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MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function. The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths. The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone. The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients. Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.

The provided document is a 510(k) Summary for the MIS LYNX Conical Connection Implant System. It details the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical testing.

However, the document does not describe a study that proves the device meets specific acceptance criteria based on clinical performance or an AI/algorithm-driven component. Instead, it focuses on non-clinical testing (fatigue, biocompatibility, sterilization, shelf-life, and MRI compatibility) to demonstrate the safety and effectiveness of the dental implant system itself, relative to predicate devices. There is no mention of an AI component, human-in-the-loop study, or any performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI-driven medical device.

The section titled "8. Clinical Tests Summary and Conclusion" explicitly states: "Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Therefore, based solely on the provided text, I cannot generate a response that fulfills the request for acceptance criteria and study details related to an AI/algorithm's performance because such information is not present in the document. The device in question is a dental implant system, not a software device that would typically have acceptance criteria focused on AI performance metrics.

To directly answer your prompt, given the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes non-clinical testing for a dental implant system, not performance metrics for an AI/algorithm. The "acceptance criteria" for the non-clinical tests are implied as meeting the standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 series for biocompatibility) and demonstrating equivalence or superiority to predicate devices. For example, "Fatigue testing... confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices." And "Test results met acceptance criteria" for shelf-life testing. However, specific numerical acceptance criteria and reported performance values for each of these tests are not provided in a table format within this summary.

2. Sample sized used for the test set and the data provenance:
Not applicable for an AI test set. The document refers to samples used for non-clinical tests (e.g., implants for fatigue testing, materials for biocompatibility). Specific sample sizes are not detailed, but the tests are conducted on representative devices. Data provenance is implied as being from the manufacturer's internal testing as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/imaging device requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm providing standalone performance.

7. The type of ground truth used:
Not applicable.

8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

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NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NUVENTUS NV.CTM Dental Implants are compatible for use with the following prosthetic interfaces.

The purpose of this submission is to obtain marketing clearance for NUVENTUS NV.C™ Dental Implant System endosseous dental implants and cover screws. The dental implants are intended to interface with Internal Conical Connection (CC) prosthetic components from Nobel Biocare.

A summary of the subject device implant and the associated compatible OEM prosthetic connection is provided in the table Summary of Subject Device Implant Designs.

| Subject Device Implant
Description | Platform
Designation | Length (mm)* | | | | | OEM Prosthetic Compatibility
(K071370, K161435, K161416) |
|---------------------------------------|-------------------------|--------------|----|------|----|----|-------------------------------------------------------------|
| Implant, NV.C, Platform NP, Ø3.5 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform NP, Ø4.3 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform RP, Ø5.0 mm | RP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, RP Platform |

The subject device dental implants have a conical abutment seating surface on the interior of the implants and internal threads so that prosthetic components may be fastened to the implant. The implant lines have two (2) abutment interface connections with internal geometric features to allow for rotational resistance of the mating abutment. All subject device implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

The external surface of all subject device implants is threaded, and the implant body tapers at the apical end. which includes two (2) cutting flutes. At the coronal end. the Ø4.3mm and Ø5.0mm (body diameter) subject device implants have two (2) fluted features on the body of the implant spaced 180° apart. Each fluted feature has horizontal grooves spaced vertically within the flute surface. The number of grooves within each flute ranges from 3 to 5 and the actual number is a function of the implant length. The Ø3.5mm (body diameter) subject device implants do not have fluted features. The endosseous surface of all subject implants is textured by blasting with resorbable media

The subject device implants are compatible with prosthetic components that interface with Nobel Biocare Internal Connection implants. The subject device cover screws are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 and are anodized to identify the prosthetic platform (NP and RP).

The compatible Nobel Biocare Internal Conical Connection prosthetic components (NP and RP platforms) include cover screws, healing abutments, temporary abutments esthetic abutments, straight multi-unit abutment, and angled multi-unit abutments.

All subject device implants and cover screws are individually packaged and are provided sterile.

The FDA document provided pertains to a 510(k) premarket notification for a dental implant system (NUVENTUS NV.C™ Dental Implant System). This document focuses on demonstrating substantial equivalence to predicate devices through engineering analysis, non-clinical performance data (e.g., mechanical testing, biocompatibility), and a review of clinical literature. It does not present a study proving the device meets specific acceptance criteria based on AI/ML performance metrics, expert consensus, or clinical outcomes from a new study specific to an AI device.

Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details because this information is not present in the provided text.

The document discusses performance data related to the dental implant itself (e.g., sterilization, biocompatibility, mechanical testing, surface analysis), and clinical literature data to support the substantial equivalence of the implant's design features with established predicate devices. The "Clinical Testing Literature Table" outlines existing studies on predicate implants, reviewing their clinical outcomes (like bone level changes) to support the subject device's design principles. This is not the same as a study testing an AI device's performance against defined acceptance criteria.

In summary: The provided text is a 510(k) submission for a dental implant system, not an AI/ML-based medical device. Thus, the requested details specific to AI/ML device performance and validation studies are not available in this document.

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JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations

JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.

In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.

JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.

The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.

Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.

The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.

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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.

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MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved, and the occlusal load is appropriate.

Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

The subject MIS Dental Implant Systems are endosseous dental implant devices which are modified as subject to this premarket notification with a revised sterile packaging configuration. There are no modifications subject to this premarket notification which relate to the geometric or material composition design of the subject dental implant devices themselves. The individual product variants of the MIS Dental Implant Systems which are modified as subject to this premarket notification will be rebranded "MIS CLEAR". The subject implants are identical to the predicate and reference MIS implant systems in terms of their indications for use, design, constituent materials and manufacturing process. The subject MIS Dental Implants Systems only differ in their final packaging configuration, as subject to this premarket notification. The subject, predicate and reference MIS Dental Implants Systems are supplied in a double tube packaging configuration, wherein the outer tube serves as the sterile barrier, and the implant device is located within the inner tube. While the predicate and reference MIS Dental Implants Systems are supplied within a "dry" inner package tube, the subject devices as modified in this premarket notification are supplied in a modified inner tube containing liquid, in the form of NaCl solution. The liquid environment is intended to maintain the super-hydrophilic property (contact angle exhibited by water in contact with the surface is equal to zero degrees) of the subject MIS Dental Implants Systems, as subject to this premarket notification, until their use in patients. The outer tube serving as the sterile barrier is unchanged compared to the predicate and reference devices.

The provided context describes a 510(k) premarket notification for MIS Dental Implant Systems. The primary change being assessed is a modification to the inner packaging of the implants, specifically, the introduction of an NaCl solution to maintain the super-hydrophilic property of the implants.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria. Instead, it describes various non-clinical tests performed and states that the data supports the desired outcome. The device's performance, as reported, is that it meets the requirements of these tests.

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

The document does not specify the sample sizes used for each non-clinical test mentioned (e.g., number of implants tested for cytotoxicity).

The data provenance is from non-clinical bench testing performed to support this premarket notification. The country of origin of the data is not specified, but the applicant, Dentsply Sirona, is based in York, Pennsylvania, USA, and MIS Implants Technologies Ltd. (a Dentsply Sirona company) is listed as the manufacturer.

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

This section is not applicable because the studies detailed are non-clinical (bench testing) rather than clinical studies involving human observers or expert interpretation. Therefore, there was no ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable as the studies are non-clinical bench tests and do not involve human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence..."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the device is a physical dental implant system, not an algorithm or AI software for which standalone performance would be assessed.

7. Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" or reference criteria would be defined by the standards and methods used for each test:

• Cytotoxicity: Negative control or established biocompatibility standards.
• Chemical Characterization: Baseline material composition and absence of unexpected leachables.
• Sterilization: Sterility assurance level (SAL) of 10^-6^ as per ISO 11137-1:2015 and ISO 11137-2:2015.
• Transportation: No damage or compromise to packaging or device integrity after simulated transport, as per ASTM 4332-14 and ASTM D 4169-16.
• Hydrophilicity: Maintenance of super-hydrophilic properties (contact angle of water is zero degrees).
• Fatigue Testing: Mechanical endurance limits established by ISO 14801:2016 for dental implants (referenced from predicate devices).

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm that requires training data.

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

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

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MIS Ti-base abutment is a titanium base placed onto MIS dental implants to provide support for customized cement-retained or screw retained single or multiple-unit restorations.

It is used with a digitally designed mesostructure. MIS Ti-base and the mesostructure make up a two-piece abutment used in conjunction with MIS dental implants, to be placed in the upper or lower jaw arches, in order to restore masticatory function.

Narrow platform Ti-bases are indicated for use only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.

MIS short implants are to be used only with straight abutments.

Mesostructures for use with the MIS Ti-base abutment are to be made from inCoris ZI, designed and manufactured using Sirona CEREC SW version 4.6.1 Software.

MIS Ti-base abutments are intended for use with the following MIS implants:

C1 conical connection implant system. V3 conical connection implant system. SEVEN internal hex implant system. M4 internal hex implant system and Lance+ internal hex implant system.

The subject MIS Ti-base abutments are endosseous dental implant abutments intended to be connected to MIS dental implants and used to support CAD/CAM customized cement-retained or screw retained single or multiple-unit restorations.

MIS Ti-base abutments consist of a titanium base and a prosthetic screw, both made of TI-6AI-4V ELI complying with ASTM F136. The prosthetic screw tightens the finished CAD/CAM abutment to the dental implant.

MIS Ti-base abutments are the bottom-half/base of a two-piece custom zirconia-titanium abutment consisting of a zirconium coping/mesostructure and a titanium base.

The top-half custom zirconia coping/mesostructure or crown is intended to be fabricated from Sirona inCoris ZI zirconium oxide ceramic block and designed and milled using Sirona chairside Dental CAD/CAM System, with software version: CEREC SW version 4.6.1. The mesostructure design will be subject to the Sirona system controls, such as: A maximum angulation of 20° and minimum wall thickness of 0.5mm. The InCoris Zi mesostructure is to be cemented to the subject MIS Ti-base abutments using PANAVIA F 2.0 dental cement in order to complete the two-piece, CAD/CAM abutment.

lt is not permitted to reduce the Ti-base's diameter, shorten the Ti-base or modify its implant-abutment connection and emergence profile in any way.

The subject pre-fabricated titanium base abutment is designed with interface compatibility to specific MIS dental implant systems. The subject MIS Ti-base abutments are MIS conical connection and internal hex connection Ti-base abutments, and their connection is compatible with MIS conical connection C1 and V3 implants, and MIS SEVEN, M4 and Lance+ internal hex implants, which are not subject to this submission and were previously cleared.

Here's a breakdown of the requested information based on the provided FDA 510(k) document for the MIS Ti-base Abutment.

Important Note: This document describes a dental abutment, not an AI/ML device. Therefore, many of the requested fields regarding AI/ML-specific study aspects (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of medical device submission. The FDA 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing.

Device Name: MIS Ti-base Abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML medical devices like this, "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device, often through mechanical and material testing against established standards. The performance is assessed against these standards and comparative data from the predicate.

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

• Sample Size for Test Set:
  • For Fatigue Testing (ISO 14801:2016), samples were tested. While a specific number isn't explicitly stated on the provided pages, ISO 14801 typically requires a sufficient number of samples (often 5-10 per test group) to achieve statistically meaningful results for fatigue curves. The document refers to testing "worst case abutments" from both narrow and standard platforms.
  • For Sterilization Testing, an unspecified number of representative samples would have been used for validation.
  • For Software Verification & Validation, the "test set" would be various design scenarios and inputs used to confirm software functionality and adherence to design constraints. The specific "sample size" of test cases is not quantified here.
• Data Provenance: The studies were non-clinical performance tests conducted by MIS Implants Technologies (manufacturer). The location of testing is not specified, but the manufacturer (Dentsply Sirona / MIS Implants Technologies Ltd.) is located in the USA (York, Pennsylvania) and Israel, respectively. These are prospective tests performed specifically for this 510(k) submission.

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

• N/A (Not Applicable for this device type). Ground truth based on expert consensus is typically relevant for AI/ML diagnostic or prognostic devices. For a dental implant abutment, "ground truth" is established by adherence to engineering standards, material specifications, and mechanical performance limits. The "experts" involved would be engineers and quality control personnel responsible for developing and conducting the tests, interpreting standard requirements, and designing robust products. Their qualifications would be in relevant engineering, materials science, and quality assurance fields.

4. Adjudication Method for the Test Set

• N/A (Not Applicable for this device type). Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for AI/ML devices, where human readers (often physicians) independently evaluate medical images or data, and a tie-breaking or consensus process is needed. For mechanical and software performance testing, adjudication is based on objective measurements and established pass/fail criteria from international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is mechanical and procedural, not algorithmic. The software component (CEREC SW) is for design and manufacturing, not for automatic diagnosis or interpretation.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established by:
  • Engineering Standards: Adherence to established international voluntary consensus standards (e.g., ISO 14801:2016 for fatigue, ANSI/AAMI/ISO 17665 for sterilization).
  • Material Specifications: Compliance with material standards (e.g., ASTM F136 for TI-6Al-4V ELI).
  • Validated Design & Manufacturing Parameters: Verification that the CAD/CAM software maintains design limitations and that the manufacturing process yields correct physical properties.
  • Predicate Device Performance: Comparative performance data against the legally marketed predicate devices serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no "training set." The development process relies on engineering design, material science, and established manufacturing practices, not machine learning.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable.

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MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function.

When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The proposed devices consist of dental abutments and represent a line extension to the MIS CONNECT Conical Connection System.

The proposed MIS CONNECT Conical Connection Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations in the upper or lower jaw and used in conjunction with MIS conical connection implants, MIS V3 and MIS C1 (K163349 and K112162, respectively).

The abutment is placed above the bone level and within the gingival tissue, and is designed to be fitted with a variety of complementary abutment superstructures, including caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject abutments.

Once connected to the implant, the MIS CONNECT Conical Connection Abutment is not intended to be removed.

The abutments are provided in 4.0 and 5.7 mm platform diameters, with an angulation of up to 20°, and at gingival heights of 1.5, 2.0, 3.0, and 4.0 mm.

The proposed MIS CONNECT Conical Connection Superstructures are mounted over the proposed and predicate MIS CONNECT Conical Connection Abutment (Ø4 mm or Ø5.7 mm) and intended for use as an aid in prosthetic dental restoration. The proposed superstructures consist of healing caps, temporary abutments, aesthetic abutments, final abutments, and angulated abutments. Prosthetic screws are included as a system component for use with the subject superstructures.

The provided text describes a 510(k) premarket notification for a dental device, the "MIS CONNECT Conical Connection System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness or establishing performance criteria based on an AI model or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study components related to AI/ML medical devices (such as MRMC studies, ground truth establishment for a test set, etc.) are not applicable to this submission.

The "device" in this context is a physical dental implant component (abutments and superstructures), not a software or AI/ML-driven diagnostic tool. The "acceptance criteria" here refer to demonstrating that the new device is as safe and effective as the predicate device.

Here's an analysis of the "acceptance criteria" and "study" as implied by a 510(k) submission for a physical medical device, addressing the relevant points from your request:

Device Name: MIS CONNECT Conical Connection System (dental abutments and superstructures)

Nature of Device: Physical dental implant components, not an AI/ML-driven diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a physical device like this, "acceptance criteria" typically relate to demonstrating the new device performs equivalently to the predicate devices through non-clinical testing (e.g., mechanical testing, biocompatibility, sterilization). There are no "performance metrics" in the sense of accuracy, sensitivity, or specificity as would be for a diagnostic AI.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. For physical device performance testing (fatigue, sterilization), samples would refer to the number of physical devices or batches tested, not patient data. The document mentions "worst case representative samples."
• Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). The data submitted for this 510(k) are from non-clinical laboratory testing (e.g., mechanical fatigue testing, sterilization validation).

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

• Not Applicable. This is not a study assessing diagnostic accuracy or clinical decision-making based on expert consensus. The "ground truth" for mechanical performance is established by engineering standards (e.g., ISO 14801 for fatigue) and laboratory measurements.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" of patient cases requiring adjudication as in a diagnostic accuracy or clinical trial setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially those involving human readers and AI assistance). This 510(k) is for a physical dental implant component, not a diagnostic tool, and involves no human readers or AI assistance in its function.

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

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

7. The Type of Ground Truth Used

• For Fatigue Testing: Ground truth is defined by the ISO 14801:2016 standard specifications for dynamic fatigue of endosseous dental implants. The "truth" is whether the device withstands specified forces for a specified number of cycles.
• For Biocompatibility: Ground truth is established by ISO 10993-1, and the "truth" is that the materials and manufacturing processes are identical to a previously cleared device.
• For Sterilization: Ground truth is defined by ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat) standards, ensuring a specific sterility assurance level.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device requiring machine learning training.

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

• Not Applicable.

Summary of Study Proving Substantial Equivalence:

The study proving the device meets the acceptance criteria is a collection of non-clinical performance tests and comparisons to predicate devices, rather than a clinical trial or a study assessing diagnostic accuracy. The key components of the "study" are:

• Fatigue Testing: Performed on "worst case representative samples" of the proposed abutments and superstructures according to ISO 14801:2016. The results demonstrated comparable performance to ensure the new dimensions/designs maintain mechanical integrity.
• Biocompatibility Assessment: No new testing was conducted. Substantial equivalence was demonstrated by asserting that the proposed device uses "identical materials" and is "manufactured in the identical manufacturing facility and under the identical manufacturing processes" as the primary predicate device (K173326), and that the intended use and patient contact are identical. This relies on the prior biocompatibility clearance of the predicate.
• Sterilization Validation: For both sterile and non-sterile configurations (for end-user sterilization), validation was conducted on "worst-case construct" samples following ISO 11137-2:2013 (radiation) and ANSI/AAMI/ISO 17665-1:2006/(R)2013 (moist heat), respectively, to achieve a SAL of 10^-6.
• Packaging and Shelf Life: Assessed by demonstrating identity to the predicate device's packaging and material, therefore relying on the predicate's established shelf-life data.

Key Conclusion from the Submission:

"The comparison of the indications for use, technological characteristics, with the inclusion of the results of non-clinical testing, support a conclusion of substantial equivalence of the proposed MIS CONNECT Conical Connection Abutments and Superstructures to the predicate devices." (Page 13)

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The ATLANTIS® Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS® Abutment to the endosseous implant.

The ATLANTIS® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS® Crown Abutment to the endosseous implant.

The ATLANTIS® Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis. in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.

ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.

ATLANTIS® products are compatible with the implants shown in the table below.

Implant Diameter V3: Ø3.30 mm C1: Ø3.30 mm C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm C1: Ø5.0 mm

The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments.

The proposed devices are compatible with:

• MIS V3 conical connection narrow and standard dental implant diameters Ø3.3, 3.9, 4.3 and a. 5.0 mm (K163349)
• b. MIS C1 narrow, standard and wide platform conical connection implant diameters Ø3.3, 3.75, 4.2, and 5.0 (K172505, K112162)

Refer to Table 5.1 for the implants the proposed ATLANTIS® Abutments for MIS Conical Connection Implant are compatible with.

| Table 5.1 Implant systems which proposed ATLANTIS® Abutments for MIS Conical Connection

The abutments are available in four (4) designs:

• ATLANTIS® Abutment for MIS Conical Connection Implant, a.
• ATLANTIS® Crown Abutment for MIS Conical Connection Implant, b.
• ATLANTIS® Conus Abutment (Custom or Overdenture) for MIS Conical Connection C. Implant
• d. ATLANTIS® Healing Abutment for MIS Conical Connection Implant

The materials composition of the proposed devices are described below in Table 5.2.

The maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutments are provided straight and up to 30° of angulation.

All proposed abutments are patient-specific abutments fabricated using CAD/CAM technology by Dentsply Sirona Implants. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS® Abutments for MIS Conical Connection Implant can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment for MIS Conical Connection Implant or ATLANTIS® Conus Abutment for MIS Conical Connection Implant), fabricated as a single tooth final restoration onto which porcelain is added ATLANTIS® Crown Abutment for MIS Conical Connection Implant) or fabricated with a short core for soft tissue healing (ATLANTIS® Healing Abutment).

This document describes the Dentsply Sirona ATLANTIS® Abutment for MIS Conical Connection Implants and its substantial equivalence to predicate devices, based on non-clinical performance data. There is no information provided about an AI/ML device in this document, so the questions regarding AI/ML device performance are not applicable.

Here's an analysis based on the provided text, focusing on the mechanical and material aspects of the device, and addressing the questions where applicable:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance metrics to directly compare. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The performance is assessed against established standards and predicate device characteristics.

However, based on the non-clinical performance data section, we can infer some criteria and the types of performance reported:

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 explicitly state the sample size for the "test set" in terms of number of abutments or implants used, nor does it specify the country of origin or whether the data was retrospective or prospective for the non-clinical tests. It refers to "fatigue testing" and "geometric compatibility analysis," which are bench tests.

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 question is not applicable as the document describes a dental abutment, not an AI/ML device requiring expert ground truth for interpretation of images or other data. The "ground truth" for this device would be its physical and mechanical properties, assessed through engineering and materials testing, not expert review.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical or image interpretation studies, which are not relevant to the non-clinical bench testing described for this dental abutment.

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 document is about a dental implant abutment, not an AI-assisted diagnostic or therapeutic device. There are no human readers or AI involved in its function.

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

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

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 and material properties, and comparison to legally marketed predicate devices' performance.

• Fatigue Resistance: Ground truth would be defined by the specified load cycles and failure criteria outlined in ISO 14801.
• Geometric Compatibility: Ground truth is the precise dimensional specifications of the OEM implant bodies, OEM abutments, and OEM screws.
• Sterilization: Ground truth is the successful validation according to ISO 17665-1.
• Biocompatibility: Ground truth is the conformity of materials to ASTM F136 and the established biocompatibility of the predicate device (K172225) using identical materials and processes.
• Design Specifications: Ground truth lies in the adherence to predefined maximums and minimums for angulation, height, and width.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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Atlantis® 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® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: (list of compatible implants and abutments follows in the document)

Atlantis 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. The subject Atlantis suprastructures include new compatible interfaces of the currently marketed Atlantis suprastructures made by milling (K163350) or additive manufacturing techniques (K163398) for the following abutments and implants: (list of compatible implants and abutments follows in the document). The design of the subject device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the Atlantis suprastructures are fabricated using additive manufacturing (AM) to produce a customized, patient-specific device. The Atlantis suprastructures subject of this bundled premarket notification are fabricated by milling or by additive manufacturing techniques.

The milled Atlantis suprastructures are composed of commercially pure titanium (CPTi) or cobalt chrome alloy and are available in following design types: Bar, Bridge, Hybrid and 2 in 1. Additional design limitations regarding minimum required segment cross-section, maximum span between implants and maximum cantilever extension, have been introduced for Atlantis suprastructures made by milling.

Atlantis suprastructures made by additive manufacturing are provided as Bridge and Hybrid types with optional mechanical retention (pin or cell retention) on the surface. The manufacturing of the Bridges and Hybrids of the Atlantis suprastructures by an additive manufacturing technique start from a titanium alloy and a cobalt-chrome alloy in powder form.

Milled variants of the subject Atlantis® suprastructures are offered in versions composed of unalloyed titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and cobalt chromium alloy (CoCr) conforming to ISO 22674 (Dentistry – Metallic materials for fixed and removable restorations and appliances). Variants of the subject Atlantis® suprastructures which are fabricated utilizing additive manufacturing are manufactured using titanium alloy powder or cobalt chromium alloy powder conforming to ISO 22674 (Dentistrv – Metallic materials for fixed and removable restorations and appliances).

Fixation screws for use with the subject Atlantis® suprastructures are composed of titanium alloy confirming to ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications).

Screws are available for all compatible implants and abutments to screw the Atlantis suprastructures into the implant or onto the abutment.

Labeling is modified by providing a separate compatibility chart which lists all implants and abutments compatible with the Atlantis suprastructures.

This FDA 510(k) summary for the Dentsply Sirona Atlantis® suprastructures does not describe a clinical study for acceptance criteria. Instead, it argues for substantial equivalence to existing predicate devices based on non-clinical performance data and a comparison of indications for use, design, manufacturing techniques, and materials.

Here's an analysis of the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on the equivalency to previously cleared devices. Therefore, explicit "acceptance criteria" in the sense of predefined thresholds for a new study are not presented. Instead, the performance is demonstrated through comparisons to the predicate devices and by referencing a previous fatigue test.

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

The document mentions "cross-sectional material analysis" and "geometric measurement data and statistical compatibility analysis." However, it does not provide specific sample sizes for these analyses. The data provenance is implied to be internal testing conducted by Dentsply Sirona or its subsidiaries, and it's non-clinical. There is no mention of country of origin for this testing data.

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

Not applicable. This device's clearance is based on non-clinical engineering and material testing, and substantial equivalence to existing devices, not a clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is a dental implant suprastructure, not an imaging AI device where MRMC studies are typically performed.

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

No, this is a physical medical device. The "algorithm" aspect refers to the CAD design process, but the testing focuses on the resulting physical product's performance and compatibility, not an AI algorithm's diagnostic performance.

7. The Type of Ground Truth Used:

For the evaluation of the new compatible interfaces and materials, the "ground truth" is defined by:

• Engineering specifications and dimensional accuracy.
• Material property standards (ASTM F67, F136, ISO 22674).
• Performance standards, particularly ISO 14801 for fatigue testing.
• Comparison to the established performance of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set for an AI algorithm. The CAD design uses pre-programmed libraries and patient-specific scans, but "training set" in the context of machine learning is not relevant here.

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

Not applicable, as there is no "training set" in the machine learning sense described for this device. The design process is CAD-based, utilizing established engineering principles and material science.

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OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;

Dental Implants:

Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);

Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;

RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;

Dental Abutments:

Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.

The provided document is a 510(k) Premarket Notification summary for the OsteoReady® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/ML-driven medical device.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML performance are not present in this document.

The document details the device's technical specifications, materials, and intended use, and then compares them to predicate devices to argue for substantial equivalence. The "performance" mentioned in the document refers to non-clinical bench testing (e.g., sterilization, shelf life, fatigue, biocompatibility) rather than clinical performance metrics typically associated with AI/ML device validation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

The document does not define explicit quantitative acceptance criteria for clinical performance that would typically be seen for an AI/ML device, nor does it report clinical performance metrics. Instead, the "performance" discussed relates to non-clinical bench testing.

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

This information is not provided as the submission focuses on substantial equivalence based on material properties, design, and non-clinical bench testing, not clinical studies with test sets of patient data for an AI/ML device.

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 provided. Ground truth for an AI/ML device performance study would typically involve expert annotations or pathology reports, which are not relevant to this type of 510(k) submission for a dental implant system.

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

This information is not provided as no clinical test set for performance evaluation of an AI/ML device was conducted or reported.

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 provided. This type of study is specifically relevant to AI/ML devices that assist human readers, which is not the nature of the OsteoReady® Dental Implant System.

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

This information is not provided. This refers to AI/ML algorithm performance, which is not applicable to a physical dental implant system.

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

The "ground truth" in this context is the conformity to established engineering and material standards through non-clinical testing (e.g., ISO, ASTM, USP standards). There is no "ground truth" derived from clinical patient data or expert consensus in the sense of an AI/ML device.

8. The sample size for the training set

This information is not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.

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

This information is not provided as there is no training set mentioned or relevant to this type of device.

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