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The intended use of the Tacahe PC1350 is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Tacahe PC1350 Power Wheelchair

The provided text is an FDA 510(k) clearance letter for the Dalton Medical Corp. Tacahe PC1350 Power Wheelchair. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria for a new AI or diagnostic device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or AI improvement effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory document confirming clearance based on substantial equivalence, not a clinical or performance study report.

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The intended use of the Segaego 4D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Scooter Segaego 4D," classifying it as a motorized three-wheeled vehicle. It primarily discusses regulatory classification, substantial equivalence to a predicate device, and general controls provisions.

There is no mention of:

• A table of acceptance criteria or reported device performance metrics.
• Sample sizes or data provenance for a test set.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

This document pertains to the regulatory clearance process for a medical device (a scooter), not a study evaluating its performance against specific acceptance criteria for a diagnostic or AI-driven aid.

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The intended use of the Segaego 3D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

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The provided text is an FDA 510(k) clearance letter for the "Scooter Segaego 3D," a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

The letter primarily focuses on the regulatory aspects of the device, stating that it has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

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

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The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a US FDA 510(k) substantially equivalent letter for a powered wheelchair (Trade/Device name: Tacahe, later identified as ELEXUS(PC-1450)). It primarily addresses the regulatory approval process, confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory requirements. The "Indications for Use" section simply describes the intended purpose of the wheelchair.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

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The intended use of the eLexus(MP3C-1) is to provide mobility to persons limited to a seated position t are capable of operating a powered wheelchair.

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This document is a 510(k) premarket notification letter from the FDA regarding the "Primechair" (later referred to as eLexus(MP3C-1)), a powered wheelchair. It is a regulatory approval document and not a scientific study report. Therefore, it does not contain information about acceptance criteria for an AI/device's performance or a study proving that the device meets such criteria in the way you've outlined.

The information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in clinical study reports or scientific publications for AI/medical device performance evaluation, not in 510(k) clearance letters for powered wheelchairs.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance characteristics evaluated in the context you're asking about for AI systems.

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

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The intended use of the eLexus is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

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I am sorry, but the provided text does not contain the information requested to answer the prompt. The document is an FDA 510(k) clearance letter for a powered wheelchair called "Primechair" (later corrected to "eLexus"). It discusses the regulatory approval process but does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or multi-reader multi-case studies.

Ask a specific question about this device

Ask a specific question about this device