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.

AI/ML Overview

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.

Summary

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K123855

Premarket Notification 510(k) Section 5 - 510(k) Summary

Water-Filled Teether

510(k) Summary Page 1 of 4

MAY 2 4 2013

Date Prepared

11-Dec-12

Solid Toy Ind. Ltd.

No. 39, Pengfei Road, Pengcheng Community, Dapeng Town, Longgang District Shenzhen City, Guangdong Province, China

Tel - 86-755-84315188 Fax - 86-755-84315979

John Chow - Managing Director Official Contact:

Proprietary or Trade Name: Water-Filled Teether

Fluid-filled teething rings Common/Usual Name:

Classification Code/Name: KKO - Fluid-filled teething ring 21 CFR 872.5550 Class 2

Predicate Devices:

Device Description:

K 992384 - Stevenson CPAP/Pro

Indications for Use:

Indicated to soothe and cool teething babies and help reduce teething pain.

Patient Population: Teething babies

Environment of Use: Home

Predicate Device Comparison:

The Water-Filled Teether is viewed as substantially equivalent to the predicate device because:

Indications -

The indication to soothe and cool teething babies and help reduce teething pain is identical . to the predicate.
Discussion - Identical to MAM Teether (K092781)

Patient Population -

For teething babies ●

Discussion - Identical to MAM Teether (K092781)

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510(k) Summary Page 2 of 4 11-Dec-12

Technology -

. The use of a water filled ring is the identical technology to the predicate.
Discussion - Identical to MAM Teether (K092781)

Materials -

. The materials in patient contact have been tested per ISO 10993-1 as direct communicating, mucosal, prolonged contact for cytotoxicity, sensitization, and irritation. Discussion - Identical to MAM Teether (K092781)

Environment of Use and OTC -

The environment is home use and OTC. .
- Discussion Identical to MAM Teether (K092781)

Differences -

There are no differences between the predicate and the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent.

Attributes	Water-Filled Teether	MAM Teether
Indications for Use	Indicated to soothe and cool teethingbabies and help reduce teething pain.	Developed for the needs of babies who arehaving their first teeth It is designed to offeroptimum comfort and safety for the baby andoffers all soothing textures and coolingcomfort in order to ease babies teething pain
Patient Population	Teething babies	Teething babies
Environment of Use	Home	Home
Prescriptive	No - OTC	No - OTC
Water-filled	Yes	Yes
Materials	Tested per ISO 10993-1 asDirect communication, mucosal,prolonged contactCytotoxicitySensitizationIrritation	Same
Characteristics
Bacteriological	ASTM F963 - 4.3.6.1	ASTM F963 - 4.3.6.1
General lead ban - leadin substrate	CPSIA Sec 101	CPSIA Sec 101
Mechanical Hazards	16 CFR 1500	16 CFR 1500
Flammability of solids	16 CFR 1500	16 CFR 1500
Small part requirements	16 CFR 1501	16 CFR 1501
Ban on Phthalates	CPSIA Sec 108, CA prop 65	CPSIA Sec 108, CA prop 65
Bite test	16 CFR 1500.52(c)	16 CFR 1500.52(c)

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510(k) Summary Page 3 of 4 11-Dec-12

Non-clinical Testing Summary -

Biocompatibility of Materials -

Materials were evaluated per ISO 10993-1. There are parts and thus their respective materials which have the following patient contact and duration.

The device is consider Direct communicating, Mucosal, Prolonged contact which require the following tests.

Cytotoxicity (tested per ISO 10993-5) . ●
Sensitization (tested per ISO 10093-10)
Irritation (tested per ISO 10993-10) ●
. Pass / fail criteria was for the each respective ISO 10993 test

Discussion -

All materials were tested according to ISO 10993-1 for the appropriate level of patient contact and duration and found to pass the applicable ISO 10993-1 test requirements.

We performed the following tests:

Standard	Test
16 CFR 1500 - MechanicalHazards	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

16 CFR 1501 - FHSA	Small part requirement
ASTM F963-08 Standardconsumer safety for toys	4.1 Material Quality
	4.6 Small Objects
	4.7 Accessible Edges
	4.9 Accessible Points
	4.22 Teethers and Teething Toys
	5.16 Promotional materials
	6.1 Definition and description
	7.1 Producer's name and address
	Drop Test

CPSIA 2008AndCA Prop 65AndII. PA 095-1019	Total lead content

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510(k) Summary
Page 4 of 4
11-Dec-12

Standard	Test
CPSIAAndCA Prop 65	108(a) PhthalatesBBP/DBP/DEHP/DnHP/DIDP
	ASTM F963-08

	Total Cadmium
	Soluble Heavy metals
	BPA

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2013

Solid Toy Ind. Limited C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS FL 34134

Re: K123855

Trade/Device Name: Water-Filled Teether Regulation Number: 21 CFR 872.5550 Regulation Name: Teething Ring Regulatory Class: II Product Code: KKO Dated: April 5, 2013 Received: April 8, 2013

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to -legally -marketed predicate -devices -marketed -in-interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Image /page/5/Picture/7 description: This image shows the closing of a letter with a signature. The letter is signed by Anthony D. Watson, who is the Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health. The letter is signed "Sincerely yours,"

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K123855
(To be assigned)

Device Name:

Water-Filled Teether

Indications for Use:

Indicated to soothe and cool teething babies and help reduce teething pain.

Over-the-counter use XX Prescription Use or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner, DDS, MA

Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Mary S. Runner -S,
0.9.2342.19200300.100.1.1=13000879
50
Date: 2013.05.22 12:03:57 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120853

Regulation Number and Section

§ 872.5550 Teething ring.

(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.