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The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.

Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9

The provided text describes a 510(k) summary for the "MAM Twister" Fluid-Filled Teething Ring. It outlines the device's technical characteristics and how it meets various safety standards.

Here's an analysis of the acceptance criteria and the study information:

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 the sample size used for the test set for any of the standards. It also does not provide details on the data provenance, such as the country of origin or whether the studies were retrospective or prospective. The studies are non-clinical, focusing on product characteristics rather than human subject data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for the device's performance is established by meeting predefined technical and safety standards, not by expert consensus on clinical data. These are non-clinical laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. As the tests are non-clinical against objective standards, an adjudication method for human interpretation is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a "Fluid-Filled Teething Ring," and the testing focused on its physical and chemical properties as per toy safety standards, not on clinical effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical product (teething ring), not an algorithm or software. The performance tests are for the physical product itself.

7. The Type of Ground Truth Used

The ground truth used consists of established regulatory and industry standards for toy safety and material composition. These standards (e.g., USP <61>, ASTM F963, 16 CFR regulations, CPSIA, EN 71 series) define objective criteria for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical device undergoing non-clinical safety and performance testing against predefined standards, not a machine learning model that requires a training set.

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

Not applicable. No training set is involved in the evaluation of this device. The standards themselves serve as the "ground truth" for the non-clinical tests.

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