PEDO CUSH PEDO CUDDLE by CAVITY FREE KIDS, INC.

Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.

Device Description

A combination restraint and cushion for securing a pediatric patient in a dental chair, said combination comprising; a restraint comprising a main body portion which has a plurality of flaps attached thereto, each of said flaps having hook and loop fasteners affixed thereto, such that said flaps can be positioned and fastened around said patient to hold said patients torso in position a plurality of strings (straps) for tying said restraint around said dental chair and a headpiece which fits around the top of said dental chair, said restraint having adhesive material affixed to the back thereof to hold said restraint in position on said dental chair, and a cushion having an arcuste indentation at its top end to hold said petient's buttooks in position, said cushion being enclosed in a pillowcase having an adhesive material affixed to the underside thereof in order to maintain said cushion in position on said dental chair, said pillowcase having a plurality of flaps attached thereto, said flaps each having hook and loop fasteners affixed thereto such that said flaps can be positioned and fastened around said patient's legs to hold them in position. Pedo Cush Pedo Cuddle is covered by U.S. Patent N. 5,425, 381 and is described in more detail therein.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Pedo Cush Pedo Cuddle." This document is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study designed to prove the device meets specific acceptance criteria in the way a clinical trial or performance study would. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.

However, based on the information provided, we can infer some aspects and extract others.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner as would typically be seen in a performance study. Instead, the device's performance is described qualitatively in comparison to the predicate device. The primary "acceptance" is the FDA's determination of substantial equivalence, which is based on similar technological characteristics and performance for the stated intended use.

Acceptance Criterion (Inferred from Performance Section)	Pedo Cush Pedo Cuddle Reported Performance
Control of Patient Motion	Controls side-to-side and up-and-down motion of patient in dental chair. Tested on over 1,000 child patients with behavior ranging from uncooperative and fearful to hysterically out-of-control; successfully managed the patients to allow dental procedures to be performed.
Sterility/Cleanability	Jacket can be laundered and bleached.
Safety	Secures patient firmly and comfortably in dental chair.
Anatomical Coverage	Secures patient's torso and legs.
Human Factors (Comfort)	Comfortable and relaxing for patient.
Compatibility	Can be used with any standard dental chair.
Intended Use Fulfillment	To protect both patient and clinician from sudden and unsafe patient movement. (Stated in intended use, performance section implicitly supports this by successful management of patients). Tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. (Stated in Indications for Use).

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: "over 1,000 child patients" were reportedly tested.
- Data Provenance: Not specified, but given the submitter's address (St. Paul, MN), it can be inferred the testing was likely conducted in the USA, at the submitter's facility or associated clinics. The data appears to be retrospective observation of clinical use rather than a controlled prospective study, as it describes a range of patient behaviors encountered in practice.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "testing" appears to be based on the experience of "Cavity Free Kids," likely dentists or dental professionals at their practice, observing the device's effectiveness. No independent experts or specific qualifications beyond being the users are mentioned for establishing a formal "ground truth."
Adjudication method for the test set:
- No formal adjudication method is described. The performance claim is based on the general observation of "successfully managed the patients to allow dental procedures to be performed."
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:
- No, an MRMC study was not done. The device is a physical pediatric restraint, not an AI or imaging device that would involve "readers" or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a physical device, not an algorithm. Its performance is inherently tied to human (clinician) interaction and application.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is implicitly the successful completion of dental procedures on uncooperative children, as observed by the clinicians using the device. This is a form of outcomes data based on clinical observation, though not formally structured as a study with predefined endpoints and expert consensus. The "management" of the patients to allow procedures is the key outcome.
The sample size for the training set:
- Not applicable/Not provided. This is not a machine learning model, so there is no training set in that sense. The "testing" on "over 1,000 child patients" appears to be the only data mentioned for performance evaluation.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of an AI/machine learning model.

Summary

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K972446

NOV 1 3 1997

Summary:

• Submitter's name:	Cavity Free Kids
Address:	1224 Arcade St.St. Paul, MN
Telephone:	612-774-0583
Fax Number:	612-793-0967
Contact person:	Dr. Vacharee S. Peterson
Summary prepared:	May 16, 1997
• Trade Name:	Pedo Cush Pedo Cuddle
Common Name:	Protective Restraint

Identification of legally marketed device to which equivalency is claimed: Olympic ● Papose Board, manufactured by Olympic Medical Co. Seattle, WA.

Description of Pedo Cush Pedo Cuddle:

Intended use:

To protect both patient and clinician from sudden and unsafe patient movement.

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Comparison of technological characteristics:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

	Pedo Cush Pedo Cuddle	Papoose Board
Design	Wrap and Cushion, eachhaving flaps with Velcroclosures	Wrap with Velcro closures;board and head stabilizercan be added
Materials	Wrap (including flaps,straps, and headpiece) madeof soft cloth with non-slip-rubber backing, has Velcroclosures. Foam cushionenclosed in hospital tickingvinyl inserted in cottonouter jacket	Mesh fabric wrap withVelcro closures. Vinyl-covered board, plastic headstabilizer.
Performance	Controls side-to-side andup-and -down motion ofpatient in dental chair.Tested on over 1,000 childpatients with behaviorranging from uncooperativeand fearful to hystericallyout-of-control;successfully managed thepatients to allow dentalprocedures to be performed.	Controls side-to-side andup-and-down motion ofpatient in dental chair.Currently on market.
Sterility:	Jacket can be laundered andbleached.	Same
Safety:	Secures patient firmly andcomfortable in dental chair.	Same
Anatomical sites:	Secures patient's torso andlegs	Same
Human factors:	Comfortable and relaxingfor patient	Same
Compatibility with otherdevices:	Can be used with anystandard dental chair	Same
Where used:	Dental office	Same

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's role in serving the American people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Vacharee S. Peterson Cavity Free Kids, Incorporated 1224 Arcade Street St. Paul, Minnesota 55106

K972446 Re : Pedo Cush Pedo Cuddle Trade Name: Regulatory Class: I Product Code: ISMO October 9, 1997 Dated: October-14, 1997 --Received:

Dear Dr. Peterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

NOV 1 3 1007

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Page 2 - Dr. Peterson

through 542 of the Act for devices under the Electronic Chrough Jaz Or the notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA deberraco in formalence of your device to a legally Finding or babbancear or coults in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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.Enclosure

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K972446

Indications For Use

$10(k) Number (if known)	K972446
Device Name:	PEDO CUSH PEDO CUDDLE

Indications For Use:Pedo Cush Pedo Cuddle is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purpose of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she feels the overwhelming of the exnotions he/she must take a break, deliver the child back to the parent's arms. After the emotions are under control then helshe may continue to work. Remember that the option of referring out to another dentist is a possibility.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Crescenti

(D) === Sigr "><< Divis and Or Controller Control. and Garnral Hispital Device 972446 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 4

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.6760 Protective restraint.

(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.