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The Lite is a mobility assistive device for indoor use and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Lite scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Lite alone and to safely steer under all driving conditions. The Lite is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. The Lite can be folded. This allows for easy storage and enables portability of the Lite. The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off, a lever for forward/reverse driving and a knob for speed adjustment. The control panel also contains the control indicator for the status of the device and a battery gauge. The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified. The steering column can be adjusted and put it in the position which is most comfortable for the operator. The armrests can be lifted to enable easy entry and exit from the scooter.

The provided document describes the FDA 510(k) clearance for the "Lite" mobility assistive device. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with clinical endpoints and statistical power for performance metrics like sensitivity, specificity, etc., that would be expected for an AI/ML powered device.

Therefore, many of the requested fields are not applicable (N/A) in this context, as the "Lite" is a physical mobility device and not a diagnostic or AI-powered system that would require such studies.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for "Lite" Mobility Assistive Device

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally met by demonstrating compliance with various ISO 7176 series safety standards. The reported device performance is presented as a comparison to a predicate device ("Elite").

Additional Performance Characteristics (Comparison to Predicate):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is not an AI/ML or diagnostic device that typically uses "test sets" of data in the common sense. The testing involved physical units of the device to confirm compliance with international standards.

• Sample size: Not explicitly stated, but typically, a limited number of physical prototypes or production units would be tested for compliance with engineering standards.
• Data provenance: Not applicable in the context of data for an AI/ML model. The tests were performed on the device itself. The manufacturer is Tzora Active Systems Ltd., located in Israel. The standards are international (ISO).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device. Compliance is determined by objective measurements against established engineering and safety standards (ISO 7176 series). The "experts" would be the engineers and technicians performing the standard compliance tests, trained in their respective fields.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to resolve disagreements in expert readings for diagnostic or AI/ML evaluations. This is a physical device tested against objective standards.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical mobility device that requires a human operator for its intended function. There is no standalone algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series). This involves objective physical measurements and tests performed on the device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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