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The intended use of the Mega Motion, Inc, Travel Pal Four Wheel Scooter is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

The Travel Pal Four - Wheel Scooter is a battery-operated compact scooter equipped with a digital controller. Features include an adjustable and removable molded plastic seat, a foldable tiller, one-piece solid frame, and an off board charger, designed for ultimate performance, stability and portability. Additional features include electronic regenerative / electromechanical disc brakes, and rear anti-tip wheels designed for ultimate safety.

The device described is the Travel Pal Four-Wheel Scooter (K080288), manufactured by Mega Motion, Inc.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are derived from compliance with various ANSI/RESNA WC standards. The document states that the device has "passed all the necessary testing procedures," implying that it has met the requirements of each standard.

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

The document does not provide details on the sample size for the "non-clinical testing" (the testing against the ANSI/RESNA WC standards). These tests are typically performed on a limited number of production or pre-production units. The data provenance is not specified beyond being "non-clinical testing." It's generally assumed such testing is performed in a controlled laboratory environment. It is implicitly "prospective" as it's done specifically to demonstrate compliance for regulatory submission.

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)

The concept of "experts establishing ground truth" as it applies to clinical diagnostics or imaging interpretation (like radiologists) is not relevant for this device. The standards themselves define the "ground truth" or the acceptable performance parameters. The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standard's specifications. Their qualifications are not specified but would typically involve expertise in mechanical engineering, electronics, and product safety testing.

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

Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex data (e.g., medical images). This is not applicable to the non-clinical testing of a mobility scooter. The "adjudication" is inherent in the pass/fail criteria defined by each specific ANSI/RESNA WC standard.

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 MRMC comparative effectiveness study was done. This type of study (often used for AI-assisted diagnostic tools) is not relevant to a mobility scooter. The study performed focuses on safety and performance characteristics against established engineering standards.

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

This question is not applicable. The device is a physical mobility scooter, not a software algorithm.

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

The "ground truth" for the performance claims is defined by the ANSI/RESNA WC standards and CAL 117 Flammability Testing. These are widely accepted industry standards that specify test procedures and acceptable performance limits for wheelchairs and scooters.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This question is not applicable for the same reason as point 8.

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The intended use of the Mega Motion Inc., Travel Pal Powered Scooter, is to provide mobility to persons that have limited walking capabilities or simply those who wish to ride a scooter for transportation purposes.

The Travel Pal is a compact battery-operated Three Wheel power Scooter featuring rear anti-tip wheels, a standard digital controller, and a foldable tiller. The Travel Pal is designed for, but not limited to Mega Motion, Inc. providers / retailers and their consumers. As a motorized Scooter, the Travel Pal offers economical mobility, and is equipped with; electronic regenerative disc brakes, off-board battery charger, and removable batteries. Accessories include a front basket. The Travel Pal is designed with ultimate safety, stability, performance, and portability in mind. The product also has a lightweight, foldable seat, which is removable and allows for ease of portability when traveling or storing the unit.

The provided text describes a 510(k) premarket notification for the Travel Pal 3-Wheel Scooter. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a clinical study involving human patients. Therefore, many of the requested categories related to clinical study design (e.g., sample size for test set, number of experts, adjudication, MRMC study, standalone performance, ground truth for training set) are not applicable in this context.

Here's the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not applicable. The testing described is non-clinical, involving the device itself against engineering standards, not a set of patient data.
• Data provenance: Not applicable. The testing is device-based.

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 context of clinical studies, refers to disease presence/absence or other clinical outcomes. For non-clinical engineering tests, the "ground truth" is defined by the technical specifications of the ANSI/RESNA and CAL standards.

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

• Not applicable. This pertains to human reader agreement in clinical studies.

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-powered diagnostic device, and no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm. The device itself underwent performance testing in a standalone fashion against established engineering standards.

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

• For the non-clinical testing, the "ground truth" is the compliance with the specified engineering and safety standards (ANSI/RESNA WC series and CAL 117). These are objective, measurable criteria.

8. The sample size for the training set:

• Not applicable. There is no AI component or training set involved.

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

• Not applicable. There is no AI component or training set involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Travel Pal 3-Wheel Scooter's acceptance criteria are defined by compliance with a comprehensive set of non-clinical engineering and safety standards. The study proving the device meets these criteria was a series of non-clinical tests performed against the following established standards:

• ANSI/RESNA WC/93: Maximum Overall Dimensions
• ANSI/RESNA WC/01: Determination of Static Stability
• ANSI/RESNA WC/02: Determination of Dynamic Stability
• ANSI/RESNA WC/03: Effectiveness of Brakes
• ANSI/RESNA WC/04: Determination of Energy Consumption - Theoretical Range
• ANSI/RESNA WC/05: Overall Dimensions, Mass & Turning Space
• ANSI/RESNA WC/08: Test methods for Static, Impact and Fatigue Strengths
• ANSI/RESNA WC/09: Climatic Tests
• ANSI/RESNA WC/10: Obstacle Climbing
• ANSI/RESNA WC/15: Documentation and Labeling
• ANSI/RESNA WC Vol. 2-1998 Section 21: Requirements and Test Methods for Electromagnetic Compatibility
• CAL 117: Flammability Testing

The submission states that the Travel Pal "has passed all the necessary testing procedures" and that "Compliance to applicable Testing Standards is as follows: [list of standards]". This indicates that the device's performance was measured against the objective metrics and thresholds established by each of these standards, and in each case, it met the required criteria. The purpose of this testing was to demonstrate substantial equivalence to a predicate device (Mega3, MM-333, K982145) by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness.

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The Mega 4 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 4 is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.

The Mega 4 is a four-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 4-wheel scooter with a two wheel front end provides for a very stable ride. The Mega 4 scooter is an ideal outdoor scooter capable of traversing bumpy or uneven terrain. The Mega 4 is a four-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 4 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion. The Mega 4 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated by two devices: a throttle lever and a speed potentiometer. The Mega 4 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 4 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 ¼" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 4 has an adjustable tiller for user comfort and easy transportation. The Mega 4 scooter has an on board charger as standard equipment. The Mega 4 uses two 12-Volt 31 Amp sealed lead acid batteries.

This document is a 510(k) summary for the Mega 4 power scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report as typically seen for novel medical devices.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and pathology/outcomes ground truth) are not applicable or not provided in this type of submission.

The "acceptance criteria" here are implied by the standards the device was tested against and the performance compared to the predicate device. The "study" is a non-clinical test report.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated but implies testing was performed on one or more Mega 4 power scooters as part of the non-clinical testing. This is typically a device-level test, not a patient-level study.
• Data Provenance: The tests were conducted by the manufacturer (Mega Motion, Inc.) or a contracted testing facility. The country of origin of the data is not specified but would presumably be where the manufacturing and testing occurred.
• Retrospective or Prospective: These were prospective non-clinical tests performed on the device to demonstrate compliance with standards and for the 510(k) submission.

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

• Not Applicable. This submission details non-clinical device testing against engineering standards, not a clinical study involving experts to establish diagnostic ground truth.

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

• Not Applicable. This refers to clinical study ground truth establishment, which is not relevant here. The "adjudication" for non-clinical tests would be whether the device passed the specified test criteria as performed by the testing engineers.

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 a non-clinical device submission, not an AI or diagnostic imaging device.

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

• Yes (in principle, for the device as a whole). The non-clinical tests assess the performance of the Mega 4 scooter itself (e.g., EMI, battery safety, power system functionality) without human intervention in the assessment process. It's the device's inherent performance that is being evaluated against the standards.

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

• The "ground truth" for the non-clinical tests was the established engineering standards and regulatory requirements (e.g., ANSI/RESNA WC/14, FDA/U.L. requirements for chargers, battery transport regulations, and the performance characteristics of the predicate device). The device either met these objective criteria or it did not.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; therefore, no training set data would be used.

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

• Not Applicable. See point 8.

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The Mega 3 scooter is intended to help the user achieve a more independent lifestyle by increasing their personal mobility. The Mega 3 scooter is intended for use by people who due to medical reasons, accident, or injury do not have adequate mobility to lead the active lifestyle they want. It is also intended for any person who would simply rather ride a scooter than walk.

The Mega 3 is a three-wheel power scooter designed to help people with poor mobility lead a more active lifestyle. The fact that this is a 3-wheel scooter with a sharp turning radius makes it ideal for indoor use and cornering in close quarters. The Mega 3 scooter is also ideal for outdoor use as it is capable of traversing bumpy or uneven terrain.

The Mega 3 is a three-wheel scooter with exceptional handling and is quiet due to the use of pneumatic tires and a sealed transaxle as opposed to a separate motor, differential, and chain application. It is equipped with two kinds of brakes: dynamic regenerative and a parking brake. The electronic parking brake is normally on and is released when the driver moves the throttle lever. When the driver releases the throttle lever, the regenerative braking will slow the scooter to a stop and the parking brake will be activated 1/2 second thereafter, holding the scooter, preventing any movement. The electronic controller of the Mega 3 has a water-resistant casing with no exposed wires. This feature protects the electronics from environmental damage and corrosion.

The Mega 3 Scooter's maximum forward speed is 5.0mph. The maximum speed in reverse is 60% of the maximum forward speed or 3.0mph. The speed in reverse is reduced for safety purposes as it is more difficult to negotiate a scooter in reverse motion than in forward motion. The speeds are regulated in two ways: a throttle lever and a speed potentiometer.

The Mega 3 has several user-friendly features. It comes equipped with an external freewheeling release lever, external battery charger jack, and an external circuit breaker reset button all for easy accessibility. It has a special light-weight-seat (21 lbs.) for easy disassembly and transportation. The seat is adjustable up and down, swivels 360°, and has flip up arms. The Mega 3 is equipped with two lateral and two rear high visibility reflectors to increase the scooter's visibility. This feature, as well as the anti-tip wheels located 1 1/2" from the ground on the rear of the scooter, provide added safety for the passenger. The Mega 3 has an adjustable tiller for user comfort and easy transportation.

The Mega 3 scooter has an on board charger as standard equipment. The charger has passed the minimum voltage ground leakage as required by the FDA/U.L. Certification from the charger supplier is included in section 4 of the 510(k)-application package.

The Mega 3 uses two 12-Volt 31 Amp sealed lead acid batteries. Certifications from the battery supplier that the batteries used on the Mega 3 meet the requirements of 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries and are therefore, unrestricted for transportation by any means are enclosed in section 4 of this 510(k)-application package.

The provided text describes a 510(k) application for a power scooter, not a medical device involving AI or complex performance criteria related to diagnostics. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted and a clear indication of what is not present in the provided text:

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

Since this is a physical device (a power scooter) and not a diagnostic or AI-driven system, the "acceptance criteria" are implied by the standards it passed and its technical specifications. There isn't a table specifically outlining acceptance criteria in the manner requested for an AI model's performance metrics (e.g., sensitivity, specificity).

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

• Sample Size for Test Set: Not applicable in the context of this device. The testing described is for the physical scooter's performance against engineering standards.
• Data Provenance: Not applicable. The testing is reported as nonclinical, laboratory-based performance testing of the device itself.

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)

• Not applicable. The "ground truth" for a power scooter's performance is objective measurement against established engineering standards (e.g., speed, weight capacity, EMI immunity tests). No human expert consensus was needed to establish this.

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

• Not applicable. This concept applies to diagnostic interpretation where disagreements need resolution. For physical device testing, the results are typically directly measured or observed.

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 a power scooter, not a diagnostic system or AI-assisted tool for human readers. No MRMC study was conducted.

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

• Not applicable. This is a physical device, not an algorithm. Its operation is "standalone" in the sense that it functions independently once operated, but not in the context of an AI algorithm evaluation.

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

• Ground Truth Type: Objective engineering standards and direct measurements. For example, maximum speed is a direct physical measurement, EMI immunity is tested against a defined electromagnetic field.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning model that undergoes "training."

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

• Not applicable. As there is no training set for this type of device.

Summary of Relevant Information:

The study conducted was a nonclinical test of the Mega 3 power scooter against the ANSI/RESNA Standard, Wheelchairs – Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05, and 10.

The device passed these tests. Additional nonclinical tests included:

• EMI testing, where it passed at an immunity level of 20 V/m.
• Charger safety for minimum voltage ground leakage, which it passed.
• Battery safety, with certifications confirming compliance with 49CFR173.159(d) and Special Provision A67 of the IATA Dangerous Goods Regulations for non-spillable batteries.

No clinical tests were submitted. The conclusions drawn are based on the comparison of design, function, and features to predicate devices and the results of the nonclinical testing against the ANSI/RESNA standards.

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