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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.

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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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