(130 days)
Esteem scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly person limited to a seated position.
The Esteem invalid scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly person limited to a seated position. The Esteem invalid scooter consist of a chassis, shroud, transaxle, seat, controller, batteries, and battery charger. It also includes a tiller handle for steering and a thumb or finger operated potentiometer throttle control level to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt 28ah sealed lead-acid (AGM or Gel type) batteries with 19 miles range. The maximum speed is up to 6mph. The rigid chassis features an advanced design that weight distribution resulting in dynamic performance that greatly improves safety and ride comfort
The provided text describes the 510(k) summary for the "Esteem scooter" by Letrix Power Hangzhou Pty Ltd. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (K103771), rather than a clinical study evaluating diagnostic performance. As such, many of the requested categories related to medical device studies proving acceptance criteria (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission for a mobility device.
However, I can extract information related to the acceptance criteria as defined by the non-clinical testing standards and the reported device performance against those standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Esteem scooter are primarily derived from various parts of the ISO 7176 series of standards, which are specific to wheelchairs, and the CE Council Directive MDD93/42/EEC essential requirements. The document states that the Esteem invalid scooter "has passed all testing requirements" and "has been tested to wheelchair standard and approvals."
| Acceptance Criteria (Standard & Parameter) | Reported Device Performance (as stated or implied) |
|---|---|
| ISO7176-1:1999 Static Stability | Passed testing requirements of this standard |
| ISO7176-2:2001 Dynamic Stability | Passed testing requirements of this standard |
| ISO7176-3:2003 Brake Efficiency | Passed testing requirements of this standard |
| ISO7176-4:2008 Energy Consumption (Range) | 19 miles range (also implies meeting standard) |
| ISO7176-5:2008 Overall Dimensions, Mass, space | Scooter weight: 175 lbs; Length: 47.5 in; Width: 25 in; Wheelbase: 36.5 in (also implies meeting standard) |
| ISO7176-6:2001 Max Speed, Acceleration | Maximum speed: up to 6mph (also implies meeting standard) |
| ISO7176-9:2001 Climatic Tests | Passed testing requirements of this standard |
| ISO7176-10:2008 Obstacle-Climbing Ability | Passed testing requirements of this standard |
| ISO7176-11:1992 Test Dummies | Implicitly used in testing for relevant standards |
| ISO7176-13:1989 Coefficient of Friction | Implicitly tested as part of other standards |
| ISO7176-14:2008 Power and Control Systems | Passed testing requirements of this standard; Uses Curtis PMC controller |
| ISO7176-15:1996 Information Disclosure, Documentation, Labeling | High quality plastic labels, easy to read, correctly positioned, informative. Meets 21CFR820.130. |
| ISO7176-16:1997 Resistance to Ignition | Passed testing requirements of this standard |
| ISO7176-21:2009 Electromagnetic Compatibility (EMC) | Passed testing requirements of this standard (Intertek test report no. SH10071042-001) |
| Slope holding ability | Will stay firmly on a slope of greater than 15 degrees without slipping |
Study Information (Based on the provided text):
The document details non-clinical testing to various ISO standards applicable to wheelchairs and scooters. It does not describe a clinical study in the typical sense of evaluating diagnostic performance with human subjects. Instead, it relies on engineering testing and comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for a typical clinical study of diagnostic performance. The "test set" here refers to the physical device (Esteem scooter) undergoing engineering tests. These tests are performed on the device itself and its components. The number of individual scooters tested is not specified, but typically this would involve a limited number of production units or prototypes.
- Data Provenance: The testing was conducted by Intertek Testing Services for EMC and implicitly by Letrix Power Hangzhou Pty Ltd. or a contracted lab for the other ISO standards. The document mentions the device has been in the Australian market since 2003 with "no adverse outcomes or safety related issues having been detected," implying retrospective market surveillance data from Australia.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. The "ground truth" for these engineering tests is defined by the technical specifications and performance limits set within the ISO standards themselves. The experts involved would be engineers and technicians conducting the tests and verifying compliance, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of medical data. For engineering tests, compliance is determined directly by measurements against specified thresholds in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance. This document concerns a physical mobility device, not a diagnostic AI.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. The performance described is the standalone performance of the physical scooter based on engineering tests.
7. The Type of Ground Truth Used
- Engineering Standards and Specifications: The ground truth is defined by the requirements and test methods outlined in the various ISO 7176 standards, as well as the manufacturer's own design specifications (e.g., maximum speed, range, slope holding).
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. See point 8.
§ 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).