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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1.

All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.

This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).

Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

This document is a 510(k) Premarket Notification from the FDA regarding the "Elos Accurate® Hybrid Base" dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information required to directly answer some of your questions, particularly those related to the performance study design for an AI/ML-based medical device (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models), is not present in this document. This is because the device in question is a physical dental implant component, not an AI/ML algorithm.

However, I can extract the relevant information regarding the performance data provided for this physical device.

Here's a breakdown based on the provided document:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML device submission would. Instead, it states that substantial equivalence is demonstrated through:

• Biocompatibility evaluation and confirmatory cytotoxicity testing: According to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Dynamic compression-bending testing: According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
• Engineering and dimensional analysis: To confirm compatibility with OEM implant bodies, OEM abutments, and OEM abutment fixation screws.
• Sterilization validation: In accordance with ISO 17665-1 and ISO 17665-2.

Reported Performance/Demonstration:

• "Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility."
• "Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants."
• "The coatings used on selected screws are identical to coatings on previously cleared devices."
• "Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2."
• "Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines... do not affect substantial equivalence. These minor differences... are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing."

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

• Sample Size: Not specified for any of the non-clinical tests (biocompatibility, dynamic fatigue, engineering analysis, sterilization). The document indicates "No clinical data were included in this submission," further confirming that there wasn't a "test set" in the context of patient data for AI performance evaluation.
• Data Provenance: Not applicable as it's not clinical data. The tests are laboratory-based.

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

• Not applicable. This device is a physical component, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.

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 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. No clinical or human-in-the-loop study was conducted or required for this physical device.

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

• Not applicable. This is not an algorithm. The "performance data" refers to the physical and mechanical properties of the dental abutment.

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

• For the non-clinical performance data, the "ground truth" or reference standards are the ISO standards themselves (ISO 10993-5, ISO 14801, ISO 17665-1, ISO 17665-2), and the engineering specifications/dimensions of OEM implant components for compatibility analysis. This is a technical ground truth based on established material science and mechanical engineering principles, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

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

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

• Not applicable. As above, no training set for an AI/ML model.

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The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.

The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Regular (Ø3.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.

The Wide (Ø5.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).

The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.

The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.

The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.

The provided text describes a 510(k) submission for the UV Active Implant System, which is an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design for acceptance criteria based on performance metrics such as sensitivity, specificity, and AUC. The "acceptance criteria" discussed are related to meeting standards for medical devices and demonstrating substantial equivalence.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in the format of sensitivity/specificity/AUC, but rather conformance to established medical device standards and demonstrated substantial equivalence to predicate devices.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects, nor does it refer to data provenance in terms of country of origin or retrospective/prospective collection for an AI/CAD-like device. The testing described is non-clinical testing on the device itself (e.g., sterilization, fatigue, biocompatibility). Therefore, there is no mention of sample size for human subjects or data provenance.

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

Not applicable. This device is not an AI/CAD system evaluated by experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

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/CAD functionality is described in this submission.

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

Not applicable. No AI/CAD functionality is described in this submission.

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

The "ground truth" in this context is the fulfillment of established engineering, material, and biological standards through laboratory testing. For example:

• Sterilization: Measured sterility assurance level (SAL).
• Fatigue: Measured force resistance and cycles to failure against ISO 14801:2007.
• Biocompatibility: In vitro cytotoxicity assays and general biological evaluation against ISO 10993 series.
• Dimensional/Material: Conformance to specified dimensions and material properties (e.g., CP Ti Gr4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136)).

8. The Sample size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/CAD device.

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

Not applicable.

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

All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.

DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.

The document describes the DESS Dental Smart Solutions, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a typical tabular format with specific numerical targets. Instead, it relies on demonstrating equivalence to predicate devices through various performance tests and comparisons. The "acceptance criteria" are implied by the successful completion of these tests and the determination that the device is "substantially equivalent" to already marketed devices.

However, some design parameters are mentioned as remaining the same or being comparable to the predicate devices, which can be seen as implicit performance criteria:

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

The document states: "Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization... biological evaluation... and compatibility analysis by reference to K170588."

• The report does not specify sample sizes for the sterilization or biocompatibility tests.
• The data provenance is implied to be from the manufacturer's (Terrats Medical SL) internal testing as part of their submission for regulatory clearance. It's not explicitly stated whether the data is retrospective or prospective, or the country of origin of the raw data, beyond the manufacturer being from Spain. The "compatibility analysis by reference" means using existing data/information from the predicate device (K170588).

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

This type of information – number and qualifications of experts for ground truth – is typically relevant for studies involving subjective assessments, like image interpretation in AI/ML medical devices. This document is for a physical dental implant abutment, and the tests performed are objective, non-clinical tests (sterilization, biocompatibility, mechanical properties based on design parameters). Therefore, this information is not applicable and not provided in the submission.

4. Adjudication Method for the Test Set

As the tests are objective non-clinical tests, an adjudication method for a "test set" (in the context of expert review) is not applicable and not mentioned. The results of the non-clinical tests would either meet or not meet the specified standards (e.g., SAL, non-cytotoxicity).

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 type of study is specifically relevant for AI/ML-driven diagnostic or interpretative devices involving human readers. The device described here is a physical dental implant abutment, not an AI/ML diagnostic tool.

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 not an AI/ML device. The "CAD/CAM process" mentioned refers to computer-aided design and manufacturing for custom abutments, which is a manufacturing process, not an analytical algorithm for diagnosis or interpretation.

7. The Type of Ground Truth Used

For the non-clinical tests conducted:

• Sterilization: The ground truth is the scientific standard for sterility, defined as a Sterility Assurance Level (SAL) of $10^{-6}$ based on ISO 17665-1 and ISO 17665-2.
• Biocompatibility: The ground truth is the absence of cytotoxicity, determined by adherence to ISO 10993-1 and ISO 10993-5.
• Design Parameters/Mechanical Equivalence: The "ground truth" for design parameters (e.g., wall thickness, post height) is derived from engineering specifications and comparison to the proven safety and effectiveness of the legally marketed predicate devices (K170588 and other reference devices). The ultimate ground truth effectively is that the device performs equivalently to previously approved devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.

The provided text describes the regulatory filing for a dental implant abutment and does not contain information about an AI/ML device. Therefore, it's not possible to extract the requested details regarding acceptance criteria, study design for AI models, or expert ground-truthing. The document pertains to a traditional medical device (Straumann® CARES® Abutments CoCr) and its equivalence to predicate devices based on material, design, and mechanical performance testing.

However, I can extract the acceptance criteria and performance data for the traditional medical device as described:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
• ISO 10993-5:2009 "Tests for in vitro cytotoxicity"
• ISO 10993-18 "Chemical characterization of materials" |
  | Veneering Performance | Performed per ISO 9693-1 "Dentistry – Compatibility testing – Part 1: Metal ceramic systems". |
  | Corrosion Resistance | Demonstrated according to ISO 10271:2011 "Corrosion test methods for metallic materials". |
  | Sterilization Validation | Carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10^-6 in accordance to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. |
  | Design Limits | Max Angulation 30°, Minimum thickness 0.33mm. Minimum surface area requirements based on tooth position were also identical to the predicate. |

The following information is not present in the provided document, as it describes a non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Additional Study Information (from the document for the traditional device):

• Study Type: Bench testing (mechanical, material, biocompatibility, corrosion, sterilization).
• Clinical Studies: "No animal or human clinical studies were conducted."
• Ground Truth: For traditional device testing, "ground truth" is typically defined by established engineering and material science standards (e.g., ISO, ASTM) and manufacturing specifications.

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Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments).

The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.

Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.

The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.

The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.

There are three components to the Straumann® SC Variobase™ Abutments:

• Straumann® SC Variobase™ Abutments (Ti-base)
• Prosthetic restoration (coping and/or crown)
• Basal Screw

The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

• Cast materials:
  • Type 4 metals (ISO 22674)
  • Base metal alloys (e.g., cobalt-chromium (CoCr))
  • Noble metal alloys (e.g., gold alloy)
• Press materials:
  • IPS e.max® Press Ceramic (K120053)
• Digital materials:
  • coron®
  • zerion® LT
  • polycon® ae

All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.

The provided document (K162890) describes the regulatory submission for Straumann dental implants and associated components. However, it does not contain information about studies proving the device meets acceptance criteria for performance metrics related to diagnostic accuracy, such as sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic or AI-powered devices.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through various non-clinical tests. The "acceptance criteria" here relate to the successful completion of these engineering and safety tests, rather than clinical performance metrics for diagnostic capability.

Therefore, the requested information cannot be fully provided in the format desired for diagnostic devices because this submission deals with dental implants, not a diagnostic AI.

However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.

Acceptance Criteria and Device Performance (Not applicable in the typical sense for diagnostic AI):

The document does not present acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) because the devices (dental implants and abutments) are not diagnostic AI devices. Instead, the "performance testing" focuses on engineering, biocompatibility, and sterilization validations to demonstrate substantial equivalence to predicate devices.

Summary of Performance Testing Conducted (which can be seen as meeting "acceptance criteria" for safety and efficacy in this context):

1. Sterilization Validation (Section 5.8.1):

   • Acceptance Criteria: Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
   • Reported Device Performance: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated.

2. Biocompatibility Testing (Section 5.8.2):

   • Acceptance Criteria: Compliance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016". The subject devices should have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, raising no new biocompatibility issues.
   • Reported Device Performance: The subject devices have identical biocompatibility characteristics to the primary and reference predicate devices. Therefore, no additional biocompatibility testing was required or performed.

3. Software Verification and Validation Testing (Section 5.8.3): (Applicable to CARES Visual software for abutment design, which is part of the manufacturing process, not a diagnostic AI)

   • Acceptance Criteria: Compliance with FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".
   • Reported Device Performance: Software verification and validation testing were conducted; the software for the device (CARES Visual) was considered a "moderate" level of concern.

4. Bench Testing (Section 5.8.4):

   • Acceptance Criteria: Compliance with the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue, static strength, and insertion torque tests.
   • Reported Device Performance: Dynamic fatigue, static strength, and insertion torque tests demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.

Regarding the specific questions about diagnostic AI studies:

1. A table of acceptance criteria and the reported device performance: As explained above, not applicable for diagnostic metrics. The performance relates to engineering and safety tests.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical engineering and bench tests, not studies on patient data for diagnostic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set or ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a diagnostic AI scenario. The "ground truth" for the bench tests would be the established engineering standards and physical properties of the materials.
8. The sample size for the training set: Not applicable, as there is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Silicone Seal, Titanium Coping, Temporary Cap, abutment screws, and Smileloc Activator (or Smileloc Remover). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable.

Rodo Abutment is provided in five series designs (100 F. 200 P. 300 S. 400 M. 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 200 P and 500 D series are designed for multi-unit restorations only, the 300 S series is designed for limited occlusal space, and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 0 3.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided document is a 510(k) summary for the Rodo Abutment System, a dental device. It outlines the device's indications for use, its classification, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of algorithm-based metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/ML device.

The closest information available that might relate to "acceptance criteria" for a medical device (not specifically an AI/ML device) typically involves demonstrating substantial equivalence to a legally marketed predicate device through various tests and comparisons.

Here's an analysis based on the provided document, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical dental abutment system and not an AI/ML device, there are no specific performance metrics like sensitivity, specificity, or accuracy mentioned as "acceptance criteria" for an algorithm. Instead, the "performance" is demonstrated through various non-clinical and clinical tests to show safety and effectiveness and substantial equivalence to predicate devices.

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

• Sample Size (Clinical Trial): 34 subjects were enrolled, 32 subjects received Rodo Abutments and restorations. Out of these, 3 subjects received 4 abutments each as part of full arch treatment, resulting in a total of 41 Rodo Abutments placed and restored.
• Data Provenance: The document states, "A prospective multi-center clinical trial... was conducted under an Investigational Device Exemption study according to FDA guidelines." This indicates it's prospective data. The document does not explicitly state the country of origin, but given the FDA submission context, it's presumed to be a US-based study or at least data acceptable for US regulatory purposes.

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

This information is not provided in the document. For a physical device like a dental abutment, "ground truth" might refer to clinical outcomes assessed by trained dental professionals, but the study description does not detail the number or qualifications of experts involved in assessing device performance or generating the "ground truth" of safety and effectiveness outcomes beyond the medical staff conducting the trial.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically relevant for studies where multiple readers interpret data and discrepancies need to be resolved, which is common in imaging studies for AI/ML devices. For a clinical trial of a physical implant, such a method for "test set" adjudication is not typically described in this manner.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic performance, often of AI/ML systems or diagnostic tests, comparing multiple readers' interpretations of cases. The Rodo Abutment System is a physical dental device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The Rodo Abutment System is a physical dental device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for evaluating the Rodo Abutment System's safety and effectiveness was based on clinical outcomes data from human subjects who received the device. This included:

• Observation of adverse events (e.g., abutment screw loosening, crown separation, non-device related events).
• The overall clinical assessment that the system "provides an appropriate method of attaching prosthetic restorations to dental implant abutments" and "if necessary, it allows repeated removal of the restoration."

For non-clinical tests, the "ground truth" was based on engineering standards and direct measurement/testing results (e.g., SAL for sterility, acceptable ranges for biocompatibility, mechanical strength, corrosion resistance).

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical and non-clinical data collected serve as validation for the device's design and manufacturing rather than training an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the implants of the Straumann Dental Implant System (SDIS) to protect the inner features of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights. They are also not intended for use in immediate loading protocols; none of the devices of the Straumann Sterile Healing Solution are indicated for use in immediate loading protocols as they are intended to protect the internal features of the implant during the healing phase. When the implant has sufficient primary stability, the closure caps and fixation caps are used as a means to retain a bone graft used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.

The document provided is a 510(k) premarket notification for a medical device called "Straumann Sterile Healing Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on studies involving AI or complex performance metrics typically associated with diagnostic algorithms.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML or a complex diagnostic system. The document focuses on material, design, and intended use comparison to an existing predicate device for dental implants and associated healing components.

Specifically, the following points from your request cannot be addressed from the given text:

• A table of acceptance criteria and the reported device performance: This document doesn't provide such data. The performance data section refers to sterilization, biocompatibility, and shelf-life validation, not performance metrics for an AI-enabled device.
• Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI model is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI model or ground truth establishment process described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: The document explicitly states "No animal or human clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document is primarily a regulatory submission demonstrating substantial equivalence based on material, construction, and intended use, rather than performance validation data of an AI-driven or complex diagnostic device.

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The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System 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 (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The provided text describes a 510(k) premarket notification for a medical device, the LOCATOR® F-Tx Attachment System. It focuses on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting a study design with specific acceptance criteria and detailed performance data often seen for novel AI/ML devices. As such, many of the requested points regarding acceptance criteria, study types (MRMC, standalone), sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or cannot be extracted from this document, as it is not a performance study report for an AI/ML device.

This document outlines the device's intended use, design, materials, and provides a comparison to legally marketed predicate devices to establish substantial equivalence. The "Performance Data" section primarily details the non-clinical testing performed to meet various ISO standards related to sterilization, biocompatibility, and mechanical testing, which are typical for dental implant components.

Here's an attempt to address the request based only on the available information, noting where information is absent:

Acceptance Criteria and Device Performance for LOCATOR® F-Tx Attachment System

Based on the provided 510(k) summary, the "acceptance criteria" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant non-clinical performance standards. The performance data presented focuses on material properties, sterilization, biocompatibility, and mechanical retention, rather than performance metrics for an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

• "Substantial equivalence in indications and design principles to legally marketed predicate devices." Comparing language: "The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments." |
  | - Similar Design Principles | - "LOCATOR F-Tx and Locator (K072878) are each provided with varving cuff heights. The abutment/implant interfaces of all LOCATOR F-Tx abutments are identical to those of the corresponding Locator (K072878) abutments." |
  | - Similar Materials | - Abutment: Ti-6Al-4V ELI (same as predicate).
• Abutment Coating: TiN (same as predicate), TiCN (same as reference predicate K150295).
• Prosthetic Retention Component: PEEK (predicate uses Nylon). This difference is noted but deemed acceptable. |
  | Material Biocompatibility (ISO 10993-1, -5, -12) | - "Characterization and biocompatibility testing of the TiCN coating,"
• "Biocompatibility testing of the PEEK Healing Caps."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Sterilization (ISO 17665-1, -2) | - "Sterilization testing."
• (Specific results not detailed, but testing was performed and deemed acceptable for submission). |
  | Mechanical Performance (Specifically Retention Strength) | - "The mechanical testing demonstrated the retention strength of the LOCATOR F-Tx Attachment System when using the High Retention Balls was statistically greater than the tensile force created when masticating worst case sticky food (p

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The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).

The temporary copings are manufactured from polymethylmethacrylate (PMMA).

This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.

Let's break down what information is available based on your request and what is not available for a device like this.

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

For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.

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 (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
• Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.

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

This section is not applicable to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.

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

This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.

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 section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.

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

This section is not applicable. This is not an AI algorithm.

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

• Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.

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

This section is not applicable for the same reason as point 8.

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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 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.

The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.

TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.

Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.

The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.

The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:

• Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
• Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
• Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
• Biocompatibility testing: For cytotoxicity according to ISO 10993-5.

The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).

In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.

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