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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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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant.

This is a Premarket Notification (510(k)) summary for the IPD Dental Implant Abutments. This document does not describe a study proving the device meets acceptance criteria as would be found in a clinical trial for a novel AI device with specific performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on bench testing and engineering analysis.

Here's an breakdown of the information provided, tailored to your request, but emphasizing that this is not a typical AI/ML performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for dental abutments, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity for an AI model), but rather as compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to successful completion of various non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data or AI model test sets. The "test set" here refers to the physical samples of the IPD Dental Implant Abutments (and their components, potentially in various configurations) that were subjected to the specified bench and biocompatibility tests. The exact number of physical abutments, screws, or zirconia superstructures tested for each specific criterion is not detailed in this summary but would be found in the full test reports.
• Data Provenance: Not applicable in the context of country of origin for patient data. The tests were performed on the manufactured device components. The materials are specified (e.g., Titanium alloy conforming to ISO 5832-3).

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

Not applicable. "Ground truth" in this context would generally refer to expert-derived labels for clinical data, which is not part of this 510(k) submission. The "truth" for the performance tests is established by adherence to recognized international standards (e.g., ISO, FDA Guidance) and objective measurements from engineering or biological tests.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers or expert labelers of clinical data, which is not relevant here. The evaluation criteria for the bench tests are objective and defined by established 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 device is a dental implant abutment, not an AI software. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.

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

No. This is a physical medical device (dental abutments), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization).
• Engineering specifications and dimensional analysis to ensure compatibility with other specified dental implant systems.
• Validated digital dentistry workflow parameters (e.g., minimum gingival height, wall thickness, post height, angulation for zirconia superstructures), which are based on established dental prosthetic principles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is used for this physical device.

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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.

Compatible Implant Systems: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1

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 Straumann® Bone Level SC Implant System, BioHorizons® Tapered Internal Implant System and MIS® C1 Implant System. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to fabricate one-piece, alltitanium, 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 zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is prescribed by a clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. 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 and used in conjunction with the OEM BioHorizons® Tapered Internal and OEM MIS® C1 multi-unit abutment. 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 multi-unit 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 text describes a medical device called "Inclusive® Titanium Abutments" and details its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The document is a 510(k) summary for a dental implant abutment, which is a physical component, not a software device or an AI/ML powered device. The "performance data" section focuses on physical and material properties (Biocompatibility Evaluation, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, Use in MR Environment) to demonstrate substantial equivalence to a predicate device, as opposed to functional performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document discusses performance related to physical properties and material compatibility, not AI/ML metrics.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the AI/ML sense. "Ground truth" here relates to established standards for material science and dental mechanics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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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. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific 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. The system also includes a TruBase screw for fixation to the implant body.

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. The TruBase screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.

The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.

Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.

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

The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.

• Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
• Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.

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

This information is not applicable to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.

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

Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.

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

Not applicable. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical dental implant abutment, not an AI algorithm.

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

The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.

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MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 stability is achieved and the occlusal load in appropriate.

Narrow implants (03.3mm) 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 Lance+ Conical Connection Implant are dental implants with a cvlindrical and conical shaped outer profile. The implants have an internal conical implant-abutment connection geometry with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The conical implant-abutment connection is identical to the internal conical connection geometry incorporated in the design of the reference device MIS C1 Conical Connection Implants (K172505). The implant abutment connection surface of the MIS Lance+ Conical Connection Implant is anodized for coloring coding purposes to indicate the platform. The color coding is identical to the reference devices MIS C1 Conical Connection Implant System (K172505).

The MIS Lance+ Conical Connection Implants are intended to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments and screwretained abutments, which were previously cleared for use with the MIS C1 Conical Connection Dental Implant System (K172505 for NP abutments and K112162 for SP and WP abutments). These abutments are manufactured with a conical connection compatible with the implants interface. Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. The abutments in combination with two-stage endosseous implants are intended to be used as a foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions. No new Abutments are being proposed as part of this submission.

In addition, the proposed MIS Lance+ Conical Connection Implants will be provided in a wet package configuration immersed in NaCl solution as cleared under K200102 and branded as "CLEAR". The MIS CLEAR Lance+ Conical Connection Implants which are intended to be packaged in NaCl solution are not anodized.

The provided text is a 510(k) summary for a dental implant system (MIS Lance+ Conical Connection Dental Implant System) seeking FDA clearance. It describes the device, its intended use, and comparison to predicate devices, focusing on non-clinical performance data to demonstrate substantial equivalence.

There is no information in the provided text regarding acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device submission.

The document discusses:

• Device Type: Dental implants (physical medical device, not an AI/ML software device).
• Performance Testing: Mechanical fatigue testing (ISO 14801:2016), biocompatibility, sterilization, and shelf-life testing. These are standard tests for physical implants.
• Comparison to Predicate Devices: The submission aims to demonstrate substantial equivalence to existing dental implants (MIS Lance+ Internal Hex Dental Implant System and MIS C1 Conical Connection Dental Implant System).
• Absence of Clinical Data: The document explicitly states, "No human clinical data were included to support substantial equivalence."
• Absence of AI/ML components: The device described is a physical dental implant. There is no mention of any AI or machine learning components.

Therefore, I cannot extract the requested information (acceptance criteria for AI/ML performance, study details for AI/ML, human expert involvement, MRMC studies, standalone AI performance, ground truth for AI, training/test set sizes, etc.) from this document, as it pertains to a different type of medical device lacking AI/ML features.

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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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