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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

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The provided document is an FDA 510(k) clearance letter for a "Mobility Scooter". It is a regulatory document confirming substantial equivalence to a predicate device, which allows the manufacturer to market the product.

This type of document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed technical report would. It is not a performance study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This is not included in an FDA clearance letter.
2. Sample size used for the test set and the data provenance: Not applicable for this type of document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparativeeffectiveness study: Not applicable.
6. Standalone performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The FDA clearance letter primarily focuses on:

• The device's trade name and regulatory classification.
• The determination of substantial equivalence to a legally marketed predicate device.
• The applicable regulatory requirements (e.g., general controls, quality system regulations, UDI rule).
• The stated Indications for Use: "It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."

To get the kind of information you are asking for, one would typically need to review the 510(k) summary or the full 510(k) submission (if publicly available and containing such details), which would include details of the design verification and validation testing, risk analyses, and performance data submitted by the manufacturer to demonstrate substantial equivalence and safety/effectiveness. This clearance letter is the result of that review, not the review itself.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter. Models: W3331. has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided text is a 510(k) summary for a Mobility Scooter (Model W3331). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study design for AI models, and performance metrics for AI assistance is not applicable.

However, I can extract the general acceptance criteria and the methods used to prove the device meets these criteria as described in the document.

Device: Mobility Scooter (W3331)

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

The acceptance criteria are primarily derived from various ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The reported device performance indicates compliance with these standards.

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

The document describes non-clinical tests conducted on the device itself (Mobility Scooter Model W3331) to evaluate its performance against engineering standards. This is not a study involving patient data, test sets, or populations. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically applied to AI/ML or clinical studies is not applicable. The "test set" in this context refers to the physical device being tested against various standard requirements.

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)

This information is not applicable as the document describes physical device testing against established engineering standards (ISO 7176, ISO 10993) rather than an AI/ML model where expert ground truth is typically assessed. The "ground truth" here is the pass/fail criteria defined by the ISO standards.

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

This is not applicable as there is no human adjudication process described for establishing ground truth in this non-clinical engineering testing. The compliance is determined by measurements against standard specifications.

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

This is not applicable as the device is a physical mobility scooter, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the device is a physical mobility scooter and does not involve AI algorithms.

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

The "ground truth" in this context is the performance specifications and acceptance criteria defined by international engineering standards (ISO 7176 series and ISO 10993 series). The device's performance is measured against these objective, predefined values.

8. The sample size for the training set

This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.

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

This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever. speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The device discussed is a Mobility Scooter (Models: W3431D). Its acceptance criteria and performance are based on non-clinical testing against a series of ISO 7176 standards.

Here's the breakdown of the information requested:

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

The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device (K222507). These tests were performed in accordance with the specified ISO standards mentioned above.

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 explicitly state the sample size for the test set. It refers to "the device" implying testing was done on one or more units of the Mobility Scooter (Models: W3431D). The tests are non-clinical, meaning they are likely engineering/performance tests on manufactured units, not studies involving human subjects or medical data. The provenance of the data is from Zhejiang Innuovo Rehabilitation Devices Co., Ltd, located in Dongyang, Zhejiang, China. The testing appears to be prospective in nature, performed on the device to demonstrate compliance.

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)

This is a non-clinical device safety and performance study. Therefore, the concept of "experts establishing ground truth for a test set" as would be used in a medical imaging or diagnostic device study is not applicable. The "ground truth" here is compliance with the engineering and safety standards (ISO 7176 series and ISO 10993 series). The evaluation would have been performed by qualified testing personnel and engineers, whose qualifications are not detailed in this submission.

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

Not applicable for this type of non-clinical device performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective expert review of medical data. The tests performed are objective, quantitative measurements against established international engineering 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 a non-clinical submission for a mobility scooter, which does not involve "human readers" or "AI assistance" in the context of medical image interpretation or diagnosis.

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

Not applicable. This is not an AI/algorithm-driven device. It is a physical medical device (mobility scooter).

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

The "ground truth" for this device's acceptance is its compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The tests are designed to objectively measure the device's physical and mechanical properties and performance against the specified criteria within these standards.

8. The sample size for the training set

Not applicable. This is a non-clinical device performance and safety study for a physical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI or machine learning model in this submission.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided document is a 510(k) Summary for a Mobility Scooter (Models: W3431Q, W3431R). This type of regulatory submission is for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or significant improvements over existing technology through clinical studies.

Therefore, the acceptance criteria and study that proves the device meets those criteria are not related to a traditional clinical trial or AI/imaging performance metrics. Instead, the "acceptance criteria" here refer to demonstrating that the new device meets established safety and performance standards relevant for a mobility scooter and is substantially equivalent to a previously cleared device.

Here's an analysis based on the provided document, addressing the prompt's points where applicable for this type of submission:

Acceptance Criteria and Device Performance (for a Mobility Scooter)

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device (K220206) and compliance with relevant international standards for wheelchairs and mobility scooters (ISO 7176 series and ISO 10993 for biocompatibility). The study undertaken to prove this involved non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices tested. The non-clinical tests typically involve testing one or more units of the device to confirm compliance with each specified standard. Given the nature of mechanical/electrical testing, typically a representative sample or even a single unit is sufficient if it demonstrates compliance.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China. The data would therefore be prospective from these tests.

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

• Not Applicable. For this type of device and submission, "ground truth" as it relates to expert consensus or clinical diagnosis (e.g., in AI/imaging) is not relevant. The "truth" is established by adherence to the engineering and performance standards (ISO series) and comparison to the predicate device. The experts involved would be engineers and technicians proficient in conducting these specific ISO tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not part of this 510(k) submission for a mobility scooter. The "results" are objective measurements and compliance statements against defined standards.

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

• No. An MRMC study is not relevant for this device. It is a method used to evaluate diagnostic performance (e.g., of an AI algorithm or a new imaging modality) involving multiple human readers interpreting cases. This submission focuses on the mechanical, electrical, and safety performance of a mobility scooter against established engineering standards and comparison to a predicate device.

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

• Not Applicable. This is not an AI/algorithm-based device. "Standalone performance" is relevant to AI's diagnostic accuracy without human intervention. This device is a mobility scooter.

7. The Type of Ground Truth Used

• Engineering/Performance Standards and Predicate Device Specifications. The "ground truth" for this submission is defined by the technical specifications and performance requirements outlined in the ISO 7176 series of standards (e.g., static stability must meet ISO 7176-1) and the demonstrated performance of the legally marketed predicate device (e.g., maximum speed, braking distance). The tests confirm that the new device's performance aligns with or is sufficiently similar to the predicate and meets safety standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device, so there is no training set in the context of data used to train an algorithm. "Training" for this device would refer to the manufacturing processes and quality control, not data training.

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

• Not Applicable. As there is no "training set" in the context of AI, this question is not applicable. The design and manufacturing of the device would follow established engineering principles and quality management systems to meet the desired performance characteristics.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter, Models: W3331F, has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided document is a 510(k) summary for a Mobility Scooter, Model W3331F, and focuses on demonstrating substantial equivalence to a predicate device (K220206). It primarily relies on non-clinical performance testing against established ISO standards rather than clinical studies or AI performance metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on compliance with specifically cited ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The "reported device performance" is a statement of compliance with these standards.

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

• Sample Size for Test Set: Not specified. The document describes non-clinical testing against ISO standards for a single device model (Mobility Scooter, Model W3331F). It does not involve a "test set" in the context of a dataset for an AI algorithm. The testing is on the physical device itself.
• Data Provenance: Not applicable in the context of patient data. The "data" are the results of physical and electrical engineering tests performed on the device. No country of origin for the data is explicitly mentioned, but the manufacturer is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China, suggesting the testing likely occurred there. The tests are non-clinical, so the "retrospective or prospective" distinction does not apply.

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

This section is not applicable as the document describes physical device testing against engineering standards, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

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. The document explicitly states: "No clinical study is included in this submission." The device is a physical mobility scooter, not an AI diagnostic or assistance tool that would typically undergo such a study.

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

This section is not applicable. The device is a physical mobility scooter and does not involve an AI algorithm with standalone performance to be evaluated.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The test results demonstrate that the device meets the specifications outlined in these standards.

8. The Sample Size for the Training Set

This section is not applicable. The document does not describe an AI algorithm that requires a training set. The device is a physical product.

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

This section is not applicable as there is no AI algorithm or training set for this device.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter, Models W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The document is a 510(k) Summary for a Mobility Scooter (Model: W3468). It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device (K182471).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mobility Scooter (Model: W3468) are based on demonstrating compliance with a series of ISO 7176 standards. The reported device performance indicates that the device met these standards.

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

The document does not explicitly state the "sample size used for the test set" in terms of number of devices. Non-clinical tests were conducted on the "proposed device" (Mobility Scooter, Model W3468).

The provenance of the data is from non-clinical testing performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co., Ltd, in China. This is a prospective testing approach conducted specifically for this premarket notification.

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

Not applicable for this type of submission. The "ground truth" for the non-clinical tests is established by the specifications and criteria outlined in the referenced ISO standards. The tests are typically performed by qualified engineers or technicians in a testing facility. The document does not specify the number or qualifications of these individuals, but generally, such testing requires expertise in the relevant engineering and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests against ISO standards usually involve objective measurements and comparisons against predefined thresholds, rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve AI or human readers for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on the objective, measurable requirements and specifications defined by the international standards of the ISO 7176 series, ISO 10993 series, and FDA regulations for labeling.

8. Sample Size for the Training Set

Not applicable. This is a non-clinical 510(k) submission for a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable, as there is no training set for this type of device submission.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter, Models: W3468A, has a base with Steal frame, two front wheels, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided document is a 510(k) premarket notification for a Mobility Scooter (Model: W3468A). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical safety and effectiveness through extensive studies involving human subjects and AI performance metrics.

Therefore, many of the requested details, such as those related to AI algorithm performance, expert ground truth establishment, MRMC studies, or training set specifics, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally that the Mobility Scooter (Model: W3468A) meets the specifications outlined in various ISO 7176 series standards and demonstrates performance comparable to the predicate device (K182471).

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or algorithm testing. The evaluation involved non-clinical testing against various ISO standards. These standards define the test conditions, procedures, and potentially the number of tests or samples (e.g., number of test cycles for fatigue, number of stability tests), but a single overarching "sample size" isn't provided.
• Data Provenance: The tests are "Non-clinical tests" conducted to verify design specifications and substantial equivalence. The document does not specify a country of origin for the testing data itself, beyond the applicant being from China. These are laboratory/engineering tests, not human subject data.

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

• Not Applicable. This submission does not involve AI performance evaluation or ground truth established by medical experts. The "ground truth" here is the adherence to established international safety and performance standards (ISO 7176 series) for mobility scooters. The experts involved would be engineers and testing personnel verifying compliance with these standards, not medical professionals establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. There's no mention of an adjudication process in the sense of resolving discrepancies between expert opinions, as this is not a study involving human interpretation of medical images or data. The "adjudication" is the determination of whether the device met the requirements of the specified ISO standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This is a 510(k) submission for a physical medical device (mobility scooter), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are not relevant.

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

• Not Applicable. There is no AI algorithm involved in this device.

7. The type of ground truth used

• The "ground truth" for this submission is based on engineering and performance standards (ISO 7176 series) and the demonstrated physical properties and function of the device meeting these standards. These are objective measurements and comparisons against established criteria for device safety and performance, rather than expert consensus on medical pathology or clinical outcomes.

8. The Sample Size for the Training Set

• Not Applicable. There is no AI component requiring a training set.

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

• Not Applicable. There is no AI component requiring a training set or its associated ground truth establishment.

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