Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.

Device Description

The Ohlendorf Clear Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane.

A dental clinician prescribes the Ohlendorf Clear Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to the using standard dental software for planning the tooth alignments.

The software used is Ortho Analyzer by 3Shape (Reference device K180941). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models.

After the plan is developed by Ohlendorf, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, Ohlendorf produces the aligner trays. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The clear, thin, thermoplastic polyurethane-polyester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.

AI/ML Overview

The provided document is a 510(k) summary for the Ohlendorf Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive study proving the device meets specific performance acceptance criteria for an AI/algorithm-driven medical device.

The "Device Testing" section mentions "Laboratory Testing" and states:
"Test data were submitted to:

assure the mechanical properties of the aligner material ■ meet specifications for up to 5 years shelf life [according to ASTM D638 standard’s testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)];
assure the aligner material packaging retains the required moisture barrier properties;
validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner’s digital design and the manufactured aligners."

It then concludes with: "All testing met the pre-determined acceptance criteria."

However, the document does not provide the specific acceptance criteria values or the reported performance data for these physical and manufacturing properties. It also explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device."

Therefore, based on the provided text, it's not possible to fully answer your request regarding the acceptance criteria and study details as they would apply to an AI/algorithm-driven device with typically robust clinical or performance studies. The device in question is a physical medical device (clear aligners) and its clearance is based on substantial equivalence to a predicate device, primarily focusing on material and manufacturing process similarity, not on an AI algorithm's diagnostic or predictive performance.

The questions you've posed (e.g., MRMC studies, ground truth for AI, training set size) are highly relevant for AI/ML-based medical devices that perform tasks like image analysis or diagnosis. This document, however, does not describe such a device or its associated studies.

Given the information, I can only provide a hypothetical table based on the mention of "pre-determined acceptance criteria" for the physical and manufacturing aspects, and state that the detailed study information for AI-specific performance is not available in this document.

Based on the provided document, here's what can be extracted and what cannot:

The document describes the Ohlendorf Clear Aligner, a physical medical device for orthodontic treatment, and its 510(k) clearance process. The clearance is based on substantial equivalence to an existing predicate device. The performance claims primarily relate to the material properties and manufacturing consistency of the physical aligners, not the performance of an AI algorithm in a diagnostic or treatment planning context that would typically involve human-in-the-loop performance or standalone AI performance evaluation.

1. A table of acceptance criteria and the reported device performance

Based on the document, specific numerical acceptance criteria and reported performance values for the mechanical properties (tensile strength, elongation, etc.) or manufacturing validation are not provided. The document states: "All testing met the pre-determined acceptance criteria."

Acceptance Criteria Category	Acceptance Criteria (Specific values not provided in document)	Reported Device Performance (Specific values not provided in document)
Material Properties	ASTM D638 standards for:	All tests met pre-determined acceptance criteria.
Tensile Strength (PSI)	To meet specifications for up to 5 years shelf life.
Elongation (%)
Tensile @ Yield (PSI)
Elongation @ Yield (PSI)
Tensile Modulus (PSI)
Packaging Properties	Retain required moisture barrier properties.	All tests met pre-determined acceptance criteria.
Manufacturing Consistency	Validate processes to ensure consistency between digital design and manufactured aligners.	All tests met pre-determined acceptance criteria.
Biocompatibility	Compliance with ISO 10993 (Parts 5, 10)	All testing showed material met requirements and is safe/biocompatible.

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

The document does not specify the sample sizes for the material property or manufacturing consistency tests. It also does not mention the provenance of any data in terms of country of origin or clinical (retrospective/prospective) studies, as such studies were explicitly stated as "not required" for this submission.

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

This information is not applicable as the device is a physical product (clear aligner), and the studies described are related to its material and manufacturing properties, not an AI algorithm requiring expert ground truth for clinical performance. The "ground truth" here would relate to laboratory standards (e.g., ASTM D638).

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

This information is not applicable for the type of testing described (material and manufacturing process validation).

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

No, an MRMC study was not done. The document explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This type of study is relevant for AI-assisted diagnostic devices, which the Ohlendorf Clear Aligner is not described as.

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

No, a standalone algorithm performance study was not done. The device description mentions the use of "Ortho Analyzer by 3Shape (Reference device K180941)" software for planning, but the submission is for the physical aligner product, not the software itself as a novel AI/ML device. The software is used by a dental clinician, who then approves the plan before manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the material and manufacturing tests, the "ground truth" would be established by engineering standards (e.g., ASTM D638 for material properties) and internal quality control specifications for manufacturing consistency. It does not involve clinical ground truth types like pathology or outcomes data for performance evaluation.

8. The sample size for the training set

This question is not applicable. The device itself is a physical product. While software (Ortho Analyzer) is used for planning, the document does not describe the development or training of a novel AI algorithm by the applicant, nor does it specify a training set for such a purpose. The 3Shape software is referenced as a separate device (K180941).

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

This question is not applicable as no training set for a novel AI algorithm developed by the applicant is described in this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 19, 2021

Patsy Trisler, Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K210540

Trade/Device Name: Ohlendorf Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 23, 2021 Received: February 24, 2021

Dear Patsy Trisler:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adiodha. M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210540

Device Name

Ohlendorf Clear Aligner

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)

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510(k) Summary – K210540

Submitter Name:	Ohlendorf Appliance Laboratory
Submitter Address:	2840 Clark AvenueSt. Louis, MO 63103
Phone Number:	800-325-8921
Contact Person:	Kevin Ohlendorf, President and Owner
Date Prepared:	May 10, 2021
Device Trade Name:	Ohlendorf Clear Aligner
Common Name	Aligner, Sequential
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Primary Predicate Device:	182826, Ormco™ Aligner System, Sybron Dental Specialties
Reference Device	K180941 OrthoSystem™, 3Shape A/S
Indications for Use	Ohlendorf Clear Aligner is indicated for the alignment of teethduring orthodontic treatment of malocclusion in patients withpermanent dentition (i.e. all second molars). The Ohlendorf ClearAligner positions teeth by way of continuous gentle force.
Device Description,and Summary ofTechnologicalCharacteristics	The Ohlendorf Clear Aligner consists of a series of dental-clinicianprescribed customized clear plastic removable orthodontic alignertrays that are made from a clear, thin thermoformed polyurethane.A dental clinician prescribes the Ohlendorf Clear Aligner based onan evaluation of the patient's teeth. Either intraoral scans orphysical impressions of the patient's teeth are taken, after whichthe clinician determine course of treatment with the system. Theclinician completes a prescription form using standard dentalsoftware used for tooth alignment. The series of plastic alignertrays are designed according to the using standard dentalsoftware for planning the tooth alignments.The software used is Ortho Analyzer by 3Shape (Referencedevice K180941). It is used for managing 3D scanned orthodonticmodels, orthodontic diagnosis by measuring, analyzing, inspectingand visualizing 3D scanned orthodontic models, virtual planning oforthodontic treatments by simulating tooth movements and designof a variety of orthodontic appliances based on 3D scannedorthodontic models.After the plan is developed by Ohlendorf, the prescribing dentalclinician reviews and approves the model scheme before the

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molds are produced. Following approval, Ohlendorf produces the aligner travs. The travs are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The clear, thin, thermoplastic polyurethane-polvester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.

Mechanism of Action The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. This occurs through forces applied by the appliance to the teeth over time until final correction, according to the dental clinician's prescription, has been achieved. Standard treatment time for each aligner tray is 2-3 weeks, worn by patients for approximately 22 hours per day.

Device Testing Laboratory Testing

Test data were submitted to:

assure the mechanical properties of the aligner material ■ meet specifications for up to 5 years shelf life [according to ASTM D638 standard's testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)]:
. assure the aligner material packaging retains the required moisture barrier properties;
. validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner's digital design and the manufactured aligners.

All testing met the pre-determined acceptance criteria.

Biocompatibility

The thermoplastic polyurethane used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:

Part 5 (Cytotoxicity Elution - MEM),

Part 10 (Intracutaneous/Intradermal Reactivity),

Part 10 (Oral Mucosa; Irritation),

Part 10 (Maximization for Delayed-Type Hypersensitivity)

All testing showed that the material met the requirements of the test methods and is safe and biocompatible for the stated intended use.

Animal | Human Testing

Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device.

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Comparison to There are no notable differences comparing the Ohlendorf Clear Aligner to the predicate Ormco Spark Aligner System: Predicate Device:

The intended use is the same.
. The mechanism of action is similar.
I The polyurethane material used to make the aligners is the same.
I The method of manufacture for producing the customized clear aligners is similar.
I The use of software for planning and manufacturing are similar.

Substantial Equivalence Conclusion

Based on the documentation presented in the 510(k), as summarized above and illustrated in the following comparison table, it can be concluded that Ohlendorf Clear Aligner is substantially equivalent to the predicate device.

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	Proposed: Ohlendorf ClearAligner	Predicate: Ormco™ Spark™Aligner System
510(k) Number	K210540	K182826
Manufacturer	Ohlendorf Applicance Laboratory	Sybron Dental Specialties
Classification #and NameProduct CodeClass	21 CFR 872.5470Orthodontic Plastic BracketNXC2	21 CFR 872.5470Orthodontic Plastic BracketNXC2
Indications forUse	The Ohlendorf Clear Aligner isindicated for the alignment ofteeth during orthodontictreatment of malocclusion inpatients with permanent dentition(i.e. all second molars). TheOhlendorf Clear Aligner positionsteeth by way of continuous gentleforce.	The Ormco Spark System isindicated for the alignment ofteeth during orthodontic treatmentof malocclusion in patients withpermanent dentition (i.e. allsecond molars). The OrmcoSpark Aligner System positionsteeth by way of continuous gentleforce.
Mechanism ofAction	Alignment of teeth by applicationof continuous gentle force, bysequential use of preformedplastic trays.	Alignment of teeth by applicationof continuous gentle force, bysequential use of preformedplastic trays.
Description ofUse	Each preformed plastic tray isworn by the patient as prescribedby the dental practitioner, usuallya few weeks prior to using thenext sequential aligner tray.	Each preformed plastic tray isworn by the patient as prescribedby the dental practitioner, usuallya few weeks prior to using thenext sequential aligner tray.
Material	Thin thermoplastic polyurethanepolyester composite resin	Thin thermoplastic polyurethanepolyester composite resin
Biocompatible	Yes, meets ISO 10993requirements	Yes, meets ISO 10993requirements
Prescription Use	Yes, Rx Only	Yes, Rx Only
Software Usedfor TreatmentPlanning /Manufacturing	Yes	Yes
Single PatientUse	Yes	Yes
Non-SterilePackaging	Yes	Yes

Substantial Equivalence Comparison

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.