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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 expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.

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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 Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908, K191986, K203464, K212577, and K212628 to:

• include new OEM platform compatibilities (that have not been previously cleared) for previously ● cleared DESS designs,
• include previously-cleared OEM platform compatibilities for previously-cleared DESS abutment ● designs for which the specific combinations of compatibility and design were not cleared previously,
• add angulation to previously cleared Ti Base Abutments, Pre-Milled Blank, Ti, and Multi Unit Abutment,
• include a new abutment design, ZRN Multi Unit Abutment,
• include additional gingival height variations for the Ti Base Interface and DESSLoc Abutment, ●
• include two attachments: Interface Attachment for UniAbutment and Bar Attachment. ●

This submission includes five (5) abutment designs [Healing Abutments, Temporary Abutments, Multi Unit Abutments (straight and angled), ZRN Multi Unit Abutments (straight and angled), and DESSLoc Abutments], one (1) abutment blank (Pre-Milled Blank, Ti), three (3) base designs (Ti Base, C-Base, CrCo Base), two (2) attachments, and twenty (20) screws.

This submission includes one (1) new abutment design (ZRN Multi Unit abutment), based on the previously cleared Multi Unit abutment, but with an added zirconium nitride (Zr\V) coating. The identical coating is used on the DESSLoc Abutments that have been cleared in K170588, and K212628.

This submission includes two attachments. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in K170588. The subject device DESSLoc for Bar is designed to attached directly to the bar. The top portion of this attachment has the same design and material as the DESSLoc abutment cleared in K170588. K191986, and K212628.

The subject device includes the addition of new and previously cleared OEM compatibilities to previously cleared abutment design (Healing Abutments, Temporary Abutments, Ti Base, C-Base, Pre-Milled Blank Ti, Multi Unit abutments, and DESSLoc abutment). New compatibility is introduced for four (4) implant systems for which Terrats Medical has no prior clearance, for a total of eleven (11) new platforms. The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems.

The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

The document provided is a 510(k) Pre-market Notification for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove performance against specific acceptance criteria for a novel AI/software component.

Therefore, the tables and information requested regarding acceptance criteria, study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details are not present in this document.

This type of submission typically demonstrates that a new version of an existing device (e.g., with expanded compatibilities, minor design variations, or new materials) is as safe and effective as a legally marketed predicate device. The performance data section explicitly states: "No clinical data were included in this submission." The non-clinical data primarily involve sterilization validation, biocompatibility, and reverse engineering analysis to confirm compatibility, all leveraged from previous clearances.

In summary, this document does not contain the information necessary to fulfill the request concerning acceptance criteria for an AI/software device and the study proving it meets those criteria.

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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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.

Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.

The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.

Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance (for non-AI device):

The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.

Regarding the AI-specific questions (2-9), the document provides no relevant information.

• 2. Sample sized used for the test set and the data provenance: Not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
• 4. Adjudication method for the test set: Not an AI device.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
• 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
• 8. The sample size for the training set: Not an AI device.
• 9. How the ground truth for the training set was established: Not an AI device.

Summary of Device and its "Study":

The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:

• Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
• Biocompatibility testing: Referenced from previous 510(k) submissions.
• Sterilization validation: Referenced from previous 510(k) submissions.
• MR environment compatibility analysis: Based on scientific rationale and published literature.
• Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.

This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.

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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 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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908 and K191986 to add additional components for previously cleared OEM platform compatibilities and to additional OEM platform compatibilities for previously cleared DESS designs. This submission includes three (3) abutments (Healing Abutments, straight Multi Unit Abutments and DESSLoc Abutments), three (3) bases, two (2) blanks, and seven (7) screws.

Among the subject devices for this submission are abutments and screws compatible with three (3) implant systems for which Terrats Medical has no prior clearance and one (1) implant system for which new platform compatibilities are included, for a total of nine (9) new platforms.

The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in the table Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems. The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks 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.

The provided document is a 510(k) premarket notification for dental implant abutments. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the manner one might see for an AI/ML medical device.

Therefore, many of the requested items related to AI/ML device studies (such as test set details, expert ground truthing, MRMC studies, or training set information) are not applicable to this submission.

However, based on the information available in the document, here's a breakdown of the relevant points:

Acceptance Criteria and Device Performance for DESS Dental Smart Solutions Abutments

The acceptance criteria for this device are largely implicit in the demonstration of substantial equivalence to predicate devices, particularly regarding material composition, design principles, intended use, and performance data (non-clinical).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for dental implant abutments and not an AI/ML device, the acceptance criteria are not typically expressed as performance metrics (e.g., sensitivity, specificity) against a ground truth dataset. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

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

Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing (material properties, sterilization, biocompatibility, reverse engineering). There isn't a "test set" in the context of clinical performance data or AI/ML model evaluation. The "data provenance" for non-clinical testing would relate to the test reports from specific labs and the standards applied.

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. No "ground truth" establishment by experts in a clinical context is described for this device type. The ground truth for engineering specifications and material properties would be established by relevant industry standards and validated test methods.

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

Not applicable. No "adjudication method" as described for clinical interpretation or AI/ML ground truth is mentioned or relevant.

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

Not applicable. No MRMC study or AI assistance is mentioned. This is a traditional medical device (dental implant abutment).

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

Not applicable. This device is not an algorithm or AI.

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

For the non-clinical performance data, the "ground truth" is derived from:

• Established standards: e.g., ISO 17665-1, ISO 14937 for sterilization; ISO 10993-5, ISO 10993-12 for biocompatibility; ASTM F136, ASTM F1537, ISO 13356 for material composition.
• Reverse engineering analysis: Comparison to OEM implant bodies, OEM abutments, and OEM abutment screws to confirm mechanical compatibility (page 9).

8. The sample size for the training set

Not applicable. This device is not an AI/ML system and does not involve a training set.

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

Not applicable. This device is not an AI/ML system and does not involve a training set.

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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.

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