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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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The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.

Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in:

• Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system.
• Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system.
• Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system.
• Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system.
• Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System.
• Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system.

Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.

This is a 510(k) premarket notification for KLOCKNER Dental Implant Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, many of the requested points, particularly those related to AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets, cannot be extracted from this document because they are not applicable to the type of device and submission presented.

Here's an analysis of the provided text based on the questions, noting where information is not applicable or available:

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

This document does not present quantitative acceptance criteria or device performance metrics for a novel device in the way a clinical study for an AI/ML device would. The submission aims to establish "substantial equivalence" based on similar materials, design, and intended use to existing predicate devices.

The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons to predicate devices and bench testing.

• Bench Testing: The document states, "The results of bench testing confirm acceptable device performance as per its intended use." Specific performance values or acceptance criteria for these bench tests (e.g., torsion, fatigue testing according to ISO 14801) are not provided in this summary.
• Sterilization: "A sterilization according ISO 17665-1 was carried out to confirm the recommended sterilization."

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

Not applicable. This is a 510(k) for dental implant abutments, not an AI/ML device requiring a test set for diagnostic performance evaluation. The "testing" referred to is bench testing on the physical device components.

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. There is no "ground truth" establishment in the context of an AI/ML device for this submission.

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

Not applicable. No test set for diagnostic performance evaluation is described.

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/ML device.

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

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

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

Not applicable. There is no "ground truth" in the context of an AI/ML device for this submission. The "truth" for substantial equivalence rests on comparison to predicate devices and standard engineering/material testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device.

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

Not applicable. As above, this pertains to an AI/ML device, which this is not.

Summary of available information:

• Device: KLOCKNER Dental Implant Abutments (healing caps, protective caps, temporary abutments, angled abutments, straight abutments, overdenture abutments).
• Intended Use: To be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges, or overdentures.
• Study Type: 510(k) premarket notification for substantial equivalence. The "study" involves comparison to predicate devices and bench testing.
• Acceptance Criteria & Performance:
  • Demonstration of substantial equivalence to predicate devices (K080224, K082200, K010132, K062129, K071585, K033243, K071357, K050705, K992334, K060291, K072624, K092248, K101798, K083876, K102804, K072055). This involves comparing indications for use, basic design, operating principles, material, and packaging.
  • Bench testing for torsion and fatigue (according to ISO 14801) under worst-case conditions.
  • Bioburden and sterility testing (in accordance with ISO 11737-1 and ISO 17665-1).
  • The document explicitly states: "No clinical data are presented in this submission."
• Data Provenance: The document does not discuss clinical data or patient data. The "data" are from non-clinical bench tests and comparisons to specifications of predicate devices.
• Conclusion: The submitter believes the device is substantially equivalent to predicate devices, and bench testing confirms acceptable performance for its intended use. The FDA concurred with this determination.

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