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The SMARTbase Abutment System is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or fully edentulous patient. The SMARTbase Abutment System is intended for use in the mandible or maxilla in support of single or multiple unit restorations.

The SMARTbase Abutment System integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTbase Abutment System consists of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

• SMARTbase abutment for narrow (3.2mmD) Legacy implants: Indicated for single-tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors.
• SMARTbase abutment for short (8mm) 3.7mmD Legacy implants: Indicated for tooth replacement of mandbular and maxillary central and lateral incisors.
• SMARTbase abutment for narrow diameter (3.2. 3.3mm) InterActive implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.

The SMARTbase Abutment System is a two-piece engaging and non-engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). There are three device lines offered in the SMARTbase Abutment System: Legacy™ SMARTbase Abutment, InterActive™ SMARTbase Abutment, and SMARTbase Cylinder.

The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm for Legacy™ and 3.0mm, 3.4mm for InterActive™, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The SMARTbase Cylinder is a two-piece non-engaging dental implant and multi-unit abutment cylinder comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The SMARTbase Cylinder is offered in two heights 9.0mm (that can be shortened to 4.0mm) and 4.0mm and in one width, platform diameters and collar (titanium base) height in order to accommodate different patient anatomies.

The subject device is supplied with fixation screws that function as an extension of the implant or multi-unit abutment to which the SMARTbase Abutment or SMARTbase Cylinder is secured and is used with several accessories in digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The available design options for the zirconia top components to be provided either as a superstructure (to then receive a separate crown or bridge) or hybrid abutment-crown. There are three workflow options for fabricating the zirconia top component which fits the titanium abutment base:

(1) end user creation of a press-ceramic material by conventional wax-up technique,

(2) Implant Direct design and milling of zirconia in stock sizes using ceramic material of ZirCAD Prime (K142233) and provision of same to the end user, and

(3) digital workflow using 3Shape or Exocad software where CAD design and milling of the superstructure or hybrid crown component is done at the end user's dental laboratory/office; the CAD design requires loading of Implant Direct's abutment design library to the 3Shape or Exocad software to design the superstructure or hybrid crown component within the established design limitations and specifications. The digital workflow includes use of the following products (not subject devices of this submission):

• Ceramic material: ZirCAD Prime (K142233) .
• . Cement: Maxcem Elite Self-Etch/Self-Adhesive Resin Cement (K060469)
• . Composite: Kerr Harmonized (K151332)
• Intra oral scanners: Medit Scanner, ITero Scanner Trios Scanner, CareStream . Scanner
• Abutment design software: 3Shape Abutment Designer™ Software (K151455) and • Exocad AbutmentCAD Software (K193352)
• . Milling machine: Wieland-Zenotec Select, Zenotec CAM, iCAM V5, and imes icore

This document describes a premarket notification for the "SMARTbase Abutment System," a dental implant abutment. The document focuses on demonstrating that the new device is substantially equivalent to existing predicate devices through various performance tests.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format for each test. Instead, it states that "The test results support that the Subject Device met the performance specifications as intended." and "The difference does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent."

However, we can infer the types of performance tests and the general acceptance (i.e., compliance) from the "x. Performance Testing Data" section.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the performance tests (e.g., number of abutments subjected to fatigue testing).
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that this is a premarket notification for regulatory clearance, the testing would generally be conducted by the manufacturer or a contract research organization on manufactured devices, following established protocols. It is non-clinical testing, meaning it's not performed on patients.

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

This question is not applicable as the document describes non-clinical performance testing for a medical device (dental abutment), not studies involving expert evaluation of diagnostic outputs or ground truth for AI algorithms. The "ground truth" here is defined by engineering standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (like 2+1) are typically used for establishing ground truth in clinical or diagnostic studies involving human interpretation or pathology.

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

This question is not applicable. The document describes non-clinical performance testing of a physical dental abutment and associated design software. It does not involve human readers, cases, or AI assistance in a diagnostic context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

For the software component:

• Standalone Performance: Yes, standalone software verification and validation testing was performed for the abutment design library. This testing demonstrated that the software's inherent design restrictions and specifications for creating the top half of the two-piece abutment prevent designs outside allowable limitations and that the design limitations are locked and cannot be modified. This is essentially an "algorithm only" test to ensure the software functions as designed within its specified parameters.

7. The Type of Ground Truth Used

• For Physical Device Performance (Fatigue, MR Compatibility, Biocompatibility, Sterilization, Shipping): The ground truth is based on established international and national standards (e.g., ISO 14801, ISO 10993-1, ISO 17665-1, ASTM F2052, ASTM D4169). Compliance with these standards serves as the "ground truth" for acceptable mechanical, safety, and operational performance.
• For Software Verification & Validation: The ground truth is the defined design limitations and specifications established by the manufacturer for the abutment components. The software's ability to enforce these limitations (preventing designs outside them and locking specifications) constitutes meeting this "ground truth."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental abutment and associated design software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data to make predictions or classifications. The "training" for the software is its programmed adherence to design rules and specifications.

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

This question is not applicable for the same reasons as #8. There is no training set mentioned for an AI/ML model. The software's functional parameters are established through engineering design and specifications.

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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.

Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.

The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

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The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.

Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.

To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.

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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Machine

The provided text describes the TIB Abutment System and its performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a study with specific performance metrics.

Therefore, I cannot populate the table or answer questions 2 through 7 directly from the provided text as the document does not present acceptance criteria in a quantitative format, nor does it detail a standalone study with performance metrics for the TIB Abutment System against such criteria. Instead, it relies on comparative equivalence with already cleared devices and various non-clinical tests.

However, I can extract information related to the performance data and ground truth establishment that were conducted as part of the substantial equivalence demonstration.

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

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" for the TIB Abutment System in a format that would fit a table like the one requested. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons. The performance data listed are primarily compliance tests against recognized standards rather than specific device performance metrics against predefined thresholds.

2. Sample sizes 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 sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests mentioned. It only lists the types of tests performed.

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. The document refers to non-clinical tests and compliance with standards, not expert-adjudicated ground truth.

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

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert 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 is a dental abutment system, not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

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

The document describes non-clinical testing of the device components and workflow, which can be considered a form of standalone evaluation for the device itself. The types of standalone tests performed include:

• Biocompatibility testing per ISO 10993-1 and ISO 10993-5.
• Validated sterilization instructions per ISO 17665-2.
• Software validation testing per FDA Guidance.
• Scanning and milling validation.
• Static and dynamic compression-bending to ISO 14801.
• Mechanical ISO 14801 Fatigue Testing for implant platforms.

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

The "ground truth" in this context is established by adherence to recognized international standards and FDA guidance documents for medical device testing. For example:

• Biocompatibility: ISO 10993-1 and ISO 10993-5 standards.
• Sterilization: ISO 17665-2.
• Software Validation: FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
• Mechanical Testing: ISO 14801.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dental abutment system) and its non-clinical testing for substantial equivalence, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model mentioned.

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Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

• Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
• Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
  Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.
  Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

The Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments (collectively the "Custom Titanium Abutments") are one-piece hex type engaging abutments comprised of Titanium 6AL-4V ELI, which serve as a final abutment upon which a prosthetic dental restoration will be fitted.
The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices:

• 3Shape Abutment Design Software (K151455)
• Dental System Control Panel
• Dental Designer
• Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, Product Code NOF)
• Intra-oral scanners
• 3M True Definition Scanner (K122467)
• Itero Scanner Software (K131101)
  The Custom Abutments are patient-specific and may be modified within the following parameters:
• Maximum angle of 30° from the axis of the implant
• Minimum wall thickness of 0.4mm
• Minimum post height of 4mm
  The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing.
  The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

This document is related to a 510(k) premarket notification for dental implant abutments, which are physical medical devices, not AI/software-based devices. Therefore, the concepts of "acceptance criteria for an AI model," "study proving the device meets acceptance criteria" (in the context of algorithm performance), "test set," "training set," "ground truth establishment," "experts," "adjudication," and "MRMC studies" are not applicable here.

The document discusses performance data for the physical dental abutments, but this refers to traditional engineering and biological testing, not AI model validation.

Here's a breakdown of why your desired information isn't present in this document:

• Device Type: The device is "Custom Legacy and Custom InterActive Titanium Abutments," which are physical, custom-milled dental prosthetics. They are not AI algorithms.
• Study Purpose: The studies mentioned (Biocompatibility, Fatigue Testing, Steam Sterilization, Software Verification and Validation) are engineering and biological tests designed to ensure the physical device is safe and performs its mechanical function, and that the design software adheres to specified parameters. They are not studies to evaluate the diagnostic or predictive performance of an AI model.

However, I can extract information related to the device's technical specifications and how its engineering performance was validated:

Acceptance Criteria and Device Performance (in a physical device context):

The document details various non-clinical tests performed to support the device's safety and performance, acting as "acceptance criteria" for a physical medical device. The "reported device performance" is that the device passed these tests, indicating it performs as intended and is substantially equivalent to predicate devices.

Table of "Acceptance Criteria" and "Reported Device Performance" (adapted for a physical device K192218):

Regarding the other points, as they pertain to AI/ML, they are not applicable to this physical device submission:

1. Sample size for the test set and data provenance: Not applicable. This document refers to the number of physical abutment samples tested for biocompatibility and fatigue, not a test set for an AI model.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model's performance on medical images is irrelevant for this physical device.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which is not relevant here.
5. Standalone (algorithm only) performance: Not applicable. The device itself is a physical object; there's no "algorithm-only" performance to evaluate in this context. The software mentioned (3Shape Abutment Designer) is a design tool, not a diagnostic or predictive AI.
6. Type of ground truth used: Not applicable. Ground truth for AI (e.g., pathology, outcomes) is not relevant for testing the mechanical and biological properties of a dental abutment.
7. Sample size for the training set: Not applicable. There is no AI training set for this physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document thoroughly covers the engineering and biological validation required for a Class II physical medical device, demonstrating its substantial equivalence to predicate devices through well-defined tests, but it does not contain information about AI model validation.

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The On1™ 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, 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, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.

The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.

The On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal Abutment is made of titanium vanadium alloy.

The document does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints. Instead, it describes a 510(k) summary for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is a series of non-clinical performance tests designed to show that the On1 Universal Abutment performs comparably to its predicate and reference devices, and that any differences do not raise new questions of safety or effectiveness.

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

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

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it does list "Restorative design specifications" which act as internal design criteria, and various performance tests that the device successfully met. The key "acceptance criterion" implied throughout the document is "substantial equivalence" to the predicate devices.

• Compliance with minimum required fatigue properties per ISO 14801.
• Restorative design specifications:
  • Angle from axis of the implant: 20° Max
  • Wall Thickness Circular: 0.8mm min.
  • Wall Thickness Margin: 0.275mm min.
  • Post Height: 5.2mm min.
  • Maximum Length, width and Height: EM-14 blank 12x14x18mm, EM-10 blank 8x10x15mm | Mechanical Performance:
• "Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal Abutments were equivalent to the predicate devices."
• Device design adheres to the listed restorative design specifications. |
  | Biocompatibility:
• Compliance with ISO 10993-1, ISO 10993-5 (Cytotoxicity), CEN EN ISO 10993-12, and CEN EN ISO 10993-18 (GC-MS analysis for organic leachables/extractables). | Biocompatibility:
• "Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed... Results indicate that the devices met biocompatibility requirements for its intended use." |
  | Software Verification and Validation:
• Restrictions prevent design of mesostructure component outside of design limitations.
• Established design limitations and specifications are locked and cannot be modified within the abutment design library. | Software Verification and Validation:
• "Validation was completed on the On1 Universal Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). ...testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations... In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library." |
  | Sterilization Validation:
• Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for steam sterilization. | Sterilization Validation:
• "Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2." |
  | Device Packaging:
• No new worst-case in terms of device packaging and shelf life compared to predicate. | Device Packaging:
• "The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required." |

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: The document does not specify the exact sample sizes for the mechanical, biocompatibility, software, or sterilization testing. It refers to "worst case dynamic fatigue testing" and "the finished devices" for biocompatibility without providing numbers.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from Nobel Biocare AB (Sweden) and Nobel Biocare USA LLC (USA), it's likely the testing was conducted in facilities accustomed to international and US regulatory standards, but specific locations are not mentioned. The nature of the tests (mechanical, biocompatibility, software, sterilization) suggests controlled laboratory experiments, not patient data.

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 section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic or screening device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established international standards (e.g., ISO 14801, ISO 10993 series).

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

This is not applicable for the type of non-clinical performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving reader interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth for a test set. The tests here are objective engineering and material science evaluations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance, often in diagnostic tasks, and is not relevant for a dental implant abutment. The device is a physical component, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical dental implant abutment, not an algorithm or AI system. Software verification and validation were performed for the accompanying design software, but this is distinct from "standalone algorithm performance" in the context of AI.

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

The "ground truth" for the performance testing described are established international standards and specifications (e.g., ISO 14801 for dynamic fatigue, ISO 10993 series for biocompatibility, AAMI-TIR30, ISO 17665-1/2 for sterilization). For software, the ground truth is the predefined design limitations and specifications that the software must enforce and protect.

8. The sample size for the training set

This is not applicable. The device is a physical component, not an AI model that requires a training set. The descriptions of "design workflow" and "manufacturing workflow" refer to the process by which the abutment is designed and fabricated, not machine learning model training.

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

This is not applicable as there is no training set for an AI model.

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The Universal Base Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The Universal Base Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-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.

The Universal Base Abutment is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing external hex style connections. The Universal Base Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process. The Universal Base Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Abutment is made of titanium vanadium alloy.

This document describes the Universal Base Abutment, a dental implant abutment. The information provided outlines the device's technical specifications, comparisons with predicate devices, and performance data from various tests. However, it does not include specific acceptance criteria with numerical targets for clinical performance, nor does it detail a study proving the device meets those specific acceptance criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the following information is extracted based on the provided text, and points that cannot be addressed due to the nature of the document (a 510(k) summary for a dental abutment, not an AI/diagnostic device) are explicitly stated as "Not Applicable".

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical device (dental abutment) and not an AI or diagnostic device, the acceptance criteria are based on mechanical and biological safety and performance, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "performance" reported is related to adherence to established standards for dental implants and abutments.

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 for Test Set: Not explicitly stated in terms of a "test set" for clinical performance. The mechanical testing (dynamic fatigue) would have used a sample size determined by ISO 14801 standards (e.g., typically N=10 or more per group for fatigue testing), but this is not a diagnostic test set.
• Data Provenance: Not applicable in the context of clinical patient data for a diagnostic device. The testing described (mechanical, biocompatibility, software V&V) is laboratory-based.

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 device is a dental abutment, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis. Ground truth in this context relates to engineering standards and material science.

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

• Not Applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy to reconcile conflicting expert opinions. This document describes non-clinical, laboratory-based performance testing against ISO standards.

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 dental abutment, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a dental abutment. While there is "Software Verification and Validation" for the design library to ensure it prevents designs outside limitations, this is about the design tool's functionality, not about an AI algorithm's standalone diagnostic performance.

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

• The "ground truth" for this device's evaluation is based on established international standards for medical device performance (e.g., ISO 14801 for dynamic fatigue, ISO 10993 for biocompatibility) and engineering specifications for the CAD/CAM workflow.

8. The sample size for the training set

• Not Applicable. This device submission does not describe an AI algorithm that requires a training set. The software mentioned (3Shape Abutment Designer Software) is a CAD/CAM design tool, not a machine learning model.

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

• Not Applicable. As no AI training set is described, this question is not relevant.

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