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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.

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

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant.

This is a Premarket Notification (510(k)) summary for the IPD Dental Implant Abutments. This document does not describe a study proving the device meets acceptance criteria as would be found in a clinical trial for a novel AI device with specific performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on bench testing and engineering analysis.

Here's an breakdown of the information provided, tailored to your request, but emphasizing that this is not a typical AI/ML performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for dental abutments, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity for an AI model), but rather as compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to successful completion of various non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data or AI model test sets. The "test set" here refers to the physical samples of the IPD Dental Implant Abutments (and their components, potentially in various configurations) that were subjected to the specified bench and biocompatibility tests. The exact number of physical abutments, screws, or zirconia superstructures tested for each specific criterion is not detailed in this summary but would be found in the full test reports.
• Data Provenance: Not applicable in the context of country of origin for patient data. The tests were performed on the manufactured device components. The materials are specified (e.g., Titanium alloy conforming to ISO 5832-3).

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

Not applicable. "Ground truth" in this context would generally refer to expert-derived labels for clinical data, which is not part of this 510(k) submission. The "truth" for the performance tests is established by adherence to recognized international standards (e.g., ISO, FDA Guidance) and objective measurements from engineering or biological tests.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers or expert labelers of clinical data, which is not relevant here. The evaluation criteria for the bench tests are objective and defined by established standards.

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

No. This device is a dental implant abutment, not an AI software. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.

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

No. This is a physical medical device (dental abutments), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization).
• Engineering specifications and dimensional analysis to ensure compatibility with other specified dental implant systems.
• Validated digital dentistry workflow parameters (e.g., minimum gingival height, wall thickness, post height, angulation for zirconia superstructures), which are based on established dental prosthetic principles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is used for this physical device.

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

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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Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments 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. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).

This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.

Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.

Here's why each point is not applicable and what information is provided:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant here.

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 an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.

8. The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does provide regarding device performance and testing:

• Type of Testing:

  • Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
  • Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
  • Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
  • Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
  • Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
  • MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.

• Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.

In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.

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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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Multi-Unit DAS System 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.

Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure.

The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm.

The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.

All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3.

All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the Multi-Unit DAS System are:

Minimum wall thickness - 0.25 mm

Minimum post height for single-unit restorations - 4.0 mm

Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants

Minimum gingival height - 0.5 mm (in the Ti-Base)

Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants

The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.

Here's a breakdown of the acceptance criteria and study information for the Multi-Unit DAS System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mechanical Testing (ISO 14801) & Sterilization Validation: The document does not explicitly state the sample sizes used for these tests. For ISO 14801, typically a statistically significant number of samples are tested to demonstrate fatigue resistance, but the exact number isn't provided. For sterilization, typically multiple runs with biological indicators are performed.
• Data Provenance: The document does not specify the country of origin for the data for specific tests, but the manufacturer, Talladium España, SL, is located in Lleida, Spain. The data is non-clinical.

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 (N/A) as the submission details non-clinical data (mechanical testing, material specifications, biocompatibility, sterilization, MR safety analysis) rather than studies involving human expert assessment of images or clinical outcomes.

4. Adjudication method for the test set

• N/A, as no expert adjudication for medical diagnoses/interpretations was conducted due to the non-clinical nature of the studies.

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

• No MRMC comparative effectiveness study was done. This is a medical device for dental implants, not an AI software intended for diagnostic assistance. 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

• No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

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

• Mechanical Testing: Ground truth is defined by the ISO 14801 standard and the manufacturer's performance specifications.
• Biocompatibility: Ground truth is established by the cellular responses and lack of toxicity as defined by ISO 10993-5.
• Material Composition: Ground truth is defined by the ASTM F136 and ISO 5832-3 standards.
• Sterilization: Ground truth is defined by the Sterility Assurance Level (SAL) of 10^-5, validated against microbiological indicators as per ANSI/AAMI/ISO 17665.
• MR Safety: Ground truth is established by scientific rationale and published literature, determining the device's behavior in an MR environment.
• Compatibility with OEM Implants: Ground truth is established by the precise measurements and design characteristics obtained through reverse engineering analysis of the OEM implants and their components.

8. The sample size for the training set

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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

• N/A. There is no AI component or machine learning model that requires a training set for this device.

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Dynamic 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.

Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration. All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The provided text is a 510(k) Summary for a medical device (Dynamic TiBase dental abutments). It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria, the study design, or performance metrics typically associated with AI/ML-based medical devices.

The document explicitly states: "No clinical data were included in this submission." and focuses on non-clinical data to demonstrate substantial equivalence, primarily through:

• Mechanical testing: "mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants."
• Reverse engineering analysis: "reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement."
• Material compatibility and sterilization: referencing previous 510(k) submissions for biocompatibility and sterilization validation.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based device (e.g., sample size, ground truth, expert adjudication, MRMC studies), as this information is not present in the provided text. The device described is a physical dental abutment, not an AI/ML diagnostic or assistive tool.

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TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes the regulatory clearance for the TruAbutment DS and TruBase devices, citing substantial equivalence to predicate devices, and includes details about non-clinical testing. However, it does not contain information about a study proving device performance against specific acceptance criteria for AI or algorithmic performance. The studies mentioned are focused on mechanical and biocompatibility testing of the physical dental implant abutments.

Therefore, for aspects related to AI/algorithmic performance, sample sizes, expert ground truth, adjudication, and MRMC studies, the information is not present in the provided document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The document describes "Design Limitations" for both TruAbutment DS and TruBase, which can be interpreted as design acceptance criteria. It also references compatibility and mechanical performance tests.

TruAbutment DS Design Limitations / Reported Performance:

TruBase / Zirconia Superstructure Design Limitations / Reported Performance:

Mechanical Performance:

• Acceptance Criteria: Met the criteria of ISO 14801:2016 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments."
• Reported Device Performance: "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

Sterilization Validation:

• Acceptance Criteria: Met the criteria of ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010.
• Reported Device Performance: Achieved through end-user moist steam sterilization.

Biocompatibility:

• Acceptance Criteria: Met the criteria of ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Reported Device Performance: Not explicitly stated as "passed" for the subject device, but mentioned it was leveraged from predicate device testing and supports substantial equivalence.

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

• Test Set Sample Size: For mechanical testing (ISO 14801), "worst-case constructs" were subjected to static compression and compression fatigue testing for each compatible OEM implant line. The exact number of samples is not specified.
• Data Provenance: Not specified; the context implies laboratory testing. The document does not refer to real-world patient data for performance evaluation in the context of AI.

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

Not applicable. The tests performed are non-clinical (mechanical, sterilization, biocompatibility) of physical devices, not assessments requiring expert interpretation of data or images.

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

Not applicable for non-clinical, physical device testing.

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

Not applicable. No AI component is described in the performance evaluation section for either TruAbutment DS or TruBase. The software mentioned (3Shape Abutment Designer Software) is for CAD/CAM design, which is a tool for designing the physical device, not an AI for diagnosis or interpretation that would involve human readers.

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

Not applicable. As noted above, the device itself is a physical dental abutment, and its design process involves CAD/CAM software, not a standalone AI algorithm for medical decision-making or image analysis.

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

• Mechanical Testing: Ground truth is established by the specified ISO standards (ISO 14801) and FDA guidance, defining acceptable force and fatigue limits for dental implant systems.
• Dimensional Analysis: Ground truth is against design specifications and reverse engineering of OEM implant-to-abutment connections.
• Sterilization: Ground truth is against ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 standards for sterilization efficacy.
• Biocompatibility: Ground truth is against ISO 10993 standards for biological safety.

8. The sample size for the training set

Not applicable. The document describes a physical medical device and its manufacturing process, not an AI/ML algorithm that requires a training set. The CAD/CAM software aids in design, but the document does not detail its internal development or any associated training sets.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Reflect™ Implant System prosthetic components are compatible with the following implant systems.

| Implant System
Compatibility | Implant Body Diameter
(mm) | Platform Diameter
(mm) |
|---------------------------------|-------------------------------|---------------------------|
| OsseoSpeed™ | 3.5 | 3.5/4.0 |
| | 4.0 | 3.5/4.0 |
| | 5.0 | 4.5/5.0 |
| 3i Certain® | 3.25 | 3.4 |
| | 4.0 | 4.1 |
| | 5.0 | 5.0 |
| NobelActive® | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| NobelReplace Conical | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| Tapered Screw-Vent® | 3.7 | 3.5 |
| | 4.1 | 3.5 |
| | 4.7 | 4.5 |

Reflect™ Implant System implants are root form endosseous dental implants with a tapered body and a grit blasted and acid etched surface intended for bone level placement. The subject device consists of five product lines (Reflect™ Aspire, Reflect™ Certus, Reflect™ Rapid, Reflect™ Recover, and Reflect™ Tapered) and three component designs (Cover Screw, Healing Abutment, and 30° Abutment). The Reflect™ implant sizes are summarized in the following table.

The Reflect™ abutment sizes are summarized in the following table. Note: each abutment is provided in each platform diameter listed.

Subject device implants are made of unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNS R50550, UNS R50700) Grade 4, and subject device abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The subject device implant surface is produced by blasting with alumina (Al2O3) powder, and etching with hydrochloric acid and sulfuric acid. After etching, the remaining acid is removed by washing with distilled water, followed by cleaning with an alkaline solution using a high temperature and high-pressure hydrothermal method.

The provided document describes a 510(k) premarket notification for the Reflect™ Implant System, a dental implant device. This document does NOT contain information about acceptance criteria and device performance as typically expected for diagnostic or AI-powered medical devices (e.g., sensitivity, specificity, accuracy, F1-score).

Instead, this submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, by showing similar indications for use, technological characteristics, and materials.

Therefore, the information requested in your prompt regarding acceptance criteria for device performance (like sensitivity, specificity, etc.) and related studies (sample sizes for test/training sets, expert ground truth, MRMC studies) is not present in this document.

The "Performance Data" section (Page 6) explicitly states: "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2; biocompatibility according to ISO 10993-1, 10993-5, and 10993-12; dynamic compression-bending testing according to ISO 14801; and engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws. No clinical data were included in this submission."

This indicates that the performance data for this type of device (dental implant hardware) is primarily based on bench testing and material science, not clinical accuracy or diagnostic performance evaluated against ground truth in a clinical setting.

To answer your prompt with the available information in the document, I will have to explain why the requested information is not present and what type of "acceptance criteria" and "performance data" are typically used for a 510(k) submission for a non-AI hardware device like this.

Based on the provided document (K180924 for Reflect™ Implant System):

This 510(k) submission demonstrates substantial equivalence for a dental implant system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to non-clinical performance benchmarks and comparisons to predicate devices, rather than diagnostic performance metrics (e.g., sensitivity, specificity) typically associated with AI or diagnostic imaging devices.

Here's a breakdown of the requested information based on what is and is not available in the document:

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

The document does not present acceptance criteria or reported performance in a table format for diagnostic accuracy or similar metrics. Instead, the "acceptance criteria" for this type of device (dental implant hardware) are implicit in demonstrating substantial equivalence to predicates, meaning the device must perform comparably in terms of:

• Materials: Conforming to recognized standards (e.g., ASTM F67 for unalloyed titanium, ASTM F136 for titanium alloy).
• Mechanical Strength: Meeting or exceeding benchmarks from standards like ISO 14801 for dynamic compression-bending.
• Biocompatibility: Conforming to ISO 10993 series.
• Sterilization: Validation according to ISO 11137 series and ISO 17665 series, and bacterial endotoxin testing per ANSI/AAMI ST72.
• Packaging Integrity: Meeting ASTM standards for sterile barrier shelf testing (F88, F1140, F2096, F1929, F1608).
• Dimensional & Engineering Analysis: Demonstrating compatibility with existing implant systems and consistency with predicate device dimensions.
• Surface Characteristics: Confirmation of no residual material from manufacturing processes (via SEM with EDS).

Reported Device Performance (as described for non-clinical testing):
The document states that tests were "performed according to" or "conforming to" these standards, implying successful completion. For example:

• "sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2;"
• "biocompatibility according to ISO 10993-1, 10993-5, and 10993-12;"
• "dynamic compression-bending testing according to ISO 14801;"
• "engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws."
• "bacterial endotoxin testing was performed according to ANSI/AAMI ST72."
• "Sterile barrier shelf testing was performed according to ASTM standards F88. F1140. F2096, F1929, and F1608."
• "Scanning electron microscopy (SEM) with energy dispersive X-ray spectroscopy (EDS) was performed on the implant endosseous threaded surface to confirm there was no residual material from the blasting or cleaning operations present on the final devices."

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

• Sample Size: Not specified in terms of clinical patient data, as "No clinical data were included in this submission." For non-clinical validation (e.g., mechanical testing, biocompatibility), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not enumerated in the summary.
• Data Provenance: Not applicable for clinical data. The non-clinical testing data provenance is not specified (e.g., where the testing labs were located).

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 submission focuses on hardware components, materials, and mechanical integrity, not diagnostic or AI performance requiring expert truth-labeling of medical images or patient outcomes.

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

• Not applicable. No clinical test set or ground truth labeling requiring adjudication is described.

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

• Not applicable. This device is a physical dental implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• Not applicable. This is a hardware device, not an algorithm.

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

• Not applicable for clinical ground truth. The "ground truth" for this device lies in its adherence to material specifications, mechanical performance standards, and biological compatibility, as demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no AI training set.

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

• Not applicable. There is no AI training set.

In summary, the provided FDA 510(k) document for the Reflect™ Implant System is for a physical medical device (dental implant hardware), not a diagnostic or AI-powered device. Therefore, the "acceptance criteria" and "performance data" presented are based on non-clinical engineering, materials science, and successful demonstration of substantial equivalence to already-cleared predicate devices, rather than clinical efficacy or diagnostic accuracy metrics.

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