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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 Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908, K191986, K203464, K212577, and K212628 to:

• include new OEM platform compatibilities (that have not been previously cleared) for previously ● cleared DESS designs,
• include previously-cleared OEM platform compatibilities for previously-cleared DESS abutment ● designs for which the specific combinations of compatibility and design were not cleared previously,
• add angulation to previously cleared Ti Base Abutments, Pre-Milled Blank, Ti, and Multi Unit Abutment,
• include a new abutment design, ZRN Multi Unit Abutment,
• include additional gingival height variations for the Ti Base Interface and DESSLoc Abutment, ●
• include two attachments: Interface Attachment for UniAbutment and Bar Attachment. ●

This submission includes five (5) abutment designs [Healing Abutments, Temporary Abutments, Multi Unit Abutments (straight and angled), ZRN Multi Unit Abutments (straight and angled), and DESSLoc Abutments], one (1) abutment blank (Pre-Milled Blank, Ti), three (3) base designs (Ti Base, C-Base, CrCo Base), two (2) attachments, and twenty (20) screws.

This submission includes one (1) new abutment design (ZRN Multi Unit abutment), based on the previously cleared Multi Unit abutment, but with an added zirconium nitride (Zr\V) coating. The identical coating is used on the DESSLoc Abutments that have been cleared in K170588, and K212628.

This submission includes two attachments. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in K170588. The subject device DESSLoc for Bar is designed to attached directly to the bar. The top portion of this attachment has the same design and material as the DESSLoc abutment cleared in K170588. K191986, and K212628.

The subject device includes the addition of new and previously cleared OEM compatibilities to previously cleared abutment design (Healing Abutments, Temporary Abutments, Ti Base, C-Base, Pre-Milled Blank Ti, Multi Unit abutments, and DESSLoc abutment). New compatibility is introduced for four (4) implant systems for which Terrats Medical has no prior clearance, for a total of eleven (11) new platforms. The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems.

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

The document provided is a 510(k) Pre-market Notification for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove performance against specific acceptance criteria for a novel AI/software component.

Therefore, the tables and information requested regarding acceptance criteria, study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details are not present in this document.

This type of submission typically demonstrates that a new version of an existing device (e.g., with expanded compatibilities, minor design variations, or new materials) is as safe and effective as a legally marketed predicate device. The performance data section explicitly states: "No clinical data were included in this submission." The non-clinical data primarily involve sterilization validation, biocompatibility, and reverse engineering analysis to confirm compatibility, all leveraged from previous clearances.

In summary, this document does not contain the information necessary to fulfill the request concerning acceptance criteria for an AI/software device and the study proving it meets those criteria.

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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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.

Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.

The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.

Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance (for non-AI device):

The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.

Regarding the AI-specific questions (2-9), the document provides no relevant information.

• 2. Sample sized used for the test set and the data provenance: Not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
• 4. Adjudication method for the test set: Not an AI device.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
• 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
• 8. The sample size for the training set: Not an AI device.
• 9. How the ground truth for the training set was established: Not an AI device.

Summary of Device and its "Study":

The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:

• Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
• Biocompatibility testing: Referenced from previous 510(k) submissions.
• Sterilization validation: Referenced from previous 510(k) submissions.
• MR environment compatibility analysis: Based on scientific rationale and published literature.
• Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.

This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.

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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations.

Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.

IPD Dental Implant Abutments submission includes the following categories of dental abutment designs:

• Healing abutments; -
• -Temporary abutments;
• Cementing titanium abutments; -
• -Titanium base (interface) abutments;

The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. Specifically:

• Ti Screw: Used during restoration fabrication.
• TiN Screw: Used in finished restorations, with TiN coating.
• TPA Screw: Used in finished angulated restorations, with TiN coating.

All subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

Unfortunately, the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a clinical trial report or a performance study summary.

The document is an FDA 510(k) Premarket Notification letter for IPD Dental Implant Abutments. This type of document aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a clinical or algorithmic study.

While it mentions "bench testing to determine fulfillment of design and performance requirements" and "Static and dynamic fatigue testing...in accordance with ISO 14801," these are engineering performance tests for mechanical properties and material compatibility, not studies that would involve:

• Acceptance criteria for clinical or diagnostic performance (e.g., sensitivity, specificity, accuracy for a diagnostic device; efficacy for a therapeutic one).
• Sample sizes for a test set of data (e.g., patient cases/images).
• Experts establishing ground truth for a diagnostic or AI-assisted task.
• Multi-reader multi-case (MRMC) studies or human reader performance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data.
• Training set sample size or ground truth establishment for a machine learning model.

The "performance data" section primarily discusses:

• Sterilization validation.
• Biocompatibility testing (cytotoxicity, skin sensitization, irritation).
• Reverse engineering and dimensional analysis for compatibility.
• Validation of the digital workflow and software system to ensure that design and manufacturing of the top half was within the specified design parameters. (This is about engineering design parameters, not clinical acceptance of a diagnostic tool).
• Static and dynamic fatigue testing (mechanical strength).
• Modified Surfaces Information.

Therefore, I cannot extract the requested information from this document because it is not present. This document is focused on establishing substantial equivalence based on material, design, and manufacturing processes, supported by bench engineering tests, rather than a clinical or AI performance study with acceptance criteria for diagnostic or clinical outcomes.

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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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908 and K191986 to add additional components for previously cleared OEM platform compatibilities and to additional OEM platform compatibilities for previously cleared DESS designs. This submission includes three (3) abutments (Healing Abutments, straight Multi Unit Abutments and DESSLoc Abutments), three (3) bases, two (2) blanks, and seven (7) screws.

Among the subject devices for this submission are abutments and screws compatible with three (3) implant systems for which Terrats Medical has no prior clearance and one (1) implant system for which new platform compatibilities are included, for a total of nine (9) new platforms.

The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in the table Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems. The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks 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.

The provided document is a 510(k) premarket notification for dental implant abutments. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the manner one might see for an AI/ML medical device.

Therefore, many of the requested items related to AI/ML device studies (such as test set details, expert ground truthing, MRMC studies, or training set information) are not applicable to this submission.

However, based on the information available in the document, here's a breakdown of the relevant points:

Acceptance Criteria and Device Performance for DESS Dental Smart Solutions Abutments

The acceptance criteria for this device are largely implicit in the demonstration of substantial equivalence to predicate devices, particularly regarding material composition, design principles, intended use, and performance data (non-clinical).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for dental implant abutments and not an AI/ML device, the acceptance criteria are not typically expressed as performance metrics (e.g., sensitivity, specificity) against a ground truth dataset. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

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

Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing (material properties, sterilization, biocompatibility, reverse engineering). There isn't a "test set" in the context of clinical performance data or AI/ML model evaluation. The "data provenance" for non-clinical testing would relate to the test reports from specific labs and the standards applied.

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. No "ground truth" establishment by experts in a clinical context is described for this device type. The ground truth for engineering specifications and material properties would be established by relevant industry standards and validated test methods.

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

Not applicable. No "adjudication method" as described for clinical interpretation or AI/ML ground truth is mentioned or relevant.

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. No MRMC study or AI assistance is mentioned. This is a traditional medical device (dental implant abutment).

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

Not applicable. This device is not an algorithm or AI.

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

For the non-clinical performance data, the "ground truth" is derived from:

• Established standards: e.g., ISO 17665-1, ISO 14937 for sterilization; ISO 10993-5, ISO 10993-12 for biocompatibility; ASTM F136, ASTM F1537, ISO 13356 for material composition.
• Reverse engineering analysis: Comparison to OEM implant bodies, OEM abutments, and OEM abutment screws to confirm mechanical compatibility (page 9).

8. The sample size for the training set

Not applicable. This device is not an AI/ML system and does not involve a training set.

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

Not applicable. This device is not an AI/ML system and does not involve a training set.

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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

The purpose of this submission is to obtain marketing clearance for two designs of DESS Dental Implants. The implants are compatible with DESS Dental Smart Solutions abutments manufactured by the sponsor of this submission, Terrats Medical SL and cleared under K170588, K173908 and K191986. The new dental implants are parallel-walled root-form threaded endosseous dental implants made from unalloyed titanium, ranging in diameter from 3.0 mm to 5.5 mm and in length from 7 mm to 18 mm, as described more fully below.

This submission includes two designs of DESS Dental Implants, designated Active and Bone Level. The external portion of each design is threaded, with a uniform major diameter and a slightly decreasing minor diameter along the length of the apical portion of each is tapered and includes cutting flutes to facilitate the insertion of the implant into the alveolar bone. Both designs have an internal connection, an internal anti-rotation feature (used for engaging abutment designs) that also serves to facilitate insertion into bone, and an internal screw channel to secure an abutment. Differences between the designs include the type of antirotational feature which, in the Active implant is an internal hex and in the Bone Level implant is an internal 4-lobed design. The external thread of the Active implant ends below the crest of the implant and a machined collar with shallow grooves is located between the end of the external thread and the crest of the implant. The external thread of the Bone Level implant ends below the crest of the implant, and the collar is included in the surface treatment. The endosseous surface of each implant is treated with a grit blasting and acid etching process to provide a rough surface for attachment of bone.

The provided document describes the 510(k) premarket notification for the DESS Dental Implants. This is a regulatory submission for a medical device seeking substantial equivalence to already legally marketed devices, not a study proving the device meets acceptance criteria derived from a clinical trial or algorithm performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly applicable to this type of regulatory submission. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and non-clinical performance data, rather than establishing efficacy or accuracy through human reader studies or similar clinical investigations.

However, I can extract the relevant information from the document as it pertains to the device's characteristics and the non-clinical performance data provided to support its safety and effectiveness relative to predicate devices.

Here's a breakdown of what can be extracted based on your request, with an explanation of why some fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical data, there are no specific "acceptance criteria" in the sense of performance metrics from a diagnostic study, nor is there "reported device performance" in terms of clinical accuracy or reader improvement. Instead, the device's characteristics are compared to predicate devices, and testing ensures it meets established engineering and safety standards.

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

This information is not provided in the document as it refers to non-clinical bench testing, not a clinical test set from human data. The tests performed (sterilization, endotoxin, cytotoxicity, shelf-life, surface characterization, mechanical testing) would have involved a specific number of manufactured devices or material samples. The provenance is internal to the manufacturer's testing or contract labs.

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

Not applicable. There is no "test set" in the context of human data requiring expert ground truth in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human data requiring adjudication in this 510(k) submission.

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 medical device for surgical placement (dental implant), not an AI-powered diagnostic tool. No MRMC studies were performed or are relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" would be established by:

• Standards Compliance: Meeting the specifications of international standards (ISO 11137, ANSI/AAMI ST72, ISO 10993, ASTM F1980, ISO 25178, ISO 14801).
• Material Specifications: Conforming to recognized material standards (ISO 5832-2).
• Engineering Specifications: The design and functional requirements of the implant itself (e.g., thread form, dimensions, anti-rotational features).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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

All digitally designed custom abutments for use with Ti Base abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K173908 to add additional components for previously cleared OEM platform compatibilities and to add additional OEM platform compatibilities for previously cleared DESS abutment designs. In total, this submission includes abutments compatible with 43 implant platforms from 16 OEM implant systems. Note that, because Nobel Active and NobelParallel Conical Connection implants share conical connection platforms, we have shown them as one system for purposes of this submission.

This submission includes abutments compatible with five (5) additional OEM implant systems (11 platforms) and abutments compatible with six (6) additional platforms for OEM implant system compatibilities that were cleared in K170588.

Additional subject device components for previously cleared compatibilities include addition of gingival heights of 1.5 mm and 3.0 mm for titanium bases and addition of 17° and 30° angled multi-unit abutments to the previously cleared straight multi-unit abutments.

Abutment designs and the correlation between each subject device abutment design and the corresponding compatible implant platforms are shown in Table 1 Summary of DESS Components and Abutment Platforms for Compatible Implant Systems.

All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

All subject device abutments are made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). All ceramic components of the Ti Base abutments are composed of zirconia conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

This document is a 510(k) premarket notification for DESS Dental Smart Solutions, specifically for endosseous dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with acceptance criteria and performance data like a typical medical device AI/ML submission would.

Therefore, the requested information regarding acceptance criteria and performance data in the context of an AI/ML study (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC study, standalone performance) is not applicable to this type of regulatory submission.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical testing performed to demonstrate the device's functional equivalence and safety compared to predicates.

Here's a breakdown of the relevant information provided in the document:

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

The document does not present quantitative acceptance criteria or performance metrics in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons.

The "acceptance criteria" here are implied to be that the new abutment designs and expanded compatibilities perform equivalently to the predicate devices and meet established standards for dental implants.

The "reported device performance" is described qualitatively as:

• Sterilization validation: According to ISO 17665-1 and ISO 14937.
• Biocompatibility: According to ISO 10993-12. (No new testing performed as materials are identical to cleared predicates).
• Reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static compression and compression fatigue testing: According to ISO 14801.
• Dynamic testing: For Multi-unit Abutments Angled according to ISO 14801.

The conclusion states that minor differences in design, dimensions, sizes, or compatible OEM implant lines do not affect substantial equivalence because these differences are either related to compatible OEM implant designs or are mitigated by mechanical performance testing.

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

• Sample Size: The document does not specify exact sample sizes for the mechanical tests (static compression, fatigue, dynamic testing). For instance, ISO 14801 typically requires a minimum of 5 samples for fatigue testing and 3 for static testing, but the document does not provide the exact numbers used for this submission.
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Terrats Medical SL) or outsourced labs. The country of origin of this test data is not explicitly stated but would presumably align with the manufacturer's location (Barcelona, Spain) or the testing facilities they contracted. The data is "prospective" in the sense that it was generated for this specific submission, but it's not "clinical" data from patient cohorts.

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

This is not applicable. For this type of mechanical device clearance, "ground truth" is established by engineering specifications, material standards (e.g., ASTM, ISO), and established testing methodologies, not by expert consensus on clinical data. No human experts are used to "read" or "interpret" test results in the same way they would for medical images.

4. Adjudication method for the test set

This is not applicable. "Adjudication" typically refers to resolving discrepancies in expert interpretations of clinical data (e.g., for ground truth establishment). Since this submission involves non-clinical mechanical testing, there is no need for such an adjudication method. Test results are compared against predetermined engineering specifications and 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

This is not applicable. This submission is for dental implant abutments, a physical medical device, not an AI/ML algorithm that assists human readers.

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

This is not applicable. This is a hardware device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Engineering specifications and design parameters: For abutment dimensions, materials, and connections.
• International standards: Such as ISO 14801 (dynamic fatigue test), ISO 17665-1 (sterilization), ISO 14937 (sterilization), and ISO 10993-12 (biocompatibility).
• Material specifications: Conforming to ASTM F136 (titanium alloy), ASTM F1537 (Co-Cr-Mo alloy), and ISO 13356 (zirconia).
• Compatibility analysis: Through reverse engineering of OEM implant bodies and abutment screws.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML model for this device.

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

This is not applicable. There is no "training set" for this device.

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