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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 Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Not Found

The provided text describes a 510(k) premarket notification for a "Fluid-Filled Teether" (K092910). This document is a regulatory approval letter and does not contain information about acceptance criteria, study methodologies, or performance data as typically provided for medical devices that undergo rigorous clinical or technical validation.

The "Fluid-Filled Teether" is a Class II device (Teething Ring, Product Code: KKO), which falls under general controls and potentially special controls, but the specifics of those controls or any performance studies are not detailed in this letter. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval for marketing the device based on substantial equivalence, not on a detailed performance study with acceptance criteria and results.

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Ask a specific question about this device

The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for a Fluid-Filled Teether, a non-AI medical device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI-related metrics, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment, is not applicable and cannot be extracted from this document.

The document indicates that the device is substantially equivalent to legally marketed predicate devices and is intended to relieve teething discomfort by providing a cool soothing effect.

Here's a breakdown based on the document:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. This document establishes substantial equivalence based on the device's intended use and comparison to predicate devices, not on specific performance metrics typically associated with AI/software devices. The "acceptance criteria" for a 510(k) for this type of device would generally involve demonstrating safety and effectiveness comparable to a predicate.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No specific test set or data provenance is mentioned as this is a traditional medical device (teether), not an AI/software device whose performance would be evaluated on such a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical fluid-filled teether, not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. Ground truth, in the context of AI/diagnostic devices, is not relevant here. The "truth" for this device revolves around its physical properties and intended physiological effect (soothing discomfort).

8. The sample size for the training set:

• Not Applicable. No training set for an AI model is mentioned or implied.

9. How the ground truth for the training set was established:

• Not Applicable. No training set or ground truth establishment relevant to AI is mentioned.

In summary, this document pertains to a traditional, non-digital medical device (a teether) and evaluates its substantial equivalence to predicate devices, not its performance against specific AI-related metrics or clinical study criteria typically associated with AI/software.

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The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Fluid Filled Teether

This document is a 510(k) submission for a fluid-filled teether, which is a medical device. However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The provided text is a summary of the 510(k) submission, primarily focusing on the administrative details, intended use, and substantial equivalence determination by the FDA. It states that the Global Fluid Filled Teether is substantially equivalent to a previously cleared device (K031094). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require extensive clinical trials or performance studies if the technological characteristics are similar and the intended use is the same.

Therefore, I cannot provide the requested information based on the input text. The information typically requested (such as sample sizes, ground truth, expert qualifications, efficacy studies, etc.) is more relevant for novel or high-risk devices that require more rigorous performance testing and clinical data. For a device like a teether seeking substantial equivalence, such detailed performance studies as those outlined in your request are generally not required for the 510(k) pathway.

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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