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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.

The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.

Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.

Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:

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

Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.

• Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
  | CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
  | Material Conformance | - Zirconia materials conform to ISO 6872.
• Titanium alloy conforms to ASTM F136.
• Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
  | Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.

3. 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 applicable. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.

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

Not applicable. This is not a diagnostic device involving expert review adjudication.

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI/ML algorithm.

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

For this device, the "ground truth" is based on:

• Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
• Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
• Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
• Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.

8. The sample size for the training set

Not applicable. This device does not involve a machine learning training set.

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

Not applicable. This device does not involve a machine learning training set.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.

The subject device DESS Dental Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The digital workflow includes the following products (not subject devices of this submission):

• Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
• Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
• . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software

The provided text describes a 510(k) premarket notification for DESS Dental Smart Solutions, which are dental implant abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through clinical performance studies with specific statistical acceptance criteria for accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like accuracy, sensitivity, specificity).
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence, specifically:

1. Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
2. Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
3. Fatigue testing and reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. This includes fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions.
4. MR Conditional labeling.
5. Validation testing of CAM restriction zones: Including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software.
6. Software verification: Included testing of restrictions that prevent design of components outside of the stated design parameters. The abutment design library was validated to demonstrate that established design limitations and specifications are locked and cannot be modified by the user.

The acceptance criteria and reported "performance" for this submission are based on these engineering and design validations, ensuring the device meets safety and performance standards equivalent to the predicate device, K221301. The key "performance" metrics are about maintaining physical and material integrity and compatibility.

The core of the submission is to expand the DESS Dental Smart Solutions abutment system to:

• Allow design using AbutmentCAD software (in addition to 3Shape software).
• Add angulation (up to 30°) to some Pre-milled (Blank) Abutments for specific implant systems.

The document explicitly states: "No clinical data were included in this submission." and "The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above."

Therefore, this FDA submission is for a physical medical device (dental implant abutment) and its manufacturing/design software modifications, not an AI or diagnostic device that would involve clinical performance metrics like sensitivity or specificity.

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RAYDENT SW is a software designed to assist dental professionals in planning patient treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).

To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.

RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate three-dimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.

The document K233625 is a 510(k) Premarket Notification for the device "RAYDENT SW," a software designed to assist dental professionals in planning patient treatment devices. As such, the document provides information on the device's intended use, comparison to predicate devices, and a summary of performance testing. However, it does NOT include detailed information about acceptance criteria or a specific study proving the device meets those criteria, particularly not in the context of an AI/ML-enabled medical device performance study.

The document states that RAYDENT SW includes "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: YES" in its comparison table (Page 7). However, the "Performance Testing" section (Page 9) does not describe an AI/ML-specific performance study with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop evaluation. It merely states that "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Device Software Functions' and 'Guidance for the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'." It then concludes that "All test results have been reviewed and approved, showing the RAYDENT SW to be substantially equivalent to the predicate devices."

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

To answer your specific points:

1. A table of acceptance criteria and the reported device performance: Not found in the provided document. The document mentions general validation testing but no specific performance metrics or acceptance criteria for an AI component.
2. Sample sized used for the test set and the data provenance: Not found.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found.
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: Not found. The document explicitly states "Clinical testing is not a requirement and has not been performed" (Page 9), implying no such MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed for an AI component. The general performance testing is mentioned, but without specifics for the AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not found.
8. The sample size for the training set: Not found.
9. How the ground truth for the training set was established: Not found.

The document focuses on substantiating equivalence primarily through comparison of indications for use, technological characteristics, and general software/hardware validation, rather than an in-depth AI/ML performance study.

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TERA HARZ II is intended as an indirect restorative for both anterior restorations, including occlusal surfaces.

The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.

Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.

The TERA HARZ II is a light-cured, methacylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including dcclusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays, and veneers. Methacrylate based resin is well known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical and biocompatible properties.

The TERA HARZ II is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3/B1/B2/B3/C1/C2/C3/D1/D2/D3/OM1/OM2/OM3/M4. This resin is a liquid photopolymer material that is polymerized by UV laser at 405412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100um in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm.

However, scanner, design software, 3D printer and post-cure unit are not included with the device.

TERA HARZ II can be used in combination with all lasers and DLP based 3D printers which support dental materials. TERA HARZ II is a resin for the generative production of longterm temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ II is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ II is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereo-lithographic drawing.

The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization.

These fabrications of TERA HARZ II are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ II, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible.

The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models.

Once dental clinic manufacturing unit receive the data that * .stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for TERA HARZ II:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a dental material, and its performance is evaluated against the international standard ISO 10477:2020: Dentistry - Polymer-based crown and veneering materials. The key performance characteristics and their acceptance criteria (as per ISO 10477:2020) and reported performance are:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each specific test (e.g., number of specimens for flexural strength, water sorption tests). However, it implies multiple specimens were tested for each characteristic. The data provenance is not explicitly mentioned as retrospective or prospective or specific country of origin, but it is implied to be laboratory-based bench testing conducted by the manufacturer or a third-party for regulatory submission.

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

This information is not applicable to the type of device and testing described. The "ground truth" for this device's performance is established by adherence to recognized international standards (ISO 10477:2020 and ISO 10993 series). The standards themselves are developed by expert committees, but there isn't a "test set" requiring individual expert adjudication for ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. The performance is measured against objective, quantitative criteria defined by international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted interpretation, where human readers interact with the device's output. TERA HARZ II is a dental restorative material, and its effectiveness is determined by its physical and chemical properties and biocompatibility, not by human interpretation of its output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is also not applicable in the typical sense. TERA HARZ II is a material, not a standalone algorithm. Its performance is measured directly through bench testing of the material itself. The manufacturing process does involve CAD/CAM systems and 3D printers, which are "standalone" in their function, but the performance evaluation focuses on the resulting material.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's performance is established international consensus standards for dental materials, specifically ISO 10477:2020 and a battery of ISO 10993 standards for biocompatibility. These standards define the acceptable range for various physical, mechanical, and biological properties.

8. The Sample Size for the Training Set

Not applicable. TERA HARZ II is a material, not an AI or machine learning algorithm that requires a training set.

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

Not applicable. No training set is involved for this device.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K22288 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be manufactured via a digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. There are no changes to the abutment design or implant compatibilities, however, there is a new material for the zircomia superstructure. All part numbers have been cleared within previous submissions for manufacturing at a validated milling center. The purpose of this submission is to allow manufacturing via digital dentistry workflow and to add a new zirconia material for the superstructures of the two-piece abutment.

The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The provided text is a 510(k) summary for a dental device, specifically DESS Dental Smart Solutions abutments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML-based device.

Therefore, I cannot provide the requested information as the document does not contain details about:

• Acceptance criteria for an AI/ML device: This document is about dental implant abutments, not a medical device driven by AI/ML.
• Study proving device meets acceptance criteria: There is no performance study described for an AI/ML component. The "Performance Data" section refers to non-clinical data for biocompatibility and fatigue testing of the physical dental abutments, and software verification to ensure design parameters are met and restriction zones are locked, not AI/ML performance.
• Sample size for test set and data provenance: Not applicable to a non-AI/ML device.
• Number of experts and their qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document describes the physical characteristics, materials, manufacturing processes (including digital dentistry workflows), and compatibility of the dental abutments, and asserts their substantial equivalence to previously cleared devices. It does not mention any AI/ML components or their performance evaluation.

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TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following:

Design:
Scanner: 3Shape A/S, TRIOS 3 Basic
Design software: 3Shape A/S, 3Shape Ortho System™

Printing:
3D Printer: UNIZ, SLASH 2; SprintRay Inc., SprintRay Pro 95

Post-Curing:
Post-cure unit: CureM, U102H

TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth.

This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician.

TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners.

TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 µm on the x, y axis, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100 um.

However, scanner, design software, 3D printer and post-cure unit are not included with the device.

These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylatebased resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, is manufactured in a 3D printer that is compatible.

The dental clinician can generate a digital file by scanning the patient's mouth directly using listed with Intraoral scanner under FDA Classification Product Code NOF, regulation 872.3661.

This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 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 sequential aligners based on 3D scanned orthodontic models.

Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners are provides them to the patient the confirming fit and design.

This document describes the premarket notification for the "TERA HARZ CLEAR" sequential aligner and its substantial equivalence determination by the FDA. The information provided focuses on the device's technical characteristics and performance testing against a predicate device and relevant standards.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The acceptance criteria are generally based on the ISO 20795-2:2013 standard for "Dentistry - Base Polymers - Part 2: Orthodontic base polymers," and comparisons to a predicate device (Blue Sky Bio Aligner, K180107).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: For physical properties testing (such as Ultimate Flexural Strength, Flexural Modulus, Solubility, Water Sorption, Surface characteristics, Shape capability, Colour, Freedom from porosity, and Precision), 5 samples of the "TERA HARZ CLEAR" device were used for each test. These samples were from the same lot and tested using two different 3D printers (UNIZ Slash 2 and SprintRay Pro 95).
• Data Provenance: The document does not explicitly state the country of origin for the test data but indicates that the submitting company, Graphy Inc., is located in Seoul, Republic of Korea. The testing itself involved comparisons to a legally marketed predicate device (Blue Sky Bio Aligner) and adherence to international standards (ISO 20795-2:2013). The study appears to be prospective bench testing performed specifically for this submission.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical evaluation. The ground truth for the physical and mechanical properties was established by adherence to the ISO 20795-2:2013 standard and direct comparison against a legally marketed predicate device's performance data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the study primarily involved bench testing of physical and mechanical properties against a standard and a predicate device.

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

No MRMC comparative effectiveness study was conducted or reported in this document. The device is a physical product (sequential aligner), and the evaluation focuses on its material properties and manufacturing validation rather than diagnostic performance or human-in-the-loop effectiveness.

6. Standalone Performance (Algorithm Only)

This section is not applicable as the "TERA HARZ CLEAR" is a physical medical device (sequential aligner), not a software algorithm or AI-powered diagnostic tool. The document describes the design software and 3D printing systems used in its fabrication, but the device itself is the physical aligner.

7. Type of Ground Truth Used

The ground truth for the device's performance was primarily based on:

• International Standard Requirements: ISO 20795-2:2013.
• Predicate Device Performance: Direct comparison of physical and mechanical properties with a legally marketed predicate device (Blue Sky Bio Aligner, K180107).
• Manufacturing Validation: Verifying that manufactured devices meet predefined dimensional tolerances (0.150 mm of the target input value) using independent software and digital calipers.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. Since this is a physical medical device and not an AI/software product, the concept of a training set as typically understood in AI/ML studies is not applicable.

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

This question is not applicable for the reasons stated in point 8.

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The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.

The TERA HARZ DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures). Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, and biocompatible properties. The TERA HARZ DENTURE is made from methacrylate-based resins. It is stored in a black 1,000g HDPE bottle. This resin is a liquid photopolymer material that is polymerized by a ultraviolet (UV) laser at 405412 nm. The resin can be used to create customized removable full and partial dentures with a 3D printer cured by UV light. The UV curable liquid resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. The process parameters of the 3D printer affect the quality of the 3D printed objects. The printer equipment should be set to a resolution of 40 to 90 um on the x,y axis (horizontal resolution) and 100 µm on the z axis (vertical resolution). The TERA HARZ DENTURE should be used with a specific 3D printer that uses a UV light source and produces 3D printed objects with layer thickness of 100 um. The TERA HARZ DENTURE does not come with a scanner, design software, 3D printer, or post-cure unit. The TERA HARZ DENTURE can be used to manufacture customized removable full and partial dentures using compatible equipment.

The provided text describes the regulatory filing for the Tera Harz Denture, a light-curable resin for dental prosthetics. This document primarily focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of an AI-powered diagnostic device. Therefore, much of the requested information regarding AI study design (e.g., sample size for AI test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the non-clinical performance testing of the dental resin itself, as this is the "device" in question and its performance is being proven against established standards.

Here's a summary based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TERA HARZ DENTURE are based on the ISO 20795-1:2013 standard for dentistry — base polymers. The performance data is from non-clinical bench tests.

Additional performance tests were conducted, and the results met standard criteria, but specific numerical acceptance criteria and reported values for those tests (e.g., visual inspection, capacity, package integrity, surface characteristics, shape capability, porosity, translucency, color, color stability, bonding between resin teeth, total fracture work, maximum stress intensity factor) are not explicitly detailed with thresholds and results in the provided tables.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Performance Tests: The document does not specify the exact sample size (number of specimens) used for each performance test (flexural strength, water sorption, etc.). It only refers to "test specimens."
• Data Provenance: The data provenance is from non-clinical bench tests conducted by Graphy Inc., likely in the Republic of Korea (where Graphy Inc. and SMB Korea are located). The study type is experimental bench testing, not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission is for a material (dental resin) and its manufacturing process, not an AI diagnostic device requiring expert interpretation of medical images or data. Ground truth is established through adherence to international standards and validated laboratory testing procedures for material properties.

4. Adjudication Method for the Test Set

Not applicable for material property testing. The "ground truth" is measured objectively according to standardized laboratory methods.

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

Not applicable. This is not an AI-assisted diagnostic device where human reader performance is evaluated.

6. Standalone Performance

The "standalone performance" refers to the non-clinical bench testing of the Tera Harz Denture material itself, without human interpretation as part of the performance evaluation. The results listed in the table above demonstrate its standalone performance against the ISO standards.

7. Type of Ground Truth Used

The ground truth used for the performance testing is international standard criteria (ISO 20795-1:2013) for dental base polymers, measured through objective laboratory tests.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" here refers to the development and formulation of the resin material and the optimization of its manufacturing process through empirical testing.

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

Not applicable as there is no "training set" in the context of an AI algorithm. The development of the material and process relies on established chemical and engineering principles and iterative testing against performance specifications to achieve desired properties.

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The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:

• Dental Scanner .
• TIA Tip ●
• Computer with Software ●

With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.

The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.

The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.

The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.

In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.

The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.

The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.

The software operates on a laptop or desktop pc. A network connection is required for interoperability.

When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.

The provided text describes the TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx and its substantial equivalence to a predicate device. However, the document explicitly states that "Clinical testing is not required and has not been performed," and therefore it does not contain a study proving the device meets acceptance criteria.

Instead, the document focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, noting where information is not available:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed to establish acceptance criteria for detection performance, this table cannot be provided from the given text. The document refers to "Key performance attributes tested and compared include: a. LED illumination and output power, b. Image Quality" to demonstrate similar performance to the predicate device, not to meet specific acceptance criteria for caries detection.

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

Not applicable, as no clinical or comparative performance study using a test set was conducted for caries detection. The non-clinical tests relate to hardware performance and safety.

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

Not applicable, as no clinical study or test set requiring expert ground truth was conducted.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring adjudication was conducted.

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 MRMC comparative effectiveness study was done. The device does not incorporate AI; it is a transillumination accessory for direct visualization.

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

Not applicable, as the device is a diagnostic aid for human viewing and does not involve a standalone algorithm for performance.

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

Not applicable, as no ground truth for caries detection performance was established due to the absence of a clinical study for this purpose.

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

Summary of Non-Clinical Performance Testing (as described in the document):

The TIA Tip was evaluated through non-clinical performance testing to demonstrate substantial equivalence to the predicate device, the CamX Triton HD Proxi. The key aspects tested and compared were:

• LED illumination and output power: The comparison table indicates that while the TIA Tip uses 727nm wavelength LEDs and the predicate uses 850nm, the output power (Max 3.74mW/cm² for TIA Tip at 3.845 mm vs. Max 2.00 mW/cm² for predicate at 7mm) was considered "almost the same" when measured side-by-side using the same equipment and test environment, accounting for measuring distance differences.
• Image Quality: Specific metrics or quantitative results for image quality are not provided in this summary, but it states "image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip."

Additionally, the device complied with several safety and biocompatibility standards:

• IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• ISO 17665-1 (Sterilization validation – Moist Heat)
• ISO 10993 series (Biocompatibility Testing), specifically ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.

Conclusion stated in the document:
Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system. This substantial equivalence determination allows the device to be marketed without the need for a new clinical study demonstrating specific acceptance criteria for caries detection performance.

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DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, cramomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. intraoral X-Rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

This document is a 510(k) Premarket Notification for the DTX Studio Clinic 3.0. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study report with specific acceptance criteria and performance metrics for novel functionalities.

Therefore, the requested information regarding detailed acceptance criteria, specific performance data (e.g., accuracy metrics), sample sizes for test sets, data provenance, expert qualifications, and ground truth establishment for the automatic annotation of mandibular canals is not explicitly detailed in the provided text.

The document states that "Automatic annotation of the mandibular canals" is a new feature in DTX Studio Clinic 3.0, and it is compared to the reference device InVivoDental (K123519) which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature." However, it does not provide the specific study details for validating this new feature within DTX Studio Clinic 3.0. It only broadly states that "Software verification and validation testing was conducted on the subject device."

Based on the provided text, I cannot fulfill most of the requested information directly because it is not present. The document's purpose is to establish substantial equivalence based on the overall device function and safety, not to detail the rigorous validation of a specific AI/ML component with numerical acceptance criteria.

However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Study for DTX Studio Clinic 3.0's Automatic Mandibular Canal Annotation (Information extracted from the document):

Given the provided text, the specific, quantitative acceptance criteria and detailed study proving the device meets these criteria for the automatic annotation of the mandibular canal are not explicitly described. The document focuses on a broader claim of substantial equivalence and general software validation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for the automatic mandibular canal annotation feature. The document states "Software verification and validation testing was conducted on the subject device," but provides no numbers.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or detailed. The document primarily makes a substantial equivalence claim based on the device's overall functionality and features, not a comparative effectiveness study involving human readers.

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

• Standalone Performance: Not explicitly detailed. The document describes the automatic segmentation functionality and mentions that the user can manually adjust, implying a human-in-the-loop scenario. No standalone performance metrics are provided.

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

• Type of Ground Truth: Not specified for the automatic mandibular canal annotation. Given the context of a dental/maxillofacial imaging device, it would likely involve expert annotations on CBCT scans, but this is not confirmed in the text.

8. The sample size for the training set:

• Training Set Sample Size: Not specified. This document is a 510(k) submission, which focuses on validation, not the development or training process.

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

• Ground Truth Establishment for Training Set: Not specified.

Summary of what can be inferred/not inferred from the document regarding the mandibular canal annotation:

• New Feature: Automatic annotation of mandibular canals is a new feature in DTX Studio Clinic 3.0 that was not present in the primary predicate (DTX Studio Clinic 2.0).
• Comparison to Reference Device: This new feature's "functionality is similar as in the reference device InVivoDental (K123519)", which has "Creation and visualization of the nerve manually or by using the Automatic Nerve feature."
• Human Oversight: The user has the ability to "manually indicate or adjust the mandibular canal," suggesting that the automatic annotation is an aid to the diagnostic process, not a definitive, unreviewable output. This is typical for AI/ML features in medical imaging devices that are intended to support, not replace, clinical judgment.
• Validation Claim: The submission states that "Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." This implies that the validation was performed in accordance with regulatory guidelines, but the specific details of that validation for this particular feature are not disclosed in this public summary.

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TERA HARZ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces.

The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.

Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The TERA HARZ is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical and biocompatible properties.

The TERA HARZ is made by Methacrylate-based resins. It has stored in a black 1,000g of HDPE bottle. It contains materials with shade A1/A2/A3. This resin is a liquid photopolymer material that is polymerized by UV laser at 405412nm. the resin can be used to create a customized artificial permanent tooth model with a 3d printer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 100μm in layer thickness, and is output at a resolution of 40 to 90μm on the x, y axis. This device should use specific 3D Printer equipment using UV light source, and it is possible to produce three-dimensional printed matter by curing lamination step by step a thickness of 100μm.

However, scanner, design software, 3D printer and post-cure unit are not included with the device.

TERA HARZ can be used in combination with specified lasers and DLP based 3D printers which support dental materials. TERA HARZ is a resin for the generative production of permanent or temporary dental restorations based on image projection systems (405-412 nm). The formulation of TERA HARZ is optimized for the requirements of a robust production guaranteeing constant high quality. The TERA HARZ is successfully tested for biocompatibility, certainly meets all mechanical and application demands. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing.

The material can be used for build processes with layer thicknesses from 25 up to 100 um. After printing, the printed product is recommended to use a UV-light curing for final polymerization.

3D printer is not included with the device.

These fabrications of TERA HARZ are beginning with the dental clinician prescribing indirect restorative to treat a patient's both anterior restorations, including occlusal surfaces, and decision to use methacrylate-based resins is made by the dental clinician. TERA HARZ, a permanent or temporary restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations, is manufactured in a 3D printer that is compatible.

The dental clinician can generate a digital file by scanning the patient's mouth directly using approved Intraoral scanner software. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate permanent or temporary restorations. Commonly used standard dental software is used by dental professionals to virtually design a restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3D Scanner by 3Shape A/S (510(K) Exempt). The specialized prosthetic treatment planning software has a establishment registration for the intended use under FDA Classification Product Code NOF, regulation 872.3661. This software is used for management of 3D scanned prosthetic models, prosthetic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned prosthetic models, virtual planning of prosthetic treatments by simulating tooth movements, and design of permanent or temporary restorations based on 3D scanned prosthetic models.

Once dental clinic manufacturing unit receive the data that *.stl CAD files of crown and bridge the 3D printer begins additive manufacturing. The dental clinician (e.g., dentist) generates sequential 3D printed models replicating the approved treatment plan. The permanent or temporary restorations is 3D printed and cured in a post-curing unit. The fabricated permanent or temporary restorations are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the permanent or temporary restorations are provides them to the patient the confirming fit and design.

This document is a 510(k) summary for a dental resin material, TERA HARZ. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study to prove acceptance criteria for an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets these criteria is not present in the provided text, as this document pertains to a material for dental restorations, not an AI-powered diagnostic or assistive tool. Specifically, there is no mention of AI, machine learning, expert readers, ground truth establishment for a test set, MRMC studies, or standalone algorithm performance.

However, I can extract information related to the physical and chemical performance criteria for this dental material:

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

The document compares the performance of TERA HARZ (Subject Device) with two predicate devices (K201668 and K193553). While explicit "acceptance criteria" are not listed in a dedicated table, the comparisons imply the criteria the subject device aims to meet or exceed based on the predicate devices and relevant ISO standards.

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

• Manufacturing Validation: For translational measurements, "All translational measurements" implies multiple measurements were taken, but a specific number / sample size is not stated.
• Flexural Strength, Water Sorption, Solubility: Sample sizes are not explicitly stated for these tests, but they are typically conducted on a set number of specimens as per ISO standards.
• Data Provenance: The tests were conducted internally by Graphy Inc. or by independent 3rd parties as part of the manufacturing validation and performance testing process for the TERA HARZ product. The document does not specify country of origin for the test data (beyond the applicant being based in Republic of Korea). The data is generated from testing the physical properties of the manufactured resin, so it is "prospective" in the sense that the testing was performed specifically for this submission.

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

• This is not applicable as the device is a dental material, not an AI/ML-powered diagnostic device requiring expert annotation for a test set. Ground truth relates to physical property measurements, not clinical interpretation.

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

• Not applicable for this type of device. Physical property measurements do not involve adjudication by multiple experts in the same way clinical image interpretations do.

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:

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted. The document explicitly states: "No clinical data is included in this submission."

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

• Not applicable. This is a material, not an algorithm.

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

• The "ground truth" for the performance tests (Flexural Strength, Water Sorption, Solubility) and manufacturing validation is based on physical and chemical measurements obtained through standardized laboratory testing methods (e.g., ISO 4049, ISO 10477) using calibrated equipment. For biocompatibility, the "ground truth" is compliance with ISO standards (e.g., ISO 10993 series).

8. The sample size for the training set:

• Not applicable. This device is a material, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this information is not relevant.

In summary, the provided document is a regulatory submission for a dental resin material, focusing on its physical, chemical, and biocompatibility properties to demonstrate substantial equivalence to existing predicate devices. It does not contain information related to the development or validation of an AI/ML-powered medical device.

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