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510(k) Data Aggregation
(161 days)
SOLID TOYS IND. LTD.
Indicated to soothe and cool teething babies and help reduce teething pain.
The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
The provided text is for a Water-Filled Teether, which is a medical device of Class II (Fluid-filled teething ring, 21 CFR 872.5550). This type of device does not typically involve complex algorithms, AI, or advanced imaging, and as such, the concept of a "study that proves the device meets the acceptance criteria" in the context of clinical trials with human readers, ground truth establishment, or multi-reader multi-case studies, as described in your prompt's subsequent questions, is not applicable here.
Instead, acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing against established safety standards for toy and medical device materials, as well as an identical indication for use.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical indications to predicate device | Indicated to soothe and cool teething babies and help reduce teething pain. (Identical to MAM Teether K092781) |
| Patient Population | Identical patient population to predicate device | Teething babies. (Identical to MAM Teether K092781) |
| Environment of Use | Identical environment of use to predicate device | Home. (Identical to MAM Teether K092781) |
| Technology | Identical technology (water-filled ring) | The use of a water-filled ring is identical to the predicate. (Identical to MAM Teether K092781) |
| Materials/Biocompatibility | ISO 10993-1 (cytotoxicity, sensitization, irritation) for direct communicating, mucosal, prolonged contact | All materials tested according to ISO 10993-1 for appropriate contact level and duration and found to pass the applicable test requirements. Tests conducted: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10093-10), Irritation (ISO 10993-10). Pass/fail criteria were "for the each respective ISO 10993 test." |
| Mechanical Hazards | 16 CFR 1500, ASTM F963-08 | Passed tests including: 1500.51(b) Impact Test, 1500.52 Bite test, 1500.53(e) Torque Test, 1500.53(f) Tension Test, 1500.53(g) Compression Test, 1500.3(c)(6)(vi) Flammable solid, 1500.3(c)(6)(iii) Combustible, Small part requirement. Also ASTM F963-08 sections: 4.1 Material Quality, 4.6 Small Objects, 4.7 Accessible Edges, 4.9 Accessible Points, 4.22 Teethers and Teething Toys, Drop Test etc. |
| Chemical Safety (Lead) | CPSIA Sec 101, CA Prop 65 | Passed Total lead content requirements. |
| Chemical Safety (Phthalates) | CPSIA Sec 108, CA Prop 65 | Passed 108(a) Phthalates (BBP/DBP/DEHP/DnHP/DIDP) requirements. |
| Other Chemical Safety | CPSIA, CA Prop 65, ASTM F963-08 | Passed Total Cadmium, Soluble Heavy metals, BPA requirements. |
| Small Parts | 16 CFR 1501 | Passed small part requirements. |
| Bacteriological | ASTM F963 - 4.3.6.1 | Passed bacteriological requirements. |
Regarding the other questions in your prompt, as explained above, they are not applicable to the evaluation of this specific medical device (a water-filled teether) as described in the 510(k) summary. This document concerns a physical product with predetermined safety and performance characteristics, not an AI or software-driven diagnostic or image analysis tool.
Here's why the other points are not relevant in this context:
- 2. Sample size for the test set and data provenance: No "test set" in the sense of patient data is used. The testing involves physical samples of the device and its materials. The provenance of the actual materials used for the physical device would be its manufacturing origin (Shenzhen City, Guangdong Province, China).
- 3. Number of experts used to establish the ground truth for the test set and their qualifications: "Ground truth" in this context refers to compliance with established international and national safety standards (ISO, CFR, ASTM, CPSIA, CA Prop 65). The "experts" are the regulatory bodies and standard-setting organizations that define these criteria, and the laboratories that perform the tests according to these standards, not medical experts evaluating AI performance.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Compliance is determined by objective laboratory test results against predefined pass/fail criteria for each standard.
- 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, as this is not an AI/diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is the objective performance against established safety standards and regulatory requirements. For example, a "pass" on a phthalates test means the device's material has phthalate levels below the regulated limit.
- 8. The sample size for the training set: Not applicable, as no algorithm or AI model is being trained.
- 9. How the ground truth for the training set was established: Not applicable.
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