Search Results

The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.

This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.

However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
• Sample sizes used for the test set and data provenance (not applicable for this type of device)
• Number of experts used to establish ground truth and qualifications (not applicable)
• Adjudication method (not applicable)
• MRMC comparative effectiveness study (not applicable)
• Standalone (algorithm-only) performance (not applicable)
• Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
• Sample size for the training set (not applicable)
• How the ground truth for the training set was established (not applicable)

The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:

• Sterilization validation testing (ISO 17665-1 & 2)
• Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
  • Cytotoxicity
  • Oral mucosa irritation
  • Skin sensitization
  • Acute systemic toxicity
  • Subchronic systemic toxicity
  • Bacterial reverse mutation
• Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
• TiN coating tests (F1044, F1147, F1160)
• Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.

Ask a specific question about this device

ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm
• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular)
• · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP
• · Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm.

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

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

• Test Set Sample Size:
  • The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
• Data Provenance:
  • The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
  • The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

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

• This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
• The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

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

• This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

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

• For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
• For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

The DenQ Sub SLA Implant 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The DenQ Sub SLA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile.

The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling).

This document is a 510(k) Pre-market Notification for a dental implant system (DenQ Sub SLA Implant System). It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets acceptance criteria through clinical or comparative effectiveness studies in the typical sense of a novel AI/software device.

Therefore, many of the requested elements (like MRMC studies, number of experts for ground truth, training set information for an AI device) are not applicable to a 510(k) submission for a physical dental implant system. The "acceptance criteria" here refers to demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and comparison of characteristics.

Here's a breakdown of the available information relevant to your request, adapting it to the context of this specific document:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

For a physical device like a dental implant, "acceptance criteria" are the relevant ISO standards and material specifications that the device must meet to be considered safe and effective and substantially equivalent to a predicate. The "reported device performance" is the demonstration that these tests were passed.

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

This document is for a physical medical device, not an AI/software device that would typically have a "test set" of patient data. The "tests" here refer to laboratory and bench testing on the physical device components.

• Sample Size: Not specified for individual non-clinical tests (e.g., how many implants were subjected to fatigue testing). This information is typically detailed in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: Not applicable in the sense of patient data. The results are from in-vitro (laboratory) and bench testing of the devices themselves. The tests were performed "in accordance with ISO standards and US regulations." The manufacturer is located in the Republic of Korea.

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

• Not applicable. This submission relies on engineering standards and laboratory measurements for its performance criteria, not expert interpretations of medical images or clinical data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" requiring adjudication in the context of this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done (and effect size):

• No. MRMC studies are typically for diagnostic AI devices assessing human reader performance. This is a physical dental implant.
• Summary of clinical testing: "No clinical testing was performed for this submission."

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

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

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established by engineering and material standards (e.g., ISO, ASTM, USP), and the physical measurements and observations derived from in-vitro and bench testing of the device's components (e.g., fatigue resistance, material properties, sterility).

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data.

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

• Not applicable. As above, no training set.

Ask a specific question about this device

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).

This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.

Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.

Here's why each point is not applicable and what information is provided:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.

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. Ground truth, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is relevant 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: Not applicable. This is not an AI-assisted device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.

8. The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does provide regarding device performance and testing:

• Type of Testing:

  • Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
  • Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
  • Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
  • Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
  • Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
  • MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.

• Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.

In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.

Ask a specific question about this device

AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• · Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
• · Implant Direct Legacy2(K192221) 3.0
• · Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
• · Nobelactive Wide Platform (Wp) (K133731) WP 5.5
• · TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• · Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Study Details

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

   • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
   • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

2. 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 is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

   • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

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:

   • Not applicable. This is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

   • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

   • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

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

   • Not applicable for the same reason as above.

Ask a specific question about this device

The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.

Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

The Osstem Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The Ultra-Wide implants are intended to be used only to replace molar teeth and angled abutments are not to be used with the Ultra-Wide implants.

Osstem Implant System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:

The document is a 510(k) summary for the Osstem Implant System, seeking substantial equivalence to predicate devices. As such, it focuses on demonstrating that the new device modifications (primarily additional dimensions and a non-hex connection for some implants) are as safe and effective as the previously cleared predicate devices. Therefore, the "acceptance criteria" discussed are primarily about meeting existing performance standards (like ISO 14801 for fatigue testing) and demonstrating consistency with the predicate devices in terms of materials, manufacturing, indications for use, etc.

Since this is a substantial equivalence submission for a dental implant system involving physical product variations rather than a novel AI/software device, many of the typical AI-specific criteria (like MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set size/ground truth establishment) are generally not applicable or explicitly stated in the context of this traditional medical device submission.

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

For the specific modifications in the proposed device, the primary acceptance criterion for mechanical performance is successful fatigue testing according to ISO 14801:2016 for the worst-case scenario. Other performance criteria are met by leveraging tests performed on predicate devices, demonstrating equivalence in materials, manufacturing, and design principles.

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

• Fatigue Testing (ISO 14801:2016): The document mentions "worst-case implant-abutment combination" was chosen. ISO 14801 typically specifies minimum sample sizes (e.g., 5 or 10 samples per test condition for static or dynamic testing). The exact number of samples tested for the new Non-Hex implants is not explicitly stated in this summary, nor is the provenance of the test data (e.g., conducted in-house, by a certified lab). However, such tests are generally conducted prospectively on newly manufactured devices or representative samples.
• Other tests (Sterilization, Shelf-Life, Biocompatibility, Bacterial Endotoxin): These were leveraged from predicate devices (K121585, K121995, K161604). The sample sizes and provenance for those original predicate device studies are not detailed in this submission.

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 for this type of device submission. This is a mechanical and material performance evaluation, not a diagnostic or interpretative device requiring clinical expert ground truth for a test set. Design requirements and performance standards (like ISO 14801) define the "ground truth" to be met.

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

• Not applicable for this type of device submission. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among experts.

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 dental implant system, not a diagnostic or AI-assisted device.

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

• Not applicable. This is a hardware medical device; there is no algorithm or AI component for standalone performance.

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

• For mechanical performance (like fatigue testing), the "ground truth" is defined by international standards (ISO 14801:2016) and applicable FDA guidance documents. These standards specify test methods, failure criteria, and acceptable performance limits for dental implants.
• For material and biological compatibility, the "ground truth" is established by adherence to ISO 10993 standards for biocompatibility, ISO 11137 for sterilization, and ASTM F1980 for shelf-life. These are laboratory-based, objective performance measures.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.

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

• Not applicable.

Ask a specific question about this device

SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Compatible System Implant Body Diameter(mm) Implant Platform
Osstem TS (K121995) 3.5, 3.75 Mini
Osstem TS (K121995) 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.9, 5.05, 5.08, 5.1 Regular
Straumann Bone Level (only the Roxolid® implants from K140878) 3.3 NC
Straumann Bone Level (only the Roxolid® implants from K140878) 4.1, 4.8 RC
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Design parameter (Patient-specific abutment) Subject System Design Limit
Minimum and Maximum Gingival (Cuff) Height 0.55mm
Minimum and Maximum diameter at abutment/implant interface ⌀4.0⌀8.0
Minimum and Maximum length of abutment 4.513mm
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) 48mm
Minimum wall thickness at abutment/implant interface 0.4mm
Minimum and Maximum abutment angle 0~25°

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.

Raw material blanks

• InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ●
  Cement
• . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Design Limitation for Zirconia superstructure:

Design Limits for Zirconia top-half (Min. ~ Max.)

• Post Angle (°): 0~15
• Cuff Height (mm): 0.55.0
  -Post Length (mm): 4.06.0
  -Diameter (Ø, mm): 5.0~8.0
  -Thickness (mm): 0.4

This FDA 510(k) summary (K223663) concerns a dental implant abutment, not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML model performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set information, is not available in the provided document.

The document discusses the substantial equivalence of the SIMDA Abutment to existing predicate devices based on non-clinical testing for mechanical properties (fatigue), sterilization, and biocompatibility.

Here's an attempt to answer the relevant sections based on the provided text, and noting where information is not applicable or unavailable for an AI/ML device:

Acceptance Criteria and Device Performance for SIMDA Abutment

Since this is a non-AI/ML device (a dental abutment), the "acceptance criteria" are related to mechanical and biological performance rather than AI/ML algorithm metrics. The study described is a non-clinical study to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the document. Non-clinical mechanical fatigue testing typically uses a small number of samples (e.g., 5-10 per test condition) to demonstrate compliance with standards.
• Data Provenance: The tests are non-clinical (laboratory) studies. The manufacturer is SIMDA Co., Ltd. from REPUBLIC OF KOREA. The studies are prospective in the sense that they were designed and conducted to evaluate the device for this submission.

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 for this type of device/study. This section typically applies to AI/ML devices where human expert consensus is used to label medical images for ground truth. For a dental abutment, "ground truth" is established by engineering and material science standards, measurements, and physical testing.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling of data, which is not part of the non-clinical testing for a dental abutment.

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, this was not done. An MRMC study is performed for AI/ML devices to assess the impact of AI assistance on human reader performance. This is not applicable to a physical dental abutment. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."

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

• Not applicable. This pertains to AI/ML algorithm performance in isolation. The product is a physical dental abutment.

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

• Engineering and material science standards, physical measurements, and established performance criteria. Ground truth is implicitly defined by the referenced ISO standards (e.g., ISO 14801 for fatigue testing, ISO 17665-1 for sterilization) and the performance characteristics of the predicate devices. The "worst-case scenarios" were tested to ensure safety and effectiveness.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

Summary of what the study did prove:
The study proved that the SIMDA Abutment is substantially equivalent to a legally marketed predicate device (TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment K220562, and others) by demonstrating comparable:

• Intended Use
• Material composition
• Mechanical properties (through fatigue testing)
• Sterilization efficacy
• Biocompatibility
• Dimensional compatibility with specified implant systems
• Safety in an MR environment

The conclusion is based on non-clinical testing, which was deemed sufficient by the FDA to demonstrate substantial equivalence without the need for clinical studies.

Ask a specific question about this device

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to patientspecific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:

• · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
• · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
• · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
• · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
  All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase Screw for fixation to the implant body.
TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

The provided text describes a 510(k) premarket notification for two dental devices, TruAbutment DS and TruBase. The submission asserts substantial equivalence to a predicate device based on material, intended use, and mechanical testing. The document focuses on regulatory compliance and mechanical performance, rather than clinical efficacy measured by expert assessments or comparative effectiveness studies with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental implants and abutments and ensuring mechanical integrity. The reported performance indicates that the devices met these criteria.

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

• Test Set Sample Size: The document does not explicitly state a sample size for the mechanical fatigue testing beyond "worst-case constructs." For other tests (sterilization, biocompatibility, MRI review), specific sample sizes are not provided, though these are typically laboratory-based tests rather than patient-data-based studies.
• Data Provenance: The document does not specify the country of origin for any data or whether the data is retrospective or prospective. The studies mentioned (e.g., fatigue testing, sterilization) are engineering and laboratory tests, not clinical studies involving patient data.

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

This information is not applicable to the provided document. The studies described are non-clinical (mechanical, sterilization, biocompatibility, MRI safety) and rely on testing against established engineering and safety standards, rather than expert interpretation of a 'ground truth' in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical laboratory tests and material/design assessments, not studies involving human judgment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission relates to dental abutments, which are physical medical devices, and does not involve AI or image-based diagnostics requiring human reader performance studies.

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

This information is not applicable. The device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is based on:

• Established international and national standards (e.g., ISO 14801, ISO 17665, ISO 10993, ASTM F-136, ANSI/AAMI ST79).
• Engineering specifications and design limits (e.g., minimum thickness, maximum angle for abutments).
• Physical measurements and compatibility assessments (e.g., dimensional analysis and reverse engineering of implant-to-abutment connections).
• Scientific rationale and published literature for MRI safety.

8. The Sample Size for the Training Set

This information is not applicable. The devices are physical dental abutments, not AI models that require training data.

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

This information is not applicable as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of physical medical devices through adherence to established engineering and safety standards, rather than clinical performance based on human reader assessments or AI model evaluations.

Ask a specific question about this device

s-Clean SQ-SL Implant System Mini 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

s-Clean SQ-SL Implant System Mini is composed of Fixture and Abutments. s-Clean SQ-SL Mini 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 Hex. The s-Clean SO-SL Implant System Mini Abutments are composed of s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-ioint feature is for diverse screw connection for 1.6M or 2.0M sizes. The implant bodies are only compatible with subject abutments of S-Clean Sole Abutment s-Line and s-Clean TiN Half Coating Sole Abutment s-Line with 2.0M screw. These abutments are connected with only upper screw of the implant body. The 1.6M size allows the implant to be compatible with potential future cleared abutments. The surface of fixture 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 provided text describes a 510(k) premarket notification for a dental implant system (s-Clean SQ-SL Implant System Mini) and its substantial equivalence to predicate devices. It does not contain information about an AI/ML-driven device, nor does it present acceptance criteria or a study proving the device meets those criteria in the context of an algorithmic performance study.

The document primarily focuses on demonstrating the substantial equivalence of a physical medical device (dental implants) through comparison of technological characteristics, materials, and non-clinical engineering test data (e.g., sterilization, biocompatibility, fatigue testing) against legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies from the provided text. The document is about a hardware dental implant system, not a software or AI/ML product.

Ask a specific question about this device

Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Honorst Implant System are devices made of titanium 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 patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.

This is a 510(k) premarket notification for a medical device called "Honorst Implant System," a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about the performance criteria of a device or a study proving that it meets them in the way described in your request.

The document is a submission to the FDA for market clearance, arguing that the new device is as safe and effective as devices already on the market. It describes the Honorst Implant System's features and compares them to predicate devices, particularly the "CHAORUM Implant System (K160536)" by the same manufacturer.

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

1. Acceptance Criteria and Reported Device Performance: This document does not list explicit performance acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, etc.) for the Honorst Implant System. Instead, it argues that the device is "substantially equivalent" to existing devices based on similar design, materials, and intended use. The "Performance Data" section (page 6) states that "The verification/validation testing activities were conducted on the subject device for the modifications made" and that a "worst-case analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing." It also explicitly states that "Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests." This means the performance data is primarily focused on mechanical aspects and demonstrating that changes did not negatively impact the existing safety/effectiveness profile, rather than establishing new performance metrics.

2. Sample Size for Test Set and Data Provenance: Not applicable. There is no clinical trial or performance study detailed with a "test set" in the context of AI/diagnostic device performance. The testing mentioned is engineering/materials-based.

3. Number of Experts and Qualifications: Not applicable. There are no experts establishing ground truth in the context of diagnostic performance for this type of device submission.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical dental implant system, not an AI-assisted diagnostic tool.

6. Standalone Performance (Algorithm only): Not applicable. This is a physical device.

7. Type of Ground Truth Used: Not applicable in the context of AI/diagnostic performance. The "ground truth" here is implied by the established safety and effectiveness of the existing predicate devices through their long-standing use and prior FDA clearances. The applicant validates the new device's engineering and material properties against industry standards and comparisons to these predicate devices.

8. Sample Size for Training Set: Not applicable. There is no AI component or training set in this submission.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, this document is a regulatory submission for market clearance based on substantial equivalence, not a performance study that measures and reports against acceptance criteria for a diagnostic/AI device.

Ask a specific question about this device