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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

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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The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a Water Filled Teether. It is a regulatory approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device based on existing standards, rather than new performance studies with specific statistical outcomes.

Therefore, I cannot extract the requested information from the provided text.

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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 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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The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.

Teething Ring – Water or Gel Filled

This document is a 510(k) premarket notification for a Teething Ring - Water or Gel Filled. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way medical device AI/software studies typically do.

The FDA 510(k) clearance process for this type of device (a physical teething ring) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring specific performance studies with quantitative metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document is primarily a regulatory clearance letter and an "Indications For Use" statement.

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The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

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This document is an FDA 510(k) clearance letter for the "Fu Hong Industries Limited Soother Teether". It determines that the device is "substantially equivalent" to legally marketed predicate devices.

The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for medical device performance. Instead, the FDA's 510(k) process focuses on showing substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness from scratch for every new device.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Study: The document explicitly states "substantially equivalent" rather than detailing specific performance metrics or a study. The FDA review in this context typically compares the new device's technological characteristics, materials, and intended use against a lawfully marketed predicate device.
• Device Type: This is a teether, which is a Class II device. While Class II devices have "Special Controls," the provided letter does not elaborate on them. For many Class II devices, particularly consumer-facing ones like a teether, the "substantially equivalent" determination does not typically involve the rigorous clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) that would be associated with more complex or higher-risk medical devices (e.g., AI-powered diagnostic tools).

The provided text focuses on regulatory compliance aspects and the determination of substantial equivalence, not on a detailed performance study as you've requested.

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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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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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The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

Water Filled Teether

I am sorry, but this document contains no information about acceptance criteria or study results for a medical device. The document is a 510(k) premarket notification letter from the FDA to Allied Hill Enterprises, Limited, regarding a "Water Filled Teether." It primarily discusses the substantial equivalence determination for the device and regulatory requirements.

Therefore, I cannot provide the requested information.

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