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The intended use of the Golden Liteway is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.

The intended use of the Golden Liteway is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of operating a simple hand control.

The Golden Liteway is a three wheeled battery powered scooter. It has a 45-amp controller, which is used to operate the Golden Liteway. The one-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable fold down seat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users' weight near the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Golden Liteway comes standard with a compact removable 24-volt battery pack with auto contact and lock and an off board charger. The Golden Liteway has an operating range of 7.5 miles on a full charge at Maximum weight of 300 lbs. The frame can be separated from the rear wheel assembly for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4-mph.

The Golden Liteway is a three-wheeled battery-powered scooter intended to provide mobility to persons limited to a seated position who are capable of operating an electric scooter. The submission is a 510(k) premarket notification, and therefore, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the document addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary demonstrating substantial equivalence to a predicate device (the Buzzaround, K041025) and not a de novo clearance or PMA submission for a novel device, the "acceptance criteria" are primarily established by conformity to relevant industry standards and comparison to the predicate. The performance reported focuses on meeting these standards and having similar characteristics to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a "test set" in the context of clinical trials or AI/algorithm performance. The non-clinical tests refer to standardized testing of mechanical and electrical components, not typically involving distinct "test sets" of patient data or users.
• Data Provenance: Not applicable in the context of this 510(k) for a mobility scooter, as it relies on engineering and performance standards rather than clinical data sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. This submission concerns a physical medical device (scooter) and relies on engineering standards and technical specifications rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this involves technical standards and physical product testing, not subjective expert adjudication.

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-enabled device requiring MRMC studies.

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

• Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering and safety standards (e.g., ISO, ANSI/RESNA, EN, California Bulletin 117). Compliance with these standards serves as the benchmark for acceptable performance. The performance characteristics of the predicate device also serve as a "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm device.

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

• Not applicable. This is not an AI/algorithm device.

Summary of the Study and Substantial Equivalence:

The study proving the device meets its acceptance criteria is a series of non-clinical engineering tests (as listed in Section {1} and {2}) and a comparison to a predicate device. The Golden Liteway demonstrates its substantial equivalence to the predicate device, the Buzzaround (K041025), by:

• Having the same intended use: providing mobility to persons limited to a seated position capable of operating an electric scooter.
• Possessing similar technological characteristics: both are controlled by a paddle-type potentiometer, have onboard batteries and chargers, and equivalent safety features.
• Successfully undergoing a battery of non-clinical tests (e.g., stability, energy consumption, speed, flammability, EMC) according to recognized international and national standards (ANSI/RESNA, EN, ISO, TB117). The successful completion of these tests implicitly demonstrates compliance with the safety and performance requirements of these standards.

The conclusion is that the differences in technological characteristics of the Golden Liteway compared to the Buzzaround do not raise any new questions of safety or effectiveness, thus establishing substantial equivalence. No clinical trials were performed or deemed necessary for this type of device.

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The intended use of the Golden Spyder is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Golden Spyder is to provide mobility for those persons limited to a seated position that are capable of operating a simple hand control.

The Golden Spyder is a six wheeled battery powered wheelchair. It has a Dynamics Shark controller which is used to operate the Golden Spyder. The main frame of the wheelchair is made of welded steel construction. The main frame also consists of a battery box. The center drive wheels are mounted on the drive shafts of separate motor/gear assemblies, one on the left side of the wheelchair, the other on the right side. It would frame via a four-post mounting system. The seat connected, to the drive and near the center wheels to aid in traction. All seating Concentrates the ascrowing to the Golden Spyder comes standard with two easily removable 12-volt batteries and an on or off board charger. It has an operating range of 15-20 miles on a full charge. The weight capacity is 300-lbs and it has a maximum speed of 5-mph.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Golden Spyder. The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on clinical performance metrics typically associated with AI/software devices.

Therefore, many of the requested sections regarding AI device performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as this is a traditional medical device (a wheelchair) and not an AI-powered device being evaluated.

Here's an analysis of the information that is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a wheelchair, acceptance criteria are generally based on compliance with recognized consensus standards for safety and performance rather than clinical performance metrics (like sensitivity, specificity, etc.) typically found in AI/software evaluations.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. This refers to a physical device evaluated against standards, not a data-driven model.
• Data Provenance: Not applicable. The evaluation is of the physical wheelchair.

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

• Not applicable. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for a wheelchair's performance is its direct measurement against engineering and safety standards.

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, as this is not an AI-assisted device.

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

• Not applicable, as this is not an AI/algorithm.

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

• For this device, the "ground truth" is adherence to established engineering and safety standards (e.g., stability, braking effectiveness, EMC). There's no clinical "ground truth" in the sense of a diagnosis or outcome that an AI would predict.

8. The sample size for the training set

• Not applicable. This is not an AI device trained on data.

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

• Not applicable.

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The intended use of the Buzzaround is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
The intended use of the Buzzaround is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of overating a simple hand control.

The Buzzaround is a three wheeled battery powered scooter. It has a 70-amp controller, which is used to operate the Buzzaround. The two-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable fold down scat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users weight over the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Buzzaround comes standard with a compact removable 24-volt battery pack and on or off board charger and has an operating range of 10 to 15 miles on a full charge. The front and rear frames can be separated for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4.5-mph

The provided submission K041025 is for a motorized three-wheeled vehicle (scooter) named Buzzaround. The acceptance criteria and the study performed for this device are focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, rather than clinical studies with human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/ML powered device, so there is no reported performance in terms of metrics like sensitivity, specificity, or AUC as might be seen for diagnostic algorithms. Instead, the acceptance criteria are met by demonstrating compliance with specific ANSI/RESNA performance standards for scooters.

2. Sample Size Used for the Test Set and Data Provenance

The submission does not detail a "test set" in the context of clinical data for AI/ML validation. The "testing" referred to comprises non-clinical performance tests conducted on the physical device itself. Therefore, a sample size of human subjects or medical images for a test set is not applicable. The data provenance is from the results of a series of engineering and performance tests on the Buzzaround device according to specified industry standards (ANSI/RESNA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable as the ground truth for this type of device (a mobility scooter) is established through adherence to engineering standards and safety tests, not through expert review of clinical data. The "ground truth" here is the physical performance and safety characteristics of the device when subjected to standardized tests.

4. Adjudication Method for the Test Set

This question is not applicable for the reasons stated above. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated, either with or without AI assistance. The Buzzaround is a physical mobility device, not a diagnostic tool or AI algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Buzzaround is a physical medical device, not a software algorithm, so the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily engineering and performance standards compliance. Specifically, the device's performance was compared against the requirements stipulated in:

• ANSI/RESNA WC/01 1990 Determination of Static Stability Testing
• ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing
• ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes
• ANSI/RESNA WC/05 1990 Determination of Overall Dimensions, Mass, and Turning Space
• ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability
• ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.

The "ground truth" also includes the design specifications and features of the predicate device (Companion 221, K012258) for comparison of substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. The Buzzaround is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated above.

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The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

Not Found

The provided text is a set of FDA 510(k) clearance letters for three models of motorized three-wheeled vehicles (Companion 221, 321, 421). These documents are regulatory approvals and DO NOT contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report or a detailed technical submission.

Therefore, I cannot provide the requested information from the given text.

The documents focus on:

• Device Name & Regulation: Identifying the specific device models and their regulatory classification.
• Indications For Use: Defining the intended purpose and user population for the devices.
• Substantial Equivalence: Stating that the devices are substantially equivalent to pre-amendment devices, which is the basis for 510(k) clearance.
• General Controls: Mentioning the regulatory requirements for the device.

To answer your request, information from a different type of document (e.g., a 510(k) summary, a design validation report, or a clinical study report) would be needed.

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The scooter is designed to enhance user mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users who simply prefer to ride but can, if need be, walk.

This is a modular electrically-powered scooter including as modular components a seat, seat post, main front frame and, motor assembly, removeable rear plastic body and 2-12VDC batteries connected in series to provide a 24VDC power source The scooter is built in a manner allowing quick and easy assembly/disassembly.

The mainframe includes a rotably-affixed front wheel and tiller for steering, a seat post pedestal I he maintrains modules a panel with direction/speed control, a headlight, a rear half weldment (anti-ip wheelie bars and leaf springs) hinged to main floor pan and a latch/receiver mechanism to capture motor assembly locking bar.

The motor assembly includes a pair of rear wheels coupled to a transaxle which is driven by an electric motor. The motor assembly also includes an electric brake, motor control board, battery charger, 2-12VDC batteries, a battery tray and a connector panel for battery and control signal cable hook-ups.

The motor assembly is secured to main front frame by threading motor carriage pins just under rear weldment leaf springs, rotating motor assembly to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, insert seat post into seat pedestal (receiver), hold latch in a "locked" upright position.

The provided text describes the Golden Eagle GT2000 motorized 3-wheeled vehicle (K971043) and its substantial equivalence to a predicate device, the Pride Health Care Legend Scooter (K926295). It lists safety and effectiveness information based on adherence to various ISO and IEC standards through testing.

However, the document does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text is related to a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data or performance metrics for complex AI/ML devices. Therefore, much of the requested information is not applicable or not present in this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

The document lists standards the device was tested against, and in some cases, indicates "PASS" or "PASS WITH FIX". It does not provide specific numerical acceptance criteria or detailed performance metrics beyond this.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document states "The scooter has been tested to the following standards," implying physical testing of one or more units, but does not quantify the number of units or test iterations.
• Data provenance: Not explicitly stated. The testing seems to be internal and/or by a third-party lab against international standards (ISO, IEC, UL). Location of testing, and whether it's retrospective or prospective, is not mentioned.

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

• This information is not applicable to the type of device and testing described (physical product safety and performance against engineering standards). Ground truth, in the context of expert review, is typically relevant for interpretative tasks, e.g., image analysis or diagnostic support, which is not the function of this device.

4. Adjudication method for the test set

• Not applicable as this is not a study requiring adjudication of expert interpretations.

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

• No. This is not an AI/ML device, and no MRMC comparative effectiveness study is mentioned.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the tests performed would be defined by the specifications and pass/fail criteria within the referenced UL, ISO, and IEC standards for physical product safety, stability, and electromagnetic compatibility. For example, for static stability, the ground truth would be whether the scooter maintains stability under defined conditions according to the standard.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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