The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.

Device Description

Align Technology Inc. (Align) has developed the Align System, which is a series of clear plastic appliances (Aligners) that are intended to replace conventional wire and bracket technology for many orthodontic cases. The series of Aligners moves the patient's teeth in small increments from their original state to a final, treated state. The Align System will use a computer as a tool to assist in creating a series of Aligners that represent sequential movements to generate light and consistent forces on the patient's teeth.

A Dental Practitioner using the Align System diagnoses a patient, determines a treatment plan, and makes dental stone models of a patient's teeth. The Dental Practitioner then sends the molds, along with a prescription for treatment to Align. Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. For each of these intermediate states, a rapid prototyping machine (such as a stereolithography machine) produces corresponding dental molds. In the final step, Align uses a conventional air pressure device (e.g., a Biostar) and commercially available retainer or positioner material (made by Raintree Essix or equivalent) to craft plastic Aligners to fit the developed teeth molds. The models with their corresponding Aligners are then mailed back to the Dental Practitioner. The total number of Aligners can vary from 1 to over 100 per patient, depending on the complexity of the case. The Aligners are individually identified and are dispensed to the patient by the Clinician with specific instructions for use (i.e., the Aligners are to be worn in a prescribed sequence).

AI/ML Overview

This document is a 510(k) premarket notification for the "Align System" (later known as Invisalign). It describes the device and claims substantial equivalence to existing predicate devices. However, it does not provide a study to prove the device meets specific acceptance criteria in the way you've outlined.

Here's a breakdown based on the provided text, highlighting what's missing and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Hypothetical)	Reported Device Performance (as stated in document)
(Not explicitly defined in the document)	"The Align System positions teeth by way of continuous gentle force."
(Not explicitly defined in the document)	"The Aligners are equivalent to the currently marketed predicate devices."
(Not explicitly defined in the document)	"Sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."

Explanation: The document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical trials. Therefore, explicit, quantified acceptance criteria and specific performance metrics designed to meet them are not present in this filing.

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

Sample Size: Not applicable. No "test set" in the context of controlled clinical efficacy studies is described.
Data Provenance: Not applicable. The submission relies on the concept of substantial equivalence, stating that "sufficient information available from the scientific literature" supports the safety and effectiveness of preformed tooth positioners in general. There is no specific original test data presented in this document.

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

Number of Experts: Not applicable. No test set requiring expert ground truth establishment is described.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set requiring adjudication 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

MRMC Study: No. This device is a physical orthodontic appliance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant here.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. While the Align System "will use a computer as a tool to assist in creating a series of Aligners," the device itself is the physical aligner, and its performance is assessed by its ability to move teeth, not as a standalone diagnostic algorithm. The computer is described as a "tool to assist" in the design process, not as a standalone diagnostic or treatment algorithm.

7. The type of ground truth used

No specific ground truth data for a novel study is presented. The "ground truth" implicitly relies on:
- The known mechanisms of action for orthodontic forces.
- The established clinical effectiveness of predicate preformed tooth positioners.
- The "Dental Practitioner's prescription" which guides the desired final state of the teeth.
- The "scientific literature" mentioned for general assurance of safety and effectiveness of the device type.

8. The sample size for the training set

Sample Size: Not applicable. The document does not describe a "training set" in the context of machine learning or AI development for the device's performance evaluation. The "Align System" itself is the series of physical aligners. While their software generates images, there's no mention of a training set for an AI model that diagnoses or predicts treatment outcomes in a general sense.

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

Ground Truth Establishment: Not applicable. No training set is described.

Summary of Device and Evidence Presented:

This 510(k) submission for the Align System (Aligners) describes a series of clear plastic appliances intended to treat malocclusion. The key to its regulatory clearance is the claim of substantial equivalence to existing, legally marketed preformed tooth positioners (e.g., those from Great Lakes Orthodontics, TP Orthodontics, and Ortho-Tain).

The evidence provided to support this claim focuses on:

Technological Characteristics: Stating that "The Aligners are equivalent to the currently marketed predicate devices."
Intended Use: The Align System's intended use ("treatment of tooth malocclusion in patients with permanent dentition...positions teeth by way of continuous gentle force") is aligned with that of predicate devices.
Performance Data: The document explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."

In essence, the "study" proving the device meets criteria is the argument for substantial equivalence, relying on the established history and scientific understanding of its predicate devices, rather than new, primary clinical or bench studies for this specific product.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is a symbol consisting of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2000

Align Technology, Incorporated 881 Martin Avenue Santa Clara, California 95050

Re: K981095

Trade/Device Name: Align System Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: July 30, 1998 Received: July 31, 1998

Dear Mr. Kolesar:

This letter corrects our substantially equivalent letter of September 8. 1998. We are issuing this letter solely because The Align System, as described in the indication for use, is equivalent to an orthodontic plastic bracket.

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 (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.

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 vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

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Page -2 Mr. Kolesar

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

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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ALIGN TECHNOLOGY, INC. ALIGN SYSTEM SIOK APPLICATION

INDICATIONS FOR USE

K 481095 To Be Assigned By FDA 510(k) Number:

Align System Device Name:

The Align System is indicated for the treatment of tooth Indications For Use: malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K95.1695

Prescription Use レ

Over-The-Counter Use

(Per 21 CFR 801.109)

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SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 19:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

198 1098

SUBMITTER INFORMATION 19.1

a.	Company Name:	Align Technology Inc.
b.	Company Address:	2991 El Camino Real, Suite 120Redwood City, CA 94061
c.	Company Phone:Company Fax:	(650) 306-8912(650) 306-8915
d.	Contact Person:	Kelsey WirthPresidentAlign Technology Inc.
e.	Date Summary Prepared:	March 20, 1998

19.2. DEVICE IDENTIFICATION

a.	Trade/Proprietary Name:	Align System
b.	Classification Name:	Preformed Tooth Positioner (872.5525)

IDENTIFICATION OF PREDICATE DEVICE 19.3

Device	510(k) No.	Date Cleared
Great Lakes OrthodonticsPreformed Tooth Positioner	Class I Exempt	Not Applicable
TP Orthodontics Tooth Positioner	K780619	June 28, 1978
Ortho-Tain Tooth Positioner	Class I Exempt	Not Applicable

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DEVICE DESCRIPTION 19.4

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SUBSTANTIAL EQUIVALENCE 19.5

The Align Technology Inc. Align System is of comparable type and is equivalent to the Preformed Tooth Positioners manufactured by Great Lakes Orthodontics, TP Orthodontics, and Ortho-Tain.

INTENDED USE 19.6

TECHNOLOGICAL CHARACTERISTICS 19.7

A comparison of the technological characteristics of the predicate and legally marketed devices has been performed. The results of this comparison demonstrate that the Aligners are equivalent to the currently marketed predicate devices.

19.8 PERFORMANCE DATA

Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness.

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510(K) CHECKLIST 19.9

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist has been provided with this submission.

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.