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To provide an optional means of mobility for physically challenged people.

F-10 Folding Power Chair

This is a 510(k) premarket notification for a medical device (F-10 Folding Power Chair), which is a regulatory submission to demonstrate substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence for the powered wheelchair to a legally marketed predicate device.

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To provide an optional means of mobility for physically challenged people.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Coach 777-3," which is a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria for device performance, reports of device performance, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document solely states that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the input text.

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The intended use of this product is to offer another choice of mobility to physically challenged people.

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I am sorry, but the provided text does not contain the acceptance criteria and study details you are asking for. The document is a 510(k) clearance letter from the FDA for a motorized three-wheeled vehicle named "Coach 777-4". It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include information about performance studies, test sets, ground truth, or expert qualifications.

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To provide an optional means of mobility for physically challenged people.

F-11 Folding Power Chair

The provided document is a 510(k) clearance letter from the FDA for the F-11 Folding Power Chair. This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/CADe device.

The questions you've asked are typically relevant for the regulatory review of a diagnostic or AI-powered medical device, where performance metrics like sensitivity, specificity, or AUC are evaluated against pre-defined acceptance criteria based on clinical studies.

For a physical device like a powered wheelchair, the "acceptance criteria" and "proof" would be satisfied through different types of testing and documentation, such as compliance with recognized standards (e.g., ISO, ANSI/RESNA for wheelchairs), mechanical stress tests, battery life tests, electromagnetic compatibility (EMC) tests, and documented risk management. These details are usually found in the full 510(k) submission, not in the public-facing clearance letter.

Therefore, I cannot extract the information requested from the provided text because it does not exist within the scope of this FDA clearance letter.

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To provide an optional means of mobility for physically challenged people.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Coach 888," which is a "Motorized three-wheeled vehicle." This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any clinical performance data.

Therefore, I cannot provide the requested information based on the input text. The text does not describe an AI/ML device or its performance characteristics. It simply confirms that the Coach 888 device is substantially equivalent to legally marketed predicate devices and can proceed to market.

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To provide an optional means of mobility for physically challenged people.

Coach 888W

The provided document is a 510(k) clearance letter from the FDA for a powered wheelchair (Coach 888W). It's a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, and expert qualifications is not available in this document.

Companies must conduct testing and provide data to the FDA to demonstrate substantial equivalence, but this particular letter is the result of that process, not the detailed report of the studies themselves.

To answer your request, here's what can be inferred or stated about the information that is not present:

Information Not Found in the Document:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or performance data for the Coach 888W. Regulatory letters like this generally summarize the FDA's decision, not the underlying test results.
• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as this device is a powered wheelchair and likely evaluated based on engineering and safety standards, not interpretation by medical experts to establish a "ground truth" in the way an AI diagnostic tool might.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
• 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. MRMC studies are relevant for diagnostic AI devices where human readers interpret images or data. This is a powered wheelchair, not a diagnostic AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a powered wheelchair.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic "ground truth" for this type of device. The "ground truth" for a powered wheelchair would relate to its ability to meet performance and safety standards, not a diagnostic outcome.
• 8. The sample size for the training set: Not applicable; powered wheelchairs are not typically "trained" in the machine learning sense.
• 9. How the ground truth for the training set was established: Not applicable.

What the document DOES tell us:

• Device Name: Coach 888W
• Regulation Number: 890.3860 (Powered wheelchair)
• Regulatory Class: II
• Product Code: ITI
• Indications for Use: To provide an optional means of mobility for physically challenged people.
• FDA Finding: Substantially equivalent to legally marketed predicate devices.
• Date of Clearance: July 10, 2003

In summary, this document is a regulatory approval notice and does not contain the detailed technical study information you've requested. That kind of information would typically be found in the 510(k) submission itself, not the clearance letter.

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To provide an optional means of mobility for physically challenged people.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Little Coach," which is a motorized three-wheeled vehicle. This type of document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has cleared the device based on its substantial equivalence to a predicate device, not necessarily on a detailed study demonstrating its performance against specific acceptance criteria in the manner one might find for a novel or high-risk device requiring comprehensive clinical trials.

Therefore, I cannot extract the requested information from the provided text.

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