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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
UNIZ Nbee
SprintRay Inc. SprintRay Pro 95
Post-Curing:
Post-cure unit CureM U102H
Tera Harz Cure THC

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. TERA HARZ CLEAR have 3 models : TC-85DAC, TR-07, TA-28. 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 um on the x, y axis, and it is possible to produce threedimensional 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 methacrylate- based 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, regulation872.3661. 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 industrystandard "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 areprovides them to the patient the confirming fit and design.

The provided text describes the regulatory clearance of a dental device, "TERA HARZ CLEAR," an orthodontic plastic bracket (sequential aligner), by the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, K180107 (Blue Sky Bio Aligner).

The information provided is primarily related to bench testing of material properties, rather than performance of an AI/ML algorithm or a multi-reader, multi-case study. Therefore, many of the requested points regarding AI/ML performance, ground truth establishment for AI models, and human reader studies (MRMC) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

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

The acceptance criteria are primarily derived from the ISO 20795-2:2013 standard, "Dentistry - Base Polymers - Part 2: Orthodontic base polymers." The device performance is compared to these criteria and the predicate device.

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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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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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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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