The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for "The Slide," an intraoral device for snoring and obstructive sleep apnea. It outlines the device's characteristics, comparison to a predicate device (SomnoDent G2), and performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device for which such detailed performance metrics, ground truth establishment, and clinical study designs (MRMC, standalone) would be highly relevant.

The document makes it clear that clinical testing was NOT required and that substantial equivalence was based upon "benchtop performance testing" and comparison to a predicate device. This is a traditional medical device clearance, not an AI/ML device clearance that would typically involve the kind of rigorous performance evaluation against established ground truth as outlined in your request.

Therefore, many of your requested points cannot be answered from the provided text because the study type (benchtop mechanical testing, not a clinical study assessing diagnostic or therapeutic accuracy in humans based on ground truth data) does not lend itself to those questions.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (as per the provided text for a mechanical device):

The "acceptance criteria" detailed in the document primarily revolve around mechanical integrity and biocompatibility, not performance metrics related to diagnostic accuracy or AI assistance.

Acceptance Criteria (Benchtop/Mechanical)	Reported Device Performance
Material biocompatibility in compliance with ISO 10993-1:2018	Established to be in compliance with ISO 10993-1:2018.
Maximum force the device can withstand (compared to forces in patient's mouth)	The mean peak force the device can withstand is 10 standard deviations above the acceptance criteria. (This indicates it far exceeds the minimum required strength).
Substantial equivalence to predicate device (SomnoDent G2)	Demonstrated through comparison of indications for use, intended use, design, and materials (Table 1 and Section 7).

Study Details (Based on the Provided Text):

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data for an AI/algorithm. The performance data is primarily benchtop mechanical testing. The document states, "Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand..." No human test subjects or clinical data are described.
- Data Provenance: Not applicable for clinical data. The context is benchtop testing of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of expert consensus on patient conditions (e.g., diagnosis of sleep apnea from physiological data), was not established for this type of testing. The "truth" here is engineering specifications and material properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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 explicitly not done. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing." This device is a physical intraoral device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this regulatory submission was compliance with engineering standards (ISO 10993-1:2018 for biocompatibility) and achieving specific mechanical properties (withstanding force) that were deemed sufficient compared to the predicate device and expected in-mouth forces. Clinical ground truth was not part of this evaluation.
The sample size for the training set:
- Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. There was no training set for an AI/ML model.

In summary, the provided document details the regulatory clearance of a physical medical device (intraoral snore/sleep apnea appliance) based on engineering performance and substantial equivalence to a predicate, rather than the performance evaluation of an AI/ML diagnostic or assistive algorithm. Therefore, many of your questions regarding AI-specific criteria are not addressed by this document.

Summary

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July 20, 2021

Wade Munsch, Regulatory Affairs Manager Biotex, Inc. 114 Holmes Rd., Houston, Texas 77045

Re: K203712

Trade/Device Name: The Slide Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LQZ, LRK Dated: January 19, 2021 Received: January 19, 2021

Dear Wade Munsch:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203712

Device Name The Slide

Indications for Use (Describe)

The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

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

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

1. SUBMITTER

Biotex. Inc. 114 Holmes Road Houston, TX 77045 USA Tel: (713) 741-0111 ex 208 Fax: (713) 741-0122 Email: wade.munsch@biotexmedical.com Contact Person: Wade Munsch Date Prepared: July 19th, 2021

2. DEVICE

Name of Device:	The Slide
Classification Name:	Device, Anti-Snoring
Regulation:	21 CFR §872.5570
Regulatory Class:	Class II
Product Classification Code:	LQZ, LRK
510(k):	K203712

3. PREDICATE DEVICE

Predicate Manufacturer:	Somnomed
Predicate Trade Name:	Somnodent G2
Predicate 510(k):	K121340

No reference devices were used in this submission.

4. DEVICE DESCRIPTION

The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce 4.1. nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.

5. INDICATIONS FOR USE

5.1. The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

6.1. The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

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	The SlideK203712	SomnoDent G2 –K121340	Evaluation ofDifferences
Indication for Use	The Slide is foruse to reducenight-timesnoring andmild tomoderateobstructivesleep apnea(OSA) in adults.	The SomnoDentG2 is intended forthe treatment ofnightime snoringand mild tomoderateobstructive sleepapnea in patients18 years of age orolder.	N/A
Intended Use
Intended as intraoral device	Yes	Yes	N/A
Intended to reduce snoringor help alleviate snoring	Yes	Yes	N/A
Intended for treatment ofmild to moderateobstructive sleep apnea	Yes	Yes	N/A
Intended for nighttime use	Yes	Yes	N/A
Indicated for single patientmultiuse	Yes	Yes	N/A
Indicated for use in thepatient's home	Yes	Yes	N/A
Target Population: Adults	Yes	Yes	N/A
Prescription device	Yes	Yes	N/A
Design
Customized fit for eachpatient	Yes	Yes	N/A
Separate upper and lowertray pieces	Yes	Yes	N/A
Works by mandibularadvancement	Yes	Yes	N/A
Advancement componentsare attached to the occlusalside of the device.	Yes	No	The SomnoDent G2advancementcomponents areattached to the buccalside. While thesealignment featureswhich prevent shiftingfrom side to side havebeen changed to asimple rail system inline with the teeth, thereare no additional forcesintroduced and no newquestions of safety oreffectiveness.
	The SlideK203712	SomnoDent G2 –K121340	Evaluation ofDifferences
Lower jaw adjustment usingsupplied components	Yes	Yes	N/A
Permits patient to breathethrough mouth	Yes	Yes	N/A
Upper and lower traysdisengage for easy removal	Yes	Yes	N/A
Materials
Splint	Yes	No, Traysconstructed from asoft lining materialadhered to a hardsurface acrylic	The 3D trays areprinted at Dental labsfrom materialsapproved to makedental splints. Use of3D printed trays doesnot introduce anyquestions of safety oreffectiveness.
Advancement mechanismconstructed ofbiocompatible, medicalgrade polycarbonate	Yes	Yes	N/A

Table 1: Comparison of The Slide with SomnoDent G2 (K121340).

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7. SUMMARY OF TECHNICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE

The device and predicate device (K121340) are identical in the following ways: 7.1. -
- 7.1.1. Regulation name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea
- 7.1.2. Regulation number: 21 CFR 872.5570
- 7.1.3. Regulatory Class: II
7.2. The predicate device claims product code LRK (anti-snoring), and the subject device claims LRK and LQZ (jaw repositioning). While the predicate device's submission does not reference product code LQZ, the mechanisms of action and intended use are in line with this code.
7.3. The predicate device has advancement components attached to the buccal side of the mouth, while the Slide has advancement components attached to the occlusal side of the mouth. While these alignment features which prevent shifting from side to side have been changed to a simple rail system in line with the teeth, there are no additional forces introduced and no new questions of safety or effectiveness. K203712.S003 Doc 010 046-0012 Device Mechanics Comparison includes a more in-depth discussion of these differences.
7.4. To demonstrate substantial equivalence, bench testing was conducted to assess the mechanical integrity of the subject device when subjected to forces expected in the patient's mouth during use. These results, summarized in Vol 018 Doc 001 Benchtop Performance Testing Overview, indicated that the subject device performance is substantially equivalent to the predicate device, the SomnoDent G2, and it introduces no new questions of safety or effectiveness.
7.5. The subject device and predicate device have equivalent indications for use and technological characteristics, with the exception of the custom 3D printed tray, which does not introduce any questions of safety or effectiveness.

8. PERFORMANCE DATA

8.1. The following performance data were provided in support of the substantial

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equivalence determination.

8.2. Biocompatibility Testing

8.2.1. Material biocompatibility established to be in compliance with ISO 10993-1:2018.

8.3. Mechanical Testing

8.3.1. Mechanical testing was performed to verify device functionality by assessing the maximum force the device can withstand to similar forces a patient's mouth will exhibit on the device. The mean peak force the device can withstand is 10 standard deviations above the acceptance criteria.

8.4. Animal Study

8.4.1. Animal performance testing was not required to demonstrate safety and effectiveness of the device.

8.5. Clinical Studies

8.5.1. Clinical testing was not required to demonstrate the safety and effectiveness of The Slide. Instead, substantial equivalence is based upon benchtop performance testing.

9. CONCLUSIONS

9.1. The subject device, The Slide, is substantially equivalent to the predicate device, the SomnoDent G2, and it introduces no new questions of safety or effectiveness.

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.”