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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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The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Titan 3W 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 Titan 3W alone and to safely steer under all driving conditions. The Titan 3W is intended for indoor use and outdoor use. The Titan 3W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 3W can be folded and disassembled into two parts, the Front Frame and the Rear Frame. Separating both frame parts allows for easy storage and enables portability of the Titan 3W. The Front Frame consists of the steering column, control panel, front wheels, footrest plate and seat. The Rear Frame consists of the motor, controller and battery holders. 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, knobs and switches for speed adjustment and lights (front and rear lights, indicators and hazard lights). 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 provided text describes the 510(k) premarket notification for the Titan 3W, a motorized three-wheeled vehicle. It details a comparison to a predicate device, the Titan 4W, and provides performance test results against various ISO standards. However, it does not contain information related to an AI/algorithm-based device, human reader studies, or the specific criteria and study details as requested for an AI/algorithm's acceptance criteria and performance.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets them in the context of an AI/algorithm, human readers, or ground truth. The document is about a physical medical device (mobility scooter) and its substantial equivalence to a predicate device based on engineering and safety standards.

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The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Titan 4W 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 Titan 4W alone and to safely steer under all driving conditions. The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.

The provided document is a 510(k) summary for the Titan 4W, a motorized three-wheeled vehicle (scooter). It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.

The "Performance Testing" section mentions that several standards were met and a "Usability Study validated the system's usability by the intended user." This implies testing was done, but the specifics requested in your prompt regarding acceptance criteria and performance metrics for a medical device are not provided in this document.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned, other than compliance with general standards.
2. Sample sized used for the test set and the data provenance: No information on sample sizes for any tests, nor data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this document does not describe a study involving expert-established ground truth for a diagnostic or AI/ML output.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; this device is a physical mobility aid, not an AI/ML interpretative tool.
6. Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical mobility aid, not an AI/ML-driven diagnostic or interpretative tool.

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Mobility assistive device for indoor use and outdoor usc on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.

The Elite Scooter is a mobility assistive device for indoor use and outdoor use on mild terrain. The Elite Scooter is an ultra-light, compact, portable vehicle. It is designed for the use of active individuals that are able to walk short distances, but need assistance. The user must have sufficient arms and legs strength to get on and off the Elite on his/her own and to steer without effort under all driving conditions. The maximum allowed weight of the user is 250 lbs. The Elite features the patented Wheel Drive system that incorporates the motor in the front wheel for additional ease of steering. The innovation is restricted to the modification of the design and construction of the hub type magnet brush pancake motor and drive unit. The Elite has the following main components: The Foldable rear frame and the Steering column made from steel tubular welded parts with an oven baked powder coated paint finish. A single drive wheel and two free turning rear wheels. All three wheels are solid. The front wheel size is 10"x2", the rear wheel size is 8"x2". The seat is made from two Polypropylene injected molded vinyl covered foam. The backrest folds down and latches for transportation. The seat is adapted and fitted to the foldable rear-frame. The front wheel drive with a DC permanent magnet brush pancake motor. Because the reduction gear is a spur gear and not worm gear it is a very efficient system. The hub assembly, comprises the drive wheel, pancake shaped PM dc motor, reduction gearbox and an electro-magnetic brake. It has a slick structure, compact dimensions, high efficiency and low noise. It has no moving parts; is fixed to the front fork of the Elite. An electro-magnetic brake connected to its rear shaft. The brake is released electrically by the controller during motor operation, and applied after the motor decelerates and comes to a stop. A mechanical spring automatically applies the brake in case of an electrical failure. The control is a forward/reverse wigwag type that can be operated by both left and right hand. A speed adjustment knob limits the maximum speed. There is a Power On/Off key switch on the control panel, a battery gauge and a LED for low battery and fault condition indication. The brake release toggle is on the control cover. The Controller from Penny and Giles Drives Technologies Ltd. (UK), conforms to all applicable international standards. The 12V battery packs are available in two sizes: the Mini-size pack contains 7.2Ah capacity batteries and the Jumbo size pack -- 12Ah capacity. There is a short-circuit protection fuse in the Battery Pack. The 100-240 VAC charger charges the batteries either directly (off board) or via a socket on the front column with an inhibit feature that does not allow the scooter to be driven when the batteries are being charged. Carrying Basket placed below the seat.

The provided text is a 510(k) summary for "The Elite - ultra-light, compact portable scooter". It describes the device, its components, and its intended use. However, this document does not contain information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication), or MRMC/standalone study results.

Therefore, I cannot provide the requested information based on the provided input. The prompt specifically asks to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" based on the input. Since this information is not present in the provided text, I must state that.

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Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.

Motorized three wheeled vehicle

The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "EasyTravel," which is a motorized three-wheeled vehicle. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device EasyTravel and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified"

This indicates that the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria from a new clinical study or AI algorithm validation.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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