The NuBrace IRO is indicated for the treatment of tooth malocclusion and for preprosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Device Description

The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NuBrace Invisible Removable Orthodontics (IRO):

Based on the provided 510(k) summary, the device is being cleared primarily based on substantial equivalence to a predicate device, rather than explicit, quantifiable acceptance criteria from a specific clinical or performance study with defined metrics.

Here's a breakdown of the requested information, acknowledging the limitations of the provided document:

NuBrace Invisible Removable Orthodontics (IRO) Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category / Metric	Acceptance Criteria (Implicit)	Reported Device Performance	Comments / Supporting Information
Intended Use	Treatment of tooth malocclusion; pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition.	Same as predicate device (Align System (K981095)).	Stated as "similar intended uses and similar indications" to the predicate.
Safety	As safe as the predicate device.	As safe as the predicate device.	"NuBrace IRO is as safe and effective as the predicate device."
Effectiveness	As effective as the predicate device.	As effective as the predicate device.	"NuBrace IRO is as safe and effective as the predicate device." "NulBrace IRO functioned as intended and the tooth movement observed was as expected."
Technological Characteristics	No new issues of safety or effectiveness raised compared to predicate.	Dual laminated polymers for enhanced comfort and gradual tooth movement.	"The minor technological differences... raise no new issues of safety or effectiveness."
Duration of Action (in vitro)	Longer duration of action than traditional polycarbonate outer shell.	"Laminating a softer layer onto the traditional polycarbonate outer shell allows for a longer duration of action."	Demonstrated through "In vitro testing."
Patient Comfort (in vitro)	More patient comfort during wear than traditional polycarbonate outer shell.	"The softer layer allows for more patient comfort during wear."	Demonstrated through "In vitro testing."
Tooth Movement	Expected tooth movement.	"The tooth movement observed was as expected."	Demonstrated through "In vitro testing."
Principles of Operation	Similar to predicate device.	Similar to predicate device.	Stated as "similar ... principles of operation as its predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical study with human subjects. The reported in vitro testing does not specify a sample size (e.g., number of aligners, number of simulated teeth).
Data Provenance: The study described is "In vitro testing." No information on country of origin or whether it was retrospective or prospective is applicable or provided, as it's a lab-based test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as part of the 510(k) summary. The "ground truth" for the in vitro testing appears to be based on the intended mechanical properties and observable tooth movement, likely evaluated by the manufacturer's internal experts or engineers, but no specifics are given.

4. Adjudication Method for the Test Set

This information is not provided. Given the in vitro nature of the described testing, formal expert adjudication as seen in clinical trials is unlikely to have been performed or reported in this summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done (or at least, not reported in this 510(k) summary). The submission relies on in vitro testing and substantial equivalence to a predicate, not a clinical trial comparing device performance with and without AI assistance (which is not applicable here as this is a physical device).

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

Not applicable. This device is a physical orthodontic appliance, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

For the in vitro testing: The ground truth appears to be based on the expected mechanical performance (e.g., "longer duration of action," "more patient comfort," "tooth movement observed was as expected"). This would be determined by engineering specifications and dental principles. It is not pathology, expert consensus (in a clinical sense), or outcomes data from human patients.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device. There is no "training set" in the context of machine learning or AI models. If "training set" refers to prototypes or iterations during development, that information is not provided.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided documentation for this physical device.

Summary of the Study:

The "study" cited in the 510(k) summary is comprised of in vitro testing. This testing was conducted to demonstrate:

The effect of the dual laminated polymers on increasing the duration of action.
The effect of the softer layer on patient comfort during wear.
That "NulBrace IRO functioned as intended and the tooth movement observed was as expected."

The primary evidence for acceptance relies on the assertion that NuBrace IRO is substantially equivalent to the predicate device (Align Technology, Inc.'s Align System K981095) due to similar intended uses, indications, technological characteristics, and principles of operation, with the minor technological differences "raising no new issues of safety or effectiveness."

Summary

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Ko73121

FEB 1 2 2009

510(k) SUM MARY

NuBrace Inc.'s NuBrace Invisible Removable Orthodontics

Submitter's Name, Address, Telephone Number , Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan and Hartson LLP Columbia Square 555 Thirteenth Street, NW Washington DC, 20004 Phone: (202) 637-5794 · Facsimile: (202) 637-5910

Date Prepared: November 5, 2007

Name of Device and Name/Address of Sponsor

NuBrace Invisible Removable Orthodontics

Tom Kalili, D.M.D. NuBrace, Inc. 416 N. Bedford Drive Suite 307 Beverly Hills, CA, 90210 Phone: (310) 273-0153

Common or Usual Name

Invisible Removable Orthodontic Stint

Classification Name

Preformed Tooth Positioner

Predicate Device

Align Technology, Inc.'s Align System (K981095)

Intended Use / Indications for Use

The NuBrace IRO is indicated for the treatment of tooth malocclusion and for preprosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all

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second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Technological Characteristics

The NuBrace IRO consists of dual laminated polymers that enhance patient comfort and move teeth at a longer, more gradual rate of tooth movement.

Performance Data

In vitro testing has demonstrated that laminating a softer layer onto the traditional polycarbonate outer shell allows for a longer duration of action. In addition, the softer layer allows for more patient comfort during wear. In all instances, NulBrace IRO functioned as intended and the tooth movement observed was as expected.

Substantial Equivalence

NuBrace IRO is as safe and effective as the predicate device. NuBrace IRO has similar intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between NuBrace IRO and its predicate device raise no new issues of safety or effectiveness. Thus, NuBrace IRO is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuBrace IRO C/o Mr. Jonathan S. Kahan Hogan and Hartson, LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004

Re: K073121 .

Trade/Device Name: NuBrace IRO Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: February 10, 2009 Received: February 10, 2009

Dear Mr. Kahan:

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.

FEB 1 2 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Kahan

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 begin 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony 49, Austin, Tex

Ginette Y. Michaud, M.D. Acting 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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Indications for Use Statement

510(k) Number (if known):

Device Name: NuBrace IRO

Indications for Use:

K073121

The NuBrace IRO is indicated for the treatment of tooth malocclusion and for pre-prosthetic orthodontic cosmetic movement in patients with permanent dentition (i.e., all second molars). The NuBrace IRO is intended to position teeth by way of continuous gentle force.

Prescription Use x (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runore

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073122

Page

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.