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The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.

Electric Powered Scooter, Model SE03

{0} This document is a 510(k) premarket notification decision letter from the FDA to Sunpex Technology Company regarding their Electric Powered Scooter, Model SE03. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

This letter does not contain information about acceptance criteria or specific study results showing device performance. Instead, it is a regulatory document confirming the substantial equivalence determination for market approval. Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in the 510(k) submission document itself, which is a detailed technical submission to the FDA, rather than the final decision letter.

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The intended use of the Model PW is to provide mobility to adults with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.

Model PW, Electric Power Wheelchair

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, Model PW. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The information provided in the document is limited to:

• Device Name: Model PW, Electric Power Wheelchair
• Regulation Number: 21 CFR 890.3860
• Regulation Name: Powered wheelchair
• Regulatory Class: II
• Product Code: ITI
• 510(k) Number: K024175
• Manufacturer: SUNPLEX TECHNOLOGY Co. Ltd.
• Intended Use: To provide mobility to adults with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.
• Classification: Over-The-Counter Use

The letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, which means it is considered as safe and effective as a device already on the market. However, it does not describe specific performance tests or acceptance criteria for the Model PW itself, nor does it detail a study conducted to demonstrate such criteria. The substantial equivalence determination is based on a comparison to predicate devices, not on explicit performance metrics presented in this document.

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The intended use of the Model SE 01 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Model SE 01, Four Wheel Electric Scooter

I am sorry, but based on the provided document, I cannot describe the "acceptance criteria and the study that proves the device meets the acceptance criteria."

The document is a 510(k) clearance letter from the FDA for a "Sunpex Technology Company, LTD. Model SE 01, Four Wheel Electric Scooter." This letter states that the device is "substantially equivalent" to legally marketed predicate devices.

The document does not contain any information about:

• Specific acceptance criteria for device performance.
• Details of any study (test set, ground truth, expert qualifications, adjudication, sample sizes, training set, etc.) that would prove the device meets performance criteria. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria, especially for a motorized scooter.

Therefore, I cannot fulfill your request for the table or the study details.

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The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Model SE 02, Three Wheel Electric Scooter

The provided text is an FDA 510(k) clearance letter for a medical device: "Model SE 02, Three Wheel Electric Scooter". This letter primarily discusses regulatory approval based on substantial equivalence and does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance.

Therefore, I cannot provide the requested information. The document is a regulatory approval notice, not a study report or technical specification sheet.

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