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The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Ruike 3421 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. But the Ruike 3421 is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two 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.

This document is a 510(k) summary for the Ruike 3421 powered wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML-driven medical devices.

Instead, this submission is for a physical medical device (a powered wheelchair) and relies on demonstrating "substantial equivalence" to a predicate device already on the market. Therefore, the questions related to AI/ML device evaluation (like sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria or reported device performance in the traditional sense for an AI/ML device. For a physical device like a powered wheelchair, acceptance criteria would typically involve engineering specifications, safety standards (e.g., ISO or ANSI standards for wheelchairs), durability tests, and performance metrics like speed, range, turning radius, weight capacity, etc. The document only mentions "minor differences in performance specifications" compared to the predicate, implying that the Ruike 3421's performance is largely comparable while potentially being "a new class of lightweight powered wheelchair." However, no specific performance metrics or acceptance criteria are detailed.

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

• Not Applicable: This is a physical device, not an AI/ML diagnostic or prognostic tool that uses data for testing. The evaluation focused on substantial equivalence to a predicate device.

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

• Not Applicable: Ground truth establishment by experts is relevant for diagnostic accuracy studies of AI/ML algorithms. This document does not pertain to such a study.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication is used in studies with multiple readers/experts. This document describes a traditional medical device submission.

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

• No, an MRMC study was not done. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a physical device like a powered wheelchair.

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

• Not Applicable: "Standalone performance" refers to the performance of an algorithm without human intervention. This device is a powered wheelchair, not an algorithm.

7. The Type of Ground Truth Used:

• Not Applicable: The concept of "ground truth" (expert consensus, pathology, outcomes data) is for validating diagnostic or predictive algorithms. For this device, the "ground truth" for regulatory approval is primarily its safety and effectiveness being substantially equivalent to a legally marketed predicate device. This involves demonstrating compliance with relevant standards and functional requirements for a wheelchair.

8. The Sample Size for the Training Set:

• Not Applicable: "Training set" refers to data used to train an AI/ML algorithm.

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

• Not Applicable: As above, this concept applies to AI/ML algorithm development.

Summary of what the document does provide regarding the device's acceptance and study:

The acceptance of the Ruike 3421 powered wheelchair by the FDA is based on its substantial equivalence to a predicate device, the CWD01 (K062888) / EMG Technology Co. Ltd.

• Acceptance Criteria (Implied by Substantial Equivalence): The device is considered acceptable because it performs its "intended function and use" without raising "any new questions pertaining to safety or effectiveness" compared to the predicate device. This essentially means it meets the safety and basic performance expectations already established for powered wheelchairs on the market.
• Study/Evidence: The "study" for this type of submission is the 510(k) Premarket Notification itself, where the manufacturer (Shanghai Ruike Sports Goods CO., LTD.) presents a detailed comparison between their device (Ruike 3421) and the predicate device (CWD01). This comparison would typically include:
  • Intended Use: Both devices are intended for indoor/outdoor transportation for disabled or elderly persons limited to a seated position.
  • Technology/Design: The Ruike 3421 is "basically similar to other powered wheelchairs," but designed to be lightweight and break down into two components.
  • Performance Specifications: The document states "minor differences in performance specifications" but asserts these do not alter function, safety, or effectiveness. (Specific performance data is not provided in this summary, but would have been part of the full 510(k) submission).
  • Materials: (Not explicitly mentioned in the summary, but usually part of a full submission).
  • Labeling and Controls: The device must comply with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).

In essence, the document serves as evidence that the manufacturer has presented sufficient information to the FDA to demonstrate that their new device is as safe and effective as a legally marketed device, thus allowing it to be marketed.

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The Ruike 3411 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Ruike 3411 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

This document describes a 510(k) premarket notification for the Ruike 3411 scooter, an electrical scooter intended for transportation of disabled or elderly persons. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a detailed study with clinical outcomes.

Therefore, the provided text does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

• Intended Use: The Ruike 3411 scooter is an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
• Predicate Device: The LANDLEX S400X (K 050793) manufactured by Besteam Technology Inc.
• Substantial Equivalence Claim: The Ruike 3411 scooter is substantially equivalent to the predicate device. The submission claims "minor differences in performance specifications... do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."

In summary, this submission is not about clinical performance data demonstrating specific acceptance criteria with a study. It's about demonstrating equivalence to an already approved device based on design and intended use.

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The Ruike 3431 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Ruike 3431 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided document is a 510(k) Summary for a medical device (Ruike 3431 scooter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) Summary for a device like this.

Specifically:

• Acceptance Criteria and Reported Device Performance: Instead of explicit acceptance criteria being met by a study, the document presents a comparison to a predicate device (Bewell SC 20). The "performance" is described through the device's technical specifications and intended use, and the claim is that minor differences do not alter the intended function or raise new safety/effectiveness questions.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Study, Training Set: These are all concepts related to clinical or performance studies designed to validate the efficacy or accuracy of a device, especially those involving AI or diagnostic capabilities. The Ruike 3431 scooter is a mobility device, and its approval process relies on demonstrating that it is as safe and effective as pre-existing, legally marketed devices (the predicate). This usually involves engineering tests (e.g., maximum loading, speed, braking distance) and a comparison of specifications, not clinical trials with human subjects to establish ground truth or measure improvements with AI assistance.

However, I can extract the comparative performance table that serves as the basis for demonstrating substantial equivalence:

1. Table of Acceptance Criteria (or Comparison to Predicate) and Reported Device Performance

Instead of "acceptance criteria" against which a study directly validates, the 510(k) process for this device relies on demonstrating "substantial equivalence" to a predicate device. The performance comparison is therefore presented in relation to the predicate.

Since this is a 510(k) submission for a non-diagnostic, non-AI device like a scooter, the following requested information is not applicable and would not be found in such a regulatory document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text is a 510(k) summary for the Ruike 3331 scooter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Medical devices, especially those like electric scooters, are often evaluated against established performance standards and demonstrated substantial equivalence through detailed comparisons of specifications and intended use.

Therefore, the requested information components related to acceptance criteria, specific study designs (like MRMC or standalone performance), ground truth, and expert evaluation are not present in this type of regulatory submission. The 510(k) process primarily relies on comparing the new device to a legally marketed predicate device.

Here's an analysis based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document states:
"There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."

This suggests that the "acceptance criteria" are implicitly met by demonstrating that any performance differences between the Ruike 3331 and the predicate device (LANDLEX P100X) are minor and do not impact safety or effectiveness. No specific quantitative performance metrics or acceptance criteria are listed.

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

Not applicable. This is not a study reporting on a test set in the traditional sense of a clinical or performance study with a sample size. It's a regulatory submission demonstrating substantial equivalence.

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

Not applicable. Ground truth establishment with experts is not part of a substantial equivalence submission for this type of device.

4. Adjudication Method 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. This is a physical medical device (an electric scooter), not an AI/software-as-a-medical-device.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that involves a training set.

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

Not applicable.

Summary based on the document:

The regulatory submission for the Ruike 3331 scooter aims to demonstrate substantial equivalence to a previously cleared device, the LANDLEX P100X (K060042). The core "study" (or comparison) for this type of device involves:

• Comparison of Intended Use: Both devices are "intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position."
• Comparison of Device Description: Both are battery-operated, controlled by a tiller handle and thumb-operated throttle.
• Comparison of Performance Specifications: The document states "minor differences in performance specifications," but crucially, these differences "do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This implies that while specific numbers aren't given, the differences were assessed and deemed not to negatively impact safety or effectiveness compared to the predicate.

Therefore, the "acceptance criteria" for the Ruike 3331 were met by demonstrating that it is as safe and effective as its predicate device, the LANDLEX P100X, based on a direct comparison of features and performance, rather than a clinical trial with specific performance metrics and acceptance thresholds.

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