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The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672.

The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.

The provided FDA 510(k) clearance letter and associated documentation for the "T3 Pro Implants- ZimVie Packaging System" (K251660) do not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.

Instead, this submission is for a medical device (endosseous dental implant) and its new packaging system. The "performance data" section explicitly states that no clinical data was included in the submission for the substantial equivalence determination. The focus of the provided document is to demonstrate equivalence to a previously cleared predicate device for the dental implant itself, with the primary change being the packaging system.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance related to an AI-assisted or standalone AI system, nor can I provide details on sample size, expert adjudication, MRMC studies, or ground truth establishment, as these concepts are not discussed or relevant to the provided documentation for this specific 510(k) clearance.

The information provided describes non-clinical performance data related to the physical device and its packaging:

• Sterilization validation: Gamma irradiation sterilization to a sterility assurance level of 10^-6 according to ISO 13004 and ISO 11137.
• Aging studies: Demonstrating a shelf life of two (2) years for the implants, with packaging sterile barrier testing per ASTM F1980.
• Packaging studies: Simulated distribution and environmental conditioning per ISTA 3A and ASTM D4169.
• Biological evaluation: Leveraged from the primary predicate device, demonstrating no increased risks regarding biocompatibility. The material is Commercially Pure Titanium conforming to ASTM F67.
• MR Safety testing: Conducted according to ASTM F2503-13 on the primary predicate device (identical to the subject device) for MR Conditional determination.
• Bacterial Endotoxin Testing: Routinely performed using LAL assay in accordance with ISO 11737-3.

The acceptance criteria for this submission would primarily revolve around demonstrating that the new packaging system maintains the sterility, integrity, and safety of the dental implant for its stated shelf life, and that the dental implant itself remains identical to the previously cleared predicate device in all other aspects (materials, design, intended use, operating principle).

In summary, your request pertains to an AI/Software as a Medical Device (SaMD) study, while the provided document describes the 510(k) clearance process for a physical dental implant device and its new packaging.

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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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The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.

TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.

Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.

Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).

However, I can extract the information that is available and explain why other requested details are missing.

Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):

This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.

Missing Information and Explanations:

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

   • Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.

2. 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/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.

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

   • Not applicable/None. No clinical test set to adjudicate.

4. 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 (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.

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

   • Not applicable. As above, this is a physical medical device, not an algorithm or AI.

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

   • The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.

7. The sample size for the training set:

   • Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.

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

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

In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.

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

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

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

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

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

Understanding the Device and its "Acceptance":

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

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

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

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

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

Regarding the AI/ML Specific Questions:

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

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

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

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

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

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

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

• Not applicable. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.

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

• Not applicable. There is no algorithm.

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

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

8. The sample size for the training set:

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

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

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

Conclusion from the document:

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

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

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

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Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.

Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.

The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.

The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.

2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

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
No MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive 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. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of relevant performance data (non-clinical, from the document):

The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.

• Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
• Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
• Biocompatibility of PEEK material: According to ISO 10993-3, ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from predicate K190243).
• Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
• Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
• Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).

Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.

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Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, Zirconia Locator-type abutments are provided in straight and 15° angled designs. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.

The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).

The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.

To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.

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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 US SA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.

The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.

The provided text describes a 510(k) premarket notification for the "US SA Implant System," a dental implant device. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study for a new device on its own merits against specific criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's a breakdown of the information that can be gleaned from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document in the format of specific numerical acceptance criteria and corresponding device performance metrics. The document instead focuses on demonstrating substantial equivalence through comparison of materials, design, indications for use, and non-clinical testing results against predicate devices. The fatigue testing was conducted according to a guidance document, implying the device met the requirements outlined in that guidance, but specific numerical thresholds and results are not detailed.

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

• Test set sample size: Not specified. The document states "fatigue testing was conducted." The number of devices or iterations in this testing is not mentioned.
• Data provenance: The testing was conducted by the manufacturer, OSSTEM IMPLANT Co., Ltd., likely in a laboratory setting. The country of origin for this specific testing is implied to be Republic of Korea, where the company is based. The nature of the testing is non-clinical (laboratory).

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

• Not applicable. This relates to clinical studies and human interpretation of data. The submission focuses on non-clinical engineering testing (fatigue, sterilization).

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

• Not applicable. This relates to clinical studies and human interpretation of data.

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, an MRMC study was not done. This type of study is for comparing human performance, often in diagnostic imaging, with and without AI. This submission is for a dental implant, which is a physical device, and does not involve AI.

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

• Not applicable. This device is a physical dental implant, not an algorithm or AI system.

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

• For the fatigue testing, the "ground truth" would be the engineering standards and requirements for mechanical strength and durability of dental implants, aligned with ISO standards and FDA guidance. The determination of "success" or "failure" would be based on whether the device passed these mechanical tests without fracture or significant deformation.
• For sterilization validation, the "ground truth" is established by adherence to recognized international standards (ISO 11137 series for gamma sterilization and ISO 17665 series for steam sterilization), demonstrating acceptable sterility assurance levels.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device, not an AI model or a system that requires machine learning training.

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

• Not applicable. As above, there is no training set for this type of device submission.

Summary of Non-Clinical Testing Performed (from the document):

• Fatigue testing: Conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This testing confirms the mechanical strength and durability of the implant and abutment components. The document indicates that a fatigue test was specifically performed for the US Multi Angled Abutment due to differences in connection structure and shape compared to a predicate, to confirm its strength.
• Gamma Sterilization Validation: Performed with the Fixture System according to ISO 11137-1, ISO 11137-2, and ISO 11137-3.
• Steam Sterilization Validation: Provided according to ISO 17665-1 and ISO 17665-2.
• Biocompatibility and Surface Coating Characterization: The document states that the subject devices are made of the same materials, manufacturing process, chemical composition, and body contact as predicate devices (TS Fixture System, K121995 and Multi Angled Abutment, K123755), thus demonstrating substantial equivalence in these areas.

In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, indications for use, and adherence to recognized non-clinical testing standards (fatigue, sterilization) rather than presenting a clinical study with detailed acceptance criteria and performance statistics for a completely novel device.

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