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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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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Preat Abutments are compatible with the following third-party implant restorative platforms:

The purpose of this submission is to expand the use of Preat Abutments, specifically the titanium blank abutment design, to be used in a validated equipment CAD/CAM workflow where specific abutment design software, milling machines and tooling have been validated to work with the previously cleared components in K220823 and K183518.

This submission includes a titanium blank design which is compatible with sixteen (16) implant system, with a distinct connection platform, as well as varying implant diameters and implant platform diameters, for each system.

The Subject device abutments may be placed in implants located in the mandibular or maxillary arches. The Subject device abutments are compatible with implant body diameters that range from 3.0 mm to 7.0 mm and implant platform diameters which range from 2.9 to 6.0 mm.

All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user.

The design parameters for the CAD/CAM Titanium Blank custom abutment are:

• Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line);
• Minimum post height for single-unit restorations (length above the abutment collar / gingival height)– 4.0 mm;
• Maximum Angle – 30°*; and
• Minimum gingival height – 0.5 mm;
• Maximum gingival height – 1.5 mm to 4.5 mm (varies by implant line).

*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.

The minimum and maximum abutment design parameters listed above correspond to the abutment designs used in the mechanical testing data provided in the sponsor's K220823 and K183518 device submissions.

All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow which includes: Scan files from Intra-Oral and Desktop Scanners, CAD software, CAM software, a Milling machine and associated tooling and accessories.

The provided FDA 510(k) clearance letter pertains to "Preat Abutments," which are endosseous dental implant abutments. This type of device is mechanically tested and does not typically involve the kinds of studies (e.g., AI integration, human reader studies, clinical outcomes) that would necessitate the extensive "acceptance criteria" and "study proving device meets acceptance criteria" information you've requested.

The document describes non-clinical performance data to demonstrate substantial equivalence, focusing on engineering aspects and material compatibility, rather than clinical efficacy or diagnostic accuracy.

Therefore, many of the specific points you've asked for (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, ground truth for training set, training set sample size) are not applicable to this type of device and are not present in the provided FDA submission information.

Here's a breakdown based on the available information:

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

The document does not explicitly state acceptance criteria in a quantitative table format as one might find for a diagnostic AI device. Instead, it details the engineering and material performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is described qualitatively by stating that the tests were performed and that the device is substantially equivalent.

• This implies the device met the standards of ISO 14801, demonstrating mechanical integrity comparable to predicates. (Specific pass/fail values or results are not provided in this summary, but would have been in the full submission). |
  | | - Compression fatigue testing according to ISO 14801. | |
  | Software Validation | - Restrictions to prevent design outside stated design parameters. | - "Software verification included testing of restrictions that prevent design of components outside of the stated design parameters." |
  | | - Abutment design library limitations are locked and unmodifiable. | - "The abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified by the user." |
  | | - CAM restriction zones avoid damage/modification of connection geometry and are locked. | - "Validation testing of the CAM restriction zones was conducted, 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." |
  | Biocompatibility | - Conforms to ISO 10993-1 and ISO 10993-5. | - "Biocompatibility has been demonstrated through the sponsor's K220823 device testing according to ISO 10993-1, and ISO 10993-5." (Leveraged from predicate). |
  | Sterilization | - Conforms to ISO 17665-1 and ISO 14937. | - "Sterilization validation was demonstrated through and leveraged from the sponsor's K220823 device testing according to ISO 17665-1 and ISO 14937." (Leveraged from predicate). |
  | MR Safety | - Assessment of magnetically induced displacement force and torque. | - "Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,' including magnetically induced displacement force and torque." (Indicating an assessment was made to show safety, though specific results are not detailed). |
  | Material Composition | - Ti-6Al-4V ELI alloy conforming to ASTM F136. | - "All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136." |
  | Design Parameters (for CAD/CAM customizations) | - Minimum wall thickness: 0.5 mm to 0.9 mm (varies).
• Minimum post height single-unit: 4.0 mm.
• Maximum Angle: 30° (0° for some Astra Tech models).
• Minimum gingival height: 0.5 mm.
• Maximum gingival height: 1.5 mm to 4.5 mm (varies). | - The device is designed to these parameters, and software validation ensures these are maintained. |

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: The document mentions "worst-case constructs" for mechanical testing, but does not specify a numerical sample size. For software, it refers to "testing of restrictions" and "validation testing," without numerical samples. Biocompatibility and sterilization data are leveraged from previous submissions (K220823).
• Data Provenance: Not specified in terms of country of origin. The data is non-clinical/bench testing.

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

• Not applicable. This device is an implant abutment, not a diagnostic device requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" here is adherence to engineering standards and material properties.

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

• Not applicable. As above, this is not a diagnostic study requiring 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 not a diagnostic device involving AI and human readers.

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

• Not applicable. This device is a dental implant component, not an algorithm. The software mentioned is for design and manufacturing control, not for standalone diagnostic performance.

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

• The "ground truth" for this device's performance is adherence to recognized international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665-1 and ISO 14937 for sterilization), material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI alloy), and internal design parameters and software validation criteria.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable.

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PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject devices are Medentika CAD/CAM Abutments, which primarily expand the options for fabricating patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow". This workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machines, and associated tooling and accessories. The devices include Titanium Base abutments, Titanium base ASC Flex abutments, and PreFace and TI-Form (blanks) abutments.

The abutments are made of titanium alloy (Ti-6Al-4V ELI). Titanium base abutments also include a zirconia superstructure. The specified zirconia materials for milling superstructures are Ivoclar Vivadent IPS e.max ZirCAD Prime, Ivoclar Vivadent IPS e.max ZirCAD Prime Esthetic, Amann Girrbach Zolid Bion, Amann Girrbach Zolid Gen-X, and Institut Straumann AG n!ce Zirkonia HT. The specified cement for bonding superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG.

Key design parameters for CAD/CAM zirconia superstructures (on Titanium base and Titanium base ASC Flex) include: minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm for single unit restorations, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of the final abutment of 30°.

PreFace and TI-Forms abutments (blanks) are used by dental laboratories to fabricate customized abutments from titanium alloy. Their design parameters include: minimum wall thickness of 0.4 mm, minimum cementable post height of 4.0 mm, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of 30°.

Prosthetic-level components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are provided for use with previously cleared Medentika multi-unit abutments and MedentiBASE abutments.

All abutments are provided non-sterile with appropriate abutment screws. The screws attach the abutment to the implant or the prosthesis to the abutment.

The provided 510(k) clearance letter and summary describe a medical device, Medentika CAD/CAM Abutments, and its substantial equivalence to predicate devices based on non-clinical performance data. The document does not contain information about acceptance criteria or performance data for an AI/ML-based device, nor does it detail a clinical study involving human readers or expert consensus for ground truth.

Therefore, for the information requested in your prompt, I can only extract what is presented in the document, which pertains to the non-AI aspects of device acceptance and testing. Many of the points specifically refer to AI/MRMC studies, which are not applicable to this document.

Here's an analysis based on the provided text:

Device Description and Purpose:
The device is "Medentika CAD/CAM Abutments," which are dental implant abutments. The primary purpose of this submission is to expand the fabrication options for patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow" that integrates CAD/CAM software and milling machines. It also adds new sizes and OEM compatibilities.

Study Type:
This is a pre-market notification (510(k)) submission seeking substantial equivalence to existing legally marketed devices. It relies heavily on non-clinical performance data to demonstrate that the new manufacturing workflow and expanded compatibilities do not raise new questions of safety or effectiveness.

Analysis of Requested Information (based on the provided document):

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

The document outlines various performance tests conducted to demonstrate substantial equivalence, but it does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance." Instead, it states that the tests demonstrate sufficient strength or ensure accuracy and reliability.

Here's a summary of the performance tests and their implied purpose:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., how many abutments were mechanically tested, how many software validation tests were run). It simply states that "testing was conducted" or "validation was performed."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of pre-market non-clinical testing for medical devices, these are typically prospective laboratory tests conducted by the manufacturer or accredited testing facilities. The manufacturer is Medentika® GmbH (Huegelsheim, Germany), suggesting the testing likely occurred in Germany or at internationally recognized labs.

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

This information is not applicable to the provided document. The ground truth for this device is established through engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, not through human expert consensus on diagnostic images.

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

This information is not applicable to the provided document, as it describes non-clinical engineering and manufacturing validation, not a multi-reader clinical study for AI.

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

This information is not applicable to the provided document. This device is a physical dental abutment and its associated CAD/CAM workflow, not an AI-based diagnostic tool that would require human reader studies. The document explicitly states: "No clinical data were included in this submission."

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

This information is not applicable to the provided document. While the device utilizes CAD/CAM software and milling machines, it is a physical product manufactured through a workflow, not a standalone AI algorithm whose performance needs to be assessed in isolation. The software functions as a design and manufacturing aid, not a diagnostic or decision-making algorithm.

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

The "ground truth" in this context refers to established engineering and material standards:

• Standards Compliance: Adherence to ISO standards (e.g., ISO 14801 for mechanical strength, ISO 10993 for biocompatibility, ISO 17665 for sterilization).
• Dimensional Accuracy: Verification against established design parameters and compatibility specifications for dental implants (e.g., OEM implant body and abutment dimensions).
• Material Specifications: Conformance to ASTM F136 for titanium alloy and specifications for zirconia and cement.
• Software Design Parameters: The "ground truth" for the CAD software validation is the pre-defined maximum and minimum design parameters that the software must enforce.

8. The sample size for the training set:

This information is not applicable to the provided document. The "device" in question is a physical dental abutment and its manufacturing workflow, not an AI/ML model that requires a training set. The CAD/CAM software itself is validated, not "trained" on a dataset in the AI sense.

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

This information is not applicable to the provided document for the same reasons as point 8.

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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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Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.

The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.

The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.

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

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone algorithm performance study.
• The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.

The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.

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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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