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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 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.

Ask a specific question about this device