The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.

Device Description

FS Aligner is an aligner system which offers a solution to those patients who want a simple, aesthetic system of removable aligners to correct minor anterior mal-alignments in patients with permanent dentition (second molars) without the use of conventional wire and bracket orthodontic technology. The system consists of a series of clear, lightweight, flexible, plastic aligners. Each aligner applies incremental progressive force to reposition teeth to a more ideal alignment as prescribed by the treating dental practitioner.

AI/ML Overview

The provided text describes the 510(k) summary for the FS Aligner device, claiming substantial equivalence to predicate devices (Invisalign and Red, White & Blue). It does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

Instead, the submission relies on:

Biocompatibility studies: These were conducted to demonstrate the safety of the material used in the FS Aligner.
Substantial Equivalence: The primary argument is that the FS Aligner is technologically similar to and intended for the same use as legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria and a performance study are not available in the provided text.

Here is a breakdown of what can be extracted and what is explicitly stated as not conducted:

Request 1: A table of acceptance criteria and the reported device performance

Information Not Available: The document does not define specific acceptance criteria for performance (e.g., accuracy of tooth movement, percentage of cases successfully treated) for the FS Aligner, nor does it report performance metrics against such criteria. The device's "performance" is implicitly considered equivalent to the predicate devices based on its technological characteristics and intended use.

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

Information Not Available: No clinical or performance test set (as in, a group of patients or cases evaluated for the device's efficacy) was used for the FS Aligner. The document explicitly states: "Clinical testing has not been conducted on this product."

Request 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)

Information Not Available: Since no clinical or performance test set was used, there was no ground truth established by experts for performance evaluation of the FS Aligner.

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

Information Not Available: As no clinical or performance test set was used, no adjudication method was applicable.

Request 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

Information Not Available: The device is an orthodontic aligner, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant and was not conducted.

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

Information Not Available: The FS Aligner is a physical medical device (aligner system), not a standalone algorithm. Therefore, "standalone algorithm performance" is not applicable in this context. While its manufacturing process involves a "computerized version of the set up providing information similar to a 'blueprint' for the technician," the device itself is not a software algorithm.

Request 7: The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Information Not Available: As no clinical or performance test set was used to evaluate device efficacy, no ground truth types for such a study are reported. The "ground truth" implicitly assumed for regulatory clearance is that the predicate devices are safe and effective, and the FS Aligner is substantially equivalent.

Request 8: The sample size for the training set

Information Not Available: The document does not describe the development of a predictive algorithm or AI model requiring a "training set." The manufacturing process for FS Aligner involves manual repositioning guided by a computerized blueprint, not machine learning model training.

Request 9: How the ground truth for the training set was established

Information Not Available: As no training set for an algorithm is described, how its ground truth was established is not applicable.

Summary

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Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: August 2010

Device Name:

Trade Name FS Aligner .
. Common Name - Aligner, Sequential
Classification Name Orthodontic Plastic Bracket, per 21 CFR § 872.5470 .

Devices for Which Substantial Equivalence is Claimed:

. Align Technology, Invisalign
Red, White & Blue, Allessee Orthodontic Appliances ●

Device Description:

The practitioner will make a dental impression of the patient's teeth and select the teeth that are to be repositioned (corrected). The impressions, or models of the teeth made from the impression, are sent to AOA with a prescription form. The mold will be scanned and the resulting electronic mold with be altered within the computer program to both determine the

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degree of correction and to offer the practitioner the opportunity to review, alter, and approve of the digital corrections: Once approved, the teeth on the physical mold(s) will be sequentially repositioned by hand followed by the fabrication of an aligner for that stage of progressive correction. After 5-7 progressive corrections the resulting aligners are returned to the practitioner for delivery to the patient. Once that sequence of treatment is completed the practitioner will submit a new impression or bite registration to AOA laboratories for the manufacture of the next group or sequence of progressive corrections and aligners. Depending on the complexity of the mal-alignment it is possible that a patient may require 1-8 such iterations of 5-7 aligners.

The FS Aligner system will be mailed (shipped) to the practitioner, who in turn, will provide them to their patient with instructions for use.

Intended Use of the Device:

The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.

Summary of Technological Characteristics:

FS Aligner is substantially equivalent to other legally marketed devices in the United States. FS Aligner functions in a manner similar to and is intended for the same use as Invisalign that is currently marketed by Align Technology and Red, White & Blue that is currently marketed by Allessee Orthodontic Appliances.

Features	FS Aligner	Invisalign	Red, White & Blue
Intended Use	A series of clear plasticaligners intended fortreatment of toothmalocclusion by way of acontinuous gentle force. Eachaligner is produced usingmanually created individualmolds each incorporating aprogressive correction.	A series of clear, plasticaligners (from 1 – toover 100) intended fortreatment of toothmalocclusion by way ofa continuous gentleforce. Each alignerproduced throughcomputerizedgeneration of individualmolds eachincorporating aprogressive correction.	A series of 3 clear,plastic retainersintended to be used tocorrect minor tointermediate tooth mal-alignments by movingteeth progressively to afinal, treated state.
AlignerMaterial	Thin thermo formed plasticmaterial.	Thin thermo formedplastic material.	Thin thermo formedplastic material.
Mode of Use
	Each appliance is worn by the patient as determined by the treating dental practitioner, generally 2-4 weeks prior to being replaced by the next aligner in sequence.	Each appliance is worn by the patient as determined by the treating dental practitioner, generally 2weeks prior to being replaced by the next aligner in sequence.	Each appliance is worn by the patient for 2-4 weeks, or until the patient feels the appliance is passive, in the appropriate sequence of Red, White & Blue retainers.
Description of Appliance Application	Removable	Removable	Removable
Manufacturing Method	Each set up and aligner is manually formed. The technician will cut the desired teeth from the mold and will progressively reposition the teeth required to meet the prescript goal of alignment. The set up portion of the process will be guided by a computerized version of the set up providing information similar to a "blueprint" for the technician. After each repositioning the technician will create a corresponding aligner for a total of 5-7 aligners. These will be returned to the practitioner and delivered to the patient. Following the completion of wear by the patient a new bite registration or impression is returned to the laboratory (AOA) for the next sequence of aligners to be fabricated: This system of "reboot" and acquiring benchmarks to further correct the mal- alignment is continued as needed.	The aligners are manufactured through the use of three- dimensional laser scanning technology - scanning the patient's mold into computer software. From the scanned image, and following a practitioner's prescription, the software generates the image of the final, treated state and then interpolates a series of images that represent intermediate states of alignment. The resulting computer "set ups" relay this information to rapid prototyping machines that produce the physical molds and the aligners are produced from each mold to produce the sequence of aligners.	The retainers are manually formed. The technician will cut the desired teeth from the mold and will progressively repositio the teeth. After each repositioning the technician will create a corresponding appliance for a total of active appliances.

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and the state of the state of the states and

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Non-Clinical Test Data:

Biocompatibility studies (cytotoxicity, irritation and sensitization) have been completed which demonstrates that the material used to produce the FS Aligner is safe for its intended use.

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the biocompatibility and similar technological characteristics to the predicate devices, the performance of the FS Aligner is deemed to be substantially equivalent to Invisalign and Red, White & Blue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Allesee Orthodontic Appliances C/O Ms. Wendy Garman Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K093821

AUG 2 7 2010

Trade/Device Name: FS Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: July 30, 2010 Received: August 2, 2010

Dear Ms. Garman:

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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Page 2- Ms. Garman

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Susan Russo

Anthony D. Watson, B.S., M.S., M.B.A. 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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K093821

Indications for Use

510(k) Number (if known):

Device Name: FS Aligner

Indications For Use:

The FS Aligner System is intended for minor anterior tooth movement in patients with permanent dentition (second molars). The FS Aligner System positions teeth by way of continuous gentle force.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.S. Butz DDS for Dr. Susan Kummer

. Ision Sign-Off Page 1 of 1 Islon of Anesthesiology, General Hospital ifection Control, Dental Devices

10(k) Number:

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.