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The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.

Breeze C, 3&4 wheels Scooter

This is an FDA 510(k) clearance letter for a medical device (Breeze C, 3&4 wheels Scooter), not a study report or clinical trial
document. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study
details, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather
than proving performance against specific acceptance criteria through a clinical study as would be detailed in a separate
performance testing report or clinical trial submission.

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

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The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Breeze," a motorized three-wheeled vehicle (scooter) manufactured by Afikim Electric Vehicles. This letter grants clearance for the device based on its substantial equivalence to a legally marketed predicate device, but it does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

The document states:

• Device Name: Breeze
• Regulation Number: 21 CFR 890.3800
• Regulation Name: Motorized three-wheeled vehicle
• Regulatory Class: II
• Product Code: INI
• Indications for Use: "The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suitable for the use of elderly persons and physically disabled persons."

Since this document is simply an FDA clearance letter, it does not include the detailed technical study information you are requesting. Such information would typically be found in the 510(k) submission itself, which is a much more extensive document. Therefore, I cannot provide the requested details about acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications based on the provided text.

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The Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with Mobility problems are generally problems with walking or with the stamina. wanting or was as a suite for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.

The Caddy is a transportable / foldable electric scooter.

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "CADDY." This document does not contain information about acceptance criteria or a study proving the device meets acceptance 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..."

Substantial equivalence (SE) is a regulatory pathway that allows a new device to be marketed if it is as safe and effective as a legally marketed predicate device. It does not typically require the submission of clinical trials with specific acceptance criteria and detailed study results as would be the case for a premarket approval (PMA) application or certain novel devices.

Therefore, I cannot provide the requested information based on the given text. The text does not describe:

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

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