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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.

The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes the GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The subject device components mate exclusively with the GM implants cleared in K163194.

The GM Exact Co-Cr Abutment for Crown is provided in three sizes to fit the prosthetic diameter sizes of the GM implants cleared in K163194. The subject device abutments consist of a Co-Cr alloy component that interfaces directly to the implant and a cvlinder of polyoxymethylene (POM) for fabrication of a cast prosthesis by a burn-out technique. The subject device abutments are provided in three (3) sizes to match the various platforms of the mating GM implants: 3.5/3.75 mm platform diameter, 4.0/4.3 mm platform diameter, and 5.0/6.0 mm platform diameter. The subject device abutments are for single-unit prosthetic restorations only. The final prosthetic restoration may be cement-retained or screw-retained.

The GM Equator Attachment abutments are straight, ball-type abutments for the attachment of full or partial overdentures. GM Equator Attachments are provided in five gingival heights (1.5, 2.5, 3.5, 4.5, and 5.5 mm), and may be used with all GM implant diameter sizes cleared in K163194.

The subject device GM Exact Co-Cr abutments are made of Co-Cr alloy conforming to ASTM F1537, with mating abutment screws made of titanium alloy conforming to ASTM F136. The GM Equator Attachments made of titanium alloy conforming to ASTM F136 with a TiN coating identical to the TiN coating cleared in K133696.

This document describes the Neodent Implant System - GM Line, specifically introducing new abutment components. Based on the provided text, the acceptance criteria and study information are focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The document mainly uses non-clinical performance data (biocompatibility, sterilization validation, shelf-life, bacterial endotoxin testing) to support this claim.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., accuracy, sensitivity, specificity, or clinical outcomes). Instead, the performance data presented is aimed at demonstrating the device's characteristics are comparable to predicate devices. The "performance" is primarily shown through a comparison of technological characteristics and non-clinical testing results to existing standards and predicate devices to establish substantial equivalence.

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

The document focuses on non-clinical testing and refers to standards. It does not specify "sample sizes" in the context of clinical test sets or patient data.

• Sample size for testing: Not explicitly stated for each non-clinical test (e.g., number of abutments tested for biocompatibility or number of packages for shelf-life). However, regulatory standards (like ISO 10993, ISO 17665-1) inherently require specific sample sizes for valid testing.
• Data Provenance: The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. based in Curitiba, Paraná, Brazil. The non-clinical testing would presumably have been conducted by or commissioned by this company, possibly in Brazil or by certified labs internationally. The data is non-clinical, not from human subjects, hence "retrospective or prospective" does not directly apply in the clinical sense.

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. The provided document details the submission for new components of an existing dental implant system, demonstrating substantial equivalence through non-clinical testing (biocompatibility, sterilization, material specifications). It does not involve diagnostic imaging or other subjective assessments that would require expert consensus for ground truth.

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

This information is not applicable, as there is no clinical test set requiring adjudication in the context of diagnostic interpretation 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 information is not applicable. The device is a dental implant system (hardware), not a diagnostic AI device. Clinical data was explicitly not submitted: "Clinical data were not submitted in this premarket notification." Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant to this submission.

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

This information is not applicable. The device is a dental implant system (hardware), not an algorithm or AI device.

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

For the non-clinical performance data, the "ground truth" or reference for evaluating compliance consists of:

• International Standards: ISO 10993 series (biocompatibility), ISO 17665-1, ISO TS 17665-2, ISO 11135, ISO 10993-7 (sterilization), AAMI / ANSI ST72 (bacterial endotoxin testing).
• Material Standards: ASTM F1537 (Co-Cr alloy), ASTM F136 (Ti-6Al-4V alloy).
• Predicate Device Characteristics: Comparison of physical dimensions, design principles, intended use, and materials to established predicate devices (K163194, K101207, K121843, K133696) to demonstrate substantial equivalence.

There is no "ground truth" in the sense of clinical expert consensus, pathology, or outcomes data, as clinical data was not submitted.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device (dental implant components), not a machine learning or AI algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for an algorithm.

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ET System: The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System: The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.

The provided document is a 510(k) Premarket Notification from the FDA for a dental prosthetic system. It details the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria in terms of clinical effectiveness or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. Substantial equivalence is established by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Here's an analysis of the information available in the document, keeping in mind that it's a substantial equivalence filing rather than a performance validation study against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily identifies the device's characteristics (materials, dimensions, intended use) and compares them to predicate devices to establish substantial equivalence. It does not list quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or success rates) or specific performance metrics that the device is intended to meet.

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

This information is not applicable in the context of the provided document. The submission explicitly states:

• "No clinical studies are submitted." (Page 22)
• The nonclinical testing primarily involves fatigue testing and biocompatibility evaluations, which are typically performed on samples of the device components rather than a "test set" of patient data. The sample sizes for these engineering tests are not specified in this summary.
• Data provenance for clinical data is not applicable as no clinical data was submitted.

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

This information is not applicable as no clinical studies with a test set requiring ground truth establishment by experts were submitted.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies with a test set requiring adjudication were submitted.

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. The device described is a physical dental prosthetic system (abutments, screws, caps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

This information is not applicable for the same reason as point 5. The device is a physical prosthetic, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies requiring ground truth were submitted. The basis for safety and effectiveness is substantial equivalence to predicate devices, supported by nonclinical testing (fatigue, biocompatibility, sterilization validation).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning product and no clinical data or algorithms are being trained.

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

This information is not applicable as there is no training set mentioned in relation to this device.

Summary of the Study and "Acceptance Criteria" (as interpreted from the document's context):

The "study" described in the document is primarily focused on nonclinical testing and demonstrating substantial equivalence to predicate devices rather than fulfilling specific performance acceptance criteria for clinical outcomes.

Acceptance Criteria (Implicit from Substantial Equivalence):

From the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is achieved by showing:

• Same Intended Use: The ET US SS Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations (crowns, bridges, over-dentures), which is identical to the indications for use of its identified predicate and reference predicate devices (e.g., K062030, K130662).
• Same Technological Characteristics OR Equivalent Safety/Effectiveness with Different Characteristics:
  • Material: Titanium Alloy, PEEK, Polymer (Polycarbonate, POM) – consistent with predicate devices.
  • Design & Function: Described as similar in various components (e.g., Quick Temporary Abutment, Solid Abutment, ComOcta Abutment, Healing Abutment, Ti Screw, O-ring Abutment, Multi Angled Abutment, Esthetic-low Temporary Cylinder). Where there are differences (e.g., new dimensions, slight shape changes, different connection structures for Multi Angled Abutments), the submission asserts that these differences "do not raise new questions of safety and effectiveness" and that the device maintains "same principles of operation, function, material, characteristic and intended use."
  • Biocompatibility: Stated to be the same as predicates, thus requiring no additional testing.
  • Sterilization: For Cover Screw and Healing Abutment, considered substantially equivalent to a predicate. Other components are non-sterile and require steam sterilization validation according to ISO 17665-1:2006. The results implicitly meet the standard.
  • Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with a worst-case scenario. The implied acceptance is that the device met the fatigue strength requirements comparable to the predicate devices or within safe limits for its intended use, ensuring structural integrity. Specific results or detailed criteria are not laid out, but the successful completion of these tests supports substantial equivalence.

Reported Device Performance (from the perspective of 510(k) substantial equivalence):

The document reports the device's performance by demonstrating its similarities to predicate devices across various characteristics:

• Materials: Predominantly Titanium Alloy (ASTM F 136), Titanium (ASTM F 67), and various polymers (PEEK, Polycarbonate, PolyOxy Methylene). These are well-established materials in dental prosthetics, matching those of the predicate devices.
• Dimensions: Various diameters and heights are listed for each component, often including new dimensions that are added to existing product lines. The claim is that these new dimensions do not alter the fundamental safety or effectiveness and maintain the "same principles of operation, function, material, characteristic and intended use" as the predicate devices.
• Functional Principles: Described for each component (e.g., "Used to make temporary prosthesis," "Used in producing ordinary cement-retained prosthetics," "Connect an abutment with fixture by screw"). These are consistently aligned with the predicate device functions.
• Nonclinical Test Results:
  • Biocompatibility: Implicitly deemed acceptable due to using the same materials, manufacturing processes, surface treatments, and sterilization methods as legally marketed predicate devices.
  • Sterilization Validation: Cover Screw and Healing Abutment results are "considered to be substantial equivalent" to a specific predicate, indicating adequate sterilization protocols. Other non-sterile devices underwent steam sterilization validation to ISO 17665-1:2006, implying successful validation.
  • Fatigue Testing: Performed on a "worst-case scenario" sample, suggesting that the device's mechanical durability was assessed and found satisfactory based on the relevant guidance document, thereby supporting its structural integrity and equivalence.

In conclusion, the document demonstrates that the ET US SS Prosthetic System meets the "acceptance criteria" for a 510(k) submission by establishing its substantial equivalence to predicate devices through a comparison of technological characteristics and successful nonclinical testing for biocompatibility, sterilization, and fatigue. No clinical performance criteria or studies are presented.

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The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.

Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:

• Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
• Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
• Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
• Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
• Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
  All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.

The document is a 510(k) premarket notification for the Klockner Dental Implant Abutments (II). Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. Instead, it states that "Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions." It then reports that "Results obtained show that devices performance is acceptable as per their intended use."

To infer the acceptance criteria and reported performance, we can deduce them from the referenced standard, ISO 14801, which outlines specific fatigue test methods for dental implants. The acceptance criterion for fatigue testing according to ISO 14801 typically involves surviving a certain number of load cycles (e.g., 5 million cycles) at a specified load without fracture or permanent deformation beyond acceptable limits. The reported performance is a general statement that the device met these implicit criteria.

A hypothetical table based on common ISO 14801 requirements would look like this:

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

• Sample Size for Test Set: The document does not specify the exact sample size for the bench testing (fatigue testing, corrosion tests, etc.). It mentions "worst-case conditions" but no specific number of units tested.
• Data Provenance: The studies are non-clinical (bench testing) performed by SOADCO, S.L., the manufacturer, which is based in Andorra. The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not clinical patient data.

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

This is not applicable as the studies are non-clinical bench tests. "Ground truth" in this context refers to standardized measurements and material properties according to recognized standards (e.g., ISO 14801, ISO 10993, ASTM standards). The "truth" is established by the test protocols and the physical properties of the materials and device design, not by expert consensus on observable phenomena.

4. Adjudication Method (for the test set)

Not applicable. This concept typically refers to clinical studies where independent experts review and agree upon diagnoses or outcomes. For bench testing, the results are objectively measured against established scientific and engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data are included in this submission." This type of study is for clinical evaluations involving human readers and interpretations of medical cases, which is not relevant to this device's non-clinical submission.

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

Not applicable. This refers to the performance of AI algorithms. The Klockner Dental Implant Abutments (II) are physical medical devices, not software or AI-based diagnostic tools.

7. The Type of Ground Truth Used

For the non-clinical studies:

• Fatigue Testing: The ground truth is derived from engineering standards and physical principles. Specifically, the ISO 14801 standard provides the methodology and criteria for evaluating the fatigue life of dental implants and abutments.
• Biocompatibility: The ground truth is established by recognized biocompatibility standards (ISO 10993-1:2009 and ISO 7405:2008) and the known properties of the materials used.
• Corrosion Resistance: The ground truth is based on material science and engineering standards (ISO 10993-15, ASTM F746, ASTM G71) for evaluating corrosion and galvanic corrosion.
• Sterilization: The ground truth is based on microbiological testing standards (ISO 11737-1, ISO 11737-2, ISO 17665-1) to ensure the device can be effectively sterilized.

8. The Sample Size for the Training Set

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

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

Not applicable, as no training set was used.

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