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These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Transport) are not for self-propelling but, to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

TC Series (Transport) [Mechanical Wheelchair]

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of mechanical wheelchairs. It confirms the substantial equivalence of these devices to previously marketed devices and permits marketing.

The document does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes, data provenances, expert qualifications, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how ground truth was established for a training set.

Therefore, I cannot fulfill your request based on the provided input.

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These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Tilt Recliner) are for self-propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

TC Series (Tilt Recliner) [Mechanical Wheelchair]

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of wheelchairs. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical devices involving algorithmic performance or diagnostic capabilities.

The letter explicitly states that the devices (manual wheelchairs) are "substantially equivalent" to predicate devices marketed before May 28, 1976. This type of clearance primarily focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or different characteristics that do not raise new questions of safety and effectiveness.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the content of this FDA letter. The letter is about regulatory clearance for mechanical wheelchairs, not about a study assessing the performance of software or an AI-powered diagnostic device against specific metrics.

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These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

TC Series (Wide) [Mechanical Wheelchair]

This document is a 510(k) clearance letter from the FDA for a series of wheelchairs, including the "TC Series (Wide) [Mechanical Wheelchair]". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter simply states that the FDA has reviewed the submission and determined that the devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. It discusses regulatory classifications, general controls, and compliance, but not performance testing results.

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

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These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Recliner) are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

TC Series (Recliner) [Mechanical Wheelchair]

The provided document is an FDA 510(k) clearance letter for the "TC Series (Recliner) [Mechanical Wheelchair]" and related products. It primarily focuses on the device's substantial equivalence to predicate devices and regulatory compliance. This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed summary of safety and effectiveness.

Therefore, I cannot extract the requested information. The document explicitly states:

• "We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the clearance was based on substantial equivalence to predicate devices, not on a new study proving the device meets specific performance acceptance criteria in the way a clinical trial for a novel, higher-risk device would. For Class I devices like manual wheelchairs, the regulatory requirements are generally less stringent, focusing on general controls rather than extensive clinical efficacy studies.

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These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

TC Series [Mechanical Wheelchair]

The provided document is a 510(k) premarket notification letter from the FDA regarding several manual wheelchairs (TC Series). This type of document does not contain acceptance criteria or a study proving that a device meets acceptance criteria.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving safety and effectiveness through clinical trials with defined acceptance criteria in the same way a Premarket Approval (PMA) application would.

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

Ask a specific question about this device