(89 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The LERADO, AVANTICARE Electrical Scooter SM3021 is an indoor / outdoor Electrical Scooter that is battery operated. It has a base with three-wheeled The movement of the Wheelchair is controlled by the rider who uses with a seat. hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
This document is a 510(k) summary for the LERADO, AVANTICARE Electrical Scooter, SM3021. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies cannot be fully extracted as they are not explicitly present in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (LERADO, AVANTICARE SM3021) |
|---|---|
| Intended Use (Same as predicate) | Provides mobility to persons restricted to a seated position. |
| Back Upholstery (Same as predicate) | Same as predicate (WU'S Wheeled Neo Scooter WT-T3B). |
| Armrest Types (Same as predicate) | Same as predicate (WU'S Wheeled Neo Scooter WT-T3B). |
| Warranty Period (Same as predicate) | Same as predicate (WU'S Wheeled Neo Scooter WT-T3B). |
| Safety Level of Electronic Systems (Same as predicate) | Electronic systems (batteries, recharge, switching power supplier) from same UL-certified suppliers as predicate (except electric controllers). |
| Cruising Range (Substantially equivalent to predicate) | 10 miles (acknowledged to be less than predicate's 10 miles, but deemed "substantially equivalent" in real-life use depending on practice environments). |
| Weight Limit (Different from predicate) | 300 lbs (Predicate: 250 lbs). |
| Maximum Speed (Different from predicate) | 4.7 mph (Predicate: 4 mph). |
| Compliance with Standards | EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (for electrical scooters, controller, and chargers). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes a substantial equivalence comparison, not a clinical study with a test set of users. The performance testing section lists compliance with specific electrical and mechanical standards, which would involve testing the device itself, not a "test set" of patient data.
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 provided. The assessment relies on engineering and regulatory compliance, not expert clinical ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. This concept is not applicable to the type of safety and performance testing described.
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 information is not provided. An MRMC study is not relevant to an electrical scooter. The document does not mention any AI component or human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. This concept is not applicable to an electrical scooter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is the compliance with published industry standards and specifications (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the specifications of the predicate device. The document states that the electronic components were "all passed by the UL certificated," indicating adherence to safety standards.
8. The sample size for the training set
This information is not provided. There is no "training set" in the context of an electrical scooter.
9. How the ground truth for the training set was established
This information is not provided as there is no training set involved.
§ 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).