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MINICONE are dental implants that are intended for the stabilization of removable dentures.

MINICONE Implants ø2.6 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. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures.

For mandibular restorations, at least 4 MINICONE Implants should be placed.

For maxillary restorations, at least 6 MINICONE Implants should be placed.

MINICONE consists of 2 MINICONE tapered implants with an external diameter of 2.6 mm and lengths of 10 and 12 mm, as well as related accessories.

The implants are manufactured utilizing Titanium Grade 5 ELI material (Ti-4Al-6V) and are finished with a roughened surface (sandblasted/acid etched). The implant neck is machined, and the attachment element of the implants is acting as a retention feature for dentures. This retention feature is coated using a Titanium Nitride (TiN) to obtain a more wear resistant surface and has the Optiloc® geometry which is connected to the denture.

MINICONE Implants Ø2.6mm 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 MINICONE implants are intended for the stabilization of removable dentures. The removable dentures are connected to the MINICONE implants through the incorporated Optiloc® attachment element.

The provided document is a 510(k) summary for the MINICONE Implant, a dental device. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The information provided is for a traditional medical device, specifically an endosseous dental implant, and focuses on performance testing for mechanical properties and sterilization.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document describes the types of engineering and mechanical tests performed (insertion torque, wear, fatigue), but does not specify sample sizes for these tests, nor the "data provenance" in the context of clinical/imaging data as typically asked for AI studies.

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

This information is not applicable as the document describes performance testing for a physical medical device (dental implant), not an AI algorithm that requires expert ground truth for interpretation of images or other data.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm requiring adjudication of 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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that would be used in conjunction with human readers.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm.

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

This information is not applicable in the context of AI studies. For the engineering tests performed:

• Insertion Torque, Wear, Fatigue: Ground truth is established by measured physical properties against established industry standards (e.g., ISO 14801) and comparison to predicate devices, rather than expert consensus on interpretations of data.
• Biocompatibility: Ground truth is based on the known, previously cleared status of the materials (Titanium Grade 5 ELI and TiN coating).
• Sterilization: Ground truth is established by validated processes against microbiological standards (SAL of 10-6 according to ISO 11137-1 and -2).
• Shelf Life: Ground truth is established by accelerated aging tests projecting real-time performance.

8. The sample size for the training set

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as the document describes performance testing for a physical medical device, not an AI algorithm that requires a training set with ground truth.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.

The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.

Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.

The provided text is a 510(k) Summary for the S.I.N. Dental Implant System (K170392). It details the device, its intended use, and a comparison to predicate devices, but does not contain any information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies related to device performance.

The document states: "No clinical data were included in this submission."

Therefore, based on the provided text, I cannot complete the requested information. However, I can extract the information provided about performance data (non-clinical) and the device's characteristics.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the traditional sense of performance metrics for a clinical study with a device output. Instead, it describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance
Not applicable. No clinical test set. Non-clinical tests were conducted; however, specific sample sizes for these tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.

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 study was done. The device is a dental implant system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental implant system, not an algorithm or AI.

7. The type of ground truth used
Not applicable. No clinical ground truth is mentioned.

8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is mentioned.

Summary of what the document implies about meeting acceptance criteria:

The document demonstrates that the "S.I.N. Dental Implant System" meets the requirements for substantial equivalence to its predicate devices through a series of non-clinical tests. These tests cover aspects like sterilization, shelf-life, biocompatibility, and physical performance (e.g., insertion). The "acceptance criteria" here implicitly refer to the successful completion of these standard tests demonstrating that the device is as safe and effective as the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The absence of clinical data in the submission indicates that the FDA deemed the non-clinical evidence sufficient for a finding of substantial equivalence.

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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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BBX1, BBX2, BBX1MO, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.

BBX1, BBX1MO, BBX1MC and BBX2 dental implants whose material composition of the implants is titanium alloy Grade 5 ELI (Titanium 6 AL 4V), conforming to ASTM F-136 (Stundard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Surface treatment features include air blasting with Biphasic Calcium Phosphate (CaPO4) and HA micro particles, followed by acid passivation and cleaning, conforming to ASTM F1088 Surface Treatment HA, ASTM F-86 (Passivation), and ASTM F1185-03 Trace Elements.

BBX1, BBX1MQ, BBX1MC and BBX2 dental implants are all provided with screw thread and helix shape inclined grooves. For dental implant series BBX1, BBX1MC, the shoulder or abutment is integrated, that is, not a separate part of the whole implant. They are one piece dental implants.

Dental implants series BBX2 consists of three parts, one straight abutment, one screw and the implant body.

BBX1, BBX2, BBX1MO and BBX1MC dental implants consist of a threaded area, a transgingival area, mini threads, an implant body area and a vertical abutment.

This document describes a 510(k) premarket notification for dental implants (BBX1, BBX2, BBX1MO, BBX1MC). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be typically seen for a novel device or software. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for new clinical outcomes. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various characteristics. The "performance" assessment is based on non-clinical testing to ensure fundamental safety and material requirements are met, and that the new device's characteristics do not raise new safety or effectiveness concerns compared to existing devices.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data or clinical cases described for evaluating new clinical performance metrics. The demonstration of substantial equivalence relies on non-clinical testing and comparison to existing predicate devices.
• Data Provenance: The data provided is primarily technical and regulatory documentation comparing the subject device to predicate devices and demonstrating compliance with various ASTM and ISO standards for materials, manufacturing, and biocompatibility. There is no mention of country of origin for clinical data or whether it is retrospective or prospective, as clinical trials were not part of this submission for substantial equivalence.

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

• Number of Experts: Not applicable. As there is no clinical "test set" with clinical outcomes that require expert ground truth establishment, no experts were utilized for this purpose in the context of this regulatory submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical "test set" requiring adjudication of results is mentioned.

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:

• MRMC Study: No. This device is a dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant to this submission.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical medical device (dental implant), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by established international and national standards (e.g., ISO 10993-5 for biocompatibility, ASTM F-136 for material composition and properties). Compliance with these standards serves as the "ground truth" for the device's fundamental safety and material characteristics. No clinical outcomes data for a novel device/AI application is mentioned as ground truth.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this 510(k) submission for dental implants. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.

The provided 510(k) summary for the Neodent Implant System does not contain information related to acceptance criteria or a study proving device performance against such criteria.

The document is a premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a clinical study or benchmark performance testing with ground truth.

Therefore, many of the requested elements cannot be extracted from this document, as they are not present in a "substantial equivalence" submission for this type of device.

Here's an breakdown of what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not applicable. No clinical or performance test data on a "test set" are presented.
• Data Provenance: Not applicable. The submission explicitly states: "Clinical data were not submitted in this premarket notification." The non-clinical data mentioned (engineering analysis, dimensional analysis, comparative surface area analysis) would not typically involve a "test set" in the sense of patient data.

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

• Not applicable. As no clinical or performance test data are presented, there is no "ground truth" established by experts for a test set in this submission.

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

• Not applicable. No test set requiring adjudication is mentioned.

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 submission for a physical medical device (dental implants), not an AI diagnostic tool. No MRMC study was done, nor is AI assistance relevant to this device.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. No performance data requiring ground truth ascertainment is presented. The submission relies on "substantial equivalence" based on design, materials, and non-clinical characteristics (engineering, dimensional analysis) comparing the new device to existing predicate devices.

8. The sample size for the training set

• Not applicable. As no machine learning or AI model is involved, there is no "training set."

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

• Not applicable. No machine learning or AI model is involved, so no training set or ground truth for it was established.

Summary based on the provided document:

The 510(k) summary for the Neodent Implant System explicitly states: "Clinical data were not submitted in this premarket notification." The submission focuses on demonstrating that the new components of the Neodent Implant System are "substantially equivalent" to predicate devices already cleared for market. This equivalence is based on:

• Identical intended use.
• Similar design, identical material, and identical surface to a previously cleared Neodent system (K101945).
• Similar indications, design, and dimensions to other predicate devices for the new Titamax WS and Facility implants.
• Non-clinical data including engineering analysis, dimensional analysis, and comparative surface area analysis.

The conclusion drawn is that "The device is safe and effective for its intended use and performs as well as or better than the predicate devices," based on the comparison of an existing cleared device characteristics rather than new performance data against specific acceptance criteria.

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