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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 compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F-136 Standard. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5 mm, 4.5 mm, 5.5 mm, and 7.0 mm Ø sizes.

The provided document is a 510(k) summary for a medical device called Inclusive® Titanium Abutments. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials. As such, it does not detail a clinical study with acceptance criteria in the manner typically associated with AI/ML device evaluations.

Instead, the document details non-clinical testing to show equivalence. Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" in the context of this regulatory submission:

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

The document does not explicitly present "acceptance criteria" in a quantitative, measurable table as one might expect for a diagnostic AI/ML device. However, the overall acceptance criterion for this submission is substantial equivalence to predicate devices. This is demonstrated by comparing key characteristics and performance aspects.

Here's a table based on the "Comparison of Devices" section, where "performance" is reinterpreted as "similarity to predicate devices" and "acceptance" is implied by the "Same" outcome, indicating that the characteristic is equivalent or acceptable compared to the predicate.

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

The document describes non-clinical testing for mechanical performance, not a clinical test set with human subjects or patients.

• Sample Size: Not explicitly stated as "sample size" in terms of number of patients or cases. The testing involved "finished assembled implant/abutment systems" and considered "worst case scenarios." The specific number of abutments or systems tested for Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal device testing performed by Prismatik Dentalcraft, Inc.

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

Not applicable. This device is an endosseous dental implant abutment, a mechanical component. Ground truth is established through engineering and material science standards and physical testing, not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the traditional sense for this type of non-clinical device testing. Performance is evaluated against engineering standards and methods.

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/ML device or a device that impacts human reading performance.

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

Not applicable. This is not an AI/ML device. The device performs as a standalone mechanical component for dental implants.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is based on:

• Engineering Standards: Specifically, "FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'".
• Physical Measurements and Mechanical Testing: Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing.
• Material Specifications: Adherence to "Ti-6AL-4V ELI (ASTM F-136) Standard."
• Sterilization Standards: ANSI/AAMI ST79 and ISO 17665-1.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.

This looks like a 510(k) premarket notification for a dental implant system. Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The application states that the new device, the ANKYLOS® C/X Implant 6.6 mm, is a line extension of an already cleared device and has largely similar characteristics to its predicate device (K083805 - ANKYLOS® C/X Dental Implant System). The primary acceptance criteria for this type of submission are typically demonstrating substantial equivalence to a legally marketed predicate device, especially in terms of safety and effectiveness.

Here's a table based on the provided "Similarities and Differences" section and the described non-clinical performance data to outline the criteria and the device's performance against them:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many implants were used for fatigue testing or CAD analysis. It simply states "Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device" and "surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively." For a 510(k) submission, especially for a line extension, the focus is often on representative samples demonstrating conformance to standards rather than large statistical cohorts typical of clinical trials.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of mechanical testing (fatigue, CAD), it's highly likely this was laboratory-based, prospective testing rather than clinical data.

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

• This type of submission focuses on non-clinical performance (mechanical testing and CAD analysis). Therefore, no external experts or clinicians were explicitly used to establish ground truth for a "test set" in the way one might for a diagnostic AI device. The ground truth is established by an international standard (ISO 14801) for fatigue testing and engineering principles for CAD analysis, performed by the manufacturer's qualified personnel.

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

• None. As explained above, this is a non-clinical, engineering-focused evaluation based on established standards and calculations rather than subjective assessment requiring adjudication.

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

• No. This device is a dental implant, which is a physical medical device, not a diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

• No. This is a physical dental implant, not an algorithm or AI system.

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

• The ground truth for the non-clinical performance data (fatigue, surface area, bone-to-implant contact) is derived from engineering standards (ISO 14801) and CAD calculations based on the device's design specifications for the implant and comparison to the predicate. The "ground truth" for the FMEA is based on risk analysis methodologies.

8. The sample size for the training set

• Not applicable. This device is a physical dental implant. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and testing, not through training data in the AI sense.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for one. The "truth" about the device's functionality is established through its design, material properties, and adherence to performance standards.

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Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ANKYLOS® SynCone® Abutment 5°:

Acceptance Criteria and Study Details for ANKYLOS® SynCone® Abutment 5°

Based on the provided 510(k) summary, the device's acceptance criteria and the studies performed focus on demonstrating substantial equivalence to predicate devices. The primary criteria revolve around material composition, design, and performance characteristics compared to existing, legally marketed products.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for the test sets in the non-clinical performance data (fatigue testing, pull force testing). It mentions "Representative fatigue testing" and "Pull force testing."

The data provenance is non-clinical bench testing, meaning it's laboratory-generated data, not from human subjects. Therefore, country of origin and retrospective/prospective designations for human data are not applicable here.

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

This section is not applicable. The ground truth for this type of submission (demonstrating substantial equivalence through non-clinical bench testing) is defined by established international standards (like ISO 14801) and direct comparison to the performance characteristics of legally marketed predicate devices. It does not involve expert adjudication of human clinical data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation relies on objective measurements from bench testing following established standards and direct comparison to predicate device performance. No human adjudication of results is described.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The ANKYLOS® SynCone® Abutment 5° is a dental implant abutment, and its evaluation for this 510(k) submission relied on non-clinical performance data.

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

This section is not applicable. The device is a physical medical device (an implant abutment), not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, evaluated through bench testing, not through an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used for verifying the device's performance is established engineering and material science standards and metrics, and direct comparative performance against legally marketed predicate devices.

Specifically:

• ISO 14801: Dynamic fatigue test for endosseous dental implants.
• ASTM F136 and ASTM F67: Standard specifications for titanium alloys, defining acceptable material properties.
• Performance of predicate devices: The established and accepted performance of the ANKYLOS SynCone® Abutinents 4º and 6° (K041509) and Angled ANKYLOS® Balance Base Abutments (K122268) serve as the benchmark for equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. A training set is used in machine learning to teach an algorithm. This submission is for a physical medical device, not an AI/ML algorithm.

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

This section is not applicable for the same reasons as point 8.

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The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.

The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws. immediate loading is possible using a minimum of 4 implants.

The Angled XiVE® MP and ANKYLOS® Balance Base Abutment are endosseous dental implant abutments which provide a platform for prosthetic restoration with bridges or bar constructions in conjunction with XiVE and ANKYLOS® implants. The abutments are provided with an angulation of 15° and 30° at gingival heights ranging from 2.0mm - 5.0 mm for angled XiVE® MP abutments and from 3.0mm - 4.5mm for angled ANK YLOS® Balance Base abutments, respectively. The angled ANK YLOS® BalanceBase Abutments are offered in 3.45mm diameter (compatible with all ANKYLOS® implants). The angled XiVE® MP Abutments are offered in diameters ranging from 3.4mm (compatible with 3.4mm diameter XIVE® implants) to 3.8mm (compatible with XiVE® implants of 3.8mm - 5.5mm diameter). The abutments are connected to the corresponding implants by a central screw which mates with the internal thread of the implant. The abutments and the abutment screws are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy for Surgical Implant Applications).

The Angled XiVE® MP and ANKYLOS® Balance Base Abutments facilitate the SmartFixTM treatment concept in which the angled abutments are used in combination with straight abutments on a of minimum four (4) implants (with two posterior implants placed at an angle of up to 45° in the posterior region) to support prosthetic restorations.

In addition to the introduction of the Angled XiVE® MP and ANK YLOS® Balance Base Abutments, a modification to the indications for use statements of the currently marketed straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments is implemented as part of this premarket notification.

The provided text is a 510(k) summary for dental implant abutments and does not contain information about a study that proves the device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a clinical trial with human subjects.

Instead, the document details the substantial equivalence of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments to legally marketed predicate devices. The "performance data" mentioned refers to non-clinical, engineering-focused testing, specifically fatigue data, to demonstrate the structural integrity and durability of the device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the type of information presented in this 510(k) summary.

Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as this is non-clinical engineering testing (fatigue testing). The "sample size" would refer to the number of abutments tested for fatigue. This information is typically proprietary and not fully disclosed in a public 510(k) summary.
• Data Provenance: Not specified, but generally, such engineering tests are conducted in a controlled laboratory environment, often by the manufacturer or a contracted lab. The document does not indicate country of origin of data or whether it was retrospective or prospective, as these terms are not applicable to non-clinical device testing in this context.

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 is related to engineering specifications and performance standards (e.g., ASTM standards for materials, recognized test methods for fatigue). Clinical expert consensus is not used to establish this type of "ground truth."

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

• Not applicable. Adjudication methods are typically for clinical studies with subjective interpretations. This document describes objective non-clinical performance data.

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 a medical device (dental abutment), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• No. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this type of submission is based on established engineering standards, material specifications (e.g., ASTM F 136), and recognized test methods for mechanical performance (e.g., fatigue testing protocols). The implicit ground truth is that the device must meet or exceed the performance characteristics of the predicate devices according to these objective engineering metrics.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.

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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 the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.

The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angulated abutments on small implants are to be used for the anterior region of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided document is a 510(k) summary for a medical device (dental abutments) and does not contain information related to AI/ML device acceptance criteria or studies as typically found in submissions for AI-powered diagnostics or medical image analysis.

The document describes the "Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant" and its substantial equivalence to a predicate device. The "study" mentioned is non-clinical testing to demonstrate performance characteristics, not a clinical trial or AI/ML performance study.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable to this type of device submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide explicit "acceptance criteria" in the format of thresholds for metrics like sensitivity, specificity, or F1-score as you would see for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to an already legally marketed predicate device (K#101004). The performance is demonstrated through non-clinical mechanical testing, ensuring the device can withstand intended forces.

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI/ML performance evaluation. The "worst case scenario" implant assemblies used for static and fatigue testing would constitute the "test set" for the mechanical performance. The exact number of samples for these mechanical tests is not provided in this summary.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer or a contracted lab. Country of origin of the data is not specified but is presumed to be relevant to the manufacturer (Astra Tech Inc., Waltham, Massachusetts, USA). This is retrospective in the sense that the test results are reported after the tests were conducted prior to submission.

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 the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this mechanical device submission. The "ground truth" for mechanical testing is established by engineering standards and measurements.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human reviewers, which is not relevant here. Mechanical test results are typically objective measurements against predefined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is a mechanical device, not an AI/ML diagnostic.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the mechanical performance component, the "ground truth" is derived from established engineering standards and material properties, along with the results of static and fatigue compression testing measured against performance specifications that demonstrate the device "performs as intended."

8. The sample size for the training set:

• Not applicable. There is no AI/ML component or "training set" in this submission.

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

• Not applicable.

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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 the mandible or maxilla. The prosthesis can be cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

The titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos Implants:

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Dentsply Ankylos Implant and abutment screw are made from Titanium grade Ti-6A 1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.5mm, 5.5mm, and 7.0mm sizes. The titanium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Atlantis™ Abutment for Dentsply Ankylos Implant:

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device's efficacy. In this case, the device is an implant abutment, which is a component of a dental implant system. The "performance" discussed primarily relates to its compatibility and functional equivalence to existing, legally marketed components.

Based on the provided text, a formal study with quantitative acceptance criteria as one might expect for a diagnostic AI device is not presented. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence for a physical medical device (dental abutment), the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic study. Instead, the acceptance criteria are met by demonstrating the device is:

• Substantially equivalent in intended use, material, design, and performance to the predicate devices.
• Able to perform the same functions as the predicate devices.
• Made of the same material as the predicate device.

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

No specific "test set" in the context of an AI study is mentioned. The submission relies on a comparison of characteristics and intended use to existing, legally marketed predicate devices (Dentsply Ankylos C/X Dental Implant System K083805 and Astra Tech Inc. Atlantis™ Abutment K093780). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance study.

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

Not applicable. The document describes a physical medical device (dental abutment), not an AI or diagnostic device that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no human-reviewed test set or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a filing for a physical medical device, not an AI or diagnostic software subject to MRMC studies.

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

Not applicable. This is a filing for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a physical device like a dental abutment would be its physical properties, material composition, manufacturing tolerances, and functional performance (e.g., torque strength, fatigue resistance), typically evaluated through engineering tests, not a "ground truth" as understood in AI/diagnostic studies. The document mentions ASTM Standard F-136 for material, which provides a standard specification for titanium alloy for surgical implants, serving as a form of "ground truth" for material properties.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable. There is no training set or associated ground truth establishment process described.

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The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.

The provided text describes a 510(k) summary for the ANKYLOS® C/X Dental Implant System, focusing on its substantial equivalence to predicate devices. However, the document does not contain the detailed study information typically associated with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.

The document states:

• "The results regarding the fatigue tests of the ANKYLOS® C/X Implant and the predicate devices were comparable. Therefore, it concluded that the ANKYLOS® C/X Implant performs as intended."

This is the only mention of performance data. It refers to a "fatigue test" and a "comparable" result. This does not provide specific acceptance criteria, numerical performance metrics, or details about the study design beyond stating "fatigue tests."

Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

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

• Cannot be determined from the provided text. The text only mentions "fatigue tests" without any details on the number of devices tested or the origin of the data.

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

• Cannot be determined from the provided text. This type of information is not present. The evaluation focuses on non-clinical performance (fatigue tests), not expert interpretation.

4. Adjudication method for the test set:

• Cannot be determined from the provided text. This is not relevant for the type of non-clinical testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study was not done. The document describes a non-clinical performance evaluation (fatigue tests) of a dental implant system.

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

• N/A. This question is typically relevant for AI/software devices. The device is a physical dental implant system, so "standalone" performance in this context would refer to its physical function, which was assessed via "fatigue tests."

7. The type of ground truth used:

• For the "fatigue tests," the "ground truth" would be the engineering standards for fatigue life or fracture resistance of dental implants. However, the specific standards or methods for establishing this "ground truth" are not detailed beyond the mention of "fatigue tests."

8. The sample size for the training set:

• N/A. This question is typically relevant for AI/machine learning models. The device is a physical dental implant system and would not have a "training set" in this context.

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

• N/A. (See point 8)

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The FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

The FRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium and coated with FRIADENT plus surface.

This submission (K073075) is for a Dentsply International dental implant system (FRIADENT Implant Systems) seeking to expand its indications for use to include immediate loading applications. The information provided heavily focuses on regulatory details and equivalency to predicate devices, rather than detailed performance study results that would typically be found in a clinical study report.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text because the submission is primarily based on expanding indications for existing, legally marketed devices, and thus does not present new performance data in the typical format of a clinical trial.

The submission explicitly states: "No changes have been made to these implant systems. This submission expands the indications for use. Therefore, it was determined that no additional biocompatibility testing was necessary. We believe that the performance data provided and the research and development and marketing history of the unchanged device support the safety and effectiveness of the FRIADENT Implant Systems for the indicated uses."

This implies that the "acceptance criteria" are likely based on the historical performance and established safety and effectiveness of the existing implant systems for their original indications, and the "study" is the cumulative body of evidence from those existing devices and their marketing history, rather than a new dedicated study specifically proving immediate loading efficacy in a structured contemporary manner.

Given this context, I will address the requested points to the best of my ability, highlighting where the information is not present or implied by the nature of the submission.

Acceptance Criteria and Device Performance

Since this is an expansion of indications for existing devices, explicit, quantitative acceptance criteria and specific "reported device performance" from a new study designed to meet those criteria are not provided. The implicit acceptance criterion is that the devices, when used for immediate loading, maintain the safety and effectiveness demonstrated for their prior indications.

Study Details (Based on the provided text):

As explained above, a dedicated "study" in the traditional sense (e.g., a new prospective, randomized controlled trial with detailed endpoints) proving the device meets new acceptance criteria for immediate loading is not detailed in this 510(k) summary. The submission relies on the existing performance data and marketing history of the unchanged devices.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" for new immediate loading performance. The "performance data" mentioned likely refers to cumulative clinical experience and studies related to the existing devices for their original indications. No details on country of origin or retrospective/prospective nature are provided for this cumulative data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a new test set requiring expert ground truth for this submission. The safety and effectiveness determination is based on a regulatory review of existing data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical dental implant, not an AI or imaging diagnostic tool, so MRMC studies are irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the expanded indications is indirectly derived from the outcomes data and clinical experience associated with the existing, unchanged FRIADENT implant systems over their documented marketing history. This historical performance, validated by clinicians in practice, serves as the basis for asserting safety and effectiveness when expanding indications.

7. The sample size for the training set: Not applicable. This is not an AI or machine learning device that requires a training set.

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

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The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.

The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.

The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics.

The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.

This document does not contain the information required to answer your request. The provided text is a 510(k) summary for dental abutments, which outlines the device description, intended use, and substantial equivalence to predicate devices, but does not describe any studies with acceptance criteria or performance metrics in the way you've outlined.

This submission is for a medical device (Cercon® Abutments) and, based on the provided text, the FDA classified it as substantially equivalent to existing predicate devices. This typically means that the device's technological characteristics and intended use are similar enough to already-approved devices that extensive new clinical studies with defined acceptance criteria and performance reporting might not have been necessary for the 510(k) clearance process itself. The summary states that "We believe that the prior use of the components of the CERCON® ABUTMENTS in legally marketed devices, the provided, and the biocompatibility history support the safety and effectiveness of the CERCON® ABUTMENTS for the indicated uses." This suggests reliance on existing data for similar components, rather than new performance studies.

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The ANKYLOS® Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseus implant.

The ANKYLOS® Dental Implant System has been cleared for commercial distribution. The purpose of this application is to obtain clearance for additional marketing claims associated with the special features of the ANKYLOS® Dental Implant System.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the ANKYLOS® Dental Implant System. It primarily focuses on:

• Device Description and Intended Use: Explaining what the device is and what it's used for.
• Predicate Device Information: Stating that the current device is substantially equivalent to a previously cleared one.
• Technological Characteristics: Asserting that no changes have been made to the device itself, implying that previous safety and effectiveness data still apply.
• Regulatory Communication: Correspondence from the FDA affirming the substantial equivalence and permitting marketing.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., success rates, torque values, osseointegration rates).
• Any clinical or non-clinical study that was conducted to demonstrate performance against such criteria.
• Details about test sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested table or detailed information about a study based on the given text.

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