The device consists of a lower tray fitted over the lower teeth, an upper tray over the upper teeth, and a mechanism to attach the lower to the upper tray. The device allows the practitioner to determine the advancement of the mandible and the vertical opening for desired results. This technology platform consists of a stylus, slider, and the channels into which they are placed; these parts are identical in both models.
The device has a 10 mm long channel in the lower tray behind the anterior teeth that is perpendicular to the patient's tongue. This allows the upper component, which locks into the channel, to provide lateral excursion for the patient's comfort. Prior to final insertion the upper and lower trays are connected together by keying the stylus into the lower channel. The device's upper component consists of a 16 mm long titanium channel into which a nine-position latched slider will let the practitioner place the stylus in the optimum position. Both the slider and the stylus are placed into the channel's frontal opening and securely locked into place by tension attachment.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., reduction in AHI, success rates, or statistical improvements). Instead, the substantial equivalence comparison focuses on design attributes and intended use compared to predicate devices. The "reported device performance" is implicitly established by demonstrating these comparable design features and intended use.

Therefore, the table below reflects the comparison of attributes as presented in the document, which serves as the basis for determining substantial equivalence rather than quantitative performance against a pre-defined acceptance criterion.

Attribute	Acceptance Criteria (based on predicate device features)	Reported Device Performance (Silent Partner)
Intraoral device	Yes (must be an intraoral device)	Yes
Reduce snoring	Yes (must reduce snoring)	Yes
Reduce obstructive sleep apnea	Yes (must reduce obstructive sleep apnea)	Yes
Removable device	Yes	Yes
Custom fit	Yes	Yes
Adjustable forward movement	Yes	Yes
Adjustable vertical movement	Not necessarily required by all predicates, but demonstrated by some	Yes (differentiator from some predicates)
Separate trays	Yes	Yes
Holds lower jaw forward	Yes	Yes
Permits lateral jaw movement	Yes	Yes
Permits vertical jaw movement	Yes (demonstrated by some predicates)	No (differentiator from some predicates)
Upper and lower trays can be separated by patient	Yes (demonstrated by some predicates)	Yes
Permits patient to breathe through mouth	Yes	Yes
Specialized tools needed	No (demonstrated by some predicates)	No
Vacuum formed trays (Model A)	Yes (comparable material/manufacturing method)	Yes
Thermoplastic trays (Model B)	Yes (comparable material/manufacturing method)	Yes
Ti stylus and critical parts (Note: This is a material difference, not a functional criterion in the same way)	No (not present in predicates listed)	Yes (unique feature)

Study that proves the device meets the acceptance criteria:

The provided 510(k) summary does not describe a specific clinical study with performance metrics demonstrating that the "Silent Partner" device meets quantitative acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices (TOA, TAP, OASYS) based on:

Intended Use: The Silent Partner shares the identical intended use of reducing snoring and mild to moderate obstructive sleep apnea by repositioning the mandible.
Technological Characteristics/Design: The device's design features (e.g., intraoral, removable, custom fit, adjustable forward movement, separate trays, holds lower jaw forward, permits lateral jaw movement, permits patient to breathe through mouth) are compared to the predicate devices. Differences are noted (e.g., adjustable vertical movement, permitting vertical jaw movement, Ti stylus and critical parts), but these differences are either considered to not raise new questions of safety or effectiveness, or are improvements that do not change the fundamental mechanism of action.
Materials: The device uses vacuum-formed or thermoplastic trays, similar to the predicate devices. The use of a Titanium (Ti) stylus and critical parts is a material difference but is not presented as raising new safety or efficacy concerns.

The conclusion states: "To the best of our knowledge, the device is substantially equivalent to the predicate devices, and no additional risks are created." This statement, coupled with the detailed comparison table, is the "proof" presented in this 510(k) summary for meeting the criteria of substantial equivalence, which is the basis for market clearance for Class II devices like this.

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

Sample size for the test set: Not applicable. This 510(k) summary does not report on a specific test set used to generate performance data for the Silent Partner device. The submission relies on a comparison to predicate devices, not on new clinical data.
Data provenance: Not applicable. No clinical data is presented.

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

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No test set or expert adjudication process is described.

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 device is an intraoral appliance, not an AI or imaging-based diagnostic tool. No MRMC study was conducted or described.

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

Not applicable. This device is an intraoral appliance; it is not an algorithm with standalone performance.

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

Not applicable. No new ground truth data was generated or used in this 510(k) submission. The "ground truth" for the comparison is the established performance and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable. This 510(k) summary does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. No "training set" and associated ground truth establishment are relevant to this submission.

Summary

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510(k) Summary

Silent Partner, K051014

Date:	3 August 2005
Applicant:(Also manufacturing site)	DreamWRx Dental Laboratory1911 Colorado BoulevardLos Angeles, CA 90041
Registration number:	3005034462
Contact person:	Nicolaas Besseling
Phone numbers:(Contact person)	(949) 466-7472 mobile(949) 448-0312 fax
Email address:	bestechconsulting@cox.net
Device name:	Silent Partner™ series OSA appliances
Common name:	Intraoral devices for snoring and obstructive sleep apnea
Classification:	Class II
Product Code:	LRK anti-snoring device
Regulation number:	21CFR872.5570
Predicate devices:	TOA, K972061TAP, K962516OASYS - Oral Airway System K030440
Device description:	The device consists of a lower tray fitted over the lower teeth, an upper tray over the upper teeth, and a mechanism to attach the lower to the upper tray. The device allows the practitioner to determine the advancement of the mandible and the vertical opening for desired results. This technology platform consists of a stylus, slider, and the channels into which they are placed; these parts are identical in both models.The device has a 10 mm long channel in the lower tray behind the anterior teeth that is perpendicular to the patient's tongue. This allows the upper component, which locks into the channel, to provide lateral excursion for the patient's comfort. Prior to final insertion the upper and lower trays are connected together by keying the stylus into the lower channel. The device's upper component consists of a 16 mm long titanium channel into which a nine-position latched slider will let the practitioner place the stylus in the optimum position. Both the slider and the stylus are placed into the channel's frontal opening and securely locked into place by tension attachment.
Intended use:	The device is intended to reduce nighttime snoring and/or mild tomoderate obstructive sleep apnea by repositioning of the mandible.

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Substantial equivalence comparison

Device	Silent Part-ner	TOA	TAP	OASYS
Attribute	This submis-sion, K051014	K972061	K962516	K030440
Intended use
Intraoral device	yes	yes	yes	yes
Reduce snoring	yes	yes	yes	yes
Reduce obstructive sleep apnea	yes	yes	yes	yes
Design
Removable device	yes	yes	yes	yes
Custom fit	yes	yes	yes	yes
Adjustable forward movement	yes	yes	yes	yes
Adjustable vertical movement	yes	no	no	no
Separate trays	yes	yes	yes	yes
Holds lower jaw forward	yes	yes	yes	yes
Permits lateral jaw movement	yes	yes	yes	yes
Permits vertical jaw movement	no	yes	yes	yes
Upper and lower trays can be sepa-rated by patient	yes	yes	no	yes
Permits patient to breathe throughmouth	yes	yes	yes	yes
Specialized tools needed	no	no	no	yes
Materials
Vacuum formed trays	Model A	yes	yes	yes
Thermoplastic trays	Model B	yes	yes	yes
Ti stylus and critical parts	yes	no	no	no

Conclusion

To the best of our knowledge, the device is substantially equivalent to the predicate devices, and no additional risks are created.

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three human profiles facing right, representing health and human services.

AUG 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicolaas Besseling Principal DREAMWRX Dental Laboratory 1911 Colorado Blvd. Los Angeles, California 90041

Re: K051014

Trade/Device Name: Sleep Partner Series OSA Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK Dated: June 24, 2005 Received: June 30, 2005

Dear Mr. Besseling:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) promise is substantially equivalent (for the indications ferenect above and have active degally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars annount date of the Medical Device Americants, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Free) that ao not requent in the general controls provisions of the Act. The You may, therefore, market the devices, boyer is a courements for annual registration, listing of general controls provisions of the revelop labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) and existing major regulations affecting your device can may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarning your device in the Federal Register.

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Page 2 -- Mr. Besseling

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backen complies with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA nas made a decidination administered by other Federal agencies. You must of any Federal statutes and regulations paintines on the not limited to: registration and listing (21 comply with all the Act s requirements, mercesses comments of the requirements as set CFK Part 807), labeling (21 CFR Part 800); god an art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000 (1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 091 - 15 described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your besine I his letter will anow you to oegin manceing your antial equivalence of your device to a legally premarket nother. The PDA mining of basification for your device 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), please If you desire specific advice io. your as of (240) 276-0115. Also, please note the regulation entitled, a contact the Office of Compliance at (217) airfration" (21CFR Part 807.97). You may obtain "Misoranding by telefonecto promantes nowler the Act from the Division of Small other general Information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanter Plastians overdrh/industry/support/index.html.

Sincerely yours.

Susa Runne

Image /page/3/Picture/4 description: The image shows a handwritten letter 'f' and the word 'or'. The letter 'f' is written in a cursive style. The word 'or' is written in a standard font.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.. ..

3 Indications for use

510(k) number:	K051014
Device name:	Silent Partner series OSA appliances
Intended use:	Reduce nighttime snoring and/or mild to moderate obstructivesleep apnea by repositioning of the mandible.

Concurrence of CDRH, Office of Device Evaluation

Prescription use
(Per 21CFR801.109)

ﻟﺮ

147

Over-The-Counter use

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 1975 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Singa

Page 8

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.”