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

Device Description

The ClearCorrect device is fabricated of clear, thin, thermoformed polycarbonate plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

AI/ML Overview

This 510(k) summary for the ClearCorrect device does not contain the detailed information required to fill out the requested table regarding acceptance criteria and a study proving those criteria. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with acceptance criteria.

Here's a breakdown of why the information is missing from the provided text:

Type of Submission: This is a Traditional 510(k) for a device that is essentially identical to its predicates. The primary goal of such a submission is to show substantial equivalence through technological characteristics and intended use, rather than extensive de novo performance testing against specific acceptance criteria.
Device Type: ClearCorrect aligners are physical, custom-made orthodontic devices. The "performance" in this context is the physical repositioning of teeth, which is a clinical outcome over time, not a measurable, instantaneous output like a diagnostic algorithm.
Focus of the Document: The document explicitly states: "The information discussed above demonstrates that the ClearCorrect device is substantially equivalent to the predicate devices." It then provides a table comparing features like Intended Use, Mode of Action, and Material, to show this equivalence. No study data or acceptance criteria are presented.

Based on the provided text, I cannot complete the table or answer most of your detailed questions. The document does not describe:

Specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or any measurable clinical outcome percentages).
A study validating device performance against such criteria.
Sample sizes for test or training sets.
Details about ground truth establishment or expert qualifications.
Any multi-reader, multi-case studies or standalone algorithm performance.

Here's what can be inferred or stated as "not provided" based on the text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated/measured in this document)	Reported Device Performance (Not explicitly stated/measured in this document)
*No explicit numerical or qualitative acceptance criteria provided.	No quantitative device performance metrics (e.g., success rate of alignment, percentage of cases achieving desired outcome) are provided.
The submission relies on substantial equivalence to predicate devices.	The device's performance is inferred to be similar to its predicates based on identical technological characteristics and intended use.

Missing Information Based on the Provided Text:

Sample sizes used for the test set and the data provenance: Not provided. The submission does not detail a specific test set or study.
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): Not provided. No test set or ground truth establishment process is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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 is not an AI-based diagnostic or interpretative device; it's a physical orthodontic appliance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K082556

Submitter: ClearCorrect

ClearCorrect Premarket Notification: Traditional 510(k)

510(k) Summary

FEB - 6 2009

Submitter Name: ClearCorrect, Inc. 5200 Mitchelldale St., Ste F-26 Submitter Houston, TX 77092 Address: 713-850-1036 Phone Number: 713-248-9415 Fax Number: Contact Person: Jarrett Pumphrey 30 August 2008 Date Prepared: ClearCorrect Device Trade Name: Common Name Clear Braces Classification Sequential Aligner 852.5470 Name, Number & Product Code: NXC Invisalian/Align System. Align Technology Inc., K981095 Predicate Devices: Clear Image Aligners, Specialty Appliances Works, Inc., K071970 Device Description: The ClearCorrect device is fabricated of Device Description clear, thin, thermoformed polycarbonate plastic in a and Statement of sequential series to progressively reposition the teeth. Intended Use Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner. Intended Use: The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force. A dental health care professional (e.g. orthodontist or Summary of dentist), prescribes the ClearCorrect system based on an Technological assessment of the patient's teeth, determines a course of Characteristics treatment with the system, takes molds of the patient's teeth,

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and completes a prescription form The molds and prescription are sent to ClearCorrect. Utilizing standard, dental software used for tooth alignment. ClearCorrect designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, ClearCorrect produces the trays, which are formed of clear, thin, thermoformed polycarbonate plastic. The trays are sent back to the dentist, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the physician to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at anv time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced above.

Conclusion

The information discussed above demonstrates that the ClearCorrect device is substantially equivalent to the predicate devices

Declarations

o This summary includes only information that is also covered in the body of the 510(k).
o This summary does not contain any puffery or unsubstantiated labeling claims.
· This summary does not contain any raw data, i.e., contains only summary data.
o This summary does not contain any trade secret or confidential commercial information.
o This summary does not contain any patient identification information.

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Summary of Technical Characteristics

Feature	ClearCorrect	Invisalign/Align System	Clear Image Aligners
510(k) Number	Not yet assigned	K981095	K071970
Manufacturer	ClearCorrect, Inc.	Align Technology Inc	Specialty AppliancesWorks, Inc
Classification # &Product Code	852.5470NXC	852.5470NXC	852.5470NXC
Intended Use	The ClearCorrectSystem is indicated forthe treatment of toothmalocclusion inpatients withpermanent dentition(i.e. all second molars).The ClearCorrectSystem positions teethby way of continuousgentle force.	The Align System isindicated for thetreatment of toothmalocclusion inpatients withpermanent dentition(i.e., all secondmolars). The AlignSystem positions teethby way of continuousgentle force.	The Clear ImageTMAligners system isintended to correctminor discrepancies inthe alignment ofmaloccluded anteriorteeth on patients withpermanent dentition(second molars) bymoving the teeth with aprogressive series ofclear thin,thermoformed plasticaligners, fabricated instages to graduallyalign the teeth over aperiod of severalmonths. The alignersare completelyremovable by thepatient and may bediscontinued at anytime.
Mode of Action	Alignment of teeth bysequential use ofpreformed plastictrays.	Alignment of teeth bysequential use ofpreformed plastictrays.	Alignment of teeth bysequential use ofpreformed plastic trays.
Material	Thermoformedpolycarbonate	Thermoformedpolycarbonate	Thermoformedpolycarbonate
OTC or Rx	Rx	Rx	Rx

・

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....

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three legs, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ClearCorrect, Incorporated c/o Mr. William Greenrose President Oserve America, Incorporated 220 River Road Claremont, New Hampshire 03743

Re: K082556

Trade/Device Name: ClearCorrect Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: January 15, 2009 Received: January 16, 2009

Dear Mr. Greenrose:

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 - 6 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. Greenrose

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 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 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 yours.

Soutte Y. Michie Davis.

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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4.1 Indications for Use Statement

510(k) Number (if known): K082556

Device Name: ClearCorrect

Indications for Use:

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X
	OR
	Over-The-Counter Use
	(Optional Format 1-2-96)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K082556
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Section 4.0

CONFIDENTIAL

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.