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Zip'r4 and Zip'r4 Xtra scooter are intended for the indoor/outdoor electrical scooter that provide transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

The Zip'r4 and Zip'r4 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

The Zip'r4 and Zip'r4 Xtra scooters are with a 113 kg (250 Ibs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed powered. Incor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).

The provided text describes the regulatory submission for the Zip'r4 and Zip'r4 Xtra scooters and their substantial equivalence to a predicate device. It primarily focuses on compliance with existing standards for motorized wheelchairs and the administrative process of 510(k) clearance.

Unfortunately, the document does not contain the detailed information necessary to answer all the questions regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might describe for a software or AI/ML-based medical device.

The context of this document is a 510(k) submission for a physical medical device (electrical scooter), not an AI/ML diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable or not provided.

However, I can extract the information related to the device's compliance with established standards, which serve as its "acceptance criteria" in this context.

Here's the breakdown of what is available from the provided text:

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

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

• Sample Size: Not specified. Testing likely involved a representative number of units to demonstrate compliance with the listed standards, but the exact count is not detailed.
• Data Provenance: Not specified, but Global FabTech Wheelchair (Shanghai) Co., Ltd. is based in Shanghai, China, and Taichung, China (Taiwan). The testing was for international (ISO/IEC), US (ANSI/RESNA), and California standards, implying testing was conducted to meet these specific regulations. The nature of the testing for physical device standards implies prospective testing of manufactured units rather than retrospective data analysis.

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 to this type of device. "Ground truth" in the context of physical medical devices typically refers to measured performance against established engineering and safety standards, usually conducted by certified testing laboratories, not medical experts establishing diagnostic ground truth.

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

• Not applicable. This concept is relevant for expert review of medical images or data, not for testing the mechanical and electrical specifications of a mobility scooter.

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 for AI/ML diagnostic tools, not for a motorized scooter.

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

• Not applicable, as this is not an algorithm-based device.

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

• For this device, the "ground truth" for the test results (compliance with standards) is based on objective measurements and assessments against the specifications outlined in the referenced ANSI/RESNA, ISO, IEC, CISPR, and California Flammability standards, performed by qualified testing methods and equipment.

8. The sample size for the training set

• Not applicable; this is not an AI/ML device that requires a training set.

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

• Not applicable.

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The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

Here's a breakdown of the acceptance criteria and study information for the Zip'r Mantis powered wheelchair, based on the provided 510(k) summary:

This device is a physical product (a powered wheelchair), not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, and training/test set details are not applicable in this context. The study performed is engineering and safety testing against recognized standards.

Acceptance Criteria and Reported Device Performance

The Zip'r Mantis powered wheelchair's acceptance criteria are based on compliance with several international and national standards for wheelchairs. The study performed was a summary of non-clinical testing demonstrating this compliance.

Explanation of the Study and Why Other Information is Not Applicable:

The provided document is a 510(k) summary for a physical medical device (a powered wheelchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering and safety testing. It is not an AI/Software as a Medical Device (SaMD) submission.

Therefore, the following points are not applicable and cannot be answered from the provided text:

• Sample size used for the test set and data provenance: This refers to data used for AI model evaluation. For a physical device, testing involves physical prototypes or production units against specified standards. The document doesn't detail the number of wheelchairs tested, but it does state they "complied with the requirements."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" and "experts" in this context typically refer to clinical or diagnostic interpretation for AI/software. For a wheelchair, ground truth is defined by the objective pass/fail criteria of the engineering standards.
• Adjudication method for the test set: Not applicable to engineering compliance testing.
• 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: MRMC studies are specific to evaluating human reader performance with and without AI assistance in interpretation tasks. This is not relevant for a powered wheelchair.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm being evaluated in a "standalone" fashion.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the objective, quantifiable requirements outlined in the cited engineering and safety standards.
• The sample size for the training set: Not applicable, as there is no AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable, as there is no AI model requiring a training set.

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To provide mobility to disabled or elderly persons limited to a seated position.

The Zip'r3 and Zip'r3 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

The Zip'r3 and Zip'r3 Xtra scooters are with a 113 kg (250 lbs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed transaxle motor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).

The provided document describes the 510(k) summary for the "Zip'r3 / Zip'r3 Xtra scooter" by Global FabTech Wheelchair (Shanghai) Co., Ltd. This is a medical device submission, and the focus is on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials for novel devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a test set in the way a clinical study would. Instead, it refers to compliance with a series of non-clinical testing standards. These standards typically involve a defined number of units or components subjected to specific tests, but the exact number isn't specified in this summary.

• Data Provenance: The testing was conducted by Global FabTech Wheelchair (Shanghai) Co., Ltd., implying it occurred in China. It is retrospective in the sense that the results are reported after the tests were completed to demonstrate compliance for a premarket notification.

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

• This information is not applicable (N/A) for this type of submission. The "ground truth" here is compliance with established international and national technical standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, Flammability Standards). These standards themselves define the criteria for success or failure, and the testing is performed by accredited labs or internal quality control departments, not typically "experts" establishing a clinical ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

• This is not applicable (N/A). The "adjudication" in this context refers to whether the device passed or failed the specified tests within the standards. This is generally a clear pass/fail outcome determined by measurement against the standard, not an expert panel consensus or dispute resolution.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC study was not done. This document pertains to a physical medical device (an electrical scooter) and its compliance with engineering and safety standards, not a diagnostic or AI-driven system that would involve human readers interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is compliance with established international and national performance, safety, and electromagnetic compatibility (EMC) standards. These standards (e.g., ISO 7176 series, IEC 61000 series, CISPR 11, California Flammability Standards) define the objective criteria and test methods that the device must meet to be considered safe and effective for its stated intended use.

8. The Sample Size for the Training Set

• This is not applicable (N/A). There is no concept of a "training set" in the context of a 510(k) submission for a physical device demonstrating substantial equivalence through standard compliance. The device itself is the product being tested.

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

• This is not applicable (N/A) for the same reasons as point 8.

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