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The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.

The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.

They are intended for single use and provided non-sterilization recommended before installation in the mouth.

All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.

The provided text describes the Neodent Implant System - Custom Abutments, a medical device. This product is not an AI/ML device, and therefore does not have acceptance criteria or a study that proves the device meets those criteria in the way requested in the prompt.

The document discusses the substantial equivalence of the Neodent Implant System - Custom Abutments to legally marketed predicate devices, which is the basis for its 510(k) clearance by the FDA. The performance testing section describes bench tests (dynamic fatigue and torsion tests), sterilization validation, MR compatibility testing, and biocompatibility testing. These tests evaluate the physical, chemical, and biological properties of the device, comparing them to established standards and predicate devices to demonstrate equivalence, not to meet a set of acceptance criteria for an AI/ML algorithm's performance.

Because the device is not an AI/ML device, the specific information requested about acceptance criteria for AI performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established is not applicable and is not present in the provided text.

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Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

• Intended for single use;
• Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
• All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
• ZiLock prosthetic interface with internal indexer;
• Apically tapered implant with trapezoidal thread profile;
• Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
• The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.

The provided text describes a medical device submission (K201491) for the Neodent Implant System - Zirconia Implant System to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance results for a new AI/software device.

Therefore, the requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies cannot be extracted from this document as it pertains to a different type of medical device submission (dental implants and their components) and regulatory pathway (510(k) for substantial equivalence).

The document details the comparison of the subject device (Neodent Implant System - Zirconia Implant System) to predicate and reference devices in terms of indications for use, technological characteristics, and performance data from various tests. However, these are evaluations against established standards and comparisons to existing devices, not metrics of an AI's performance.

Here's what can be extracted, though it doesn't directly answer the detailed questions about AI performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for software performance in the typical sense (e.g., sensitivity, specificity, AUC). Instead, it presents a comparison of technological characteristics and states that the "tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices" in mechanical testing.

Here's a summary of the performance data presented, which implies meeting an "equivalent" performance to predicates rather than specific numerical acceptance criteria for a new software.

No information is available regarding points 2-9 as they are specific to AI/software device studies to establish performance against a ground truth. This document is a 510(k) summary for a physical dental implant system and components, establishing substantial equivalence to existing devices.

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Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

The NUVO IF Implant System consists of implants, cover screws, and abutments.

Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.

Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.

Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.

This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.

The document discusses:

• Trade/Device Name: NUVO IF Implant System
• Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
• Regulatory Class: Class II
• Product Code: DZE, NHA
• Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
• Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
• Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
• Performance Data: This section details non-AI/ML performance testing, including:
  • Dynamic fatigue testing per ISO 14801.
  • Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
  • Ethylene oxide residuals testing per ISO 10993-7.
  • Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
  • Package transport integrity per ISTA 2A.
  • Product and package stability per ASTM F1980.
  • Product endotoxin testing (LAL) per ANSI/AAMI ST72.

There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.

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• HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
• Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
• Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
• Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
• CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
• GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
• GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
• . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

• Titamax WS implants, abutments and copings (originally cleared per K123022)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Titamax WS implants are indicated for a delayed loading protocol.

• Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

• Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
  The Zygomatic implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.

• CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
• o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

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

• CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

• CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
• CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
  The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

• . The Neodent Graft Screw (originally cleared per K103084)
  The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA regarding the MRI compatibility of various Neodent Implant System devices. It primarily focuses on defining the indications for use for different components of the implant system and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/Medical Device.

The document is a regulatory approval letter and descriptive indications for use, not a study report or technical performance assessment. Therefore, I cannot extract the requested information from this text.

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Indications for Use for GM Helix Implants and conventional abutments:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for Use for GM Exact Titanium Block for Medentika Holder:
GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for GM Exact Titanium Base abutments:
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for Titanium Base C for GM Exact abutments:
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).
The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Exact Titanium Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.
The subject device abutments components mate exclusively with the GM implants cleared in K163194.

The provided text is a 510(k) Summary for the Neodent Implant System - GM Line. It outlines the device's indications for use, description, and a comparison to predicate devices to demonstrate substantial equivalence, rather than directly detailing acceptance criteria and performance data in the format requested.

Here's an analysis based on the information provided, trying to extract details relevant to your request, but please note that some of your requested information might not be explicitly present in this type of FDA submission summary:

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

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance outcomes in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data from non-clinical studies (e.g., mechanical testing).

The "performance data" reported are primarily focused on safety and mechanical integrity, rather than a clinical performance metric.

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

The document indicates that no clinical data were submitted in this premarket notification. The "test set" for performance was based on non-clinical data, primarily engineering and mechanical testing.

• Sample size for mechanical testing (ISO 14801): Not explicitly stated in terms of number of samples, but implied to be sufficient for demonstrating compliance with the standard and substantial equivalence. The document mentions "worst-case subject device constructs."
• Data provenance: Non-clinical (laboratory testing). No information on country of origin of data, as it's not a clinical study.

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 as there was no clinical study and thus no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The ground truth for mechanical testing is defined by the test standards (e.g., ISO 14801 parameters).

4. Adjudication method for the test set

This information is not applicable as there was no clinical study involving human judgment requiring an adjudication method.

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 information is not applicable. The device is an endosseous dental implant system, not an AI-assisted diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the performance evaluation in this submission is established through:

• International standards and regulatory guidelines: For sterilization (ISO 11137 series, ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2), bacterial endotoxin (AAMI/ANSI ST72), sterile barrier shelf life (ASTM F1980, ASTM E499/E499M, ASTM F1929, ASTM F88/F88M, ISO 11737), biocompatibility (ISO 10993 series, implied by referencing K163194), and mechanical testing (ISO 14801).
• Comparison to predicate devices: Demonstration of identical or similar materials, design, and intended use as legally marketed devices.

8. The sample size for the training set

This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

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

This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device. The "ground truth" for demonstrating substantial equivalence of the physical components is based on established engineering principles, materials science, and conformity to relevant international standards, effectively using the performance of the predicate devices as a benchmark for what is considered safe and effective for the described indications.

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

DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile.

This document describes the premarket notification for the DESS Dental Smart Solutions, an endosseous dental implant abutment. The information provided is for regulatory clearance based on substantial equivalence, not a standalone performance study of the device. Consequently, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device are not applicable or find direct answers within this document.

However, I can extract the relevant information from this regulatory document concerning the device's performance evaluation to demonstrate its substantial equivalence to predicate devices, which serves as its "acceptance criteria" for market clearance.

Here's an analysis of the provided text in relation to your questions, focusing on the available "performance data":

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

The "acceptance criteria" for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance metrics of an AI algorithm like sensitivity, specificity, or accuracy. The "performance" is shown through engineering and dimensional analysis, and material compatibility, to ensure it functions similarly to the predicate devices.

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: Not explicitly stated in terms of a "test set" as one would define it for an AI/algorithm study. The "test set" here refers to the actual physical devices (parts, materials) subjected to engineering, dimensional, and biological evaluations. The document does not specify the number of individual abutments or components tested for each non-clinical evaluation.
• Data Provenance: The document states that Terrats Medical SL is located in Montcada i Reixac, Spain. The testing was non-clinical. No information is provided regarding the country of origin of testing data beyond the manufacturer's location.

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 type of expertise for establishing ground truth is relevant for AI/algorithm studies involving image interpretation or clinical diagnosis. For a dental implant abutment, "ground truth" is based on established engineering and material science standards (e.g., ISO standards, dimensional specifications, material composition), which do not typically involve human expert consensus in the same way as an AI diagnostic study.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This document pertains to the physical and material properties of a medical device, which are evaluated against defined engineering and biological standards, not subjective interpretations requiring adjudication.

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

• Not Applicable: No MRMC study was performed. This document concerns the regulatory clearance of a physical medical device (dental abutment), not an AI-assisted diagnostic tool. The document explicitly states: "No clinical data were included in this submission."

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

• Not Applicable: This is not an AI algorithm. The device "DESS Dental Smart Solutions" refers to a system of dental implant abutments, which are physical components. The document indicates that "All digitally designed custom abutments... are to be sent to a Terrats Medical validated milling center for manufacture," implying a digital design process, but the device itself is a physical product, not a software algorithm.

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

• The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biological safety standards (e.g., ISO 17665-2 for sterilization, ISO 10993-1/5 for biocompatibility), and dimensional compatibility with OEM implant systems. It is a physical and material "ground truth" rather than a clinical or diagnostic "ground truth."

8. The sample size for the training set

• Not Applicable: This device is a physical product, not an AI model that requires a "training set."

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

• Not Applicable: As there is no training set for an AI model, this question is not relevant.

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