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Indications for use Bilimplant® 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 applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.

Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).

Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.

Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.

Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.

Abutment Screws: Connects and fixes the abutment and implant body.

This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.

The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.

However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.

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

Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:

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

The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.

• Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.

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 to the type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.

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

This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.

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. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

The provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.

However, I can extract the information provided that is relevant, or indicate where the information is not present.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.

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 lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were 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)

This type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.

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

This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed here.

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

No MRMC comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.

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

This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.

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

For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.

8. The sample size for the training set

No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.

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

Not applicable, as there is no training set described.

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The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw. The MagDen Fixture is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) with S.L.A surface treatment. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) with TiN coating. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) with no surface treatment. The system provides immediate masticatory function for partially and completely edentulous patients.

This document is a 510(k) Premarket Notification for the MagDen Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results for an AI/ML device.

Therefore, the requested information, which pertains to the acceptance criteria and study proving device performance (presumably for an AI/ML device, given the detailed questions on ground truth, human readers, and training sets), cannot be extracted from this document.

This document describes a medical device (dental implants) and its intended use, materials, dimensions, and biocompatibility and performance tests, but these are related to the physical properties and safety of the implant itself, and not to the performance of an AI/ML algorithm.

The sections regarding "Acceptance Criteria," "Study," "Sample Sizes," "Ground Truth," "Adjudication," "MRMC," and "Standalone Performance" are not applicable to the content of this 510(k) submission.

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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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