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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.

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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.

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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.

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