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Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.

The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.

The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.

The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.

The provided text is a 510(k) summary for the Straumann Anatomic Healing Abutments XC (AHA). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the format typically used for AI/software-based medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices through comparisons of technological characteristics, intended use, and various performance tests (sterilization, shelf life, biocompatibility, torque, and basic software verification) that confirm the new device functions as expected for a medical device of its class, rather than proving specific numerical performance metrics against defined acceptance criteria in a clinical setting.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here is what can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantifiable acceptance criteria with corresponding performance results are not provided in the document for the device itself (Straumann® Anatomic Healing Abutments XC). The document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than meeting numerical performance thresholds for image analysis or diagnostic accuracy.

The performance tests mentioned are:

• Sterilization Validation and Shelf Life:
  • Acceptance Criteria (inferred): Sterility Assurance Level (SAL) of 10^-6 for gamma irradiation and successful steam sterilization validation. Packaging stability for a 5-year shelf life.
  • Reported Performance: Met SAL of 10^-6 using VDmax25 in accordance with ISO 11137-1:2006. Steam sterilization validation met all test method acceptance criteria. Packaging stability for the 5-year shelf life of predicate devices was adopted.
• Pyrogen Testing (LAL test):
  • Acceptance Criteria (inferred): Pyrogen limit specification of 20 endotoxin units (EU)/device.
  • Reported Performance: Met the specified limit.
• Biocompatibility Testing:
  • Acceptance Criteria (inferred): No cytotoxic reaction, no extractable substances above Analytical Evaluation Threshold (AET).
  • Reported Performance: No cytotoxic reaction detected. No extractable substances detected above AET.
• Performance Testing - Bench (Torque Testing):
  • Acceptance Criteria (inferred): Withstands repeated insertion and removal torques without damage.
  • Reported Performance: Performed, demonstrating the AHA withstands repeated insertion and removal torques without damage. (Specific numerical thresholds not provided).
• Software Testing (Scan Verification and Integration):
  • Acceptance Criteria (inferred): Can be scanned with an intraoral scanner and is suitable to work with CARES Visual software.
  • Reported Performance: Performed, demonstrating the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software. (No specific metrics provided).

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

• The document describes engineering tests (sterilization validation, mechanical torque testing, biocompatibility, software verification) rather than a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of this 510(k) for a physical device.

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

• Not applicable as this is not a study involving expert-derived ground truth on a clinical dataset for AI/software performance.

4. Adjudication method for the test set

• Not applicable.

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

• Not applicable. This is a physical medical device (healing abutment), not an AI/software for diagnostic assistance.

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

• Not applicable.

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

• For the engineering tests:
  • Sterilization/Pyrogenicity: Laboratory test results against validated standards and specified limits.
  • Biocompatibility: Laboratory test results against ISO standards and AET.
  • Torque Testing: Mechanical testing results against functional requirements (withstanding torque without damage).
  • Software Testing: Functional verification (can be scanned, works with software).

8. The sample size for the training set

• Not applicable, as this is a physical device and not an AI/ML model that requires a "training set."

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

• Not applicable.

Summary of what the document implies about meeting criteria:

The document asserts that the Straumann® Anatomic Healing Abutments XC (AHA) meet the necessary performance criteria through a series of benchtop engineering tests and validations designed to demonstrate:

• Effective sterilization (gamma irradiation and steam sterilization).
• Pyrogenicity within acceptable limits.
• Biocompatibility of the materials.
• Mechanical integrity (torque resistance).
• Compatibility with intraoral scanning and associated software.

The primary "study" presented is a comparison to predicate devices to establish substantial equivalence based on similar technological characteristics and performance testing. The "acceptance criteria" are implicitly met by successful completion of these validation tests against established industry standards (e.g., ISO) and functional requirements, rather than through a clinical study with statistical performance metrics against a defined ground truth.

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The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

• Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
• Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

The provided text describes a 510(k) summary for Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL. This document evaluates the substantial equivalence of new devices to existing legally marketed predicate devices, rather than establishing acceptance criteria and providing direct evidence of device performance against those criteria in a typical clinical study format.

Therefore, the requested information elements related to "acceptance criteria and reported device performance tabletop," "sample size for test set," "data provenance," "number of experts and qualifications," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of this 510(k) submission summary.

This document focuses on demonstrating that the new devices are substantially equivalent to predicate devices through comparisons of technological characteristics and performance testing (e.g., dynamic fatigue, biocompatibility, sterilization validation). The "acceptance criteria" here implicitly refer to demonstrating equivalence to the predicate devices and compliance with relevant standards and FDA guidance.

Here's an overview of the performance testing performed, interpreted as demonstrating compliance/equivalence rather than explicitly stated acceptance criteria with numerical performance targets:

1. Acceptance Criteria and Reported Device Performance:

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

• This information is not provided in the 510(k) summary. The summary refers to "tests were conducted" and "results were substantially equivalent," but actual sample sizes for mechanical, sterilization, or other tests are not detailed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable. This is a medical device, not an AI/software device requiring ground truth established by experts for a test set. The "ground truth" for non-AI devices is typically established through direct physical measurements, chemical analyses, and standardized test methodologies.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• Not applicable. This is not an AI/imaging device.

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

• Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used:

• For a traditional medical device like a dental implant, "ground truth" refers to established physical, chemical, and biological properties measured through standardized testing. Examples include:
  • Mechanical properties: Measured against international standards (e.g., ISO, ASTM) or FDA guidance for dental implants/abutments (e.g., fatigue strength, fracture resistance).
  • Biocompatibility: In vitro (e.g., cytotoxicity tests under ISO 10993-5) and in vivo tests (if new materials are introduced) against established biological safety profiles.
  • Sterilization efficacy: Measured by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ via methods compliant with ISO 11137-1 (radiation) or ISO 17665-1 (moist heat).
  • Material composition: Chemical analysis to confirm compliance with medical-grade specifications (e.g., Titanium-6Al-4V ELI conforming to ASTM F136).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/software device that uses a "training set."

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

• Not applicable.

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BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.

However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.

Here's the summary based on the provided document:

Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)

The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.

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 for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
• Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.

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

• This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical submission for a physical medical device.

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

• Not applicable. This device is a physical dental implant system, not an AI/ML device, so no MRMC study was performed.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for establishing device performance in this context is derived from:
  • Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
  • Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
  • Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.

8. The Sample Size for the Training Set

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

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

• Not applicable.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

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

• Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

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

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench 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 is not applicable. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

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

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

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

• Biocompatibility: Conformance with ISO 10993-1.
• Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
• Sterilization Validation: Conformance with ISO 11137 series.
• Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

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Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated.

Temporary Abutments have a maximum duration of usage of 180 days.

The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.

The provided text is a 510(k) summary for Straumann® Screw-Retained Abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance data, mainly bench testing and biocompatibility assessments. It explicitly states that no device-specific clinical data has been submitted.

Therefore, the information required to describe acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study or performance metrics typical for AI devices (like sensitivity, specificity, AUC), is not present in this document.

This document describes a traditional medical device (dental implants and abutments) cleared via the 510(k) pathway, which fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies or AI algorithm validation.

To address the user's request, I must state that the information is not available in the provided document, as it pertains to a different type of device and regulatory submission pathway.

Specifically, the document states:

• "No device specific clinical data has been submitted to demonstrate substantial equivalence." (Page 12, Section 5.7.4)

Here's an explanation with respect to the user's request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence through comparison with predicates, not on meeting predefined performance metrics from a study in the way an AI/software device would. The "performance data" refers to bench testing (dynamic fatigue, static strength, torque) and biocompatibility, which are compared to predicate devices rather than against specific numerical acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical study (with test sets of patient data) was conducted or submitted. The 'samples' referred to in bench testing are physical abutment components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data involving human perception (like AI for image analysis) is not relevant here as no such clinical study was performed.

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

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

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

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI-powered device with a training set.

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

In summary: The provided 510(k) summary for Straumann® Screw-Retained Abutments does not contain the type of AI/clinical performance study information requested. The device is a traditional medical device (dental implant components) and its clearance is based on substantial equivalence to predicate devices, verified through bench testing and biocompatibility assessments, not through human reader studies or AI algorithm performance evaluations on clinical datasets.

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Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on singletooth, bar and bridges applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® BLX SRAs and Antomic Abutments: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in various sizes.

Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in various sizes and angulations.

Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cement-retained single or multi-unit restorations. They are provided non-sterile and are available in various sizes and angulations. They are delivered with the corresponding basal screw. Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.

The provided text describes a 510(k) premarket notification for the Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study to establish new acceptance criteria. Therefore, the information requested in your prompt (Acceptance Criteria and study design for proving it) is not explicitly present in the provided document in the way one might find it for a novel device undergoing clinical trials.

However, based on the performance testing section, we can infer some aspects that act as "acceptance criteria" for demonstrating substantial equivalence to the predicate devices. The study conducted is primarily a series of bench tests and validation studies rather than a clinical trial or a study designed to prove new acceptance criteria.

Here's an attempt to structure the answer based on the provided text, highlighting what is implicitly or explicitly stated about "acceptance" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, explicit "acceptance criteria" as pass/fail thresholds for a novel claim are not presented. Instead, the performance tests aimed to show that the subject device performs equivalently to the predicate devices and meets relevant industry standards. The "performance" column here reflects the outcome of those equivalence demonstrations.

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

• Sterilization Validation: The document states that the validation was in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, specifically mentioning the "over kill bioburden method." These standards outline protocols for sample size determination, but the exact sample sizes used for the sterilization validation are not specified in this document.
• Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The document mentions that "worst-case considerations" were used for testing various platforms (RB and WB) and implant sizes (e.g., Ø3.75 mm for insertion torque). Specific sample sizes for these bench tests are not provided.
• Data Provenance: All data appears to be prospective bench testing and validation studies conducted by or for the manufacturer (Institut Straumann AG / Straumann USA, LLC). No country of origin for the data is specified beyond it being conducted by the applicant's entity.

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

This information is not applicable and not provided in the document. The studies described are engineering and materials science tests (sterilization, biocompatibility, mechanical strength), not studies involving human interpretation or clinical outcomes that would require "experts to establish ground truth." The ground truth for these tests is based on established scientific and engineering principles, international standards (ISO), and FDA guidance documents.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies that involve human interpretation and potential disagreements, such as image reading studies. The described studies are objective 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

This information is not applicable and not provided. The device is an endosseous dental implant system, not an AI-powered diagnostic tool or image analysis software. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the various tests described is derived from:

• International Standards: e.g., ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2, ISO 10993-1.
• FDA Guidance Documents: Such as "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
• Engineering Principles: For mechanical testing like fatigue, strength, and torque.
• Predicate Device Performance: The underlying "ground truth" for a 510(k) submission is that the new device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively without raising new questions of safety or effectiveness.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable and not provided. There is no "training set" for this device.

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The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

The provided document describes the acceptance criteria and the study that proves the Straumann CARES M-Series CAD/CAM System meets those criteria, primarily through a substantial equivalence comparison with predicate devices and various bench studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, performance is demonstrated through a claim of "equivalence" to predicate devices, which implicitly means meeting the performance standards of those legally marketed devices. The reported device performance is presented as "Equivalent" for various features when compared to predicate devices.

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

The document does not specify a separate "test set" sample size in the context of clinical studies with patients. The studies conducted are primarily bench studies involving laboratory testing of materials and device components. The number of samples for each type of bench test (fatigue, biocompatibility, etc.) is not detailed in this summary, but these are typically standardized tests with a defined number of specimens as per the relevant ISO or FDA guidance.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" clinical data, as it primarily refers to bench testing data. These tests would have been performed in a controlled laboratory environment.

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

This information is not applicable. The evaluations are based on engineering and material performance specifications (bench studies) and comparison to predicate devices, not on expert clinical review of a test set for establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable, as the evaluation is based on bench testing and comparison to technical specifications, not human adjudication of diagnostic 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

This information is not applicable. The device is a CAD/CAM system for fabricating dental prosthetics, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to improving human reader performance with AI is not relevant to this submission.

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

The document describes the Straumann CARES M-Series CAD/CAM System as an integrated system involving CAD software, CAM software, milling machines, and material blanks. The "algorithm" component is the CAD/CAM software. The system's performance is inherently "standalone" in its function of designing and fabricating prosthetics based on input scan files, but it is a tool used by human operators (dental technicians/laboratories). The bench studies performed evaluate the output of this system (e.g., strength of the milled prosthetics), which indirectly assesses the standalone performance of the algorithms and hardware in creating the physical restorations.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench studies, the "ground truth" refers to established engineering and material standards. Specifically:

• Dynamic fatigue testing: Conforming to FDA guidance and ISO 14801. The ground truth is the performance criteria defined by these standards.
• Software validation: Conforming to the requirements of IEC 62304. The ground truth is compliance with this software safety standard.
• Sterilization validation: Conforming to ISO 17665-1 and ISO/TS 17665-2. The ground truth is achieving sterility assurance levels defined by these standards.
• Biocompatibility testing: Conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-18. The ground truth is meeting the safety criteria for biological interaction.
• Electrical safety testing: Conforming to IEC 61010-1 and IEC 61010-2-010. The ground truth is compliance with electrical safety standards.

For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning. The CAD/CAM software is likely based on computational design and manufacturing principles, not on a machine learning model that requires a labeled training set derived from large datasets of past cases. Therefore, this concept is not applicable here.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles for the software's functionality would stem from dental anatomical knowledge, engineering mechanics, material science, and manufacturing tolerances, which form the basis of its deterministic operation.

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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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Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.

This document is a 510(k) Premarket Notification for a dental abutment, specifically the "Straumann® synOcta Gold Abutments for Bridge." The purpose of this notification is to demonstrate that the new device is substantially equivalent to existing predicate devices already on the market, rather than proving a new medical claim or performance characteristic that would require extensive clinical trials. Therefore, the information provided focuses on the device's design, material, and mechanical performance compared to a predicate, not on complex acceptance criteria for a diagnostic algorithm or a clinical outcome.

Here's an analysis of the provided text in the context of the requested information, understanding that this is for a physical medical device (dental abutment) and not an AI/diagnostic tool:

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

The document does not present a formal table of "acceptance criteria" in the way one would for a diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through conformity to existing standards and showing comparable mechanical performance.

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

The document mentions "Dynamic fatigue test data" in support of the submission. However, it does not specify:

• The sample size for these tests.
• The specific data provenance (country of origin, retrospective or prospective).
• Details about a "test set" in the context of diagnostic performance. The testing here is mechanical (fatigue).

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

This question is not applicable to this submission. The device is a physical dental abutment, and its "performance" is evaluated through mechanical bench testing and material characterization, not by expert interpretation or ground truth establishment in a clinical imaging or diagnostic context.

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

This question is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. Mechanical tests are typically performed according to standardized protocols.

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 question is not applicable. MRMC studies are used for diagnostic devices involving human readers and AI. This submission is for a physical dental abutment.

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

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

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

For this device, "ground truth" is established through:

• Mechanical standards: Adherence to international standards like ISO 14801 for dynamic fatigue testing.
• Material specifications: Conforming to material standards like ISO 22674 for metallic dental materials.
• Biocompatibility and Sterilization: Relying on the established safety of the materials and manufacturing methods used in the predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through engineering and materials science, not by training an algorithm on data.

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

This question is not applicable for the reasons stated above.

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Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.

PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.

The subject abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.

The provided text is a 510(k) Summary for the Neodent Implant System. It describes a medical device approval and focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert consensus.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert qualifications, and ground truth are not present in this type of regulatory document.

However, I can extract information related to performance data and comparison to predicate devices, which serve as a form of "acceptance criteria" in the context of substantial equivalence.

Here's an attempt to answer your request based on the provided document:

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

In the context of a 510(k) submission, "acceptance criteria" are typically demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics and performance data. The reported "performance" is that the new device is at least as good as, or substantially equivalent to, the predicates.

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 specified in the document. The performance data mentioned are "non-clinical" (biocompatibility, engineering analysis, dimensional analysis, mechanical testing, sterilization testing). For mechanical testing (ISO 14801), sample sizes are not detailed, but such standards typically require a specific number of samples for statistically valid testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification from a Brazilian manufacturer (JJGC Indústria e Comércio de Materiais Dentários SA) to the U.S. FDA, meaning the testing data would typically be generated by or for the manufacturer. The data is non-clinical, likely from laboratory testing. It is not clinical data (no "retrospective or prospective" clinical studies are mentioned).

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 and not provided in the document. The document describes a medical device (dental implant abutments) that undergoes non-clinical engineering and material testing, not diagnostic performance evaluation requiring ground truth established by experts.

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

• This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or performance evaluations where there's subjectivity and disagreement among reviewers (e.g., in imaging interpretation). The tests described are objective, non-clinical tests (e.g., mechanical fatigue, sterilization parameters).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices that assist human interpretation, which is not the nature of the dental implant abutments described.

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

• No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The "performance data" refers to the physical and material properties of the abutments.

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

• This information is not applicable and not provided in the document as it pertains to non-clinical engineering and material testing. The "ground truth" for mechanical testing, for example, would be the physical measurement of failure points or fatigue limits compared against a standard. For biocompatibility, it's compliance with ISO standards.

8. The sample size for the training set

• This information is not applicable and not provided in the document. There is no AI or algorithm involved that would require a "training set."

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

• This information is not applicable and not provided in the document as there is no training set mentioned.

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