BRIUS Planner is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, Sequential Aligners, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the BRIUS Planner requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

The BRIUS Planner Software is an orthodontic appliance design and treatment simulation software. This software is used as a manufacturing software for orthodontic appliances. It is also used by professional technicians or physicians to design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and a technician or physician can then create treatment plans for each individual patient and their needs. After approval by the patient's physician, the system can be used to fabricate dental appliances using standard stereolithographic (STL) for the design of custom shape-set nitinol appliances or clear aligners.

AI/ML Overview

The provided document is a 510(k) summary for the BRIUS Planner Software, asserting its substantial equivalence to a predicate device (BRIUS Software Suite K191720). This type of regulatory submission focuses on demonstrating equivalence rather than proving novel clinical effectiveness through extensive studies with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain the detailed information typically found in a clinical study report that proves a device meets specific acceptance criteria. It primarily relies on demonstrating functional similarity and software validation.

Below is an analysis of the provided text in relation to your request, highlighting what information is available and what is not.

Request Analysis and Available Information:

The document clearly states: "Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015), BRIUS Planner Software underwent appropriate integration, verification, and validation testing."

This indicates software verification and validation (V&V) was performed, which is a form of performance testing for software. However, the document does not provide specific acceptance criteria or detailed results of these V&V activities beyond a general statement of completion. It does not present a clinical study comparing the device's output to ground truth established by experts, nor does it conduct a multi-reader, multi-case study. The focus is on demonstrating substantial equivalence to an existing cleared device.

Given this context, I cannot directly provide a table of performance against acceptance criteria in the clinical sense you've described for an AI/CADe device. The "performance" being demonstrated here is primarily the software's functional similarity and reliability in its intended use, as opposed to a diagnostic accuracy or efficacy metric.

Here's a breakdown of what can and cannot be extracted from the provided text according to your numbered questions:

A table of acceptance criteria and the reported device performance:
- Not Available directly. The document provides "Functional Specification Comparison" (Table 1) and "Feature Comparison Table" (Table 2) comparing the new device to its predicate. These tables describe functions and features, not quantitative performance metrics against specific acceptance criteria for outputs (e.g., accuracy of a measurement, classification performance). The acceptance criteria for the software V&V are not explicitly detailed, nor are the specific results of those tests beyond the general statement that testing was "appropriate."
Sample sizes used for the test set and the data provenance:
- Not Available. The document does not mention sample sizes for any test sets (e.g., patient cases or dental models). It also does not specify the provenance of data used for any testing (e.g., country of origin, retrospective/prospective). This information is typically detailed in a separate test report, not usually summarized in a 510(k) letter or summary unless a specific clinical performance study was conducted that required it.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Available. Since no clinical study proving diagnostic/measurement accuracy against expert-established ground truth is described, there's no mention of experts establishing ground truth for a test set. The software is a "front-end device" for treatment planning, not a diagnostic AI. The document does state, "The use of the BRIUS Planner requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software," indicating that the end-user (a trained orthodontist) is responsible for the clinical decisions.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Available. No such adjudication method is mentioned as no clinical performance study involving expert reads is described.
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 described. The software is for planning and design, not an AI assisting human reader interpretation in the diagnostic sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed in terms of quantitative performance. The software is inherently a "human-in-the-loop" tool, as it requires "the user to have the necessary training and domain knowledge in the practice of orthodontics." While software V&V would test its internal functions independently, specific "standalone performance" metrics (like area under the curve for a diagnostic AI) are not presented because the device's function is not a standalone diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Available. No ground truth in the context of clinical accuracy is mentioned, as the submission focuses on functional equivalence and software V&V.
The sample size for the training set:
- Not Applicable/Available. The document doesn't mention a training set, which would typically be relevant for machine learning algorithms. The device's description (treatment simulation, virtual appliance design) suggests it's a rule-based or model-based software, not necessarily a deep learning AI requiring large training sets in the typical sense.
How the ground truth for the training set was established:
- Not Applicable/Available. No training set or associated ground truth establishment process is mentioned.

In summary, the provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" of the BRIUS Planner Software to a legally marketed predicate device (BRIUS Software Suite K191720) based on similar indications for use, technological features, and confirmation of software validation (V&V). It does not present a performance study with detailed acceptance criteria and reported results in the manner one would expect for a new AI/CADe device proving its diagnostic or analytical accuracy via clinical data.

Summary

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October 1, 2021

BRIUS Technologies Inc % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K212828

Trade/Device Name: BRIUS Planner Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: September 2, 2021 Received: September 3, 2021

Dear Breanne Butler:

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

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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 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 (OS) 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. Adjodha, 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)

K212828

Device Name BRIUS Planner Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5. 510(k) Summary

510(k) SUMMARY

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92.

Submitter:	BRIUS Technologies2611 Westgrove DriveCarrollton TX 75006
Company ContactPerson:Phone:Email:	Mehdi Roein-Peikar(312) 479-1449mehdi@brius.com
SubmissionCorrespondent:Address:Phone:Email:	Breanne Butler, Regulatory Affairs Consultant1321 Upland Dr. Suite 6792 Houston, TX 77043(860) 810-5594bbutler@medavice.com
Date Prepared:	October 1, 2021
Proprietary Name:	BRIUS Planner Software
Common Name:	Orthodontic Software
Product Code:	PNN - Orthodontic Software
Device Classification:	Class II, 21 CFR 872.5470
Predicate Devices:	BRIUS Software Suite (K191720) (Primary Predicate)

Device Description:

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Indications for Use:

BRIUS Planner is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, treatment simulation and virtual appliance design options (Patient-Specific Nitinol Wires, Sequential Aliqners, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

Comparison to Predicate Devices:

BRIUS Planner Software is functionally equivalent to the following predicate device: BRIUS Software Suite (K191720 cleared April 2020).

The following table demonstrates the functional specifications of BRIUS Planner Software are substantially equivalent to the predicate devices.

Specification	BRIUS Planner Software	BRIUS Software Suite (K191720)	Comparison Result
Indicationfor Use	BRIUS Planner is intended foruse as a medical front-enddevice providing tools formanagement of orthodonticmodels, systematic inspection,treatment simulation andvirtual appliance designoptions (Patient-SpecificNitinol Wires, SequentialAligners, Export of Models,Indirect Bonding TransferMedia) based on 3D models ofthe patient's dentition beforethe start of an orthodontictreatment. It can also beapplied during the treatment toinspect and analyze theprogress of the treatment. Itcan be used at the end of thetreatment to evaluate if theoutcome is consistent with the	BRIUS Software Suite isintended for use as a medicalfront-end device providing toolsfor management of orthodonticmodels, systematic inspection,treatment simulation and virtualappliance design options(Patient-Specific Nitinol Wires,Export of Models, IndirectBonding Transfer Media) basedon 3D models of the patient'sdentition before the start of anorthodontic treatment. It canalso be applied during thetreatment to inspect andanalyze the progress of thetreatment. It can be used at theend of the treatment toevaluate if the outcome isconsistent with the	Similar

	planned/desired treatmentobjectives.	planned/desired treatmentobjectives.
	The use of the BRIUS Plannerrequires the user to have thenecessary training and domainknowledge in the practice oforthodontics, as well as tohave received a dedicatedtraining in the use of thesoftware.	The use of BRIUS SoftwareSuite requires the user to havethe necessary training anddomain knowledge in thepractice of orthodontics, as wellas to have received adedicated training in the use ofthe software.
TechnologyFeatures	Stand Alone Software Module Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files	Stand Alone Software Module Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files	Same
MinimumHardware/SoftwareRequirements	OS: Windows 10 64-bit RAM: 8 GB Monitor Resolution: 1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel compatible 2.6 GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrolling wheel or button	OS: Windows 10 64-bit RAM: 8 GB Monitor Resolution: 1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel compatible 2.6 GHz/Dual or Quad core 2.6 GHz Mouse: Any Mouse with scrolling wheel or button	Same
Login Method	Username and Password	Username and Password	Same

Table 1: Functional Specification Comparison

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Table 2. Feature Comparison Table for BRIUS Planner and K191720

Feature Comparison	BRIUS Planner	BRIUS Software(K191720)
Supported anatomicareas	Maxilla/Mandible	Maxilla/Mandible
Intended Use
Managing Patient andcase base data	Yes	Yes

Collection of study material	Yes	Yes
Alignment of study material	Yes	Yes
Measuring study material	Yes	Yes
Analyzing Study Material	Yes	Yes
Treatment Simulation	Yes	Yes
Virtual Appliance Design	Yes	Yes
Supported PC formats	Windows/Mac: Internet Browser-based	Windows/Mac: Internet Browser-based
Managing patient and case base data
Creating, editing, deleting and copying patient data	Yes	Yes
Creating, editing, deleting and copying case data	Yes	Yes
Collection of study material
Surface scan for intraoral scanner	Yes	Yes
Surface scan from STL file	Yes	Yes
CT image data (DICOM)	Yes	Yes
Analyzing study material
Arch shape	Yes	Yes
Wire length	No	No
Tooth width	No	No
Bolton	No	No
Space Analysis	No	No
Overjet/Overbite	Yes	Yes
Occlusion Map	Yes	Yes
Treatment Simulation
2D	Yes	Yes
3D	Yes	Yes
Virtual Appliance Design
Orthodontic Appliance Search	Yes	Yes
Orthodontic Appliance Virtual Preparation	Yes	Yes
Orthodontic Appliance Design	Yes	Yes
Orthodontic appliance Export	Yes	Yes

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Comparison of Indications for Use to Predicate Devices:

Based on the above comparison, the indications for use of BRIUS Planner Software is similar to that of the BRIUS Software Suite (K191720). The only change is the addition of Sequential Aligners to the appliance design options. This difference uses the same

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technology to produce similar files for the production of orthodontic appliances. Therefore, BRIUS Planner Software can be considered substantially equivalent to its predicate device.

Comparison of Technological Features to Predicate Devices:

Based on the above comparison, the design, construction, and performance characteristics of BRIUS Planner Software is the same as that of BRIUS Software Suite Therefore. BRIUS Planner Software can be considered (K191720). substantially equivalent to its predicate device.

Summary of Performance Data and Substantial Equivalence:

Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015), BRIUS Planner Software underwent appropriate integration, verification, and validation testing.

Conclusion:

Based on comparison of indications for use, technological features, performance testing, and software validation testing, BRIUS Planner Software have been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.

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.