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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate.

DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by Terrats Medical SL.

DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior region of the mouth.

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® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

This submission includes dental implants that are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by the sponsor of this submission, Terrats Medical SL, and cleared under K212628, K222288, K233316, K240208, and K242340. No claims of compatibility between the subject device implants and abutments from any OEM other than DESS® Dental Smart Solutions will be made. This submission also includes DESSLoc abutments that are compatible with eight (8) dental implant lines from five (5) OEM manufacturers. Also included in this submission is one (1) Pre-Milled Blank abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH.

This submission includes one implant line, the Dental Implant NEO GM, a series of self-tapping, threaded, root-form dental implants to be placed at bone level. The subject device implants are provided in body diameters of 3.55 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. The subject device implant body diameters will be labeled as 3.5 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. Implant with body diameters ranging from 3.55 mm to 5.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, 11.4 mm, 12.9 mm, 15.9 mm, and 17.9 mm. Implants with body diameters 6.0 mm and 7.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, and 11.4 mm. The subject device implant lengths will be labeled as 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm, and 18 mm. All subject device implants, regardless of body diameter, have an internal Morse taper connection with a 16° included angle and 2.99 mm diameter opening at the top of the implant. This NEO GM connection is identical to the connection for abutments cleared previously in K242340.

All subject device implants are made of unalloyed titanium conforming ASTM F67 and ISO 5832-2. The entire endosseous surface, except for a small coronal bevel, features a grit blasted and double acid etched (SLA) surface, which is identical to the surface treatment for DESS® implants that were cleared in K212538.

This submission also includes DESSLoc Abutments designed for overdenture retention. The subject device DESSLoc Abutments are straight, non-engaging abutments that attach directly to the implant and are compatible with eight (8) dental implant lines from five (5) OEM manufacturers.

The subject device DESSLoc Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The subject device DESSLoc abutments have a zirconium nitride (ZrN) coating produced by a physical vapor deposition (PVD) process. The ZrN coating is applied to increase the surface hardness and reduce wear of the abutment surface. The ZrN coating for the subject device DESSLoc Abutments is identical to the ZrN coating applied to DESSLoc Abutments cleared in K242340, K240208, K222288, K191986, and K170588.

This submission also includes one (1) Pre-Milled Blank Abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH, including Implant Active Konus, Implant Classic Konus, and Implant Active Bio, cleared in cleared in K210499. Reverse engineering compatibility analysis of the Alpha Dent implants, abutments, and abutment screws and Terrats Medical SL abutments and abutment screws was provided in the prior Terrats Medical SL submission K243212.

The Pre-Milled Blank Abutment has a maximum (before milling) diameter of 10 mm and a solid cylindrical design and an engaging implant connection. The Pre-Milled Blank Abutment is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All patient-specific custom abutment fabrication for the Pre-Milled Blank Abutment is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum post height for single-unit restoration – 4.0 mm (post height measured above the gingival height of the final patient-matched design)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

The abutment screw for use with the Pre-Milled Blank Abutment and the Alpha Dent implants was cleared previously in K243212.

All subject device implants are provided sterile, and all subject device abutments are provided non-sterile. The Pre-Milled Blank Abutment is supplied with the previously-cleared non-sterile abutment screw for attachment to the corresponding compatible implant. All subject device components are provided in single-unit packages for single-patient, single-use only.

The provided FDA 510(k) Clearance Letter for DESS® Dental Implants (K251280) does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML device performance.

The document is a clearance letter for a dental implant system, which is a physical medical device, not an AI/ML-driven diagnostic or treatment planning software. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth) are not applicable to the content provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use and Indications for Use
• Technological Characteristics (design, materials, surface treatment, sterilization methods, dimensions)
• Performance Data (non-clinical data such as MRI review, sterilization validation, bacterial endotoxin testing, shelf life, biocompatibility, and mechanical testing according to ISO 14801).

Since the request specifically asks for AI/ML-related performance evaluation, and the provided document is not for an AI/ML device, I cannot fulfill the request as stated with the given input.

However, I can extract the non-clinical performance data and the comparison to predicate devices, which serve as the "study" and "acceptance criteria" for this type of physical medical device in the context of a 510(k) submission.

Non-Clinical Performance Data (Serving as "Study" for Substantial Equivalence):

1. Worst-Case MRI Review:

   • Method: Scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation Volume 49, No. 2 (March/April 2021): 783–795).
   • Scope: Evaluated all compatible implant bodies, abutments, and fixation screws and their material composition.
   • Parameters: Magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
   • Outcome: Rationale addressed parameters; device components found suitable for the MR environment.

2. Gamma Irradiation Sterilization Validation (for implants):

   • Method: Selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2.
   • Acceptance Criteria: Sterility Assurance Level (SAL) of $10^{-6}$.
   • Outcome: Analysis showed the subject device implants met the SAL and did not create a new worst case compared to predicate device K212538.

3. Bacterial Endotoxin Testing:

   • Method: Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72.
   • Acceptance Criteria: Limit of

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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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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 submission 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. Specifically:

• Ti Screw: Used during restoration fabrication.
• TiN Screw: Used in finished restorations, with TiN coating.
• TPA Screw: Used in finished angulated restorations, with TiN coating.

All subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

Unfortunately, the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a clinical trial report or a performance study summary.

The document is an FDA 510(k) Premarket Notification letter for IPD Dental Implant Abutments. This type of document aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a clinical or algorithmic study.

While it mentions "bench testing to determine fulfillment of design and performance requirements" and "Static and dynamic fatigue testing...in accordance with ISO 14801," these are engineering performance tests for mechanical properties and material compatibility, not studies that would involve:

• Acceptance criteria for clinical or diagnostic performance (e.g., sensitivity, specificity, accuracy for a diagnostic device; efficacy for a therapeutic one).
• Sample sizes for a test set of data (e.g., patient cases/images).
• Experts establishing ground truth for a diagnostic or AI-assisted task.
• Multi-reader multi-case (MRMC) studies or human reader performance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data.
• Training set sample size or ground truth establishment for a machine learning model.

The "performance data" section primarily discusses:

• Sterilization validation.
• Biocompatibility testing (cytotoxicity, skin sensitization, irritation).
• Reverse engineering and dimensional analysis for compatibility.
• Validation of the digital workflow and software system to ensure that design and manufacturing of the top half was within the specified design parameters. (This is about engineering design parameters, not clinical acceptance of a diagnostic tool).
• Static and dynamic fatigue testing (mechanical strength).
• Modified Surfaces Information.

Therefore, I cannot extract the requested information from this document because it is not present. This document is focused on establishing substantial equivalence based on material, design, and manufacturing processes, supported by bench engineering tests, rather than a clinical or AI performance study with acceptance criteria for diagnostic or clinical outcomes.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

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

• Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

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

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing.

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

This is not applicable. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This is not applicable as the device is a physical dental implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

• Biocompatibility: Conformance with ISO 10993-1.
• Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
• Sterilization Validation: Conformance with ISO 11137 series.
• Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

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The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• Astra Tech Implant System® Multi Base Abutment EV, 4.8 mm, max 30°
• DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
• 3i OSSEOTITE®
• Astra Tech OsseoSpeed™
• Neodent Grand Morse
• NobelReplace® Conical
• NobelReplace® Trilobe
• Nobel Brånemark System®
• Straumann BLX Implants
• DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
• NobelActive® NobelParallel Conical
• Straumann® Bone Level
• Zimmer Screw Vent® and Tapered Screw-Vent®
• Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30°
• Keystone Multi Unit Abutment, 4.8 mm, 0°
• Implant Direct GPS® Angled Abutment, 5.0 mm, max 30°
• MIS Multi-unit Abutments, 4.8 mm
• C1 Conical Connection Implant System, max 30°
• V3 Conical Connection Implant System, max 30°
• Internal Hex Implant System, max 30°
• Conical Connection, max 30°
• Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• Nobel Biocare Brånemark Multi-Unit Abutment, 4.8 mm, max 17°
• Nobel Biocare Multi-Unit Abutment Plus, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Straumann and Astra Tech System, 4.8mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• Paltop Multi Unit Abutment, 5.0 mm, max 17°
• Southern Compact Conical Abutments, 4.8 mm
• MAX Implant System, 0°
• Provata Implant System, max 30°
• Deep Conical (DC) Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar

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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate. Implants of diameter 3.0 mm, 3.3 mm and 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.0 mm, 3.3 mm and 3.5 mm diameter implants is intended only for rehabilitation of the anterior region of the mouth.

The purpose of this submission is to obtain marketing clearance for two designs of DESS Dental Implants. The implants are compatible with DESS Dental Smart Solutions abutments manufactured by the sponsor of this submission, Terrats Medical SL and cleared under K170588, K173908 and K191986. The new dental implants are parallel-walled root-form threaded endosseous dental implants made from unalloyed titanium, ranging in diameter from 3.0 mm to 5.5 mm and in length from 7 mm to 18 mm, as described more fully below.

This submission includes two designs of DESS Dental Implants, designated Active and Bone Level. The external portion of each design is threaded, with a uniform major diameter and a slightly decreasing minor diameter along the length of the apical portion of each is tapered and includes cutting flutes to facilitate the insertion of the implant into the alveolar bone. Both designs have an internal connection, an internal anti-rotation feature (used for engaging abutment designs) that also serves to facilitate insertion into bone, and an internal screw channel to secure an abutment. Differences between the designs include the type of antirotational feature which, in the Active implant is an internal hex and in the Bone Level implant is an internal 4-lobed design. The external thread of the Active implant ends below the crest of the implant and a machined collar with shallow grooves is located between the end of the external thread and the crest of the implant. The external thread of the Bone Level implant ends below the crest of the implant, and the collar is included in the surface treatment. The endosseous surface of each implant is treated with a grit blasting and acid etching process to provide a rough surface for attachment of bone.

The provided document describes the 510(k) premarket notification for the DESS Dental Implants. This is a regulatory submission for a medical device seeking substantial equivalence to already legally marketed devices, not a study proving the device meets acceptance criteria derived from a clinical trial or algorithm performance.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly applicable to this type of regulatory submission. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and non-clinical performance data, rather than establishing efficacy or accuracy through human reader studies or similar clinical investigations.

However, I can extract the relevant information from the document as it pertains to the device's characteristics and the non-clinical performance data provided to support its safety and effectiveness relative to predicate devices.

Here's a breakdown of what can be extracted based on your request, with an explanation of why some fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical data, there are no specific "acceptance criteria" in the sense of performance metrics from a diagnostic study, nor is there "reported device performance" in terms of clinical accuracy or reader improvement. Instead, the device's characteristics are compared to predicate devices, and testing ensures it meets established engineering and safety standards.

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DESS Dental Smart Solutions abutments are in conjunction with endosseus dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K191986 to add an additional series of titanium base components for previously cleared OEM implant platform compatibilities. The new components, referred to as C-Base engaging and C-Base non-engaging abutments, are available in a range of abutment gingival heights and abutment platform diameters. This submission includes abutments compatible with 33 implant platforms from 13 implant compatibilities have been cleared in previous Terrats Medical submissions. No new implant compatibilities are added in this submission. Screws used with the subject device C-Base abutments were cleared previously, with the exception of two screws added in this submission. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.

The subject device DESS Dental Smart Solutions C-Base abutments are similar to TiBase Abutments cleared in K170588 and K191986. C-Base abutments are two-piece abutments designed to support a custom CAD/CAM zirconia superstructure on which a single-unit or multiunit restoration may be placed. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. The C-Base also may support a ceramic hybrid abutment (direct restoration) in which the crown is included in the design of the zirconia superstructure. They are available either in designs that engage with the anti-rotational feature of the implant or in non-engaging designs for multi-unit restorations. The C-Base post is 4.7 mm high. The gingival height of the abutment (distance from implant platform to abutment platform) ranges from 0.3 mm to 3.0 mm. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. C-Base abutments are made of titanium alloy (Ti-6Al-4V) with anodization and a SelectGrip® surface, described below. When used for a direct crown, a POM burn-out sleeve, an exempt laboratory component that is not a subject of this submission, is available for laboratory fabrication of the prosthesis.

When the C-Base abutment is used with a CAD/CAM zirconia superstructure, or for a direct restoration, design parameters are identical to those cleared in K191986 and in K170588, except that the minimum post height for the subject device is 4.7 mm. The superstructure or direct restoration design parameters are:

Minimum wall thickness – 0.4 mm Minimum post height for single-unit loading - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Zirconia superstructures and direct restorations are not intended for angulation correction.

Manufacture of the CAD/CAM zirconia superstructure is to be performed at a Terrats Medical validated milling center, defined as a facility that is registered with FDA as a manufacturer or contract manufacturer.

Each abutment is supplied with the appropriate abutment screw for attachment to the corresponding implant. DESS Dental Smart Solutions screws are designed to attach the abutment or restoration to the implant. With the exception of two new subject device screws, all screws were cleared in previous Terrats Medical submissions. As discussed above, the two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.

All subject device abutments and subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Zirconia superstructures for C-Base abutments are made of Y-TZP conforming to ISO 13356 Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Abutments are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color. They also are treated with the SelectGrip® surface to improve adhesion of the cement that is used to attach the superstructure or restoration to the C-Base abutment. The gold anodized surface treatment is identical to that cleared in K191986 and the SelectGrip surface treatment is identical to that cleared in K191986 and K170588. All the subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K191986 and K170588.

The provided text describes a 510(k) premarket notification for a medical device called "DESS Dental Smart Solutions" (K203464), which are endosseous dental implant abutments. The submission aims to expand the existing product line by adding new titanium base components (C-Base engaging and C-Base non-engaging abutments) compatible with previously cleared OEM implant platforms.

The core of the submission argues for substantial equivalence to predicate devices (K191986 and K170588). This means the device does not require a new approval process if it's shown to be as safe and effective as a legally marketed device. In this context, comprehensive studies with specific acceptance criteria are usually not required in the same way they would be for a novel device. Instead, the focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text for your requested information:

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

Since this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in terms of performance statistics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor are there reported device performance metrics in that sense. Instead, the acceptance criteria are implicit in demonstrating that the new device meets the same safety and effectiveness standards as the predicate devices, which is achieved through a comparison of technological characteristics and non-clinical data.

The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, rather than a standalone clinical efficacy study.

Here's a table summarizing the relevant points:

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

• Sample Size for Test Set: The document explicitly states, "No clinical data were included in this submission." The evaluation for substantial equivalence relied on non-clinical data (sterilization validation, biocompatibility, reverse engineering analysis). Therefore, there is no "test set" in the sense of patient data for performance evaluation in this submission.
• Data Provenance: The biocompatibility and sterilization validation data referenced are from the predicate devices (K191986 and K170588), which were previously submitted. The reverse engineering analysis was performed on OEM implant bodies, OEM abutments, and OEM abutment screws. The manufacturer, Terrats Medical SL, is located in Barcelona, Spain. The specific country of origin for the referenced predicate data is not detailed, but it would have been part of their previous FDA submissions. The data is retrospective in the sense that it relies on previously generated and accepted data for the predicate devices and existing OEM components.

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. As no clinical data or clinical test set was used, there was no need for experts to establish ground truth from patient data. The evaluation was based on engineering and materials science principles, and reference to previously cleared devices.

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

• Not applicable. There was no clinical test set 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. This device is a dental implant abutment, a physical component, and does not involve AI or "human readers" in its intended use or evaluation.

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

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

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

• For the non-clinical data, the "ground truth" essentially refers to established engineering standards, material specifications (e.g., ASTM F136, ISO 13356), and regulatory requirements (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). The substantial equivalence argument relies on the device meeting these established standards, which serve as the implicit "ground truth" for material properties, biocompatibility, and manufacturing quality. The "ground truth" for compatibility was established through reverse engineering analysis of OEM implant bodies and comparison to previously cleared predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not a machine learning algorithm.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

Certain BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

All digitally designed superstructures and/or hybrid abutment crowns for use with Certain BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

The Certain BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. Certain BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Biomet 3i Certain (Internal Hex) dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and nonhexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

This document pertains to the 510(k) premarket notification for Certain BellaTek® Express and BellaTek® Flex Abutments, K183138. It describes dental implant abutments and does NOT describe an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device cannot be extracted from this document.

The document discusses substantial equivalence to predicate devices based on:

• Intended Use: Similar, supporting prosthetic devices in edentulous patients.
• Operating Principle: Attaching to dental implants to restore chewing function.
• Identical Materials: Titanium Alloy (Ti-6Al-4V ELI) and Zirconia for abutments.
• Similar Fundamental Design: Including platform diameters, screw or cement retention options.

Performance Data (Non-clinical):

• Sterilization Validation: Per FDA Guidance and ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10^-6.
• Biological Evaluation: In accordance with FDA Guidance and ISO 10993-1, demonstrating acceptable biocompatibility.
• MR Testing Data: Leveraged, and the device is labeled as MR conditional.
• Design & Development: In accordance with FDA Guidance Document for Root-form Endosseous Dental Implants and Abutments.

No clinical data was included in this submission.

Therefore, I cannot provide the information requested in the format of an AI/ML device acceptance criteria and study.

Ask a specific question about this device