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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.

• Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
  | CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
  | Material Conformance | - Zirconia materials conform to ISO 6872.
• Titanium alloy conforms to ASTM F136.
• Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
  | Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |

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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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 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 add components to the DESS Dental Smart Solutions system, which includes abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Healing Abutments, Temporary Abutments, Straight Abutments, Ti Base Abutments, AURUM Base Abutments with a screw channel design that allows easier instrument access to the abutment screw), C-Base Abutments, ELLIPTIBase CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight), DESSLoc Abutments (Locator-type abutments), and abutment screws.

The provided document is an FDA 510(k) clearance letter for the DESS Dental Smart Solutions, which are endosseous dental implant abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data from studies against specific acceptance criteria.

Therefore, the document does not contain the information required to populate a table of acceptance criteria and proven device performance as typically expected for studies proving device efficacy or safety against performance metrics. It does not present specific quantitative performance data for the device.

Based on the content, here's what can be inferred or explicitly stated regarding the study that proves the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or other quantitative measures) and the device's reported performance against these criteria. The "Performance Data" section primarily describes non-clinical tests (MR compatibility, dimensional analysis, sterilization validation, shelf-life testing) that demonstrate that the device meets the design specifications and regulatory requirements for substantial equivalence, rather than clinical efficacy or diagnostic accuracy.

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

• Test Set Sample Size: Not applicable in the context of clinical performance data. The non-clinical tests would have their own sample sizes for their specific assessments (e.g., a certain number of abutments for sterilization validation, a certain number of parts for dimensional analysis). These specific numbers are not provided in this summary.
• Data Provenance: The "reverse engineering dimensional analysis" was done for BlueSkyBio implant connections and for Strawmann bone level connections (referenced from previous submissions). For Alpha dent, a contractual agreement provided measurements. No specific country of origin is mentioned for the data itself, but Terrats Medical SL is based in Barcelona, Spain. The document states "No clinical data were included in this submission," indicating a reliance on non-clinical testing and substantial equivalence. The studies referenced are non-clinical in nature.

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

This information is typically relevant for studies involving human interpretation or subjective assessment (e.g., imaging studies). Since "No clinical data were included in this submission," and the evaluation relies on non-clinical testing and engineering analyses, this concept of "experts establishing ground truth" as it pertains to medical image interpretation or clinical outcomes is not applicable here. Ground truth in this context would be engineering specifications and validated test methods.

4. Adjudication Method for the Test Set:

Not applicable, as there is no human interpretation or subjective assessment being adjudicated in the described non-clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "No clinical data were included in this submission." Therefore, an MRMC study comparing human readers with or without AI assistance was not performed or submitted.

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

Not applicable. This device is a physical dental implant abutment, not an AI algorithm or software that performs standalone analysis. The "DESS Dental Smart Solutions" in the product name refers to the brand of these physical components, not an intelligent software.

7. The Type of Ground Truth Used:

For the non-clinical tests described:

• Dimensional Analysis: The "ground truth" was established by reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws, or by contractual agreement providing measurements from the OEM manufacturer. This means the OEM specifications and existing components served as the reference.
• Sterilization: The ground truth for sterilization was meeting the sterility assurance level of 10-6 according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2 for moist heat, and ISO 11137-1 and ISO 11137-2 for gamma irradiation, and bacterial endotoxin testing according to ANSI/AAMI ST72.
• Material properties: Conformance to ASTM F136 for Ti-6Al-4V alloy and ASTM F1537 for Co-Cr-Mo alloy, and ISO 13356 for zirconia.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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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 Ti Base abutments and Pre-milled Blank Abutments 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 dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants. This submission adds various abutments compatible with the Neodent GM implant line.

The subject device abutment designs include Healing Abutments, Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments (straight and angled), Cement-retained Abutments (straight and angled), Pre-Milled Blank Abutments, DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) Summary for a medical device (DESS Dental Smart Solutions). It describes the device, its intended use, a comparison to predicate devices, and the non-clinical data submitted to demonstrate substantial equivalence. It does not contain information about acceptance criteria or studies proving device performance against such criteria in the context of an AI/ML powered device.

Based on the provided text, the device in question is not an AI/ML powered device. It is a set of dental implant abutments and related components. Therefore, the questions related to AI/ML device performance (like acceptance criteria, sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "Performance Data" section (page 8, {8} in your indexing) details the non-clinical tests performed:

• MR Safety Evaluation: Non-clinical analysis to evaluate the subject devices in the MR environment using scientific rationale and published literature. This included assessing magnetically induced displacement force and torque.
• Mechanical Testing: Conducted according to ISO 14801 to support the performance of the subject device abutments with angulation.
• Biocompatibility: Referenced from previous K-submissions (K240208, K233316, and K222288).
• Sterilization Validation:
  • Moist Heat Sterilization: Referenced from K240208, validated to a sterility assurance level of 10^-6 by the overkill method (ANSI/AAMI/ISO 17665-1 and 17665-2).
  • Gamma Irradiation: Referenced from K240208, validated to a sterility assurance level of 10^-6 using method VDmax25 (ISO 11137-1 and ISO 11137-2).
  • Bacterial Endotoxin Testing: According to ANSI/AAMI ST72, demonstrating

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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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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 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 add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.

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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

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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 by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if 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 mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.

It appears there might be a misunderstanding of the provided text. The document is a 510(k) premarket notification for a dental implant abutment, not an AI/ML medical device. Therefore, the information typically required for describing an AI/ML device's acceptance criteria and study data (like sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not present.

The document discusses the substantial equivalence of the DESS Dental Smart Solutions abutment to legally marketed predicate devices. The "performance data" section refers to non-clinical testing to demonstrate the device's physical properties and compatibility, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Let's break down what can be extracted from the provided text relevant to the device's acceptance, and then explain why the AI/ML specific questions cannot be answered.

Understanding the Device and its "Acceptance":

The "acceptance" in this context refers to the FDA's determination that the new DESS Dental Smart Solutions abutments are "substantially equivalent" to predicate devices already on the market. This determination is based on the device having the same intended use and similar technological characteristics (design, materials, performance via non-clinical testing).

Here's a summary of the information available in the document:

1. Table of Acceptance Criteria (or rather, Equivalence Criteria) and Reported Device Performance:

The document doesn't present acceptance criteria in a quantitative table with performance metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices across several characteristics. The performance is shown through non-clinical testing to ensure safety and functionality.

Important Note: The "acceptance criteria" here are qualitative statements of substantial equivalence, backed by quantitative non-clinical engineering and materials testing, not performance metrics from a clinical study or an AI model's accuracy.

Regarding the AI/ML Specific Questions:

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

• Not applicable. This document is for a physical medical device (dental implant abutment), not an AI/ML algorithm. There is no "test set" in the context of data for an AI/ML model. The "testing" refers to mechanical, material, and sterilization validation.

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

• Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices. This device's performance is assessed through engineering standards and material properties. Compatibility with implant systems is established through design agreements and reverse engineering data (referenced from K170588).

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

• Not applicable. Adjudication methods are used in clinical studies or for establishing ground truth labels for AI/ML datasets.

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. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.

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

• Not applicable. There is no algorithm.

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

• Not applicable. The "ground truth" for this device's performance is its adherence to engineering standards (e.g., ISO 14801 for mechanical properties, ASTM for materials/MR safety) and its demonstrated compatibility with specified implant systems, rather than a clinical ground truth like disease presence.

8. The sample size for the training set:

• Not applicable. There is no AI model or training set.

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

• Not applicable. As above, no AI model or training set.

Conclusion from the document:

The provided document describes a 510(k) submission for a Class II medical device, DESS Dental Smart Solutions abutments. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through:

• Identical intended use.
• Similar technological characteristics: This includes materials (Titanium alloy), design (multi-unit, screw-retained), and geometric parameters (diameters, gingival heights).
• Performance via non-clinical testing: This includes mechanical testing (ISO 14801), MR safety testing (ASTM standards), sterilization validation (ANSI/AAMI/ISO standards), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-5).
• Compatibility with specified implant systems: This is supported by contractual agreements with OEMs (ZimVie/Terrats Medical SL) and referenced reverse engineering data.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the evaluation framework is entirely non-clinical and does not involve AI/ML performance metrics, studies with human readers, or expert ground truthing as one would see for an AI-powered diagnostic tool.

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DESS Multi-Unit 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 add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.

This appears to be a 510(k) Summary for a medical device (dental abutments) rather than a study report with acceptance criteria for an AI/ML powered device. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance data (mechanical testing, biocompatibility, sterilization validation, MRI compatibility). It explicitly states: "No clinical data were included in this submission."

Therefore, I cannot extract acceptance criteria or information about a study that proves the device meets those criteria in the context of an AI/ML device, as the provided text doesn't describe such a device or study.

If the request was based on a misunderstanding of the document's content, please clarify. If you're looking for general information on what would be included in such a study for an AI/ML device, I can provide a theoretical outline.

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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 integrates multiple components: scan files from intra-oral and lab (desktop) scanners, 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 K22288 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be manufactured via a digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. There are no changes to the abutment design or implant compatibilities, however, there is a new material for the zircomia superstructure. All part numbers have been cleared within previous submissions for manufacturing at a validated milling center. The purpose of this submission is to allow manufacturing via digital dentistry workflow and to add a new zirconia material for the superstructures of the two-piece abutment.

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 digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, 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 text is a 510(k) summary for a dental device, specifically DESS Dental Smart Solutions abutments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML-based device.

Therefore, I cannot provide the requested information as the document does not contain details about:

• Acceptance criteria for an AI/ML device: This document is about dental implant abutments, not a medical device driven by AI/ML.
• Study proving device meets acceptance criteria: There is no performance study described for an AI/ML component. The "Performance Data" section refers to non-clinical data for biocompatibility and fatigue testing of the physical dental abutments, and software verification to ensure design parameters are met and restriction zones are locked, not AI/ML performance.
• Sample size for test set and data provenance: Not applicable to a non-AI/ML device.
• Number of experts and their qualifications for ground truth: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document describes the physical characteristics, materials, manufacturing processes (including digital dentistry workflows), and compatibility of the dental abutments, and asserts their substantial equivalence to previously cleared devices. It does not mention any AI/ML components or their performance evaluation.

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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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