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

The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:

• include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
• include new OEM platform compatibility for MIS C1 Dental Implant System,
• include attachment components (retention inserts and housing) including reprocessing information in labeling.

The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.

N/A

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm
• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular)
• · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP
• · Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm.

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

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

• Test Set Sample Size:
  • The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
• Data Provenance:
  • The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
  • The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

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

• This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
• The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

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

• This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

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

• For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
• For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable as there is no training set for a physical medical device.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• · Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
• · Implant Direct Legacy2(K192221) 3.0
• · Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
• · Nobelactive Wide Platform (Wp) (K133731) WP 5.5
• · TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• · Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Study Details

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

   • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
   • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

   • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

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 is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

   • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

   • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

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

   • Not applicable for the same reason as above.

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SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

SIMDA Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

This FDA 510(k) summary describes a dental device, the SIMDA Abutment. However, it does not include information that directly addresses the specific questions you've asked about acceptance criteria and a study proving a device meets them, particularly for an AI/ML powered device.

Here's why and what information is provided:

The document is a premarket notification for a Class II medical device, specifically dental implant abutments. These are physical components used in dental restorations, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concepts of "acceptance criteria for an AI model," "test set," "ground truth," "MRMC studies," "effect size of human readers with AI assistance," or "standalone algorithm performance" are not applicable to this submission.

The "studies" mentioned are non-clinical (mechanical, biological) tests demonstrating the physical safety and performance of the abutments and their compatibility with existing dental implant systems.

Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the device type:

Device: SIMDA Abutments (K232271)
Device Type: Endosseous Dental Implant Abutment (physical medical device, not AI/ML powered)

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

The document sets design limits and then demonstrates conformity through non-clinical testing. The "acceptance criteria" here are rather design specifications and performance standards for dental abutments.

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

• This information is not provided. For physical tests (fatigue, biocompatibility, sterilization), sample sizes would typically be determined by the relevant ISO standards.

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. "Ground truth" in the context of AI/ML is not relevant here. The "truth" is established by physical measurement, adherence to material standards, and documented mechanical performance.

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

• Not applicable. Adjudication methods are typically for subjective assessments, whereas these are objective physical tests.

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 a physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical dental device.

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

• For physical tests, the "ground truth" is defined by the ISO standards and FDA guidance documents to which the device is tested. This includes established methods for fatigue testing, biocompatibility evaluation, and sterilization efficacy. For compatibility, it's about precise dimensional matching and mechanical fit to existing OEM implant systems.

8. The sample size for the training set

• Not applicable. This is a physical dental device, not an AI/ML powered device that requires a "training set."

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

• Not applicable. See point 8.

In summary, this document is for a traditional medical device (dental abutments), and thus the questions formulated for an AI/ML device do not directly apply. The acceptance criteria are based on established engineering and materials standards, and performance is demonstrated through non-clinical laboratory testing rather than clinical or observational studies on diagnostic performance.

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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.

Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. 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.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:

Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.

The provided document describes the Preat Abutments and their substantial equivalence to predicate devices, based on non-clinical performance data. It does not contain information about studies involving human readers, ground truth establishment for a test or training set, or specific details on sample sizes for a test set in the context of AI/algorithm performance.

Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:

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

The document describes non-clinical performance data used to demonstrate substantial equivalence, focusing on mechanical testing and material properties. The acceptance criteria are implicitly met by comparing the subject device to predicate and reference devices, and by conforming to relevant ISO standards where applicable.

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 detail specific sample sizes for the mechanical testing ("worst-case constructs"). The data provenance is not explicitly stated in terms of country of origin, nor is it described as retrospective or prospective in the context of test sets. The studies are non-clinical (laboratory testing).

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. The studies described are non-clinical performance and material conformance tests, not diagnostic studies or those requiring expert interpretation of results to establish ground truth in the way medical imaging algorithms might.

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

This information is not applicable. Adjudication methods typically apply to human interpretation of data, often in clinical studies or when establishing ground truth for AI algorithms, which is not the nature of the studies described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. An MRMC comparative effectiveness study is used for diagnostic AI devices involving human readers. This document describes non-clinical performance testing for dental abutments, which is a physical device, not an AI algorithm.

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

This information is not applicable. The device is a physical dental abutment, not an algorithm.

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

The concept of "ground truth" as typically used in the context of evaluating diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. For the non-clinical tests, the "ground truth" or reference for performance is the compliance with specified ISO and ASTM standards and the performance of the predicate/reference devices through comparative testing. For example:

• Mechanical Testing: The "ground truth" would be the passing criteria defined by ISO 14801.
• Material Conformance: The "ground truth" would be the specifications in ASTM F136 and ISO 13356.
• Biocompatibility & Sterilization: The "ground truth" would be the specifications in ISO 10993-1, ISO 10993-5, ISO 17665-1, and ISO 14937.

8. The sample size for the training set:

This information is not applicable. There is no AI algorithm being described, and therefore no training set.

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

This information is not applicable for the same reason as above.

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The Paltop Narrow Implant 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 Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

This submission expands the Predicate Narrow Implant device to include 3.0 mm diameter implants, additional implant thread configurations and additional prosthetic components to the previously cleared Paltop Narrow Implant (K130462).

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Paltop Narrow Implant are one- and two-stage endosseous screw type dental implants with associated abutments. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy which conforms to ASTM F136. The Paltop Narrow Implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched).

The implants are available in three thread/body configurations: Advanced, Advanced+, and Dynamic. The Advanced, Advanced+ and Dynamic implants have micro threads at the neck. All implants have a parallel coronal and mid-section area with an apical taper. The families have slight differences in thread profile and either a passive or active apex. The 3.0 mm diameter implants are prosthetically compatible with the previously cleared Paltop Narrow Implant (K130462) prosthetic devices.

This submission introduces Single-Unit Abutments for the Paltop Narrow Implant device. The submission replaces the original straight Multi-Unit Abutments from the K130462 submission and includes additional gingival heights. The submission also introduces an angulated Multi-Unit titanium abutment, all compatible with the Paltop Narrow Implant device. The submission expands the compatible prosthetic components to include new temporary titanium abutments and healing caps compatible with Single-Unit and Multi-Unit titanium implant abutments.

The Subject device implants may be used with the Predicate device abutments previously cleared under K130462, based on non-clinical performance bench testing provided in this submission.

The Subject device abutments may be used with the Predicate device implants previously cleared under K130462, based on non-clinical performance bench testing provided in this submission. The only exception is the implant cover screw (P/N 80-70100) which is specific to the 3.0 mm diameter implants in this submission.

The Subject device Multi-Unit Abutment components such as copings/interfaces, temporary abutments, cylinders, and screws may be used with the Predicate device Multi-Unit Abutments previously cleared under K130462 based on non-clinical performance bench testing provided in this submission.

All implants and prosthetic components are one-time use devices. All Subject devices in this submission are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings and all replacement screws which are provided non-sterile. Devices provided as non-sterilized by steam.

Here's a breakdown of the acceptance criteria and the study information for the Paltop Narrow Implant, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics like fatigue life or bone-to-implant contact percentages. Instead, it refers to industry standards and general outcomes. The reported device performance is presented narratively.

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

The document does not explicitly state a test set sample size for each specific non-clinical test in terms of a number of devices. It refers to general testing.

• For the bone changes evaluation (part of biocompatibility/osseointegration): "A total of 174 surfaces were graded (87 implants)."
• Data provenance: The bone changes evaluation references "published literature" on patients, suggesting retrospective (or possibly prospective clinical studies mentioned in the literature). "Internal routine monitoring data" and "post-market surveillance data" are mentioned, indicating real-world data collection, likely retrospective for surveillance and ongoing for monitoring. The manufacturer is Paltop Advanced Dental Solutions, Ltd, Hashita 5, Industrial Park, Caesarea 3088900, Israel.

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

The document doesn't specify the number or qualifications of experts used to establish "ground truth" for the test set. For the bone level evaluation, it states "Mesial and distal surfaces were examined and graded." It is implied that these evaluations were done by qualified clinical professionals as part of the published literature or internal monitoring, but no specific details are provided.

4. Adjudication Method

No adjudication method is mentioned for any of the evaluations (e.g., bone level grading, or evaluation of non-clinical tests). The document implies acceptance based on test results meeting standards or being comparable to predicate devices.

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

No MRMC comparative effectiveness study is mentioned. This device is an endosseous dental implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study

The primary studies detailed are "non-clinical bench performance testing." This refers to laboratory testing of the device itself (fatigue, pull-out, etc.) and biological evaluations based on literature review and historical data, which are "standalone" in the sense that they assess the device's physical and biological properties. There is no human element being assessed.

7. Type of Ground Truth Used

The ground truth used several types:

• Industry Standards: For fatigue testing (ISO 14801:2016), endotoxin testing (USP <161>), and sterilization (ISO 17665-1).
• Clinical Outcomes Data: For osseointegration and implant survival (from published literature and post-market surveillance). This includes "bone level improvement or maintenance" and "failure rates below industry levels."
• Analytical Data: SEM/EDS data for residual particles.
• Comparison to Predicate/Reference Devices: Demonstrating similarity in design and performance to already cleared devices.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of an algorithm or AI. This is a medical device (dental implant) that undergoes physical and biological performance testing, not a machine learning model.

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

Not applicable, as there is no training set for an algorithm described in this document.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved. MUA Xeal: The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. On1 Base Xeal: The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

Onl Universal Abutment (previously cleared by K181869) The Onl 11M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutunent consist of three major parts. Specifically, the Onl Base, the Onl Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material , milling machine and associated tooling and accessories.

TREFOIL System (previously cleared per K172352) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil Implants are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm implant and 14.5 mm for 13.0implant and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

Healing Cap Multi-Unit Titanium (previously cleared per K171142) The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.

TREFOIL System (previously cleared per K170135) The Trefoil system is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil system are placed between the mental foramina in fully edentitious mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. The following prerequisities must be fulfilled: - Adequate quantity of bone (minimum width of 7 mm; and minimum heights of 13 mm implant and 14.5 mm for 13.0 mm implant) -Adequate mouth opening (minimum 40 mm) to accomodate the guided surgery intruments. -Implant-supported prosthetics seated directly on dedicated implants

Onl Concept (previously cleared per K161655) The On 17M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

NobelZygoma 0° (previously cleared per K 161598) Nobel Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Temporary Snap Abutment (previously cleared per K161435) The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that and in creating an esthetic emergence through the gingiva during period and prior to final restoration. The Temporary SnapAbutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutiment is not to exceed one hundred and eighty(180) days.

Multi-Unit Abutment Plus (previously cleared per K161416) The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelProcera HT ML FCZ Implant Bridge and Framework (previously cleared per K160158) The NobelProcera HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelSpeedy Groovy (previously cleared per K160119) NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bicortical anchorage in cases of reduced bone density. NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

TREFOIL System (previously cleared per K152836) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is acheved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

NobelZygoma 45° (previously cleared per K152093) Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthelies and chewing finction. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

NobelActive Wide Platform (WP) ( previously cleared per K133731) Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient estherics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

NobelProcera Overdenture Bar (previously cleared per K132749) The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

NobelProcera Angulated Screw Channel Abuttment Conical Connection (previously cleared per K 132746) The NobelProcera Angulated Screw Channel Conical Connection are premanufactured prostheire components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare PEEK Abutments (previously cleared per K120954) The Nobel Biocare PEEK Abuments are premanufactured prosthetic components directly connected to the endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 3.0 (previously cleared per K111581) The Nobel Active 3.0 implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate finction provided that stability requirements detailed in the manual are satisfied.

NobelActive 3.0mm (previously cleared per K102436) The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

NobelProcera Implant Bridge Zirconia (previously cleared per K091907) The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Zi Abutments (previously cleared per K091904) The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelProcera Ti Abutment (previously cleared per K091756) The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 8.5 mm & 18.0 mm (previously cleared per K083205) Nobel Biocare's Nobel Active implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's Nobel ective implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelReplace Hexagonal Implants (previously cleared per K073142) Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive Multi Unit Abutment (previously cleared per K072570) NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Internal Connection Implant (previously cleared per K071370) Nobel Biocare's Nobel Active implant are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive mplants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Adapter PS (previously cleared per K063592) Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma Angled Abutments (previously cleared per K052885) The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly connected to the implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma TiUnite (previously cleared per K050641) Nobel Biocare's zygoma TiUnite is a tianium, endosseous implant with components intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function, Nobel Biocare's Zygoma TiUnite inclueds endosseous implants, a cover screw, healing abutments, and multi unit abutments.

Nobelspeedy Implants (previously cleared per K050406) NOBELSPEEDY TM Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELS PEEDY TM Implants are indicated for single or multiple unt restorations in splinted or non-splications. Nobel Biocare NOBELSPEEDY TM Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. NOBELSPEEDY TM Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY TM Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY TM Implants are preferred in these soft bone indications because bone formation on the Til nore rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates. NOBELSPEEDY TM Implants may be tilted up to 450. When used with angulations between 300 and 450 a minimum of four implants must be used and splinted.

Groovy Implants (previously cleared per K050258) Nobel Biocare's Groovy Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Groovy Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Groovy Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. Groovy implants are indicated for use in soft bone in posterior regions or whenever immediate or early loading is applied. The Groovy implants incorporate a groove on the implant thread and are preferred over models without the grove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants.

Procera Implant Bridge, models 15-1001, 15-1002, 15-1052 (previouly cleared per K041236) The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems: Nobel Biocare Branemark System Nobel Biocare Replace SelectThe Procera Implant Bridge can be used at the implant level of the following implant systems: Nobel Biocare Replace Nobel Biocare Steri-Oss HL Nobel Biocare Novum Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6.5 The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept.

Various Branemark System Implants-Immediate Function Indication previously cleared per K022562 The Branemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on -single tooth and/or multiple tooth applications recognizing stability (type I or n bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

BRANEMARK NOVUM previously cleared per K000018 The "Immediate Loading Treatment Protocol" is intended for use with selected Brânemark System Implants, I hese implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Amorphous Diamond Coated Screw (previously cleared per K992538) The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other proshetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

Procera® Preparable Abutment System (previously cleared per K974150) Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

AurAdapt Abutment System (previously cleared per K972475) Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutnents which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

Branemark System - Zygomaticus Fixture System (previously cleared per K970499) The Nobel Biocare Brallemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Bio-Esthetic Indirect Abutment (previously cleared per K970073) The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.

Steri-Oss' Tiodized' screws (previously cleared per K964739) The intended use for Steri-Oss' Tiodized screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Replace Titanium Implant System (previously per K964220) The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

STERI-OSS GOLD ATTACHMENT SYSTEM (previously cleared per K963945) Steri-Oss Gold Attachment System, the intended use of this device is for the screw retained attachment of prosthesis to abutments is for the screw and/or abutments to retained implants.

17° Angulated Abutment (previously cleared per K961736) The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis

MirusCone Abutment System (previously cleared per K961728) The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.

Branemark System- Healing Abutment (previously cleared per K925779) The Nobelpharma Branemark System- Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Branemark System Estheticone Abutment complete (previously cleared per K925777) The Nobelpharma Branemark System - EsthetiCone Abutment Complete is intended to be used as a component to an endosseous implant.

Branemark Systems - Titanium CoverScrew (previously cleared per K925771) The Nobelpharma Branemark Systems - Titanium CoverScrew is intended to an endosseous implantprior to the first healing period to protect the innerthread of the fixture and prevent bone overgrowth.

Branemark System Abutment Complete (previously cleared per K925769) The Nobelpharma Branemark System Abutment Complete is intended to be used as a component to an endosseous implant to support a prosthetic device.

Branemark System Temporary Solutions (previously cleared per K925766) The Nobelpharma Branemark System Temporary Solutions are intended to be used in the same manner asthe permanent counterpart except that the former are usedto support transitional reconstructions.

Branemark System Standard 3.75 mm Fixture (previously cleared per K925765) All Nobelpharma fixtures for implant are indicated for use in the anterior and posterior regions of the maxilla and mandible. The fixtures are designed to support full arch reconstructions (fixed bridges and overdentures), partial arch reconstructions (fixed bridges) and single tooth replacement.

Brânemark System Self-Tapping Fixture (previously cleared per K925762) The "Immediate Loading Treatment Protocol" is intended for use with selected Branemark System Implants. These implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Titanium Plasma Spray Cylindrical Implant (previously cleared per K911592) The Steri-Oss Titanium plasma sprayed cylindrical dental implant device are indicated for use in the mandible and maxilla for denture retention in the edentulous and partially edentulous patient.

Angulated Abutment, Complete, Titanium SCDA102 (previously cleared per K905434) Devices are used as connection with osseointegration fixtures.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)

All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.

TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase S Screw for fixation to the implant body.

TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.

They also feature:

• . cylindrical shape
• hexagonal indexing at the apical end of the connection ●
• indexing guide in the cementable portion for coping fitting ●

CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

TruBase S is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase S.

The provided document describes a 510(k) premarket notification for a dental implant abutment, TruBase S. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness. As such, the information you're looking for regarding AI-specific criteria, clinical study designs, human reader performance, or training set details associated with an AI-driven device is largely not present in this document.

However, I can extract the acceptance criteria and study details relevant to the mechanical performance and substantial equivalence of this medical device.

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

The acceptance criteria for mechanical performance are implicitly set by compliance with ISO 14801:2016 for fatigue testing. The document states that the test results "met the criteria of the standard." For design parameters, the acceptance criteria are substantial equivalence to the predicate device, K201197.

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 specify a distinct "test set" in the context of an AI-driven device or clinical study. The testing performed was non-clinical mechanical performance testing on physical devices and based on technical specifications and design parameters.

• Sample Size: For the fatigue testing, the document mentions "worst-case constructs" were subjected to testing, and "the fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient." However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data originates from internal non-clinical testing conducted by the manufacturer or accredited labs for mechanical and material properties. No country of origin is specified for these tests. The nature of these tests is prospective in the sense that they are conducted specifically for the submission, but they are not clinical studies.

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. The device is a physical dental implant abutment, not an AI device that requires expert ground truth labeling for image analysis or diagnostic purposes. The "ground truth" for its performance is established through adherence to engineering standards (ISO 14801) and material specifications (ASTM F 136).

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of data (e.g., medical images) is compared with an AI's output, often involving multiple experts to resolve discrepancies. This device's evaluation relies on objective mechanical and material testing, not human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a physical dental implant abutment and is not an AI-driven diagnostic or assistive device that would participate in an MRMC study.

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

This information is not applicable. This device is a physical dental implant component, not an algorithm.

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

The "ground truth" for this medical device is based on:

• Material Specifications: Adherence to ASTM F 136 for titanium alloy.
• Engineering Standards: Compliance with ISO 14801:2016 for fatigue testing, and ISO 17665-1/2 and ANSI/AAMI ST79 for sterilization.
• Biocompatibility Standards: Compliance with ISO 10993 series.
• Dimensional and Design Parameters: Matching the design limits established by the predicate device and compatible OEM implant lines.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for this physical medical device. Manufacturing processes are based on established engineering principles and quality control, not machine learning training.

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

This information is not applicable, as there is no training set for this physical medical device.

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