205 kg (450 lbs) | Yes (An enhancement, suggests improved structural integrity) |
| Overall Height | 980 mm (38.5") | 1260 mm (50") | Yes (Difference noted, but not altering intended function/safety) |
| Overall Length | 1160 mm (45.7") | 1370 mm (54") | Yes (Difference noted, but not altering intended function/safety) |
| Overall Width | 540 mm (21.3") | 730 mm (29") | Yes (Difference noted, but not altering intended function/safety) |
| Motor Output | 350W x DC24V × 5100 RPM, 1PC | 950W x DC24V × 1PC | Yes (Higher output, suggests improved performance/power, not raising new safety/effectiveness questions) |
| Controller | Dynamic DS72K01 | Dynamic DS16K01 | Yes (Different model, assumed to meet functional requirements) |
| Rear Wheel Drive | Not explicitly detailed | Sealed transaxle direct drive | Yes (Assumed comparable or improved drive mechanism) |
| Performance Standards | Compliance with various ANSI/RESNA, ISO, CISPR, IEC, and California flammability standards. | Compliance with various ANSI/RESNA, ISO, CISPR, IEC, and California flammability standards as listed in Section 3.2. | Yes |
Study Description and How Acceptance Criteria Are Met
The "study" presented is a substantial equivalence comparison and adherence to recognized performance standards. The sponsor (LERADO CHINA LIMITED) asserts that the LERADOTECH SC scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by the same company.
The mechanism for meeting "acceptance criteria" is two-fold:
- Direct Comparison to Predicate: The LERADOTECH SC's specifications are compared feature-by-feature to the predicate device. Where there are differences (e.g., battery capacity, wheel size, maximum loading, motor output, specific controller model), the sponsor explicitly states that these "do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." In some cases, the new device exhibits improved specifications (e.g., higher maximum loading, higher motor output, additional safety features like a hand brake, or convenience features like a battery level indicator or foldable armrest).
- Compliance with Recognized Performance Standards: The device has been tested against and meets the applicable performance requirements specified in a list of international and national standards:
- ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 (Determination of static stability)
- ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 (Determination of max speed, acceleration and deceleration of electric wheelchair)
- ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (EMC of powered wheelchairs and motorized scooters)
- CISPR 11-1990 (Industrial, scientific and medical (ISM) Radio-Frequency equipment - electromagnetic disturbance characteristics - limits and methods of measurement)
- IEC 61000-4-2-1995 (EMC - Electrostatic discharge immunity test (ESD))
- IEC 61000-4-3-1995 (EMC - Radiated, RF, electromagnetic field immunity test)
- California Bureau of Home Furnishings 116 (Flammability Standards)
By demonstrating substantial equivalence to a legally marketed predicate and showing compliance with these recognized safety and performance standards, the device is deemed to meet the necessary "acceptance criteria" for market clearance in a 510(k) context.
Not Applicable/Not Provided Information for this Type of Device Submission:
As mentioned, most of the specific clinical study-related questions are not relevant here because this is a mechanical mobility device, not an AI/diagnostic/therapeutic device requiring clinical validation in the same way.
- 2. Sample size used for the test set and the data provenance: Not applicable. Performance is based on engineering testing to standards and comparison of specifications. No "test set" of patient data is used in this context.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineered performance is defined by the standards and the predicate device's specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical performance aspects, the "ground truth" is established by the specifications of the predicate device and the test limits/methodologies defined in the cited national and international performance standards (e.g., for stability, speed, EMC, flammability).
- 8. The sample size for the training set: Not applicable. No training set as this is not a machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).