Search Results

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

• "Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

Ask a specific question about this device

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 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 add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical device.

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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

Ask a specific question about this device

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.

Ask a specific question about this device

Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.

Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:

Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.

The provided document describes the Preat Abutments and their substantial equivalence to predicate devices, based on non-clinical performance data. It does not contain information about studies involving human readers, ground truth establishment for a test or training set, or specific details on sample sizes for a test set in the context of AI/algorithm performance.

Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:

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

The document describes non-clinical performance data used to demonstrate substantial equivalence, focusing on mechanical testing and material properties. The acceptance criteria are implicitly met by comparing the subject device to predicate and reference devices, and by conforming to relevant ISO standards where applicable.

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

The document does not detail specific sample sizes for the mechanical testing ("worst-case constructs"). The data provenance is not explicitly stated in terms of country of origin, nor is it described as retrospective or prospective in the context of test sets. The studies are non-clinical (laboratory testing).

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

This information is not applicable. The studies described are non-clinical performance and material conformance tests, not diagnostic studies or those requiring expert interpretation of results to establish ground truth in the way medical imaging algorithms might.

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

This information is not applicable. Adjudication methods typically apply to human interpretation of data, often in clinical studies or when establishing ground truth for AI algorithms, which is not the nature of the studies described.

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. An MRMC comparative effectiveness study is used for diagnostic AI devices involving human readers. This document describes non-clinical performance testing for dental abutments, which is a physical device, not an AI algorithm.

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 dental abutment, not an algorithm.

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

The concept of "ground truth" as typically used in the context of evaluating diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. For the non-clinical tests, the "ground truth" or reference for performance is the compliance with specified ISO and ASTM standards and the performance of the predicate/reference devices through comparative testing. For example:

• Mechanical Testing: The "ground truth" would be the passing criteria defined by ISO 14801.
• Material Conformance: The "ground truth" would be the specifications in ASTM F136 and ISO 13356.
• Biocompatibility & Sterilization: The "ground truth" would be the specifications in ISO 10993-1, ISO 10993-5, ISO 17665-1, and ISO 14937.

8. The sample size for the training set:

This information is not applicable. There is no AI algorithm being described, and therefore no training set.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

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

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B.

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.

Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.

The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.

Ask a specific question about this device

The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing 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:

• · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
  • · MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• · Paltop Multi Unit Abutment, 5.0mm, max 17°

The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.

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

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

This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's why and what information can be extracted:

• This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
• Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
• Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.

Information that can be extracted or inferred:

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

This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.

(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)

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

• Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
• Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.

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

• Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.

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

• Not applicable. See point 8.

Ask a specific question about this device

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes the regulatory clearance for the TruAbutment DS and TruBase devices, citing substantial equivalence to predicate devices, and includes details about non-clinical testing. However, it does not contain information about a study proving device performance against specific acceptance criteria for AI or algorithmic performance. The studies mentioned are focused on mechanical and biocompatibility testing of the physical dental implant abutments.

Therefore, for aspects related to AI/algorithmic performance, sample sizes, expert ground truth, adjudication, and MRMC studies, the information is not present in the provided document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The document describes "Design Limitations" for both TruAbutment DS and TruBase, which can be interpreted as design acceptance criteria. It also references compatibility and mechanical performance tests.

TruAbutment DS Design Limitations / Reported Performance:

TruBase / Zirconia Superstructure Design Limitations / Reported Performance:

Mechanical Performance:

• Acceptance Criteria: Met the criteria of ISO 14801:2016 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments."
• Reported Device Performance: "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

Sterilization Validation:

• Acceptance Criteria: Met the criteria of ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010.
• Reported Device Performance: Achieved through end-user moist steam sterilization.

Biocompatibility:

• Acceptance Criteria: Met the criteria of ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• Reported Device Performance: Not explicitly stated as "passed" for the subject device, but mentioned it was leveraged from predicate device testing and supports substantial equivalence.

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

• Test Set Sample Size: For mechanical testing (ISO 14801), "worst-case constructs" were subjected to static compression and compression fatigue testing for each compatible OEM implant line. The exact number of samples is not specified.
• Data Provenance: Not specified; the context implies laboratory testing. The document does not refer to real-world patient data for performance evaluation in the context of AI.

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

Not applicable. The tests performed are non-clinical (mechanical, sterilization, biocompatibility) of physical devices, not assessments requiring expert interpretation of data or images.

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

Not applicable for non-clinical, physical device 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

Not applicable. No AI component is described in the performance evaluation section for either TruAbutment DS or TruBase. The software mentioned (3Shape Abutment Designer Software) is for CAD/CAM design, which is a tool for designing the physical device, not an AI for diagnosis or interpretation that would involve human readers.

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

Not applicable. As noted above, the device itself is a physical dental abutment, and its design process involves CAD/CAM software, not a standalone AI algorithm for medical decision-making or image analysis.

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

• Mechanical Testing: Ground truth is established by the specified ISO standards (ISO 14801) and FDA guidance, defining acceptable force and fatigue limits for dental implant systems.
• Dimensional Analysis: Ground truth is against design specifications and reverse engineering of OEM implant-to-abutment connections.
• Sterilization: Ground truth is against ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 standards for sterilization efficacy.
• Biocompatibility: Ground truth is against ISO 10993 standards for biological safety.

8. The sample size for the training set

Not applicable. The document describes a physical medical device and its manufacturing process, not an AI/ML algorithm that requires a training set. The CAD/CAM software aids in design, but the document does not detail its internal development or any associated training sets.

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

Not applicable, as no training set for an AI/ML algorithm is described.

Ask a specific question about this device

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

Keystone Dental Implant Line Platform Diameter (mm) Body Diameter (mm) Genesis 3.8, 4.5, 5.5, 6.5 3.8, 4.5, 5.5, 6.5 PrimaConnex® 1.0 (Straight) 3.5, 4.1, 5.0 3.3, 4.0, 5.0 PrimaConnex® 1.0 (Tapered) 3.5, 4.1, 5.0 3.5, 4.1, 5.0

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC abutments include three abutment designs, MIST IC S-LINK, and MIST IC S-LINK, and MIST IC PREFIT, having connections compatible with three Keystone Dental implant systems. Subject device are provided in three interface connection diameters (SD (3.5 mm), RD (4.1 mm) and WD (5.0 mm)). All subject device abutments have the same connection type to the compatible Keystone Dental implants cleared in K101545 and K051614. Corresponding compatible implant platform diameters range from 3.5 mm to 6.5 mm. Corresponding compatible implant body diameters range from 3.3 mm. All sizes of the compatible Keystone Dental implants have one of the three interface connection sizes (SD, RD, and WD).

All subject device L-LINK and S-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD/CAM customized restoration where the superstructure produced will compose the second part of the twopiece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. The zirconia superstructure will be fabricated using a CAD/CAM process. MIST IC S-LINK has a cut out in the post to accommodate a restoration with an angled screw channel when clinically necessary. MIST IC PREFTT abutments are titanium cylindrical abutments designed for patient specific abutment fabrication using a CAD/CAM process. All patient-specific abutment fabrication on the order of the clinician.

Design parameters for the L-LINK zirconia superstructure are: minimum wall thickness -0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the S-LINK zirconia superstructure are: minimum wall thickness - 0.7 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the PREFIT patient specific abutment are: minimum wall thickness - 0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 30°.

All subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. Zirconia superstructures for subject device abutments are made of Y-TZP conforming to ISO 13356.

All subject device components are provided non-sterile, and are intended to be end-user sterilized.

Ask a specific question about this device

ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:
Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3
Biomet 3i Certain 4.0, 5/4 – Prevail 4/5/4. 5/4
Biomet 3i Certain 5.0, XP 4/5 - Prevail 5/6/5, 6/5
Biomet 3i Certain 6.0, XP 5/6
BioHorizons Internal/Tapered 3.5, 4.5, 5.7
Camlog Screw-line Implant 3.3
Camlog Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0
DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
DENTSPLY Implants OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0
DENTSPLY Implants Osseospeed™ Profile TX 4.5/5.0
DENTSPLY Implants Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4
DENTSPLY Implants Osseospeed™ Profile EV 4.2, 4.8
Keystone Dental PrimaConnex SD 3.3/3.5
Keystone Dental PrimaConnex RD 4.0/4.1
Keystone Dental PrimaConnex WD 5.0
Keystone Dental Genesis 3.8, 4.5, 5.5/6.5
Nobel Biocare NobelActive NP 3.5 - RP 4.3, 5.0
Nobel Biocare NobelReplace NP-3.5 - RP 4.3 - WP 5.0 – 6.0
Straumann Bone Level 3.3 NC - 4.1, 4.8 NC
Straumann Standard Plus 3.5 NN
Straumann Standard / Standard Plus 4.8 RN – 4.8 WN
Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Zimmer Dental Tapered Screw Vent 5.7

Abutments:
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY Implants ATIS Angled Abutment EV
DENTSPLY Implants ATIS Angled Abutment 20°
DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY Implants XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare Multi-Unit Abutment RP
Straumann Bone Level Multi-Base Angled Abutment
Straumann Bone Level Multi-Base Abutment D3.5, D4.5
Straumann RN Abutment Level, WN Abutment Level
Straumann Screw-Retained Abutment 3.5, 4.6
Zimmer Dental Tapered Abutment

The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.

The ATLANTIS™ ISUS Implant Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.

The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.

Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.

In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.

The provided document describes a 510(k) premarket notification for a medical device, specifically the ATLANTIS™ ISUS Implant Suprastructures. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices, rather than a clinical study establishing acceptance criteria in the traditional sense of AI performance metrics like sensitivity, specificity, or AUC.

Based on the document, here's a breakdown of the requested information:

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

Since this is a 510(k) for a dental implant component, the "acceptance criteria" are related to mechanical and material equivalence to predicate devices, and "device performance" refers to its ability to meet these engineering standards. There are no performance metrics like sensitivity or specificity.

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

This information is not applicable or not provided in the context of an AI device. This document is for a physical medical device (dental suprastructures). The testing performed is non-clinical, involving mechanical and dimensional analysis of device components themselves, rather than testing on a "test set" of patient data.

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

This information is not applicable or not provided. "Ground truth" in the context of an AI device, established by experts, is not relevant here as this is a physical medical device. The "ground truth" for this device's performance would be the universally accepted engineering standards for dental prosthetics and the demonstrable properties of the materials and design.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI studies. The testing described is non-clinical performance data (mechanical design analysis, dimensional analysis, static and dynamic compression-bending 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 information is not applicable or not provided. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable or not provided. This is not an algorithm-only device.

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

The "ground truth" here is the established engineering standards for dental prosthetics. This includes:

• Mechanical standards: ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants.
• Material standards: Properties of CPTi, CoCr, Ti-6Al-4V ELI, Ti-6Al-7Nb (as listed for abutment and screw materials).
• Biocompatibility: Demonstrated equivalence to the predicate device (K122424) which had prior biocompatibility testing.
• Design principles: Comparison to existing, legally marketed predicate devices to establish substantial equivalence in intended use and fundamental technology.

8. The sample size for the training set

This information is not applicable or not provided. As this is a physical device submission, there is no "training set" in the context of machine learning. The device's design is "derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription," and then fabricated using computer-assisted manufacturing (CAM).

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

This information is not applicable or not provided. There is no machine learning training set for this device. The "ground truth" for the CAD/CAM design process would be the clinician's prescription and the patient's dental models, which guide the creation of the patient-specific device.

Ask a specific question about this device

The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.

The Genesis Implant System includes implants, and associated surgical, restorative and dental laboratory components. Genesis implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement tooth root, which provides a stable foundation for restorations. Genesis implants are manufactured from Grade 4 titanium, have a tapered or straight cylindrical design with an internal indexing connection, and are available in various platform diameters and lengths. The implants have a macro-, micro- and nano-topography and are treated with the BioSpark process, which results in a hydrophilic surface enriched with calcium and phosphorous ions. The implant collar is micro-roughened and treated with the AnaTite" process, which results in a pink color for enhanced esthetics. The majority of Genesis abutments are manufactured from Grade 5 titanium and are treated with the AnaTite process. Other Genesis abutments are made from Grade 5 titanium/plastic or gold alloy/plastic. Abutments intended for fixed restorations utilize a Grade 5 titanium screw for attachment to the implant. Genesis abutments and associated restorative components are manufactured in a variety of sizes and configurations to be compatible with the implant platforms.

The provided text is a 510(k) summary for the Genesis Implant System, a dental device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. This type of submission generally doesn't include the same kind of detailed acceptance criteria and clinical study results that an AI/software as a medical device (SaMD) would. Therefore, much of the requested information regarding AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table as would be expected for a SaMD that relies on specific performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices through a combination of material properties, design characteristics, and non-clinical testing confirming those characteristics are maintained or improved.

The device performance is reported in qualitative terms, demonstrating properties consistent with or superior to predicate devices.

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

This document describes non-clinical testing (bench studies, in vitro studies, animal studies). There is no "test set" in the context of human data or AI model evaluation.

• Fatigue Testing: Conducted in accordance with ISO 14801 and FDA Special Controls Guidance. The number of implants/abutments tested is not specified.
• Insertion Torque Bench Study: Used "simulated bone material." The sample size is not specified.
• AnaTite In Vivo Study (Coloration): "An in vivo study has shown..." No details on sample size or species.
• BioSpark Animal Study (Osseointegration): "significant bone-to-implant-contact (BIC) in the cortical bone of sheep at 4 weeks." Sample size not specified.
• BioSpark In Vitro Studies: These involved "cp-Ti disks" (commercially pure titanium disks). Sample sizes for these experiments are not specified.

Data Provenance:

• Bench studies (fatigue, insertion torque)
• In vitro studies (cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, proliferation, differentiation)
• Animal studies (sheep for BIC, unspecified animal for AnaTite coloration)
• Published literature (for mineralization potential)

All these are non-clinical, controlled experiments. No human data (retrospective or prospective) is mentioned for the performance evaluation of the device itself.

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

Not applicable. This is not an AI/SaMD submission evaluating human data against expert ground truth. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, microscopy, spectroscopy, biological assays, bone-to-implant contact measurements).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no human-annotated test set requiring adjudication in this context.

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 is not an AI/SaMD. There are no "human readers" or "AI assistance" relevant to an MRMC study described in this submission.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluations relies on:

• Physical measurements and material science: e.g., chemical composition (energy dispersive spectroscopy, sputter mass spectroscopy), surface topography (scanning electron microscopy), wettability (contact angle testing), mechanical strength (fatigue testing per ISO 14801).
• Biological assays in vitro: measuring cellular metabolic activity, osteoblast proliferation, fibronectin absorption, adhesion, and differentiation.
• Histomorphometry in animal models: bone-to-implant contact (BIC) in sheep.
• Visual assessment (in vivo): comparing pink coloration to natural gingival tissue.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/SaMD. There is no concept of a "training set" for physical device testing. The "learning" for the device design would come from long-standing scientific and engineering principles in dental implantology, feedback from predicate devices, and internal R&D.

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

Not applicable. No training set in the AI sense. The design and material choices are informed by existing scientific knowledge, performance of predicate devices, and internal research and development validated by the non-clinical tests described.

Ask a specific question about this device