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Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.

Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.

Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.

The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants

The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.

The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.

1. Table of Acceptance Criteria and Reported Device Performance

• All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved.
• Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding.
• The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge."
• New specific Indications for Use for Ø 3.3 mm implants provide more details.
• The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region.
• For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress. |
  | For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging):
  Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants.
  Demonstrated through systematic literature review or clinical studies. | A systematic literature search identified 5 publications.
• 251 SLActive implants were placed in 237 patients (age range 25-65 years old).
• Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm.
• Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers.
• Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
• References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section). |
  | Sterility:
  Sterilization process validated to SAL of 10^-6.
  Meets pyrogen limit specifications. | - Sterilization via gamma irradiation after final packaging.
• Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method).
• Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1). |
  | Biocompatibility:
  Biological assessment performed according to ISO 10993-1 and FDA Guidance. | - Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed). |
  | Dynamic Fatigue:
  Assessment conducted per FDA guidance and ISO 14801. | - Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801.
• Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed). |
  | Insertion Performance:
  Demonstrated adequate insertion torque in different bone classes. | - Insertion tests performed for the subject implants.
• Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed). |
  | MR Safety:
  Evaluated for MR Conditional status. | - Obtained MR Conditional status per K180540.
• MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted). |

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

The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).

• Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
• Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.

For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."

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

• For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
• For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.

4. Adjudication Method for the Test Set

• For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
• For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.

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

• No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.

7. The Type of Ground Truth Used

• For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
• For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).

8. The Sample Size for the Training Set

• Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.

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

• Not applicable. (See point 8.)

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Straumann® Mini Implants ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Strauman® Mini Implants are intended for the stabilization of removable dentures.

The Straumann Mini Implants are tapered implants with an external diameter of 2.4 mm and lengths of 10, 12, and 14 mm. Standard manufacturing processes such machining, surface treatment, cleaning, packaging and sterilization were applied for the subject devices. There are no significant changes related to the implant material, surface treatment, fundamental operating principles, sterilization processes or procedures between the subject devices and the reference devices cleared under K083550. The main difference is the Optiloc® attachment element incorporated on the top of the implant. The implants are manufactured utilizing the Roxolid material and are finished with SLA® surface. The implant neck is machined and the Optiloc® attachment element of the implants is acting as a retention feature for dentures and it is coated using a Titanium Nitride (TiN) coating. Straumann® Mini Implants Ø2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. The Straumann Mini Implants are intended for the stabilization of removable dentures. The removable dentures are connected to the Mini Implants through the incorporated Optiloc® attachment element.

This document describes a 510(k) premarket notification for the Straumann® Mini Implants. The information provided heavily focuses on the comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance against specific quantitative acceptance criteria in a human population.

Therefore, many of the requested details regarding acceptance criteria for device performance in a clinical setting, sample sizes for test sets, expert involvement for ground truth, and MRMC studies will not be present in this type of regulatory submission. The performance testing outlined here is primarily bench testing to demonstrate mechanical and material equivalence.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The document does not specify quantitative clinical performance acceptance criteria (e.g., success rates, complication rates) and corresponding reported device performance from a clinical trial. Instead, the "acceptance criteria" discussed are related to bench testing for demonstrating equivalence to predicate devices.

Table 1: Acceptance Criteria (Bench Testing) and Reported Device Performance

Study Details (Based on Provided Document)

Given that this is a 510(k) submission primarily relying on substantial equivalence through bench testing, a traditional clinical study with a "test set" in the context of AI/diagnostic device evaluation (as implied by the detailed questions) was not conducted or reported here. The performance testing discussed pertains to physical and mechanical characteristics of the dental implants.

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

   • Test Set Sample Size: Not applicable in the context of a clinical test set for AI/diagnostic performance. The "test set" here refers to the samples of the physical device used for bench testing (e.g., number of implants for insertion torque, wear, and fatigue tests). Specific quantities are not provided, but these are typically small, controlled laboratory samples.
   • Data Provenance: Not applicable in terms of patient data. The data provenance is from laboratory bench testing.

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

   • Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical outcomes.

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

   • Not applicable. This concept applies to human reader studies or data labeling, not bench testing of a physical implant.

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:

   • No. This is irrelevant to the evaluation of a dental implant's mechanical and material properties. The device is a physical implant, not an AI-assisted diagnostic tool.

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

   • No. This also refers to AI/software performance, not a dental implant.

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

   • The "ground truth" for this device is based on engineering standards and specifications (e.g., ISO 14801, ISO 11137), and the properties of the previously cleared predicate devices. For example, a successful fatigue test to a certain threshold is "ground truth" for mechanical durability.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

   • Not applicable. As noted above, there is no training set for this type of device.

Summary of what the document primarily reports:

The document, a 510(k) summary, demonstrates the substantial equivalence of the Straumann® Mini Implants to legally marketed predicate devices. This is achieved by:

• Comparing Indications for Use: Showing the new device's indications are equivalent to a predicate (K031106), with one difference (not indicated for inter-radicular transitional applications) that does not raise new safety or effectiveness questions.
• Comparing Technological Characteristics: Detailing similarities and differences in material, dimensions, coating, surface treatment, etc., with predicates and reference devices (Table 1).
• Performance Testing (Bench Testing): Conducting various engineering tests (insertion torque, wear, biocompatibility, sterilization, shelf life, pyrogenicity, dynamic fatigue) and demonstrating that the device meets internal "acceptance criteria" for these tests, which are implicitly set to show equivalence to or non-inferiority against the predicate devices' known performance. The tests adhere to relevant FDA guidance and ISO standards.

This type of submission is common for Class II medical devices where clinical trials are not explicitly required if substantial equivalence can be demonstrated through non-clinical means.

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The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.

The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:

Table 1.
| Elos Accurate Customized
Abutment - Model Type | Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|---------------------------------------------------|-------------------------|---------------------------|-------------------------------|
| AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 |
| AB-NBA30 | Nobel CC 3.0 | 3 | 3 |
| AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 5 |
| AB-NBA60 | Nobel CC WP | 5.1 | 5.5 |
| AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 |
| AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes the Elos Accurate® Customized Abutment, a dental device, and its FDA 510(k) clearance. This document is a regulatory submission, not a study report detailing AI/ML model performance. Therefore, many of the requested criteria related to AI/ML model evaluation are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can provide information based on the device's performance against engineering and material acceptance criteria, as well as the non-clinical testing performed to demonstrate substantial equivalence to its predicate device. This is primarily focused on mechanical and biological compatibility, not AI/driven diagnostic accuracy.

Here's the information derived from the provided text, adapted to the closest relevant categories:

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

For a device like the Elos Accurate® Customized Abutment, acceptance criteria primarily relate to mechanical properties, biocompatibility, and compatibility with implant systems. The "reported device performance" here refers to the aspects that were tested and deemed acceptable through non-clinical testing to establish substantial equivalence.

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

The document does not specify a "test set" in the context of an AI/ML model. The evaluation here is based on non-clinical testing (mechanical, dimensional, and biocompatibility).

• Sample Size: The document does not provide specific numerical sample sizes for the engineering tests (e.g., how many abutments were subjected to fatigue testing). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data comes from non-clinical laboratory testing and engineering analyses performed by or for Elos Medtech Pinol A/S. The country of origin of the data is not explicitly stated, but the company is located in Denmark. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence.

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

This question is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." Ground truth, in this context, would be established by validated measurement techniques, material science principles, and biological testing standards (e.g., ISO standards for mechanical testing and biocompatibility).

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

This is not applicable. "Adjudication method" refers to the process of resolving disagreements among human readers or experts for establishing ground truth in a diagnostic study. For this device, acceptance is based on meeting predefined engineering and biological performance standards through validated 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. No MRMC study was performed as this is not an AI-assisted diagnostic device.

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

This is not applicable. This is not an AI algorithm. Its design uses CAD/CAM technology, but the clearance is for the physical abutment itself, not a diagnostic algorithm.

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

For this device, the "ground truth" or basis for acceptance relies on:

• Established engineering standards: e.g., ISO 14801 for fatigue testing of dental implants.
• Biocompatibility standards: e.g., ISO 10993-5 for cytotoxicity.
• Dimensional analysis: Verifying compatibility with specified implant systems.
• Material specifications: Conformance to Titanium Alloy 6Al-4V ELI (medical grade 5).

There is no "expert consensus" in the diagnostic sense or pathology/outcomes data used for device clearance as described in the summary.

8. The sample size for the training set

This is not applicable because there is no AI/ML model for which a "training set" would be used.

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

This is not applicable because there is no AI/ML model for which training set ground truth would be established.

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The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Straumann® CARES® Abutments CoCr are used for the restoration of Straumann dental implant platforms RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The Straumann® CARES® Abutments CoCr allow for individual customization regarding function and esthetics. Straumann® CARES® Abutments CoCr are designed by the dental laboratory technician either by means of a conventional wax-up model that is subsequently scanned or by scanning the intraoral situation and designing the shape by using a Straumann-approved software (such as Straumann® CARES® Visual). The design data is then transferred to a Straumann central milling center where the fabrication of the customized abutment is carried out. The Straumann® CARES® Abutments CoCr can be directly veneered.

The provided text describes the regulatory filing for a dental implant abutment and does not contain information about an AI/ML device. Therefore, it's not possible to extract the requested details regarding acceptance criteria, study design for AI models, or expert ground-truthing. The document pertains to a traditional medical device (Straumann® CARES® Abutments CoCr) and its equivalence to predicate devices based on material, design, and mechanical performance testing.

However, I can extract the acceptance criteria and performance data for the traditional medical device as described:

1. Table of Acceptance Criteria and Reported Device Performance

• ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
• ISO 10993-5:2009 "Tests for in vitro cytotoxicity"
• ISO 10993-18 "Chemical characterization of materials" |
  | Veneering Performance | Performed per ISO 9693-1 "Dentistry – Compatibility testing – Part 1: Metal ceramic systems". |
  | Corrosion Resistance | Demonstrated according to ISO 10271:2011 "Corrosion test methods for metallic materials". |
  | Sterilization Validation | Carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10^-6 in accordance to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. |
  | Design Limits | Max Angulation 30°, Minimum thickness 0.33mm. Minimum surface area requirements based on tooth position were also identical to the predicate. |

The following information is not present in the provided document, as it describes a non-AI medical device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Additional Study Information (from the document for the traditional device):

• Study Type: Bench testing (mechanical, material, biocompatibility, corrosion, sterilization).
• Clinical Studies: "No animal or human clinical studies were conducted."
• Ground Truth: For traditional device testing, "ground truth" is typically defined by established engineering and material science standards (e.g., ISO, ASTM) and manufacturing specifications.

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ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:

| IMPLANT BRAND
NAME | PLATFORM | Manufacturer | Implant Trade
Name | Implant
Line/Connection | Implant
Diameter |
|---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------|
| Nobel Biocare Replace
Select | 6.0mm | Nobel Biocare USA | Nobel Replace
Tapered
Conical
Connection | Nobel Replace
Internal Conical
Connection WP | 6.0mm |
| Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Straumann Bone Level | 3.3mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
NC | 3.3mm |
| Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
RC | 4.1, 4.8mm |
| Straumann Synocta | 4.8mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
4.8mm RN (Reg.
Neck) | 4.8, 6.5mm |
| Straumann Synocta | 6.5mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
6.5mm (Wide
Neck) | 4.8, 6.5mm |
| Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed | OsseoSpeed
Internal Conical
Connection RP | 3.6, 4.2, 4.8mm |
| Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed
Plus | OsseoSpeed Plus
Internal Conical
Connection RP | 3.0, 3.5, 4.0, 4.5,
5.0mm |

Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.

Minimum and Maximum Gingival Height is 0-6mm

Minimum diameter at abutment/implant interface is 3.5mm to interface base

Maximum length of abutment from abutment/implant interface is 12.5mm

Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.

Minimum wall thickness at abutment/implant interface is 0.65mm

Maximal angle in relationship to the long axis of implant is 30°

The available range of diameters and connection type is summarized on the table below:

This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.

Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.

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

• Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
• Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory 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)

Not applicable. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.

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

Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and 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

Not applicable. This device is a dental implant abutment, not an AI diagnostic tool.

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

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

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

The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

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

Not applicable. This is a physical medical device.

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Straumann® dental implants 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. Straumann dental implants can also be used 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 by the corresponding elements (abutments).

The subject devices represent a line extension of the previously cleared implants of the Straumann Dental Implant System. The subject devices represent a full line of Straumann implants having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and acid etch surface finish in the same diameters, lengths, emergence profiles and implant-to abutment interfaces as previously cleared implants in the Straumann Dental Implant System.

This document (K150938) describes the Straumann® Dental Implant System - Roxolid® SLA Implants, which are dental endosseous implants. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The key change is the use of a Titanium-13Zirconium alloy (Roxolid®) for the implants, compared to commercially pure Grade 4 Titanium in the predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" for specific performance metrics in a tabular format. Instead, it relies on demonstrating that the new material change (Roxolid®) does not negatively impact the performance compared to the predicate devices which used commercially pure Grade 4 Titanium. The performance is assessed through various bench studies.

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 explicitly states that the substantial equivalence of the device is addressed via "bench studies" and "dynamic fatigue test data consistent with FDA guidance and ISO 14801." However, it does not provide specific sample sizes (e.g., number of implants tested), the exact test parameters beyond "ISO 14801," or the provenance of the data (country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, which are not included in this summary.

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 a medical device approval based on bench testing and material equivalence, not on clinical performance or interpretation of images by experts. Therefore, the concept of "experts used to establish the ground truth" for a test set (like in a diagnostic AI study) is not applicable here. The "ground truth" for the bench tests would be the results obtained following the specified standards (e.g., force values, cycles to failure).

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

Not applicable. As noted above, this submission relies on bench testing and material characterization, not human interpretation or adjudication of outputs.

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

Not applicable. This is not an AI-assisted diagnostic tool. It is a dental implant.

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

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

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

The "ground truth" for this device's performance relies on engineering standards and scientific verification of material properties and mechanical performance. This includes:

• Material composition analysis: Verifying the Ti-13Zr alloy (Roxolid®) composition.
• Mechanical testing: Dynamic fatigue testing according to ISO 14801.
• Surface characterization: Analysis of the SLA grit blast and acid etch surface finish characteristics and surface chemistry.
• Sterilization validation: Conformance to ISO 11137-1 and ISO 11137-2 for sterility assurance level (SAL).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device approval process. The device's performance is not learned through data like an AI model; it's designed and verified through engineering principles and testing.

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

Not applicable, as there is no training set for this device.

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The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
• o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:

• Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
• Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.

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

The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.

• Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
• Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.

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

This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.

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

No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:

• Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
• Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
• Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This section is not applicable for the same reason as above; there is no training set for a physical medical device.

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DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.

DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.

Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.

Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.

Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.

The provided text describes the "IMPLADENT DEFCON TSA/TSH Dental Implant Systems," a root-form endosseous dental implant. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the way a clinical trial might.

Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for an AI/CAD device is not available in the provided text.

The document explicitly states:

• "No clinical studies are submitted." (Section 5: 510(k) SUMMARY)
• The device was subject to "bench testing to determine conformance to performance [requirements]... specifically including mechanical performance... and biological testing in accordance with the level and duration of contact with the human body, surface finish evaluation including chemical analyses, and sterilization process validation." (Section 5: 510(k) SUMMARY - NON-CLINICAL TEST SUMMARY)

This indicates that compliance was demonstrated through non-clinical, laboratory bench testing, not through human clinical studies where acceptance criteria for diagnostic accuracy (common in AI/CAD systems) would typically be evaluated.

The "acceptance criteria" in this context are related to the mechanical, biological, and material properties of the implant, which were likely evaluated against industry standards or internal specifications during bench testing. However, the specific metrics and comparison to reported performance are not detailed in the summary provided.

In summary, as this is a 510(k) for a physical medical device (dental implant) and not an AI/CAD system, the requested information on acceptance criteria, clinical study design, and performance metrics (like sensitivity, specificity, reader improvement, etc.) is not applicable or present in the provided document.

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