Search Results

The SD TL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

SD TL Implant System consist of below:
Fixture

• SD Tissue Level Fixture
• SD Bone Level Fixture

Abutment

• Multi Angled Cylinder
• Multi Digital Cylinder
• Multi Ti Cylinder
• Multi Healing Cap
• Healing Abutment
• Temporary Abutment

1. Fixture
   This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function, the product is used as a substructure implanted into the human body.

An endosseous dental implant is a device made of a material as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations.

The implant-abutment connection is tight and precise fitting with non-submerged external connection and with submerged internal connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

The dimension ranges of the subject device are below:

1. SD Tissue Level Fixture: Ø 3.7, 4.2, 4.6, 5.0 (D) x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L)
2. SD Bone Level Fixture: Ø 6.48 (D) x 7.0, 8.5, 10.0, 11.5 mm (L)

2. Abutment
   The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Angled cylinders come in engaging and non-engaging types.

1. Multi Angled Cylinder: Ø 5.5 (D) x 9.5, 10.5 mm
2. Multi Digital Cylinder: Ø 5.5 (D) x 6.5, 7.5, 8.5, 9.5 mm
3. Multi Ti Cylinder: Ø 4.8 (D) x 4.5 mm, Ø 5.5 (D) x 8.0, 9.0 mm
4. Multi Healing Cap: Ø 4.8, 5.7 (D) x 4.35, 5.85, 7.35 mm
5. Healing Abutment: Ø 3.5, 3.67, 4.2, 5.2, 6.2, 7.5, 8.5 (D) x 6.9 ~ 13.3mm
6. Temporary Abutment: Ø 3.7, 4.0 (D) x 10.4, 10.45, 12.4, 12.45 mm

Tolerance of dimension shall be within ± 1% range.

Multi Digital Cylinder and Multi Ti Cylinder are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Multi Digital Cylinder and Multi Ti Cylinder the design parameters for the CAD/CAM zirconia superstructure are:

• Minimum wall thickness – 0.5 mm;
• Minimum post height for single-unit restorations – 4.5 mm;
• Maximum gingival height – 5.0 mm;
• Minimum gingival height – 0.5 mm;
• Angulation - 0°
  *The post height is defined as measured above the gingival height of the final patient-matched design.

The digital workflow requires the use of the following equipment:

• Restorative Material: Non-Sterile Zirconia Block (K190112)
• Dental Cement: U-Cem Premium & MAZIC Cem (K193260)

The SD TL Implant System is compatible with the SD Bone Level Fixtures and NB Implant Systems. (as the below table).

The provided FDA 510(k) Clearance Letter for the "SD TL Implant System" does not contain information about acceptance criteria or a study proving the device meets those criteria in the context typically seen for Artificial Intelligence (AI) or software as a medical device (SaMD) products.

This document is for a physical medical device (dental implants and associated components), specifically an endosseous dental implant (Product Code: DZE, NHA; Regulation Number: 21 CFR 872.3640; Regulatory Class: Class II).

The "performance data" section in this document describes:

• Biocompatibility testing (ISO 10993-5, ISO 10993-12) to ensure the materials are safe for use in the human body.
• Sterilization validation (ISO 11137-1, 11137-2, ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1,-2, ISO 11138-1, AAMI / ANSI ST72:2011/(R)2016) to ensure the device is sterile.
• Shelf-life testing (ASTM F1980) to confirm stability over time.
• Mechanical performance testing (ISO 14801) for static compression and compression fatigue, which are standard tests for the structural integrity of dental implants.
• Scanning electron microscopy (SEM) and Energy dispersive X-ray spectroscopy (EDS) for surface characteristics.
• MR environment condition review to assess safety in MRI environments.

These tests are standard for a physical implantable device to demonstrate substantial equivalence to a predicate device. They are not related to AI/software performance criteria (like accuracy, sensitivity, specificity, AUC) or human reader study designs (like MRMC studies, ground truth establishment by experts, adjudication methods).

Therefore, I cannot populate the requested table or answer the questions related to AI/software performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided document.

The document explicitly states: "Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence." and "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate." This refers to the physical and material properties, not AI algorithm performance.

Ask a specific question about this device

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering. After application, this material cannot to be reused for fabrication.

The provided FDA 510(k) clearance letter pertains to a Non-Sterile Zirconia Block used for dental restorations. This document focuses on demonstrating the substantial equivalence of the new device (ARENA Star, Galaxy Star) to a predicate device (Non-Sterile Zirconia Block, K223253) based on its material properties and chemical composition, not on an AI or software-driven diagnostic or assistive system.

Therefore, the requested information about acceptance criteria, study design for AI performance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this submission. This is a material science and manufacturing equivalency clearance, not a performance study for AI.

However, I can extract the acceptance criteria related to the material properties and the type of non-clinical testing performed.

Updated Information based on the provided document:

Acceptance Criteria and Device Performance for ARENA Star, Galaxy Star (Non-Sterile Zirconia Block)

The acceptance criteria for this device are based on demonstrating mechanical and biological equivalence to a predicate device and adherence to international standards for dental ceramic materials.

1. Table of Acceptance Criteria and Reported Device Performance:

The remaining information requested is typically relevant for AI/ML-based medical devices, which operate on analyzing data (e.g., images, signals) and often involve performance metrics like sensitivity, specificity, accuracy, and comparisons to human expert performance. This 510(k) submission is for a physical medical device (zirconia block), where the "study" demonstrating criteria fulfillment is primarily non-clinical bench testing and chemical analysis to confirm material properties and biocompatibility.

Therefore, for aspects like "Sample size for the test set," "Experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," "Training set sample size," and "Ground truth for the training set" – these points are not applicable to this specific device and the information provided in the 510(k) clearance letter. The "ground truth" here is established through standardized material testing methods and chemical analysis, not through expert interpretation of data.

Ask a specific question about this device

The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.

SD Implant System consist of below:
Fixture

• SD Bone Level Fixture
  Abutment
• Cover Screw
• Healing Abutment
• Scan Healing Abutment
• Scan Healing Abutment Screw
• Cemented Abutment
• Angled Abutment
• Master Fix
• Master Fix Screw
• Digital Abutment
• Temporary Abutment
• Multi Abutment
• Multi Angled Abutment
• Abutment Screw
• Multi Scan Healing Cap
• Multi Scan Healing Cap Screw
• Multi Master Fix
• Multi Master Fix Screw
• Multi Ti Cylinder
• Multi Digital Cylinder
• Multi Temporary Cylinder

SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment, Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder)

This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function.

An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.

The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091.

SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091)

SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only.

The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations.

For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are:

Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only.

The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a twopiece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

The SD Implant System is intended for single use only. The Abutments are made of Ti-6AI-4V Eli (Conforming to ASTM F136) The SD Implant System connections compatible with NB 1 SA Implant System, NB Implant System and NB Mini Implant System

The provided text is a 510(k) summary for a dental implant system (SD Implant System) and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in the format typically used for performance studies of AI/ML-enabled devices.

Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.

The document details the device's components, materials, dimensions, indications for use, and a comparison to predicate devices, along with non-clinical performance data like biocompatibility, sterilization validation, shelf-life, and mechanical testing (ISO 14801). It does not contain information about:

• Acceptance Criteria for AI/ML performance: The document is for a physical dental implant system, not a software/AI device.
• Reported device performance for AI/ML: There's no AI component described.
• Sample size for test set and data provenance: Not applicable to this type of device submission.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for ground truth: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (pathology, outcomes data, etc.): Not applicable in the context of AI. Ground truth here refers to engineering specifications met by physical testing.
• Sample size for training set/How ground truth for training set was established: Not applicable, as there's no AI/ML training involved for a physical implant.

The document primarily focuses on demonstrating that the physical dental implant system meets established performance standards and is comparable to previously cleared devices through non-clinical testing.

Ask a specific question about this device

The SD TL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed Pre-Milled Abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

An endosseous dental implant is a device made of a material such as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations.

The implant-abutment connection is tight and precise fitting with non-submerged external connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The SD TL Implants are available with a gingival height of 1.5 mm.

The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Pre-Milled cylinders come in engaging and non-engaging types. All designed abutments are sent to an ARUM DENTISTRY validated milling center.

The diameters of Multi Pre-Milled Cylinder are 4.8 mm Square.

There were no acceptance criteria or studies on device performance to meet stated acceptance criteria discussed in the provided text. The text describes a 510(k) premarket notification for the "SD TL Implant System," which is a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, intended use, and non-clinical performance testing (biocompatibility, sterilization, shelf-life, and mechanical testing).

The document states that biocompatibility, sterilization, shelf-life, and mechanical performance testing (according to ISO 14801 for static compression and compression fatigue) were conducted. It concludes that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate." However, specific acceptance criteria values for these tests and the detailed results of how the device met them are not provided in the document.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document generally states that tests met "the criteria of the standards" but does not enumerate these criteria or specific performance values.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions mechanical testing according to ISO 14801 but does not specify sample sizes or data provenance.
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, as this device certification is for a dental implant system based on non-clinical performance, not an AI/diagnostic device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. For this dental implant, "ground truth" would be the established performance standards (e.g., ISO manufacturing standards, material properties, mechanical strength benchmarks) against which the device's physical properties and performance are measured.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Ask a specific question about this device

The Customized Abutments are intended use for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement- retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant System:

1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0
2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0
4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0

All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.5, 3.75, 3.8, 4.0, 4.3, 4.5, 4.6, 5.0, 6.0 mm and Hex connection design.

Customized abutments are supplied with an abutment and provided non-sterile.

This document is a 510(k) Premarket Notification from ARUM DENTISTRY Co., Ltd. for a dental device called "Customized Abutment." This notification aims to demonstrate the substantial equivalence of their device to legally marketed predicate devices, as required by the U.S. Food and Drug Administration (FDA).

Based on the provided information, the 510(k) summary (pages 4-12) details the device, its intended use, materials, and substantial equivalence comparison to a predicate device. The information is focused on a medical device clearance and does not describe an AI/ML-driven medical device, nor does it contain information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because the provided document does not pertain to an AI/ML device.

The document describes a physical medical device (Customized Abutment for dental implants) and its non-clinical testing to demonstrate substantial equivalence, primarily through:

• Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static and fatigue testing according to ISO 14801.

The closest information provided to "acceptance criteria" relates to the design parameters of the abutment, such as post height, angle, wall thickness, diameter, and gingival height, which are likely evaluated against engineering specifications and performance standards like ISO 14801.

Ask a specific question about this device

The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The C&B NFH Hybrid 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 physicalchemical, mechanical and biocompatible properties.

This document is a 510(k) Premarket Notification from the FDA for a dental resin material named "C&B NFH Hybrid." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a clinical study involving experts or human readers with AI assistance.

Therefore, many of the requested details about acceptance criteria and a study proving device meets them are not applicable in this context, as this document pertains to a material's physical and chemical properties and biocompatibility for substantial equivalence, rather than an AI-powered diagnostic device or a device requiring a multi-reader, multi-case study.

However, I can extract the acceptance criteria and reported performance for the physical properties of the dental resin, which are relevant to its substantial equivalence.

Acceptance Criteria and Reported Device Performance (Physical Properties of Dental Resin)

Study Information (Based on the document provided):

1. Sample size used for the test set and the data provenance: Not explicitly stated with specific numbers of samples for each test (e.g., how many specimens were tested for flexural strength). The data provenance is from non-clinical performance testing conducted by the manufacturer, ARUM DENTISTRY Co., Ltd., likely in a laboratory setting. This is not patient-specific or clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical property testing of a material, "ground truth" is typically established by standardized testing methods and measurements, not by expert interpretation in the medical sense.

3. Adjudication method for the test set: Not applicable. Standardized laboratory testing methods do not involve adjudication in the way clinical studies with human observers do.

4. 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 a dental material, not an AI-powered diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.

6. The type of ground truth used: Standardized laboratory measurements according to ISO 10477:2020 and ISO 4049:2013 for physical properties (flexural strength, water sorption, solubility). For biocompatibility, compliance was shown with ISO 7405, ISO 10993-1, -5, -10, -11, -12, and -23.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.

8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Non-Clinical Performance Data) from the document:

The device did not undergo a "study" in the clinical sense with human readers or AI. Instead, the manufacturer provided Non-Clinical Performance Data to support the substantial equivalence determination for the "C&B NFH Hybrid" dental resin.

The data presented focuses on:

• Physical Property Testing: The device was tested for flexural strength, water sorption, and solubility. The reported values demonstrate that the device meets or exceeds the requirements set by the international standards ISO 10477:2020 ("Dentistry - Polymer-based crown and veneering materials") and ISO 4049:2013 ("Dentistry - Polymer-based restorative materials").
• Biocompatibility: The C&B NFH Hybrid material (Dimethacrylate based resins) was shown to be compliant with a series of ISO 10993 and ISO 7405 standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
• Shelf-Life: Accelerated aging tests in accordance with ASTM F1980 validated a 2-year shelf-life.

The purpose of these tests was to demonstrate that the C&B NFH Hybrid has similar safety and effectiveness characteristics to its predicate device (K202846, TERA HARZ by Graphy Inc.) and meets established performance standards for dental materials. The conclusion is that the subject device is substantially equivalent to the predicate device.

Ask a specific question about this device

The Ti-Base & Master Fix 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 Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
Device Components:

1. Abutment

• Ti-Base
• Master Fix
• Abutment Screw
  The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

The provided document is a 510(k) premarket notification for the "Ti-Base & Master Fix" dental implant abutments. It includes a summary of technology characteristics and performance data but does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert opinions, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device (DESS Dental Smart Solutions, K191986) primarily through material composition, intended use, and mechanical testing that mitigates minor design differences.

Therefore, many of the requested details cannot be extracted from this document.

However, based on the information provided, here's what can be answered:

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

• The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum fracture strength, fatigue life thresholds) or report specific numerical performance outcomes against such criteria for the "Ti-Base & Master Fix" directly.
• It references mechanical performance testing as a method to mitigate differences in design and ensure safety and effectiveness, implying that such tests were conducted and their results were deemed acceptable, but the actual data/criteria are not provided in this summary.
• It also mentions biocompatibility testing according to ISO 10993-5 and ISO 10993-12, and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2. These standards implicitly contain acceptance criteria, but the specific results or criteria are not detailed in this submission summary.

Table of Acceptance Criteria and Reported Device Performance (Based only on what's implicitly mentioned as having been met)

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

• The document does not provide details on sample sizes for mechanical performance testing, biocompatibility, or sterilization validation.
• No information on the country of origin of the data or whether the studies were retrospective or prospective can be extracted.

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)

• This information is not applicable and not provided. The submission is for a medical device (dental implant abutment), and the performance data primarily relates to physical and material properties, not diagnostic imaging or clinical interpretation requiring expert ground truth establishment in that typical sense.

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

• Not applicable and not provided. This typically applies to clinical or imaging studies where expert consensus is formed, which is not the type of study described here.

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 and not provided. This is a medical device (dental implant abutment) submission, not an AI-assisted diagnostic device.

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

• Not applicable and not provided. This is a physical medical device.

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

• Not applicable. For physical device testing, ground truth would typically refer to established engineering standards, material properties, and validated test methods (e.g., ISO standards for mechanical testing, biocompatibility).

8. The sample size for the training set

• Not applicable and not provided. There is no machine learning or AI component described that would require a training set.

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

• Not applicable and not provided.

Ask a specific question about this device

The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw.

Patient-Specific Abutment is compatible with following Implant Systems:

1. Zimmer Tapered Screw-Vent®
   / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7
2. Straumann® Bone Level Tapered Implant
   / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4

All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design.

Customized abutments are supplied with an abutment screw and provided non-sterile.

The provided text describes the regulatory clearance (K234112) for the ARUM DENTISTRY Co., Ltd. Customized Abutment, particularly focusing on its substantial equivalence to a predicate device (K223634). The information provided does not outline acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets AI/ML specific acceptance criteria.

The information provided pertains to a traditional medical device (dental abutments) and focuses on engineering and material performance rather than AI/ML algorithm performance.

Therefore, many of the requested fields regarding AI/ML specific criteria cannot be extracted from the given text.

However, I can provide information on the non-clinical tests conducted for the Customized Abutment device, which are analogous to acceptance criteria and performance data for this type of medical device.

1. Table of Acceptance Criteria and the Reported Device Performance (Non-AI/ML):

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

• Mechanical Testing (Static and Fatigue): The document mentions "The worst-case construct was tested" for sterilization and that "static and fatigue testing according to ISO 14801" was conducted. Specific sample sizes are not provided.
• Data Provenance: The non-clinical tests were conducted internally or by contractors to ARUM DENTISTRY. The document does not specify a country of origin for the data beyond ARUM DENTISTRY Co., Ltd. being in the Republic of Korea. These are most likely prospective tests conducted specifically for this submission.

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):

This information is not applicable and not provided as the approval is for a physical dental abutment, not an AI/ML algorithm requiring expert interpretation for ground truth.

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

This information is not applicable and not provided. "Adjudication" typically refers to resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.

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:

This is not applicable. No MRMC study was conducted as the device is a physical dental abutment, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical product, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards and specifications used (e.g., ASTM F136 for material, ISO 14801 for mechanical testing, ISO 17655-1 for sterilization, FDA guidance for MRI safety). The device's performance is compared against the requirements of these established standards.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The device design parameters are "trained" through engineering design principles and verified through physical testing.

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

This is not applicable. There is no training set as it's not an AI/ML algorithm. The design of the abutment relies on established engineering principles, material science, and compatibility specifications with existing implant systems.

Ask a specific question about this device

The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

This document is a 510(k) summary for the NB Mini Implant System by Arum Dentistry Co., Ltd. It declares that the device is substantially equivalent to existing predicate devices. Consequently, it does not contain a typical acceptance criteria table with reported device performance as would be found in a study demonstrating novel device performance. Instead, it provides a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here’s an analysis of the "acceptance criteria" and "study" information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document is a 510(k) summary for substantial equivalence, not a standalone performance study with explicit acceptance criteria. The "acceptance criteria" in this context are implicitly that the subject device's performance is substantially equivalent to legally marketed predicate devices. The "reported device performance" is presented through direct comparison of features and results of non-clinical benchtop tests against these predicate devices.

The table below summarizes the comparative information provided for the NB Fixture Mini (one component of the NB Mini Implant System) against its primary predicate and a reference device. Similar comparative summaries are provided for other components (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment Mini, Angled Abutment Mini, and Abutment Screw), all concluding substantial equivalence.

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

The document refers to a variety of non-clinical testing data for various components of the NB Mini Implant System:

• Mechanical performance testing (Fatigue test): "For each compatible implant line, worst-case constructs were subjected to static compression and compression fatigue testing." No specific numerical sample size is provided.
• Bone to Implant Contact (BIC) analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Surface area analysis: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Pullout test: Conducted with NB Fixture Mini implants of diameters less than 3.25mm. No specific numerical sample size is provided.
• Biocompatibility: Demonstrated by reference to ARUM DENTISTRY submission K213506.
• Sterilization validation: Performed according to ISO 11137-1 and ISO 11137-2 (method VDmax25 for 25 kGy dose, referenced from K213506), End User Moist Heat Sterilization Test (ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1, -2 and ISO 11138-1, referenced from K213506), and LAL endotoxin testing (AAMI / ANSI ST72:2011/(R)2016).
• Shelf-Life: Accelerated aging method in accordance with ASTM F1980.

The data provenance is not explicitly stated as country of origin, retrospective or prospective, but all tests are non-clinical, meaning they were performed in a lab setting, likely by the manufacturer or a contract lab. The referenced 510(k) submissions (K213506, K190849, K220079, etc.) indicate these are devices marketed in the US, but the company (Arum Dentistry Co., Ltd.) is from the Republic of Korea.

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

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This section is not applicable as the studies described are non-clinical benchtop tests, not clinical studies requiring adjudication of human reader interpretations.

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

This section is not applicable. The device is an endosseous dental implant system, not an AI or software-based diagnostic tool that would typically be evaluated with MRMC studies or AI assistance.

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

This section is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical performance tests:

• Mechanical fatigue: The "ground truth" or reference for evaluating performance is the established mechanical properties and fatigue resistance standards (e.g., ISO 14801), and the performance of the predicate devices.
• Biocompatibility: Demonstrated via material testing and reference to previous submissions, ensuring the material meets established safety standards for biological interaction.
• Sterilization: Ground truth is defined by sterility assurance levels (e.g., SAL of 10^-6) and adherence to recognized standards (ISO 11137, ANSI/AAMI ST79).
• Shelf-Life: Ground truth is established by test methods (ASTM F1980) that predict long-term stability and integrity.
• BIC, Surface Area, Pullout: These are physical measurements compared against predicate device performance, implying the predicate's performance serves as the reference for "substantially equivalent" ground truth.

8. The sample size for the training set

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set.

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

This section is not applicable as the device is a physical medical implant, not an AI or software system that requires a training set and corresponding ground truth.

Ask a specific question about this device

Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.

The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506.

The dimension ranges of the subject device are below:

Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only.

The Angled Abutment is compatible with the following implant systems.

The provided text is an FDA 510(k) summary for a dental device called an "Angled Abutment." It does not contain any information about an AI/ML powered device, a study involving human readers, or any other data that would allow for the detailed description requested in the prompt regarding acceptance criteria and a study to prove performance for an AI/ML product.

The document primarily focuses on demonstrating the substantial equivalence of the "Angled Abutment" to previously cleared predicate devices based on its materials, design, intended use, and mechanical performance testing (specifically static and fatigue testing according to ISO 14801).

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods for a test set.
• MRMC comparative effectiveness study or effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for training set or how its ground truth was established for an AI/ML device.

The document is solely about a physical dental implant component and its mechanical and material properties. The 'Performance Data' section only mentions biocompatibility, sterilization validation, mechanical performance testing (ISO 14801), and MR environment condition assessment – none of which involve AI/ML.

Ask a specific question about this device