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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings 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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. 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.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. 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. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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

• Sample Size for Test Set: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering 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

• This is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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

• This is not applicable. The device is a physical dental component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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Ticare Dental Implant Systems are endosseous dental implanted in the maxilla or mandble jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro implants are indicated to support permanently fixed restorations.

Ticare Inhex and Osseous implants of 6 mm length are in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.

The subject device is a dental implant system including threaded, root-form endosseous dental implants of various diameters and lengths, straight, angled, tapered, UCLA and ball abutments + retention cap as well as healing abutments, cover screws and retaining screws to secure prosthetic restorations. Implants are commercially pure Grade IV titanium except for InHex "Mini" and InHex Quattro "Mini" implants which are Grade V titanium alloy. Abutments and screws are grade V titanium alloy 6Al 4V. Retention cap is Vestakeep D4 R. All implants have an RBM surface. Abutments must be matched to implant design and platform size. Provisional and temporary abutments are for use no more than 2-3 months. Some Inhex abutment designs have a narrow neck alternative version to allow the clinician more choices for soft tissue management.

Osseous dental implants have an external hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13 and 15mm. Standard platform comes in diameters of 3.4, 3.75, and 4.25mm with lengths of 8, 10, 11.5, 13, 15mm (no 8mm in 3.4). There is also a 5.0 standard platform implant which comes in lengths of 6, 8, 10, 11.5, 13 and 15mm. Maxi comes in a diameter of 5.0mm and lengths of 6, 8, 10, 11.5, 13 and 15mm.

InHex dental implants have an internal hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13, 15mm. Standard platform comes in diameters of 3.75, and 4.25mm in lengths of 6 (not in 3.75), 8, 10, 11.5, 13 and 15mm. There is also a 5.0mm diameter implant in standard platform which only comes in a 6mm length. Maxi platform comes in a diameter of 5.0mm with lengths of 9, 10, 11.5, 13, 15mm.

The Osseous Quattro and InHex Quattro implant thread design enables them to be used in softer bone types. Osseous Quattro dental implants have an external hex connection in standard platform and are available in diameters 3.75mm and 4.25mm and lengths of 8, 10, 11.5, 13 and 15mm. InHex Quattro dental implants have an internal hex connection in mini and standard platform and are available in diameters of 3.3mm (mini platform), 3.75mm and lengths 8 (not in 3.3), 10, 11.5, 13 and 15mm.

Maxi platform implants and abutments are for use in the molar region. Mini platform implants and abutments are for use in lateral incisors and lower central incisors. Standard platform implants and abutments are for use in all tooth locations.

Osseous straight abutments come in six designs. Prepable abutments come in hexed with a gingival height of 2mm in standard, mini, and maxi platforms. Tall straight abutments come in hexed with gingival heights of 0.5, 1, 2, 3, 4mm in standard, mini and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard and mini platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.

Inhex straight abutments come in six designs. Prepable abutments come in hexed (not in mini) with a gingival height of 2mm in standard, mini, and maxi platforms. There is an additional hexed standard platform prepable abutment with a smooth exterior for cementing. Tall straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3, 4mm (4mm not in mini) in standard, mini and maxi platforms. There are also tall abutments with smooth surfaces for 5.0 implants which come in gingival heights of 3 or 4mm for both standard and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard, mini and maxi platforms. Multitask abutments comes in standard and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard and maxi platform. Inhex narrow neck tall straight abutments hexed and non-hexed come in mini platform with gingival heights of 2, 3mm and maxi & standard platforms with gingival heights of 2, 3, 4mm. Narrow neck short straight abutments hexed come in mini platform with gingival heights of 2, 3m and maxi & standard platforms with gingival heights of 2, 3, 4mm.

Osseous healing screws come in gingival heights of 2, 3, 4, 5, 6, 7mm (no 2mm in mini) in standard, mini, and maxi platforms. Osseous aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. There is an additional model in standard platform which has a tapered seating area.

Inhex healing screws come in gingival heights of 1, 2, 3, 4, 5, 6, 7mm (no 1mm in maxi) in standard and maxi platform. Inhex mini platform healing screws come in gingival heights of 3 or 4mm.There is an additional shorter design of healing screw for 5.0mm implants in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platform. Inhex aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. Narrow neck healing screws come in mini platform with gingival heights of 2, 3, 4mm and maxi & standard platform with gingival heights of 2, 3, 4, 5mm.

Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.

Inhex angled abutments come in 15° and 20° in gingival heights of 1, 3, 5mm for standard and maxi platforms and gingival height of 2mm for mini platform. For 5mm implants there is also a shouldered design of 15° and 20° abutment in gingival heights of 1, 3, 5mm for standard and maxi platforms.

Osseous UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, maxi and mini platforms. Osseous UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the gingival collar portion are not intended to be modified.

Inhex UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, and maxi platforms. Inhex UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the portion from the gingival collar portion to the bottom of the UCLA are not intended to be modified.

Osseous ball attachments in standard, maxi and mini platforms come in gingival heights of 1, 2, 3, 4, 5.5mm (no 1mm in maxi or mini). The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.

Inhex ball attachments in standard and maxi platforms come in gingival heights of 1, 2, 3, 4, 5.5mm. The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.

Osseous tapered abutments come in six different cone configurations on the top. 10° tapered abutments come in standard platform gingival heights of 2, 3, 4, 5mm with cone type 2, mini platform gingival heights 3, 4, 5mm cone type 1 and maxi platform gingival heights of 2, 3, 4, 5mm with cone type 3. 30° tapered abutments come in gingival heights of 4 or 5mm in standard platform with cone type 4 and maxi platform with cone type 5. Straight tapered abutments come in standard platform with cone type 6 in gingival heights of 2, 3, 4, 5mm. Angled tapered abutments come in standard platform with cone type 6 with 17° in gingival heights 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.

Inhex tapered abutments come in five of the possible six cone configurations. 10° tapered abutments come in standard platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2 and mini platform gingival heights 1, 2, 3mm in cone type 1. 10° tapered non-hexed abutments come in maxi platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2. 30° tapered abutments in cone type 4 gingival heights 1, 2, 3, 4, 5mm come in standard platform and non-hexed maxi platform. Straight tapered abutments in cone type 6 with gingival heights 2, 3, 4, 5mm come in standard and maxi platform. Angled tapered abutments with cone type 6 come in standard and maxi platform with 17° in gingival heights of 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Narrow neck 10° tapered abutments come in mini platform with gingival heights of 2, 3mm and standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 10° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments come in standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.

Healing abutments for tapered abutments include ones for 10° tapered abutment in standard and maxi platforms which is used with both Osseous and Inhex, angled tapered abutments for Osseous and Inhex, and 30° angled tapered abutment specific ones which fit Osseous maxi platform or Osseous standard and Inhex standard & maxi platforms.

Covers for provisional restoration of tapered abutments come in designs for 10° tapered abutments for Osseous and Inhex, mini and standard platform specific designs for 10° tapered abutments for Osseous and Inhex, and a design for 30° angled tapered abutments for Osseous and Inhex.

Posts for use with tapered abutments come in temporary and permanent restoration versions. Temporary ones come in standard and maxi platform versions for 10° and 30° tapered abutments which can be used with Osseous or Inhex. A temporary restoration post is also available for angled tapered abutments of Osseous or Inhex and an Osseous specific mini platform for 10° tapered abutments. Posts for permanent restoration come in versions for angled tapered abutments used for Osseous and Inhex, 10° tapered abutments used for Osseous and Inhex in standard platform, 30° tapered abutments used for Osseous and Inhex in maxi and standard platforms, non-hexed for 10° tapered abutments used for Osseous and Inhex in maxi platform, and non-hexed for 10° tapered abutment for Osseous mini platform. Titanium interfaces (shorter posts) are available for 10° and 30° tapered abutments for Osseous and Inhex, angled tapered abutments for Osseous and Inhex and 10° tapered abutments for Osseous mini platform.

The provided document is a 510(k) Premarket Notification Submission for Ticare Dental Implant Systems. It is a regulatory document seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets acceptance criteria.

Therefore, the requested information cannot be fully provided as it pertains to a study demonstrating performance against acceptance criteria, which is not the primary focus of this type of regulatory submission.

However, I can extract information regarding the non-clinical testing performed to support substantial equivalence, which serves as a proxy for demonstrating that the device meets certain performance specifications.

Here's a breakdown of what can be inferred and what cannot:

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

This information is not explicitly provided in a direct table format as acceptance criteria vs. specific quantitative performance values for each test. Instead, the document states that tests "met the criteria of the standards" or "demonstrated substantial equivalence."

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

• Sample Size for Test Set: Not explicitly stated for each individual test. The document mentions "worst-case scenario" for selection of implants/abutments for certain tests (e.g., shortest implant, largest abutments).
• Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Mozo Grau, S.A., based in Spain.

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 is not applicable as the document describes non-clinical bench testing, not clinical studies involving expert annotation or ground truth establishment in a medical imaging context.

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

Not applicable, as this is related to clinical interpretation and ground truth establishment, which did not occur in this non-clinical testing.

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

Not applicable. This is a non-clinical submission for a dental implant system, not an AI/software device involving human readers or comparative effectiveness studies of that nature.

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

Not applicable, as this is not an AI/software device.

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

Not applicable. The "ground truth" in this context is adherence to validated engineering and material standards for dental implants.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning model.

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

Not applicable.

However, I can summarize the non-clinical testing performed as evidence of meeting performance expectations (implicitly serving as 'acceptance criteria' in a regulatory context for substantial equivalence):

Summary of Non-Clinical Data / Testing Performed:

The Ticare Dental Implant Systems underwent various bench tests to demonstrate conformance to performance specifications and requirements, following the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of these tests were reported to have met the criteria of the standards and demonstrated substantial equivalence to the predicate devices.

Non-Clinical Tests Performed (and how they relate to acceptance):

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Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).

This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.

Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.

Here's why each point is not applicable and what information is provided:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant here.

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 device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.

8. The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does provide regarding device performance and testing:

• Type of Testing:

  • Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
  • Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
  • Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
  • Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
  • Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
  • MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.

• Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.

In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.

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AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• · Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
• · Implant Direct Legacy2(K192221) 3.0
• · Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
• · Nobelactive Wide Platform (Wp) (K133731) WP 5.5
• · TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• · Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Study Details

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

   • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
   • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

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

   • Not applicable. This is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

   • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

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 is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

   • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

   • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

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

   • Not applicable for the same reason as above.

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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S. SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase. inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows).

The Sirona Dental CAD/CAM System which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.

Here is the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K111421) rather than explicitly detailing numeric acceptance criteria for each test. However, it lists the types of non-clinical performance data and states that the results support substantial equivalence. The implied acceptance criterion for all tests is "conformity" with the referenced standards or successful validation/analysis, and the reported performance is that these criteria were met.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of abutments for fatigue testing, number of software test cases). It refers generally to "testing" and "analyses."

The data provenance is implied to be internal testing conducted by Dentsply Sirona, as the document details their testing efforts to support the 510(k) submission. No information about country of origin of the data is provided, nor whether it was retrospective or prospective, although typically such a submission would involve prospective testing designed to meet the specified standards.

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

This information is not provided in the document. The document describes compliance with recognized standards and internal validation processes but does not detail the involvement of external experts for establishing ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not provided. The non-clinical testing appears to rely on objective measurements against established engineering and regulatory standards rather than subjective expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. This device is a CAD/CAM system for designing and fabricating dental abutments, not an AI or imaging diagnostic tool that would typically involve human reader performance studies.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study in the form of non-clinical performance data and software verification and validation testing was performed. The document describes:

• Testing to verify conformity with various IEC and ISO standards for medical electrical equipment, electromagnetic compatibility, and dynamic loading.
• Compatibility analyses of new TiBase interface geometries.
• System validation testing for the CAD/CAM software's design and fabrication workflow.
• Software verification and validation testing specifically for the abutment design library to demonstrate design restrictions and locked specifications.

These tests focus on the technical performance and safety of the device components and software, independent of human clinical application for their evaluation.

7. Type of Ground Truth Used:

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

• Engineering specifications and design requirements: For confirming the functionality and outputs of the CAD/CAM system and software.
• Recognized international standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14801 which define performance benchmarks and safety criteria.
• Original manufacturer's implant connection geometries: For compatibility analyses of TiBase interfaces.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Sirona Dental CAD/CAM System, as described, is not an AI/ML-based diagnostic device that typically requires a "training set" in the context of machine learning model development. It's a system for computer-aided design and manufacturing within predetermined parameters.

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

This information is not applicable, as there is no mention or indication of a "training set" for an AI/ML model for this device. The software functions based on established CAD/CAM principles and predefined parameters rather than learning from a training dataset.

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The ATLANTIS® Conus Structure is indicated for attachment to ATLANTIS® Conus abutment, Overdenture (OD) via prefabricated SynCone 5° Taper caps (Degulor®) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The ATLANTIS® Conus Structure is intended for conical attachment to a minimum of four (4) ATLANTIS® Conus abutments, Overdenture (OD). The ATLANTIS® Conus Structure is only intended for acrylic or composite veneering.

The proposed ATLANTIS® Conus structure is a patient-specific endosseous dental implant support structure that is indicated for attachment to dental abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS® Conus Structure is fabricated using additive manufacturing to produce a customized, patient-specific device.

The proposed ATLANTIS® Conus Structure is available in the following design types:

1. ATLANTIS® Conus Bridge Intended for direct veneering using dental resin composites resulting in a removable friction-retained prosthesis. The bridge provides a full anatomical base for composite layering techniques.
2. ATLANTIS® Conus Hybrid Intended as a removable friction-retained denture framework. The hybrid variant provides a surface with retention elements that can be finished with resin-based denture prosthesis.
3. ATLANTIS® Conus Base Intended as a removable friction-retained denture framework for finishing with the resin-based denture prosthesis.

The provided text describes the ATLANTIS® Conus Structure, a dental device, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human readers or ground truth established by experts.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and technological characteristics comparison. It does not contain information about a clinical study with acceptance criteria for diagnostic performance, human reader improvement, or ground truth established by experts.

However, I can extract the acceptance criteria and performance data for the non-clinical performance tests described:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes for the non-clinical performance tests (dynamic fatigue, bond strength, dimensional verification). The data provenance is internal testing performed by Dentsply Sirona. These are prospective tests designed to evaluate the physical properties of the device.

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 not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" here pertains to engineering specifications and performance standards outlined in ISO 14801 and internal Dentsply Sirona testing protocols.

4. Adjudication method for the test set

Not applicable. The tests are mechanical and dimensional, not requiring expert adjudication of results. The results are typically compared against pre-defined engineering specifications.

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 implant component, 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 is a physical dental implant component, not an algorithm.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" refers to established engineering standards (e.g., ISO 14801) and internal design specifications for mechanical strength, bond strength, and dimensional accuracy.

8. The sample size for the training set

Not applicable. The device is a physical product, not an AI model requiring a training set. The design and manufacturing processes are iterative but do not involve "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 this physical device. The design and manufacturing parameters are established through engineering principles, material science, and prior regulatory clearances of similar devices.

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The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

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

ATLANTIS™ Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: (list of compatible implants and abutments follows in the document)

The subject of this bundled 510(k) consists of the proposed Multibase Abutments EV with accompanying accessories and the corresponding ATLANTIS™ Suprastructures, which are currently marketed under premarket notification K160207 and are proposed for modification under this submission to include compatibility with the proposed Multibase Abutments EV. The proposed devices are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible.

The subject Multibase Abutments EV are additional components for the existing OsseoSpeed™ EV implants (cleared in K120414 under the name OsseoSpeed™ Plus) and the OsseoSpeed™ Profile EV implants (K130999). The subject Multibase Abutments EV are designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. They are provided in three platform diameters (3.6. 4.2 and 4.8 mm) and available as straight version and in two angles (17° and 30°). The straight abutments are one-piece abutments and provided in three gingival heights (1.5, 2.5 and 3.5 mm). They have a nonindexed interface. All abutments with a 17° or 30° angle represent two-piece abutments and are available in two gingival heights (1.5 and 2.5 mm) with an indexed or non-indexed interface. The two-piece, angled variants of the Multibase Abutment EV devices consist of the abutment body and a screw channel cap which is threaded to the abutment body to cover the abutment body's connection screw channel. The screw channel cap features internal threads to facilitate connection of screw-retained restorations. The subject Multibase Abutment EV devices are also designed for compatibility with the temporary prosthetic cylinder and bridge screw components of the reference predicate NobelActive Multi-Unit Abutment system (K072570).

The ATLANTIS™M Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTISTM Suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The proposed abutment-interface of the ATLANTIS™ Suprastructures, compatible with the proposed Multibase Abutments EV. are available in the same design types as cleared for the predicate ATLANTISTM ISUS Implant Suprastructures in K160207:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.
4. 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screwretained connection.

Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided text describes a 510(k) premarket notification for dental implant components (Multibase Abutments EV and ATLANTISTM Suprastructures). This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and effectiveness de novo through a clinical trial with specific performance criteria for a novel device.

Therefore, the concept of "acceptance criteria" for a new, standalone device's performance in a clinical study, and a "study that proves the device meets the acceptance criteria" in that context, is not directly applicable to this document.

Instead, the "acceptance criteria" here are essentially the demonstration that the new device shares fundamental technological characteristics and indications for use with the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" is the collection of non-clinical data (e.g., sterilization validation, fatigue testing, geometric analysis) showing substantial equivalence.

Given this, I will reframe the requested information to align with the provided document's nature as a 510(k) submission for dental implant abutments and suprastructures.

Dental Implant Abutments and Suprastructures (K163350)

1. Table of Acceptance Criteria (Substantial Equivalence) and the Reported Device Performance

ATLANTIS™ Suprastructures: Indications for use are identical to the predicate ATLANTISTM ISUS Implant Suprastructures (K160207), with the addition of compatibility with the Multibase Abutment EV device. They are indicated for attachment to dental implants or abutments in partially or totally edentulous jaws for restoring chewing function, intended for attachment to a minimum of two implants, and compatible with a listed range of implant and abutment systems. |
| Similar Fundamental Technology | Multibase Abutments EV: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design features (screw-retained, multi-unit restoration, internal interface) and material (Ti-6Al-4V) are consistent with predicate devices (OsseoSpeed™ Angled Abutment EV and NobelActive Multi Unit Abutment). Differences in abutment design (one-piece/two-piece) and angulation/gingival height ranges addressed by testing.

ATLANTIS™ Suprastructures: Classified as endosseous dental implant abutments, intended for prosthetic restoration. Design types (Bar, Bridge, Hybrid, 2 in 1), prosthesis attachment (screw-retained, friction-fit), platform diameter, interface (internal, external), and materials (CPTi, CoCr for suprastructure; Ti-6Al-4V ELI for screw) are consistent with the predicate ATLANTISTM ISUS Implant Suprastructures. |
| Biocompatibility | The materials used for both devices and their accompanying screws, as well as the manufacturing process, are unchanged compared to their respective primary predicate devices (OsseoSpeed™ Angled Abutment EV (K121810) and ATLANTIS™ ISUS Implant Suprastructures (K160207)). No additional biocompatibility testing was performed, relying on the predicates' established biocompatibility. |
| Performance (Non-Clinical) | Sterilization: Validated for sterile, straight Multibase Abutments EV variants by equivalence to existing validations conforming to ISO 11137-1/2 (SAL of 10^-6). Angled variants were specifically validated to ISO 11137-1/2 (SAL of 10^-6). Moist heat sterilization for non-sterile components validated by equivalence to ISO 17665-1/2 (SAL of 10^-9).

Packaging and Shelf Life: Validated per ISO 11607 and ASTM F1980 (referenced, no details provided).

Fatigue Testing: Dynamic fatigue testing performed on the worst-case construct (angled, two-piece assembly) of Multibase Abutments EV devices according to ISO 14801. Results support substantial equivalence.

Geometric Compatibility: Geometric measurement data and statistical compatibility analysis for Multibase Abutments EV with temporary prosthetic cylinder and bridge screw components of predicate (K072570) support compatibility.

Cross-sectional Material Analysis: For ATLANTIS™ Suprastructures' interface with Multibase Abutments EV; compared to existing worst-case interface geometry. Analysis showed the new interface does not present a new worst case, supporting substantial equivalence. |
| Safety and Effectiveness | Based on the above, the differences in technological characteristics do not raise new questions of safety or effectiveness. |

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

• Test Set Sample Size: Not applicable in the context of a clinical trial. The "test set" here comprises the various physical configurations and conditions tested in the non-clinical studies.
  • For fatigue testing (ISO 14801), multiple samples of the "worst case construct" (angled Multibase Abutments EV) would have been used. The exact number is not specified, but typically this standard requires a minimum of 5-10 samples per test group.
  • For sterilization validation, the sample sizes would depend on the specific validation protocol (e.g., bioburden testing, dose mapping) but are not explicitly stated.
  • For geometric measurements, the "sample size" would refer to the number of individual components measured to ensure dimensional compliance and compatibility, but this is not specified.
• Data Provenance: The studies are non-clinical engineering and laboratory tests performed by the manufacturer, Dentsply Sirona. No specific country of origin or retrospective/prospective status is relevant as these are not human subject studies.

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

• Not applicable. This is a 510(k) submission based on non-clinical data, not a study requiring expert consensus for diagnostic "ground truth." The "ground truth" is typically defined by engineering standards (e.g., ISO 14801 for fatigue limits, ISO 11137 for sterilization) and internal design specifications.

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

• Not applicable. Adjudication methods are used in clinical studies for interpreting human data or images amongst multiple readers. This document refers to non-clinical engineering tests.

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 device is a physical dental implant component, not an AI-assisted diagnostic or treatment planning system for which human reader performance would be assessed.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" for the non-clinical tests is established by recognized international and industry standards, such as:
  • ISO 14801: Dentistry - Implants - Dynamic loading test for endosseous dental implants. This standard defines the method for fatigue testing.
  • ISO 11137-1/2: Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices.
  • ISO 17665-1/2: Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process.
  • ISO 11607: Packaging for terminally sterilized medical devices.
  • ASTM F1980: Standard Guide for Accelerated Aging of Sterile Medical Device Packages.
  • Internal engineering specifications and CAD models: For geometric compatibility and interface analysis.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this 510(k) submission as it is for a physical device, not a machine learning algorithm.

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

• Not applicable, as there is no training set for this type of device submission.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI studies. The testing described is non-clinical performance data (mechanical design analysis, dimensional analysis, static and dynamic compression-bending testing).

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

This information is not applicable or not provided. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

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

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

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

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

8. The sample size for the training set

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

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

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

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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 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.

ATLANTISTM products are compatible with the implants shown in the table below.

The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screwretained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS™ Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the CONELOG implants from the CONELOG Implant System (K113779).

The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 mm). The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

The provided text describes a 510(k) premarket notification for the "ATLANTIS™ Abutment for CONELOG implant," a dental implant abutment. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. While the document details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format typically used for AI/ML medical devices.

Instead, the provided text focuses on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing intended use, technological characteristics, and performance data.
• Non-Clinical Performance Data: The document mentions "mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801." These are standard engineering tests for dental implants to demonstrate structural integrity and durability.
• Biocompatibility and Sterility: These aspects are addressed by referencing prior testing conducted for a primary predicate device, stating that the materials and sterilization processes are the same.

Therefore, I cannot populate the table or answer the specific questions below as they pertain to acceptance criteria, clinical study design, ground truth establishment, or human-in-the-loop performance, which are not detailed in this regulatory submission for a physical implant component.

Here's a breakdown of why I cannot answer each point based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use" and "compatibility analysis shows that the ATLANTIS™ Abutment for CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants." However, it does not state specific quantitative acceptance criteria (e.g., "must withstand X N of force") nor detailed numerical reported device performance in a table. It refers to ISO 14801, which outlines testing methodologies but not necessarily specific pass/fail values that would be reported in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components for mechanical testing, not a dataset of patient images or clinical data. No details on the number of physical samples tested are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical evaluation or ground truth for AI/ML models, which is not the subject of this submission. The "ground truth" for mechanical properties would be derived from physical measurements and engineering standards, not expert clinical consensus.

4. Adjudication method: Not applicable. This is for clinical or AI model evaluation.

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 device is a physical dental abutment, not an AI/ML algorithm for image interpretation or diagnosis.

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

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the predefined engineering specifications (e.g., material strength requirements, dimensional tolerances) and the observed performance of the tested physical components against these specifications. The document implies compliance with ISO 14801.

8. The sample size for the training set: Not applicable. This is for AI/ML models, not a physical device.

9. How the ground truth for the training set was established: Not applicable. This is for AI/ML models.

In summary, the provided document is a regulatory submission for a physical medical device (dental abutment) and outlines its demonstration of substantial equivalence through non-clinical mechanical testing, biocompatibility, and sterility, rather than clinical efficacy studies with human subjects or AI/ML model performance evaluation.

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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 or screw retained to the abutment. 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 attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. 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™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATLANTIS™ Abutment for NobelActive 3.0.

Important Note: The provided document is a 510(k) premarket notification for a medical device (dental implant abutment). These types of submissions typically focus on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance criteria or conducting extensive effectiveness studies for a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this type of traditional medical device submission.

The "studies" described are primarily non-clinical engineering tests to ensure mechanical integrity and compatibility with the predicate device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the summary. For mechanical testing (ISO 14801), devices are typically tested in small batches to statistical significance or to demonstrate compliance with a specific load rating. The exact number of abutments tested is not provided.
• Data Provenance: The "Non-Clinical Performance Data" section (Section 7) describes testing performed by DENTSPLY International, Inc., the manufacturer/submitter, and references predicate devices. This would be considered prospective testing conducted specifically for this 510(k) submission or in support of prior predicate device approvals. The country of origin of the data is implied to be within the company's testing facilities, likely in the US as the submitter is a US company.

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

• N/A. This device is a physical medical device (dental abutment), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" for its performance is established through quantitative mechanical testing and engineering analyses against defined standards (like ISO 14801).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are relevant for human evaluation processes, especially in clinical trials or AI performance evaluations involving multiple readers. This is a physical device undergoing mechanical and engineering tests, not an interpretive task.

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

• N/A. This is not an AI-powered diagnostic or assistive device. It is a physical dental implant abutment.

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

• N/A. This is a physical dental implant abutment, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Strength & Compatibility: The "ground truth" is defined by engineering standards and specifications (e.g., ISO 14801, material properties, dimensional tolerances, fit with the corresponding implant). Performance is measured against these objective standards.
• For Biocompatibility & Sterility: The "ground truth" is derived from established regulatory standards and validated testing protocols (e.g., ISO 10993 for biocompatibility, ISO 11137 or AAMI standards for sterility assurance levels).

8. The Sample Size for the Training Set

• N/A. This is not an AI algorithm that requires a training set. The design of the ATLANTIS™ Abutment is based on CAD/CAM technology, but the "training" in this context refers to the manufacturing process, not machine learning.

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

• N/A. As there is no AI training set, this question is not applicable. The design and manufacturing process for the CAD/CAM abutment are governed by engineering principles and quality control, not ground truth derived from annotated data.

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