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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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JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon.

Abutment and accessories are exclusive for JDentalCare® implant system JDIcon®

JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered.

Their surface is treated through sandblasting followed by acid etching treatment.

JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.

This FDA 510(k) summary describes the JDentalCare® Implant System JDIcon® and demonstrates its substantial equivalence to previously marketed predicate devices, rather than presenting a study proving performance against specific acceptance criteria.

The document focuses on comparing the proposed device's characteristics and performance to legally marketed predicate devices. It doesn't define absolute "acceptance criteria" in the sense of predefined thresholds for a new study, but rather demonstrates that the new device meets the established safety and effectiveness profile by being similar to already cleared implants.

Therefore, the requested tables and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not directly applicable or provided in this type of regulatory submission.

However, I can extract information related to how the device's performance was evaluated and how it compares to existing standards and predicate devices, which implicitly serve as "acceptance criteria" for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Implied by Comparison to Predicates):

Regarding the specific numbered questions:

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

   • This has been provided above, interpreting the comparison to predicate devices and standards as the implicit "acceptance criteria" for substantial equivalence.

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

   • This document is a 510(k) summary, which inherently relies on demonstrating substantial equivalence to already legally marketed devices. It describes engineering tests and biocompatibility assessments, rather than clinical trial data with patient samples.
   • Sample Size: Not specified in the document for any particular test. These are typically bench tests following standardized methodologies.
   • Data Provenance: Not explicitly stated as "country of origin for data." The tests are performed "according to ISO" or "in compliance with FDA guidance," implying standard laboratory or testing facility setups. There is no mention of human subject data, therefore, no retrospective or prospective study is described in this context for performance evaluation.

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 document does not describe a clinical study where ground truth is established by experts (e.g., for diagnostic accuracy). The "ground truth" here is compliance with engineering standards and demonstration of similar functional characteristics and safety profiles to existing devices.

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

   • Not applicable. As above, this document does not describe a clinical study requiring adjudication of expert interpretations.

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

   • Not applicable. This device is a dental implant system (a physical medical device), not an AI algorithm for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

   • Not applicable. This 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" in this context is established by:
     • Standardized Test Methods: Adherence to international standards like ISO 14801 (mechanical fatigue), ISO 10993 (biocompatibility), ISO 11137 (sterilization), and ASTM F67/F136 (materials).
     • Comparison to Legally Marketed Predicate Devices: The key "ground truth" for a 510(k) is that the device is substantially equivalent in safety and effectiveness to a device already cleared by the FDA. This relies on the established safety and effectiveness of the predicate.
     • Internal Validation: Surface validation and cleaning process validation are internally conducted and documented.

8. The sample size for the training set

   • Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set for a physical dental implant.

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ETIII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).

The provided text is a 510(k) summary for a dental implant system (ETIII Bio-SA Fixture System) and does not contain information about an AI/ML-driven medical device. Therefore, it does not describe acceptance criteria, a study proving an AI device meets those criteria, or other details typically associated with the evaluation of AI/ML performance.

The document discusses:

• Device Description: An endosseous dental implant system made of pure titanium, with specific design features and surface treatment.
• Intended Use: For partially or fully edentulous mandibles and maxillae to support various dental restorations.
• Predicate Devices: Comparison with existing dental implant systems, highlighting the key difference of an added hydrophilic coating for improved wettability.
• Non-Clinical Testing:
  • Wettability and blood affinity observations.
  • Surface analysis (EDS, FE-SEM, ICP-AES).
  • Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, chromosome aberration, implantation, pyrogenicity) conducted according to ISO and FDA guidelines.
  • Animal study (Beagle dogs): Measured removal torque, bone loss, and bone-to-implant contact.
• Clinical Testing: A study with 45 subjects and 66 implants, evaluating primary stability, bone resorption, complications, and other factors, reporting a 100% success rate after 16.3 months average follow-up.
• Shelf-life validation and sterilization.

Summary of missing information relevant to AI/ML device evaluation:

Since this document pertains to a physical dental implant device and not an AI/ML-driven device, it does not contain any of the requested information regarding AI/ML performance criteria or studies.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance.

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The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).

The temporary copings are manufactured from polymethylmethacrylate (PMMA).

This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.

Let's break down what information is available based on your request and what is not available for a device like this.

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

For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.

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 (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
• Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.

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 section is not applicable to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.

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

This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.

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 section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.

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

This section is not applicable. This is not an AI algorithm.

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

• Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.

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

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

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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. 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, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.

The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.

Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.

Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.

The provided text is a 510(k) premarket notification for a Medical Device, specifically a "Dental Implant System." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study of device performance against pre-defined acceptance criteria in the context of clinical or AI-based performance metrics.

Therefore, the document does not contain the information requested for acceptance criteria and a study that proves the device meets those criteria, especially in relation to AI/algorithm performance. It is a regulatory submission demonstrating mechanical, material, and safety equivalence.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/Algorithm Component: There is no mention of any AI, machine learning, or algorithm being part of this "Dental Implant System." The device is a physical dental implant.
• Focus on Substantial Equivalence: The entire document is geared towards proving that the proposed device is "substantially equivalent" to a legally marketed predicate device (STRAUMANN DENTAL IMPLANT SYSTEM). This is a regulatory pathway, not a clinical trial to demonstrate new performance metrics against acceptance criteria for a novel AI.
• No Clinical Study: Section 7 explicitly states: "No clinical study is included in this submission." This means there is no data from human subjects or a clinical setting to evaluate performance.
• Non-Clinical Test Conclusion: Section 6 details non-clinical tests. These tests are primarily for material properties, sterility, biocompatibility, and mechanical durability (e.g., dynamic fatigue test). These are engineering and material science tests, not performance studies for a diagnostic or AI-driven medical device.

Therefore, it is impossible to complete the requested table or answer the specific questions about acceptance criteria, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of this 510(k) submission for a physical dental implant.

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Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

Specific indications for small diameter (Ø 3.3mm) and short (length

Anker Dental Implant System is an integrated system which includes Bone Level (SB-III series) and Tissue Level (ST and AT series) dental implants.

Anker Dental Implant System SB-III series consists of fixture, abutments (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment, convertible abutment, convertible protect cap, convertible combination cylinder, convertible angled cylinder, convertible temporary cylinder, angled screw abutment, temporary cylinder) and cover screw.

Anker Dental Implant System ST and AT series consist of fixture, abutments (healing cap, solid abutment, cementable abutment, angled abutment, temporary restoration screw, screw retained abutment, locator abutment) and closure screw.

Fixtures are made of pure titanium (grade IV) and there surface was treated by SLA (Sand-blasted, Large grit. Acid-etched) process. Diameters of fixtures are including 3.3 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Cover screw, closure screw and most abutments are made of titanium alloy. Temporary abutment and convertible temporary cylinder (SB-III series) are made of SUS316L stainless steel instead of titanium alloy. All products are sterilized as finished products.

The provided text is a 510(k) summary for the Anker Dental Implant System, a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a novel AI/software medical device might.

Therefore, the information requested in your prompt (especially points 1-7, and 9 for a training set) is not directly applicable to this document. This submission does not describe an AI/software device with performance metrics like sensitivity, specificity, or reader improvement. It describes a physical dental implant system and relies on non-clinical testing to demonstrate that it meets established safety and performance standards by being similar to already approved devices.

Here's a breakdown of what can be extracted and why other parts cannot, based on the provided text:

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

• Not applicable in the AI/software sense. This document does not define quantitative performance metrics like accuracy, sensitivity, or specificity with specific acceptance thresholds for the dental implant system as a whole in the way an AI diagnostic tool would.
• Instead, acceptance is demonstrated by meeting harmonized standards for mechanical and biocompatibility testing. The "reported device performance" is that it passed these tests. The table on page 8 lists the testing items and standards referenced, implying that meeting these standards is the "acceptance criteria" for those specific aspects.
  • Compressive forces and fatigue tests: ISO14801 (Likely relates to mechanical strength and durability under chewing forces)
  • Compatibility test of dental implant/abutment interface: N/A (Indicates no specific standard, but testing was performed)
  • Corrosion test: ASTM G3-89
  • Residual of Acidic Substances Test: ISO10993-12 (Biocompatibility, specifically related to the SLA surface treatment)
  • Biocompatibility tests: ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10, ISO10993-11, Pharmacopeia US, OECD guideline #473, OECD guideline #474 (Cover various aspects like genotoxicity, cytotoxicity, irritation, sensitization, systemic toxicity)
  • Sterilization validation of GAMMA irradiation: ISO11137-1
  • Shelf life Validation: ASTM F88/F88M-09, ASTM F1140-07, ASTM F1929-98, ISO11737-2 (Relates to package integrity and sterility maintenance over time)

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

• Not applicable in the AI/software sense. There isn't a "test set" of patient data in the context of an AI algorithm. The testing involves physical samples of the dental implants. The document does not specify the number of individual implant units tested for each non-clinical test (e.g., how many implants were subjected to fatigue testing).
• Data provenance: The tests are likely performed by the manufacturer or accredited labs compliant with the referenced standards. The manufacturer is Alliance Global Technology Co., Ltd. from Taiwan.

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

• Not applicable. There is no "ground truth" establishment by experts in this context as would be done for an AI diagnostic algorithm. The "ground truth" for these physical tests is adherence to the scientific principles and methodologies outlined in the referenced ISO and ASTM standards.

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

• Not applicable. This concept relates to expert review of medical images or data for AI algorithm validation. For physical device testing, adherence to a standard's protocol and acceptance criteria is the assessment method.

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

• Not applicable. This is a physical dental implant, not an AI software. No human reader study with or without AI assistance 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 (expert consensus, pathology, outcomes data, etc):

• Not applicable in the typical AI sense. For this device, the "ground truth" is defined by the technical specifications and performance requirements derived from harmonized standards (e.g., ISO for mechanical properties, ASTM for corrosion, ISO 10993 for biocompatibility). Passing these tests constitutes meeting the "ground truth" of safety and performance for a dental implant.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" as it's not an AI/machine learning model.

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

• Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device (dental implants), not an AI/software medical device. Therefore, the questions related to AI/software performance metrics, ground truth establishment by experts, and training/test set methodologies are not relevant and cannot be answered from this text. The "study" that proves the device meets "acceptance criteria" here refers to the non-clinical testing performed according to recognized international standards, demonstrating equivalence to predicate devices.

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