The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the dentist. The maximum protrusion of the device is 15 mm in 1 mm increments.

AI/ML Overview

This document is a 510(k) premarket notification for "The Panthera Anti-Snoring Device." It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device, the Narval CC.

Based on the provided text, the device itself is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies (like training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not applicable.

Here's the information extracted and formatted as requested, with explanations for non-applicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device seeking substantial equivalence, the "acceptance criteria" are generally based on physical and material properties, and the "reported device performance" is a comparison to the predicate. The document doesn't explicitly state numerical acceptance criteria in the way one would for an AI algorithm's performance metrics. Instead, it focuses on demonstrating equivalence in design, materials, and intended use.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Comparison to Narval CC Predicate)
Intended Use: Reduce/alleviate snoring and mild-to-moderate OSA in adults.	Meets: Same intended use.
Classification: Class II, 21 CFR 872.5570.	Meets: Same classification.
Materials of Construction: Polymeric, biocompatible, durable, flexible, metal-free.	Meets: Made from polyamide type 12 (same as predicate), described as highly resilient, durable, biocompatible, flexible, and lightweight.
Design: CAD/CAM, customized, two splints, interlocking rods for mandibular advancement.	Meets: Uses CAD/CAM; enables customization; two splints with triangular protrusion for interlocking rods.
Principle of Operation: Mandibular repositioner, guides mandible forward to enlarge airway.	Meets: Adjustment of splints guides mandible forward, maintaining advancement to enlarge the airway. Vertical opening not fixed.
Adjustment Mechanism: Interlocking rods, 15 mm protrusive range in 1 mm increments.	Meets: Adjusted via interlocking rods, 15 mm protrusive range in 1 mm increments. Rods 21-36 mm.
Maximum Protrusion: 15 mm in 1 mm increments.	Meets: 15 mm in 1 mm increments.
Sterility: Non-sterile.	Meets: Non-sterile.
Target Population: Adult patients.	Meets: Adult patients.
Usage: Reusable.	Meets: Reusable.
Vertical Opening: Up to 4 mm.	Meets: Up to 4 mm.
Prescription Status: Prescription only.	Meets: Prescription only.
Biocompatibility: Established biocompatibility.	Meets: Biocompatibility established due to material similarity with predicate.
Safety: No new risks introduced compared to predicate.	Meets: FMEA performed; materials same as predicate; no new risks identified.
Effectiveness: At least as safe and effective as predicate.	Meets: Asserted to be at least as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is not an AI/ML algorithm, and no clinical "test set" in the context of algorithm evaluation was used. The submission states, "Panthera dental performed no clinical testing." The demonstration of safety and effectiveness relies on non-clinical testing (physical properties, biocompatibility) and comparison to a legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission for a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was used.

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. This is not an AI/ML device and no MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. "Ground truth" in the context of AI/ML evaluation is not relevant for this physical device submission. The safety and effectiveness are established through material characterization, design specifications, and comparison to the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. This is not an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.

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

December 15,2014

Panthera Dental, Inc. c/o Mr. David Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 10111

Re: K143244

Trade/Device Name: The Panthera Anti-Snoring Device Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK Dated: December 5, 2014 Received: December 8, 2014

Dear Mr. Yungvirt:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/Safety/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 Industry and Consumer Education 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.

Sincerely yours,

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143244

Device Name

The Panthera Anti-Snoring Device

Indications for Use (Describe)

The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position above the words "PANTHERA DENTAL" in purple. The word "PANTHERA" is in a larger font than the word "DENTAL", and the two words are stacked on top of each other.

5 .- 510 (k) Summary

[As required by 21 CFR 807.92]

Date Prepared:	31 October, 2014
Submitter:	Panthera Dental Inc.2035 rue du Haut-BordQuébec (QC) G1N 4R7CanadaFax: +1 (418) 431-9942
Official Contact:	Guy Bernard Bantsiele, Ph.D.Regulatory Affairs ManagerGuy.bantsiele@bodycad.comTel: +1 (418) 527-1388Fax: +1 (418) 431-9942
Device Trade Name:	The Panthera Anti-Snoring Device
Device Common Name:	Mandibular repositioning device
Classification:	21 CFR 872.5570 (Class II)
Product:	LRK

Predicate: Narval CC (K113201)

Description: The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods.

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Image /page/5/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther, the word "PANTHERA" is written in a bold, sans-serif font, with the word "DENTAL" written in a smaller font below it. A purple line is above the word "DENTAL".

Intended Use: The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Technological: The following table displays the differences and similarities between the new Panthera anti-snoring device and one other previously marketed (predicate) device. Equivalence is based on similarities in intended use, materials of construction, design, and operating principles, as summarized in the table below.

Feature	The Panthera Anti-Snoring	Narval CC (K113201)
	Device
Regulationdescription	Intraoral devices for snoring andobstructive sleep apnea (OSA)	Intraoral devices for snoring andobstructive sleep apnea (OSA)
Classification	Class II	Class II
Intended Use	To reduce or alleviate snoring andmild to moderate obstructive sleepapnea (OSA) in adults.	To reduce or alleviate snoring andmild to moderate obstructive sleepapnea (OSA) in adults.
Materials ofconstruction	Made from polymers (polyamidetype 12), Supplied by EOS	Made from polymers (polyamidetype 12), Supplied by EOS
	Highly resilient and durablebiocompatible polymer material andthen manufactured throughselective laser sintering to allow thedevice to be strong yet supple aswell as flexible yet highly resilient.The device is metal-free, flexibleand lightweight	Highly resilient and durablebiocompatible polymer material andthen manufactured through selectivelaser sintering to allow the device tobe strong yet supple as well asflexible yet highly resilient. Thedevice is metal-free, flexible andlightweight
Design	Use the computer-aided design(CAD) and computer-aidedmanufacturing (CAM)	Use the computer-aided design(CAD) and computer-aidedmanufacturing (CAM)
	Use CAD that enables a high degreeof customization according to thephysician or dentist prescription toaccommodate the complex dentalanatomy of individual patients. TheCAM and selective laser sintering	Use CAD that enables a high degreeof customization according to thephysician or dentist prescription toaccommodate the complex dentalanatomy of individual patients. TheCAM and selective laser sintering

	guarantees precision, accuracy andconsistency for each patient.Two customized splints that fitseparately over the upper and lowerteeth inside the mouth. The lowersplint contains a triangularprotrusion, allowing the splints toengage by means of interlockingrods on the sides.	guarantees precision, accuracy andconsistency for each patient.Two customized splints that fitseparately over the upper and lowerteeth inside the mouth. The lowersplint contains a triangularprotrusion, allowing the splints toengage by means of interlockingrods on the sides.
Principle ofoperation/means ofmandibularadvancement	Adjustment of the relative positionof the splints guides the mandibleforward and maintains advancementthus enlarging the airway. Thevertical opening of the jaw is notfixed in a single position.	Adjustment of the relative positionof the splints guides the mandibleforward and maintains advancementthus enlarging the airway. Thevertical opening of the jaw is notfixed in a single position
Fixed/removable	Removable	Removable
Adjustment	Adjusted via the use of interlockingrods placed on the sides of thesplints. The shorter the rod, thefurther the mandible is advancedEasy to titrate and highly adjustablewith connecting rods that allow for15 mm of protrusive range at 1 mmincrements. The dentist can simplyselect a shorter connecting rod untiloptimal advancement is achieved.Rods are available between 21 mmto 36 mm in 1 mm increments	Adjusted via the use of interlockingrods placed on the sides of thesplints. The shorter the rod, thefurther the mandible is advancedEasy to titrate and highly adjustablewith connecting rods that allow for15 mm of protrusive range at 1 mmincrements. The dentist/patient cansimply select a shorter connectingrod until optimal advancement isachievedRods are available between 21 mmto 36 mm in 1 mm increments
Maximumprotrusion ofthe device	15 mm in 1 mm increments	15 mm in 1 mm increments
Suppliedsterile/nonsterile	Non sterile	Non sterile
Target population	Adults patients	Adults patients
Single Use/ reusable	Reusable	Reusable
Vertical opening	Up to 4 mm	Up to 4 mm
Prescription/ OTC	Prescription only	Prescription only
Recommended Cleaning and Maintenance	Clean daily in lukewarm water with a soft toothbrush. Rinse, dry and store in case provided. Twice weekly use chlorine-free antibacterial orthodontic cleaning solution.	Clean daily in lukewarm water with a soft brush and a mild soap/baking soda. Rinse, dry, and store in case provided. Twice weekly, use the Sonic Cleaner provided with effervescent antibacterial tablet

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Image /page/6/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther is the word "PANTHERA" in a purple sans-serif font. The word "DENTAL" is below "PANTHERA" in a smaller font.

Traditional 510(k) – The Panthera Anti-Snoring Device

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Image /page/7/Picture/0 description: The image shows a logo for Panthera Dental. The logo features a black panther in a crouching position, with its tail curled up. Below the panther is the word "PANTHERA" in a stylized font, with the word "DENTAL" in a smaller font underneath.

Traditional 510(k) – The Panthera Anti-Snoring Device

RISKS: Panthera dental performed no clinical testing. However, an FMEA risk analysis, and evaluation of the materials of construction and design were performed. The function of mandibular advancement devices requires that the prescribing dentist be cognizant of the potential for soreness, soft tissue soreness, and dentition complications (soreness, motion, loosening) by mandibular advancement. Management of these risks is achieved by advising the patient and dentist in the directions for use that early and repeated examination of the fit of the device, and its performance, must be performed in the dental office by the prescribing dentist. The contraindications, warnings, precautions, storage directions, prescription preparation instructions, fitting and adjustment directions are written to avoid potential problems from arising or persisting with the dentition, tissue, or joints, caused by the OSA devices. No new materials are being used in the device; all material (polyamide type12) is already used in the predicate device (Narval CC). No new risks are introduced with the new device that are not present in the predicate device.

Non-Clinical Testing: The non-clinical testing included assessment of the physical properties of the Panthera Ant-Snoring Device and its ability to achieve its intended use. The Panthera Anti-Snoring Device meets the same specifications as set for the predicate device.

A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible, based on the similarity of the materials of construction to the predicate device (Narval CC) marketed by ResMed.

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Image /page/8/Picture/0 description: The image shows a logo for a dental practice. The logo features a black panther in a crouching position, with its tail curled up. Below the panther, the word "PANTHERA" is written in a purple sans-serif font. Underneath "PANTHERA", the word "DENTAL" is written in a smaller, purple sans-serif font with a line above it.

Clinical Testing: Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the Panthera Anti-Snoring Device. The Panthera Anti-Snoring Device does not: Use designs dissimilar from the predicate device and other previously cleared devices under a 510(k); The Panthera Anti-Snoring Device does not use new technologies different from legally marketed intramandibular repositioning devices for treating snoring and mild to moderate obstructive sleep apnea; and the Panthera Anti-Snoring Device does not deviate from the indications for use identified in the predicate device: Narval CC.

Substantial Equivalence Conclusion: The new device, the Panthera Anti-Snoring device, is considered to be substantially equivalent to the predicate based on the following: it has essentially the same intended use and is indicated for the same user population; it has equivalent technological characteristics to the predicate; it does not raise new questions of safety and effectiveness; it is at least as safe and effective as the predicative device.

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”