Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.

Device Description

The Park Dental Research Aligners device is fabricated of clear thin thermoformed polyurethane 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 document, K180648, is a 510(k) premarket notification for the "Park Dental Research Aligners." It appears to be a submission demonstrating substantial equivalence to a predicate device, rather than a submission for a novel artificial intelligence/machine learning (AI/ML) device that would typically involve extensive performance testing against acceptance criteria for AI algorithms.

Therefore, the provided text does not contain the information requested in points 1-9, as it describes a traditional medical device (clear aligners) and seeks clearance based on its similarity to an existing device, not based on AI/ML performance. The "Non-Clinical Performance Testing" section primarily discusses material biocompatibility and manufacturing validation related to software for fabrication, but this is not an AI/ML algorithm performance study.

Therefore, I cannot extract the requested information from the provided text.

To illustrate what a response would look like if the document contained AI/ML device performance data, here's a hypothetical structure and explanation of what each point would cover:

Hypothetical Acceptance Criteria and Study Proof (If this were an AI/ML device submission):

This section is not based on the provided document K180648, as the document does not describe the performance testing of an AI/ML algorithm for a medical device. It is a hypothetical example of what the requested information would look like if the submission were for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
Primary Endpoints
Sensitivity (for Condition A Detection)	≥ 90%	XX%
Specificity (for Condition A Detection)	≥ 85%	YY%
Secondary Endpoints (if applicable)
AUC (for Classification)	≥ 0.92	ZZ
Agreement with expert readers (Kappa)	≥ 0.80	WW
Processing Time per case	< 30 seconds	PP seconds

2. Sample Size for Test Set and Data Provenance:

Sample Size: [Number] cases (e.g., 500 cases)
Data Provenance: [e.g., Retrospective, multicenter study from hospitals across the United States, Europe, and Asia.]

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: [e.g., 3 independent expert readers]
Qualifications: [e.g., Board-certified Radiologists with an average of 10-15 years of experience in musculoskeletal imaging, specializing in dental radiography. One expert also held a Ph.D. in dental imaging, and all had prior experience in image annotation and consensus building.]

4. Adjudication Method for Test Set:

Adjudication Method: [e.g., 2+1 Adjudication: Initial assessment by two independent experts. In cases of disagreement, a third senior expert (adjudicator) reviewed the case and made the final determination.] OR [e.g., 3-Expert Consensus: All three experts independently reviewed cases, and ground truth was established by unanimous agreement. If disagreement persisted, the case was excluded or a dedicated consensus meeting was held to reach full agreement.] OR [e.g., None: Ground truth was established by a single, highly experienced expert, or by pathology/histology reports as the definitive source.]

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? [Yes/No]
If Yes, Effect Size (Human Readers improve with AI vs. without AI assistance):
- [e.g., The average sensitivity of human readers improved from 75% to 88% (an absolute improvement of 13 percentage points) when assisted by the AI device, as measured by a JAFROC analysis. The AUC for human readers unassisted was 0.85, improving to 0.93 with AI assistance.]

6. Standalone (Algorithm Only) Performance:

Was a standalone performance study done? [Yes/No]
If Yes, describe: [e.g., The algorithm's standalone performance was evaluated against the established ground truth, achieving a sensitivity of XX% and specificity of YY% for detecting the target condition. This was a prerequisite for evaluating human-in-the-loop performance.]

7. Type of Ground Truth Used:

Type of Ground Truth: [e.g., Expert consensus (radiologists' interpretations), confirmed by pathology/histology reports where available.] OR [e.g., Clinical outcomes data (e.g., confirmed disease diagnosis from follow-up tests over 6 months).]

8. Sample Size for Training Set:

Training Set Sample Size: [Number] cases (e.g., 10,000 cases)

9. How Ground Truth for Training Set was Established:

Ground Truth Establishment for Training Set: [e.g., Initially labeled by a team of trained clinical annotators under the supervision of a lead radiologist. A subset of these annotations (e.g., 10%) were then independently reviewed by a senior radiologist for quality control and refinement. Active learning techniques were employed, where the model's uncertain predictions were sent for expert review to iteratively improve the training data quality.]

Summary

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510(k) Summary

K180648

Park Dental Research Aligners

Park Dental Research Corporation

Trade Name: Park Dental Research Aligners

Common Name: Sequential Aligner

Date of Preparation: November 28, 2018

Submitter: Dr. Ronald A Bulard

Submitter's Address: 2401 N. Commerce St. Suite E Ardmore, OK 73401

Submitter's Phone: 800-243-7372

Product Code: NXC

Regulation No.: 872.5470 Orthodontic Plastic Bracket

Classification: Class II

Predicate 510k: K113618 ClearCorrect System from ClearCorrect LLC

Device Description:

Indications for Use:

The indications for use is highly similar to that of the predicate device, ClearCorrect, with the differences due to including the device name.

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Technological Characteristics:

Treatment of tooth malocclusions via a series of intraoral plastic appliances designed to provide forces for incremental movement of targeted teeth to a desired final position is the technological principle for both the subject device and the predicate device.

Mechanism of Action:

The mechanism of action is similar to the predicate devices. Orthodontic targeted tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.

Non-Clinical Performance Testing:

The material used for the Park Dental Research aligners is the same polyurethane material as used in the predicate device ClearCorrect System. It is called Zendura. A biocompatibility assessment determined no testing was needed since the material is the same as the predicate device. Park Dental Research conducted manufacturing validation with software to be used to fabricate the aligners and based upon the predetermined treatment plan.

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Predicate Device Comparison Table

	Park Dental Research AlignersK180648	ClearCorrect System from ClearCorrectK113618
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName/DeviceCommonName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
ProductCode	NXC	NXC
Classification	II	II
Indicationsfor use	Park Dental Research Aligners areindicated for the treatment of toothmalocclusion in patients withpermanent dentition (i.e. all secondmolars). Park Dental Research Alignerspositions teeth by way of continuousgentle force.	The ClearCorrect System is indicatedfor the treatment of toothmalocclusion in patients withpermanent dentition (i.e. all secondmolars). The ClearCorrect Systempositions teeth by way of continuousgentle force.
Mode ofaction	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.
Material	Zendura polyurethane	Zendura polyurethane

Conclusion:

Based on technological characteristics, mechanism of action, materials, indications for use and the results of non-clinical performance testing, Park Dental Research Aligners are substantially equivalent to ClearCorrect K113618.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180648

Device Name Park Dental Research Aligners

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Park Dental Research Corporation % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

January 8, 2019

Re: K180648

Trade/Device Name: Park Dental Research Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 29, 2018 Received: December 10, 2018

Dear Angela Blackwell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.08

forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.