The BinkieRT is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician. BinkieRT is meant for use with 6 MV photon beams only.

Device Description

It is a patient-specific medical device that is mounted in the oral cavity of the patient to fix the temporomandibular joint in the treatment of head and neck radiation, and the planned dose is accurately delivered to the target area, and the tongue is moved in one direction to be spaced apart to minimize the exposure of normal tissue to the surrounding area. The device consists of a Jaw Positioner (Impression, Maxiila, Mandibula), a Tongue Positioner (Head, Paddle), and a Column (Rotation Guide).

AI/ML Overview

The provided document is a 510(k) summary for the BinkieRT device and does not contain detailed information about a study with acceptance criteria and reported device performance in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device. This often relies on non-clinical (bench) testing rather than full clinical studies, which is explicitly stated in the "Clinical Test Summary" section: "Clinical testing was not required to demonstrate the substantial equivalence of the BinkieRT to its predicate devices."

However, I can extract the information related to the bench tests and the "acceptance criteria" (or verification metrics) mentioned within those tests.

Here's a breakdown of the available information based on your request, structured to address each point as much as possible, even if the information is not fully present for all points:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
X-ray backscatter shielding performance	The Dose Enhancement Ratio (backscattered radiation dose produced by the subject divided by a "baseline" dose without the subject) should indicate effective shielding. Values greater than 1 indicate increased dose and poor shielding, while a ratio of 1 indicates complete shielding with no backscatter radiation delivered to the patient.	The Dose Enhancement Ratio of the assembled BinkieRT is just below 1.0, indicating near perfect shielding.
EVA dental impression depth comparison test	The measured impression depth must be within the standard deviation of the initial impression depth measurements.	The impression depth comparison test showed that the depth was not significantly affected by the time frame, and the test performance was similar to that of the predicate.

2. Sample size used for the test set and the data provenance

X-ray backscatter shielding performance: The document states "Subjects were exposed to a 6 MV high energy photon beam," but does not specify the number of subjects (e.g., how many BinkieRT devices or test phantoms were used).
- Data Provenance: Bench test, not specified as human or animal subjects. Performed in a laboratory setting. No country of origin for the data is explicitly stated, but the manufacturer is based in South Korea. The test is retrospective in the sense that it evaluates the manufactured product.
EVA dental impression depth comparison test: The document states "using a force gauge (i.e., occlusal force qauqe) and anthropomorphic jaws," and "a force of ~800N was applied to the EVA once before treatment and repeated after each 2.25 Gy fraction of a total 67.5 Gy dose to the BinkieRT (i.e., 30 fractions)." This implies testing on at least one BinkieRT device (specifically, its EVA impression component) repeatedly. The exact number of devices/samples tested is not specified.
- Data Provenance: Bench test, not specified as human or animal subjects. Performed in a laboratory setting. No country of origin for the data is explicitly stated, but the manufacturer is based in South Korea. The test is retrospective in the sense that it evaluates the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests described are bench tests with objective measurements (Dose Enhancement Ratio, impression depth) and do not involve expert interpretation or ground truth establishment in the clinical sense.

4. Adjudication method for the test set

This information is not applicable/not provided. The tests described are bench tests with objective measurements, not requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical tongue and jaw positioner for radiation therapy, not an AI/software device that would involve human readers or AI assistance in interpretation. The "Clinical Test Summary" explicitly states that clinical testing was not required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an algorithm or AI device. The tests performed are bench tests on the physical characteristics and performance of the device.

7. The type of ground truth used

X-ray backscatter shielding performance: The "ground truth" or reference for comparison is a "baseline" dose (backscattered radiation produced without the subject in the photon beam). This is a physically measured baseline.
EVA dental impression depth comparison test: The "ground truth" or reference for comparison is the initial impression depth measurements before repeated force application. This is a physically measured baseline.

8. The sample size for the training set

This question is not applicable. This device is a physical product and not an AI/machine learning algorithm, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable as there is no "training set" for this physical device.

In summary, the provided document details non-clinical bench testing for the BinkieRT device to demonstrate its performance against specific physical criteria related to its function, rather than diagnostic accuracy studies typically associated with AI/software devices. Therefore, many of your requested points related to clinical studies, human readers, and AI algorithms are not applicable to this submission.

Summary

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November 15, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Papricalab % Jonghyum Kim, CEO GMS Consulting B612, 66, Cheongcho-ro, Deogyang-gu Goyang-si. Gyeonggi-do 10543 SOUTH KOREA

Re: K231852

Trade/Device Name: BinkieRT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: October 10, 2023 Received: October 17, 2023

Dear Jonghyum Kim:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lora D.
Weidner-S

Digital
Weid
Date:
-05'00

Digitally signed by Lora D. Weidner -S Date: 2023.11.15 14:05:58 -05'00

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231852

Device Name BinkieRT

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

June 20, 2023

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Manufacturer: ● Papricalab Address: ● 11, Yulgok-ro 14-gil, Jongno-gu, Seoul, Republic of Korea ● Contact Name: Sohyeon Woo ● Telephone No.: +82-2-742-6161 ● Fax No.: +82-2-742-6162 ● Email Address: sohyeon6125@papricalab.com

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade/Device Name	BinkieRT
Common Name	Oral fixation device
Regulation Number	21 CFR 892.5050
Regulation Name	Medical charged-particle radiation therapy system
Regulation Class	Class II
Product Code	IYE

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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

Predicate device

●	510(k) Number:	K183374
●	Applicant:	POLL Medical LLC
●	Trade/Device Name:	GrayDuck Stent
●	Regulation Number:	21 CFR 892.5050
●	Regulation Name:	Medical charged-particle radiation therapy system
●	Regulation Class:	Class II
●	Product Code:	IYE

Predicate device has not been subject to a design-related recall

Reference device

●	510(k) Number:	K153270
●	Applicant:	POLL MedicBionix Development Corporation
●	Trade/Device Name:	TruGuard Custom Tongue and Jaw Positioneral LLC
●	Regulation Number:	21 CFR 892.5050
●	Regulation Name:	Medical charged-particle radiation therapy system
●	Regulation Class:	Class II
●	Product Code:	IYE

Predicate device has not been subject to a design-related recall

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5. Description of the Device [21 CFR 807.92(a)(4)]

5.1 Device Principle

5.2 Device configuration and description

Part name	Description	Picture
Impression	Patient-specific impression collection	Image: Jaw Positioner with labels for Impression
Maxiila	Maxillary support and fixation	Image: Maxilla
Mandibula	Mandibular support and fixation	Image: Mandibula

Part name	Description	Picture
Head	Tongue pressure fixation	Image: Tongue Positioner with Head labeled
Paddle	Adjusting the insertion depth of the pressing body	Image: Paddle labeled

Part name	Description	Picture
-----------	-------------	---------

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RotationGuide	Supports the central axis of the fixedbody and the grip force of the upperand lower jaw, penetrates the pressingbody, and serves as a guide foradjusting the depth axis rotation	ColumnImage: [Column Rotation Guide]
-------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------

5.3 How to use the device

Insert the Column into the pressure paddle to adjust the insertion depth in the cavity.

1. The axis is determined by fitting the rotating Column to the tooth portion of the fixture.
1. Combine the maxilla and mandibula with the pillars.
1. The tongue is fixed by adjusting the rotation and depth according to the patient's treatment area.

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6. Indications for use [21 CFR 807.92(a)(5)]

7. Determination of Substantial Equivalence

7.1 Technological Characteristics

Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]

The BinkieRT is substantially equivalent to legally marketed predicate device(GrayDuck Stent) with respect to indications for use and technology characteristics.

The table below presents comparisons for device:

	Proposed Device	Predicate Device	Reference device	SE Note
Manufacture	Papricalab	POLL Medical LLC	Bionix DevelopmentCorporation	-
Name	BinkieRT	GrayDuck Stent	TruGuard Custom Tongueand Jaw Positioner	-
510(k) No.	K231852	K183374	K153270	-
Product code	IYE	IYE	IYE	Same
RegulationNumber	21 CFR 892.5050	21 CFR 892.5050	21 CFR 892.5050	Same
Classification	Class II	Class II	Class II	Same
Appearance	Image: BinkieRT	Image: GrayDuck Stent	Image: TruGuard Custom Tongue and Jaw Positioner	Equivalent.
Intended foruse	The BinkieRT is intendedto be used for repeatpositioning andimmobilization of apatient's tongue and jaw	The GrayDuck StentTMcustom tongue and jawpositioner from POLLMedical LLC is intended tobe used for repeat	The TruGuard CustomTongue and JawPositioner from BionixDevelopmentCorporation is intended to	Equivalent. Nonew issues onsafety andeffectiveness
	while undergoing orreceiving a course ofexternal beam radiationtherapy for treatment ofcancer and otherdiseases. It is intended tobe used by or under thedirection of a licensedphysician. BinkieRT ismeant for use with 6 MVphoton beams only.	positioning andimmobilization of apatient's tongue and jawwhile undergoing orreceiving a course ofexternal beam radiationtherapy for treatment ofcancer and otherdiseases. The GrayDuckStent is intended to beused by or under thedirection of a licensedphysician.	be used for repeatpositioning andimmobilization ofpatients undergoing orreceiving a course ofexternal beam radiationtherapy for thetreatment of cancer andother diseases.
ClinicalApplication	Radiation TherapyTreatment	Radiation TherapyTreatment	Radiation TherapyTreatment	Same
ClinicalSetting/ Siteof Use	Prescription device forclinic/ Hospital use	Prescription device forclinic/ Hospital use	Prescription device forclinic/ Hospital use	Same
User	Licensed physician	Licensed Physician	Licensed Physician	Same
Material	Jaw Positioner, TonguePositioner: Molded PlasticImpression Layer, Head ofTongue Positioner:Moldable EVA (ethylenevinyl acetate)Thermoplastic	Arch Tray (Main Stent) &Tongue DeviationComponents: Molded PlasticDental Impression Insert: Moldable EVA (ethylenevinyl acetate)Thermoplastic	Arch Tray (Main Stent) &Tongue DeviationComponents: Molded PlasticDental Impression Insert: Moldable EVA (ethylenevinyl acetate)Thermoplastic	Same
Dual bite trays	Yes	Yes	Yes	Same
Allows foropen Jawpositioning	Yes	Yes	Yes	Same
Positions theTongue	Yes	Yes	Yes	Same
Shielding frombackscatterradiation	Yes	Yes	Yes	Same
MRI Safe	Yes	Yes	Yes	Same

[Table 1. Comparison of Proposed Device to Predicate Device]

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The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices

[Table 2. Little difference with Predicate Device]

Justification to Support Substantial Equivalence

There are no significant differences between BinkieRT and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to predicate devices in indications for use and technology characteristics.

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Non-Clinical Test summary

The BinkieRT comply with voluntary standards for electromagnetic compatibility, use in the home healthcare environment and usability. The following data were provided in support of the substantial equivalence determination:

1) Biocompatibility

Bio-compatibility test is performed according to below:

FDA Guidance document Use of International Standard ISO 10993-1, `Biological evaluation of ● medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

2) Bench Testing

X-ray backscatter shielding performance .
Bench tests were conducted to verify the shielding capabilities of the Binkie RT aqainst secondary lowenergy backscatter radiation emitted by metal piling bridgework. Subjects were exposed to a 6 MV high energy photon beam and the backscatter radiation dose was radiation dose was assessed by measuring the exposure density of the industry standard Gafchromic EBT3 film placed adjacent to the subject. The Dose Enhancement Ratio was defined as the backscattered radiation dose produced by the subject divided by a "baseline" dose (backscattered radiation produced without the subject in the photon beam). Shielding effectiveness was indicated by the Dose Enhancement Ratio. Values greater values greater than 1 indicate an increased dose of backscatter radiation to the patient and a poor shielding effect, while a ratio of 1 indicates complete shielding with no dose of backscatter radiation delivered to the patient.

The Dose Enhancement Ratio of the assembled BinkieRT is just below 1.0, indicating near perfect shielding. Shows the nearly complete shielding effectiveness of the Binkie RT device in shielding backscattered radiation.

EVA dental impression depth comparation test
Bench testing was performed to compare the depth of the EVA impression to verify that the depth of the dental arch impression was not significantly affected by bite time. using a force gauge (i.e., occlusal force qauqe) and anthropomorphic jaws, a force of ~800N was applied to the EVA once before treatment and repeated after each 2.25 Gy fraction of a total 67.5 Gy dose to the BinkieRT (i.e., 30 fractions). The force was selected as the reported maximum human bite force using a soft bite surface. Impression depth was measured with calipers for every 10 fractions and analyzed over time to detect changes in the structural integrity of the BinkieRT over the course of treatment. An effect of bite time was evaluated by measuring the deviations of impression depth with fractions compared to the initial impression depth. After the 67.5 Gy was completed, the final impression depth was compared to the previous 35 fractions.

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The measured impression depth must be within the standard deviation of the initial impression depth measurements. The impression depth comparison test showed that the depth was not significantly affected by the time frame, and the test performance was similar to that of the predicate. The BinkieRT produces similar impression depths when comparing its current timeframe to the longer timeframe indicated in the Predicate device's Instructions for Use.

The non-clinical performance test results provide evidence that the BinkieRT is safe and effective when used as intended.

3) Validation

. Packaging process validation
Through several tests conducted for validation of the packaging process, optimized packaging process parameters among various packaging process conditions were identified.

The nylon packaging, which was packaged through the vacuum packaging machine, was stably packaged under the conditions of 'vacuum step 10, cooling step 10, cooling step 35', and the adhesive strength of the packaging also showed good results.

It has been verified through various tests that the wrapping paper of "BinkieRT" thermally bonded

through the validated packaging process can maintain a consistent and has the ability to protect the produet from contaminants

● Cleaning process validation

The cleaning process validation was performed on the "Oral_001 (O-TYPE)", which is a worst case sample, using the cleaner that has completed installation and operation qualification (IQ / OQ).

'Asa verification method for verifying the effectiveness of the cleaning process, it met the test criteria in the physicochemical test (TOC, pH, Electrical conductivity test) performed after the final cleaning, Also, cleaning agent residue test (HPLC), residue evaporation, microorganism test (Bioburden test) and dry Validation test were suitable for the acceptable criteria,

Based on the validation results, we can conics that cleaning process is validated and itis effective to cleaning the `BinkieRT"

Clinical Test Summary

Clinical testing was not required to demonstrate the substantial equivalence of the BinkieRT to its predicate devices.

8. Conclusion [21 CFR 807.92(b)(3)]

The BinkieRT have similar intended use and technical characteristics to the predicate device.

Based on that information, we conclude that the differences between the proposed device and predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness.

Regulation Number and Section

N/A