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The intended use is to provide mobility to persons limited to a seated position

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This document is a 510(k) clearance letter from the FDA for a powered wheelchair, the Hoveround Teknique XHD MK-V. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

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 clearance is based on substantial equivalence to a predicate device, not on a new study demonstrating performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a previously cleared device. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, etc.) is not present in this document.

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The intended use is to provide mobility to persons limited to a seated position

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This document is a 510(k) premarket notification decision letter from the FDA for a powered wheelchair, the Hoveround Teknique HD6 MKII. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document is not relevant for providing the requested information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/ML-based medical devices. The letter primarily focuses on regulatory approval based on equivalence to existing devices, not on detailed performance studies for novel algorithmic features.

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

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The intended use is to provide mobility to persons limited to a seated position.

Hoveround Teknique HD-6 Power Wheelchair

This document is a 510(k) premarket notification letter from the FDA for a power wheelchair, the Hoveround Teknique HD-6 Power Wheelchair. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It refers to regulations governing manufacturing practices, labeling, and adverse event reporting, but there is no mention of an algorithm or AI component, nor any performance study details as typically found for AI/ML devices.

Therefore, I cannot provide the requested information based on the provided document.

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The intended use is to assist transfer of an individual up or down a straight, residential, indoor staircase while in a seated position.

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The provided document is a 510(k) premarket notification letter from the FDA regarding the Hoveround HoverGlide Stairlift. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for any medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is a regulatory approval letter, not a scientific study report.

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The intended use is to provide mobility to persons limited to a seated position.

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This document is a 510(k) clearance letter from the FDA for the Hoveround Teknique GT Powered Wheelchair. It does not contain the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot answer your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical performance specifications or study results you are asking for.

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The intended use is to provide mobility to persons limited to a seated position.

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The provided text is a U.S. FDA 510(k) clearance letter for a Hoveround Teknique FWD mk4 power wheelchair. This document is a regulatory approval for a physical medical device and does not contain information about an AI/ML device or its performance study.

Therefore, I cannot extract any details regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or multi-reader multi-case studies as these concepts are not relevant to this type of medical device approval.

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The intended use is to provide mobility to persons limited to a seated position.

Hoveround SE-3 Powerchair

The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair, the "Hoveround SE-3 Powerchair." This document does not describe acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the specific details requested regarding sample sizes, ground truth establishment, or expert involvement.

Instead, this document is an administrative notification that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements and provides contact information for further guidance.

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

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The intended use is to provide mobility to persons limited to a seated position.

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The provided text is a 510(k) premarket notification approval letter for the Hoveround E100 Powerchair. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance metrics for the device itself.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided text. The document focuses on the regulatory approval process and states the intended use of the powerchair, but does not include technical specifications, performance evaluation data, or ground truth details.

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The intended use is to provide mobility to persons limited to a seated position.

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This looks like a 510K clearance letter for a powered wheelchair, not an AI device. As such, the typical information requested about AI/ML device performance, such as acceptance criteria based on accuracy metrics, sample sizes for test and training sets, expert adjudication, MRMC studies, or standalone performance, is not applicable or present in this document.

The document 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 indicates the approval is based on substantial equivalence to existing devices, not on a detailed study of novel AI performance.

Therefore, I cannot provide the requested information.

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The intended use is to provide mobility to persons limited to a seated position.

Not Found

This document does not contain the information requested for acceptance criteria and the study details.

The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair (Hoveround Power Wheelchair, model HD700). It states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.

However, this letter does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert qualifications.
3. Information on MRMC studies or standalone algorithm performance, as it's a physical medical device, not an AI/software device.

The letter primarily focuses on the regulatory clearance for the device based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.

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