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The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

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This document is an FDA 510(k) clearance letter for the "Fu Hong Industries Limited Soother Teether". It determines that the device is "substantially equivalent" to legally marketed predicate devices.

The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for medical device performance. Instead, the FDA's 510(k) process focuses on showing substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness from scratch for every new device.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Study: The document explicitly states "substantially equivalent" rather than detailing specific performance metrics or a study. The FDA review in this context typically compares the new device's technological characteristics, materials, and intended use against a lawfully marketed predicate device.
• Device Type: This is a teether, which is a Class II device. While Class II devices have "Special Controls," the provided letter does not elaborate on them. For many Class II devices, particularly consumer-facing ones like a teether, the "substantially equivalent" determination does not typically involve the rigorous clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) that would be associated with more complex or higher-risk medical devices (e.g., AI-powered diagnostic tools).

The provided text focuses on regulatory compliance aspects and the determination of substantial equivalence, not on a detailed performance study as you've requested.

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The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria.

The text is a 510(k) clearance letter from the FDA to "Fu Hong Industries Limited" for a "Soother Teether" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on regulatory approval and compliance, not on performance studies or acceptance criteria for the device's functional performance. There are no details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for any test sets.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case comparative effectiveness studies.
• Standalone performance studies.
• Type of ground truth used.
• Sample size or establishment of ground truth for training sets.

The document states the "Indications for Use" of the device, which is "to help to relieve the teething discomfort of teething infants by providing a cool soothing effect." However, it does not describe how this effect was quantified, measured, or what criteria were used to determine its effectiveness.

Ask a specific question about this device