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The JeJe Teether is intended for infants to play with and chew on, and to help soothe teething infants.

The JeJe Teether is a vibrating teething ring that is designed for infants to play with and chew on. The device is battery-operated and vibrates when activated. The JeJe Teether is constructed of ABS resin plastic material and is circular in shape.

The JeJe Teether is a relatively simple medical device (Class I) and as such, the "study" demonstrating its acceptance primarily revolves around safety evaluations rather than complex clinical performance studies typical of more advanced devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for the "test set" in the way one would for a clinical trial. The performance evaluations were conducted to verify that the device meets industry standards for consumer toy safety. This likely refers to testing a sufficient number of units to ensure consistency and compliance, but a specific number is not provided.

Data Provenance: Not explicitly stated, but implies the testing was performed on the manufactured JeJe Teether device itself. Given it's a 510(k) submission, the safety evaluations would typically be pre-market data, conducted by or for the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

No information is provided about experts establishing "ground truth" for the safety evaluations. These evaluations typically rely on standardized test protocols and mechanical/chemical analyses, not expert consensus in the diagnostic sense. The determination of "substantial equivalence" is made by the FDA based on the submission.

4. Adjudication Method for the Test Set

Not applicable. The "performance evaluations" are likely objective tests (e.g., measuring flammability, impact resistance, material composition) against predefined standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The JeJe Teether is a physical product, not an imaging device.

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

No, this question is not applicable to the JeJe Teether. The device is a physical product, not an algorithm. Its performance is inherent to its design and materials.

7. The Type of Ground Truth Used

For the safety evaluations, the "ground truth" would be the objective results of standardized tests against established safety benchmarks (e.g., "does not ignite under X conditions," "withstanding Y force without breaking," "presence/absence of PVC chemicals").

For the substantial equivalence determination, the "ground truth" is the characteristics and performance of existing, legally marketed predicate devices that the FDA has already cleared. The JeJe Teether is compared to these predicates.

8. The Sample Size for the Training Set

Not applicable. The JeJe Teether is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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