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All teethers instruct consumer to: .

• Clean before use with a damp cloth and mild soap. Air dry. o
• o Not dishwasher safe
• Freezer safe ◆

Teether acts as an aid in relieving an infant's gums due to teething. .

Fluid Filled Teether - Gel

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested. The document is an FDA 510(k) clearance letter for a "Fluid Filled Teether - Gel" (K092025), which indicates that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and compliance requirements.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes for test sets, data provenance, or retrospective/prospective nature.
3. Information on the number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a technical study report detailing performance metrics and study methodologies.

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The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

Fluid Filled Teether

This document is a 510(k) clearance letter from the FDA for a "Fluid Filled Teether." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested details based on the provided text. The document confirms that the device is cleared for market due to substantial equivalence, but it does not describe the specific testing or studies that would demonstrate its performance against acceptance criteria.

Ask a specific question about this device