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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.

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.

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:

1. 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."

2. 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.

3. 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.

4. 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.

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 described. The software is for planning and design, not an AI assisting human reader interpretation in the diagnostic sense.

6. 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.

7. 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.

8. 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.

9. 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.

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BRIUS Clear Aligners are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces.

The BRIUS Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 2 0 to 22 hours a day and are to be removed for eating and for cleaning.

BRIUS Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), 3Shape A/S's Ortho System (K180941) will be used for this application. Ortho System is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the prescribing dental health professional. This dental health professional then monitors treatment from the placement of the first aligner to the delivery of the final aligner and completion of treatment.

The provided text from the FDA 510(k) summary for BRIUS Clear Aligners (K202792) primarily focuses on establishing substantial equivalence to a predicate device through comparison of specifications and non-clinical performance testing. It does not describe a study involving expert readers or AI performance in the typical sense of diagnostic or prognostic devices.

Instead, the non-clinical performance testing described is related to the manufacturing process and material properties of the aligners themselves. Therefore, the requested information elements related to AI performance, expert consensus, sample sizes for test/training sets in an AI context, MRMC studies, or standalone performance are not applicable based on the provided document.

Here's a breakdown of the applicable information based on the provided text, adapted to the context of the device's manufacturing and material validation:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance relate to the manufacturing validation of the BRIUS Clear Aligners.

2. Sample Size for the Test Set and Data Provenance

The document mentions an "internal manufacturing validation" but does not specify a numerical sample size for the aligners tested for dimensional accuracy and qualitative assessment.

• Test Set Sample Size: Not explicitly stated as a numerical value. The study refers to "the submitted intraoral scans, digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners" being assessed, implying a collection of these components.
• Data Provenance: The validation was an "internal manufacturing validation," indicating it was conducted by BRIUS Technologies, Inc. or their associated entities. The origin country is not specified, but the company is based in Carrollton, TX, USA. It is a retrospective assessment of manufactured products against internal specifications.

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

This information is not applicable as the validation was for manufacturing accuracy and material properties, not for diagnostic or prognostic AI performance requiring expert review of medical images or data. The "ground truth" was the target input values for measurements and predefined specifications for qualitative attributes.

4. Adjudication Method for the Test Set

This information is not applicable. The assessment involved objective measurements (digital calipers and 3rd party software) and qualitative visual inspections against predefined specifications, rather than an adjudication process typically used for subjective expert panel reviews.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a clear aligner, not an AI software intended to assist human readers in a diagnostic task.

6. Standalone Performance Study (Algorithm Only)

A standalone algorithm performance study was not performed in the context of AI. The "manufacturing validation" described is a standalone assessment of the physical product's adherence to specifications.

7. Type of Ground Truth Used

• For Dimensional Accuracy: The ground truth was the "target input value" (digital design specifications) from the orthodontic CAD/CAM software (3Shape A/S's Ortho System).
• For Qualitative Assessment: The ground truth was predefined performance, cosmetic, and other detectable issue specifications.
• For Biocompatibility: The ground truth was adherence to international standards (ISO 10993-1 and ISO 10993-5).

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (clear aligner) whose manufacturing process was validated, not an AI algorithm that requires a training set. The orthodontic CAD/CAM software used (3Shape A/S's Ortho System) would have its own development and validation, but that is not the subject of this 510(k) for the BRIUS Clear Aligners.

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

This information is not applicable for the same reasons as #8.

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