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The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.

Pin with a flat head for the fixation of resorbable and non-resorbable membranes.

This is a 510(k) summary for a medical device (MP Pin without thread, flat head) which is seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy in the way a pharmaceutical might.

Therefore, the requested information, which is typically associated with clinical trials, statistical performance metrics, and AI/software device studies, is largely not applicable or present in this document.

Here's an breakdown based on the provided text, addressing why some information is absent:

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

The document does not specify formal "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would undergo. Instead, substantial equivalence is based on:

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

This information is not applicable as this submission is for a mechanical medical device (a pin) and does not involve AI or software that would typically have a "test set" of patient data. The "performance data" refers to standard mechanical and biological testing.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable as this device is a physical medical pin and does not involve AI assistance for human readers.

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

This information is not applicable as this device is a physical medical pin and does not involve an algorithm.

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

For the biocompatibility testing, the "ground truth" would be the standard biological response according to ISO 10993-5, where the absence of cytotoxicity is the desired outcome. For sterilization, the "ground truth" is compliance with the specified ISO standards for sterility. For mechanical and dimensional evaluation, the "ground truth" relates to engineering specifications and comparison to the predicate device's design, assessed through internal validation.

8. The sample size for the training set

This information is not applicable as this submission is for a mechanical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a physical medical device. The "study" proving it meets acceptance criteria consists of standard engineering, biocompatibility, and sterilization testing, not clinical trials or AI performance evaluations as would be implied by many of the questions. The acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, fundamental operation, and safety.

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The Micro Screw System, Micro Screw System Basic are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. Note: Micro Screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.

The Micro Screw System, Micro Screw System Basic are used for the safe fixation and stabilisation of cortical bone grafts. These systems contain osteosynthesis screws made of surgical stainless steel with diameters of 1.0 mm and 1.2 mm.

This is a 510(k) premarket notification for a medical device called the "Micro Screw System, Micro Screw System Basic". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the structure of the response will be different as the document does not contain information about a study designed to meet specific performance acceptance criteria in the typical sense for an AI/ML device. Instead, the "study" is a set of non-clinical bench tests comparing the new device to a predicate device to show equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (micro screws), the "acceptance criteria" are primarily established by recognized standards and requirements for substantial equivalence to a predicate device, rather than explicit numerical performance targets like sensitivity/specificity for an AI system. The "reported device performance" are the results of bench tests demonstrating compliance with these standards and comparability to the predicate.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical performance tests (e.g., how many screws were tested for torsional properties). It mentions "Several performance tests have been performed."
• Data Provenance: The tests are "Non-Clinical Bench Testing" conducted by the manufacturer, Hager & Meisinger GmbH. The country of origin for the data is Germany (where the company is based), but the standards used are international (ASTM, ISO, AAMI, DIN EN). This is retrospective data, as it describes tests already performed.

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

This information is not applicable in the context of this 510(k) submission for a physical device. Ground truth for mechanical properties is established through standardized physical measurements and material science, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for AI/ML performance evaluation, not for physical device bench testing.

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

Not applicable. This is not an AI/ML device, and an MRMC study is relevant for evaluating the impact of AI on human reader performance, which isn't the scope of this submission.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily:

• Physical Measurements: Directly measured properties like torque, angle, and pullout force.
• Material Standards Compliance: Verification against established chemical and mechanical specifications for surgical stainless steel (e.g., composition, strength).
• Biological Standards Compliance: Verification against established ISO standards for biocompatibility, typically involving in-vitro tests (e.g., cytotoxicity) and risk assessments.
• Predicate Device Data: Performance characteristics of the previously cleared predicate device (K080430, STOMA Bone Block Screw) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.

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

Not applicable. There is no training set.

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The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.

The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes various implant variations with different diameters and lengths.

Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in a table with article number, description, and specifications.

The document provided is a 510(k) Premarket Notification from the FDA for the MyPlant II Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria and study design are not explicitly available or applicable in the provided text. The document's purpose is to show that the new device is as safe and effective as a legally marketed one, not to independently prove its performance against a set of acceptance criteria in a quantitative sense with a large-scale clinical study that would yield metrics like sensitivity, specificity, or effect sizes for human readers.

However, I can extract information related to the non-clinical tests performed to demonstrate substantial equivalence, which can be seen as meeting certain underlying "acceptance criteria" for material, sterility, and mechanical performance.

Here's a breakdown based on the provided text:

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

The document does not present a table of explicit acceptance criteria and corresponding reported device performance in the manner typically seen for diagnostic algorithms (e.g., sensitivity, specificity, F-score). Instead, it lists performance tests and validations conducted against established standards to demonstrate the safety and effectiveness of the dental implant system. The "performance" is reported as conformance to these standards.

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

This information is not applicable/not provided in the context of this 510(k) submission. The document reports on non-clinical (laboratory) tests and relies on equivalence to predicate devices, rather than a clinical study with a "test set" of patients or data in the way an AI/software device would. The "samples" referred to are physical device components for testing (e.g., for fatigue, sterilization).

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 is not applicable/not provided. The ground truth for the non-clinical tests (e.g., successful sterilization, lack of cytotoxicity, fatigue resistance) is established by adherence to recognized international and national standards and validated laboratory procedures, not by expert consensus on clinical cases.

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

This is not applicable/not provided. Adjudication methods are typically relevant for clinical studies that involve human interpretation or subjective assessment. The tests performed are objective, based on standardized protocols.

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

This is not applicable/not provided. The MyPlant II Implant System is a physical medical device (dental implants and abutments), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers (e.g., dentists, radiologists) and AI assistance is not relevant or described in this document.

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

This is not applicable/not provided. The device is a physical dental implant system, not a standalone algorithm.

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

The "ground truth" for the non-clinical tests is established by technical standards and validated laboratory methods. For example:

• Sterilization: Demonstrated sterility to a specified sterility assurance level (SAL).
• Biocompatibility: Absence of toxic effects as per ISO 10993.
• Fatigue: Resistance to fracture or failure under specified cyclic loading as per ISO 14801.

8. The sample size for the training set

This is not applicable/not provided. This document pertains to a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, which are not the subject of this 510(k) submission.

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

This is not applicable/not provided for the same reasons as point 8.

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Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching. Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion. OKTAGON® Implant System includes four variations of the prosthetic connection: Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC). The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter. The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.

The provided text is a 510(k) premarket notification for the OKTAGON® Implant System, which is a dental implant device. As such, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way a clinical study or AI algorithm validation would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance directly from this document, nor can I provide details about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These concepts are typically associated with the rigorous validation of new technologies, particularly in the context of AI or novel medical devices requiring de novo clearance or PMA.

What the document does provide regarding "performance" and "acceptance criteria" (within the context of a 510(k) for dental implants):

The "performance testing" section (page 5) and the comparison table (pages 6-7) confirm that the device meets relevant standards and is comparable to previously cleared devices. The "acceptance criteria" here are implicitly tied to meeting these standards and demonstrating equivalence.

Here's a summary of the performance testing relevant to this 510(k) submission:

1. Acceptance Criteria and Reported Device Performance (as demonstrated by equivalence to predicate devices and adherence to standards):

• Performance: Referenced from predicate K143539, with a revalidation report in Section 14 of this submission. Proposed abutments determined not to present a new sterilization challenge; thus, no additional testing required. |
  | Sterile Barrier System: Packaging must maintain sterility. | - Validation Standard: ISO 11607.
• Performance: Referenced from predicate K143539. Packaging of subject device is the same as the reference device; thus, no additional testing required. |
  | Biocompatibility: Materials must be safe for patient contact. | - Assessment Standard: ISO 10993-1 (biological evaluation), ISO 10993-5 (cytotoxicity testing).
• Performance: Referenced from predicate K143539. Subject device uses the same materials and manufacturing methods, intended use, sterilization methods, and tissue contact as the reference device; thus, no additional testing required. |
  | Fatigue Strength: Device must withstand mechanical forces without failure. | - Testing Standard: ISO 14801 and FDA Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
• Performance: Referenced from predicates K143539, K162073, and K170287. Based on the same design and comparative surface area analysis, the proposed implants were determined not to represent a new worst case; thus, no additional testing required. |
  | Material Composition: Device materials must conform to established standards. | - Material Standard: Titanium Grade 4 conforming to ASTM F67-13.
• Performance: The proposed implants are made of Titanium Grade 4 conforming to ASTM F67-13, identical to predicate devices. |
  | Design/Technological Characteristics: Device design must be equivalent to predicates. | - Performance: The proposed implants are described as a line extension of previously cleared OKTAGON® implants (K170287, K162073, K143539). They share root-form design, microstructured and acid-etched titanium surface, inner cone with octagonal anti-rotation device, and comparable dimensions (increased length for some Tissue Level, increased diameter for some Bone Level Tapered). Healing abutments offer increased diameter options but maintain the same base material and purpose. The manufacturer asserts the subject device and predicate devices have "identical intended use and technological characteristics, and are made of identical materials." The changes (expanded length/diameter options) are considered within the scope of previously cleared designs, not introducing new safety or performance issues. |

Regarding the other points you've asked for, based on the provided text:

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

   • No specific sample size for a "test set" (in the context of new device validation studies like clinical trials) is mentioned. The device relies on demonstrating equivalence through non-clinical testing (material, sterilization, fatigue) and comparison to predicate devices, rather than a new clinical test set.
   • Data Provenance: The referenced standards (ISO, ASTM, FDA guidance) are international and US-based. The previous predicate devices were submitted by Hager & Meisinger GmbH (Germany).

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. This document describes a 510(k) submission, which relies on engineering and material standards, and comparison to predicate devices, not on expert-established ground truth for a clinical test set in the way an AI algorithm might be validated.

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

   • Not applicable. This relates to clinical trial or AI validation protocols, which are not detailed in this 510(k) submission.

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. MRMC studies are typically for evaluating the impact of an AI system on human diagnosticians. This device is a dental implant, not an AI diagnostic tool.

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

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

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

   • The "ground truth" for this 510(k) approval is essentially:
     • Compliance with recognized international and national standards (e.g., ISO, ASTM).
     • Demonstration of identical technological characteristics and materials to previously cleared predicate devices.
     • Demonstration that the device does not raise new performance or safety issues.
     • This is established through documented non-clinical testing (as mentioned in point 1) and comparisons of specifications.

8. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that requires a training set.

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

   • Not applicable. As above, this is a physical medical device, not an AI algorithm.

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The Dental Implants OKTAGON® Bone Level Tapered Design are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Bone Level Tapered Design are an addition to the currently distributed Dental Implant System® OKTAGON Bone Level. The implants can be used for immediate or early implantation after loss or extraction of natural teeth. The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 3.3 to 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the endosted part and has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder is polished. The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

This document is a 510(k) Pre-Market Notification for a medical device, specifically Dental Implants OKTAGON® Bone Level Tapered Design. It does not describe an AI medical device or the results of a study proving a device meets acceptance criteria related to AI/software performance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence to predicate implant devices based on material composition, design, intended use, and mechanical performance (fatigue and breakage tests for physical implants, not AI performance).

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The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.

The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.

Subject to this submission are the following implant variations:

BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm

TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm

TL RP Conical Ø4.1 mm, L 10 mm

The provided text is a 510(k) summary for a medical device (Dental Implants OKTAGON® Tissue Level and Bone Level). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of algorithm performance for an AI/ML powered device. The "performance tests" mentioned refer to fatigue tests against ISO 14801 for mechanical properties of dental implants, not AI/ML algorithm evaluation.

Therefore, I cannot extract the requested information as it does not exist within the provided document.

To be explicit, the following information is not present in the document:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (for an AI/ML algorithm).
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI/ML-powered medical device.

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Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implant System OKTAGON® Bone Level is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients.

The devices covered in this submission are angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

This document is a 510(k) Summary for the Endosseous Dental Implant Abutments OKTAGON® Bone Level. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study sizes, expert involvement, and ground truth types for AI/ML device studies is not applicable or not present in this document.

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

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

Since this is a submission for substantial equivalence based on predicate devices, explicit "acceptance criteria" for novel device performance are not listed in a quantifiable table as they would be for a new technology with specific performance claims. Instead, the "acceptance criteria" are implied by adherence to recognized standards and similarity to predicate devices.

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

• Sample Size for Test Set: Specific sample sizes for the mechanical and biocompatibility tests are not disclosed in this summary. The document states that "performance tests (breakage and fatigue tests) have been conducted," but does not provide the number of units tested.
• Data Provenance: Not specified. The manufacturer is Hager & Meisinger GmbH, located in Neuss, Germany. Testing was likely conducted in Germany or by certified labs.
• Retrospective or Prospective: Not specified, but typically, these types of laboratory tests for medical devices are conducted prospectively under controlled conditions.

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 to this type of device submission. The device is a physical dental implant abutment, and its performance is evaluated through standardized material and mechanical testing, not through expert review of data like an AI/ML diagnostic device.

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

• This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating clinical data or outputs of AI/ML systems where subjective interpretation might be involved. The testing here involves objective measurements against engineering standards.

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 to this type of device submission. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation enhanced by AI. This device is a physical implant component.

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

• This information is not applicable to this type of device submission. This device does not involve an algorithm.

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

• The "ground truth" for this device's performance is based on established engineering and medical device standards. For example:
  • Mechanical Integrity: ISO 14801 (Fatigue Testing) and the FDA's Class II Special Controls Guidance document for dental implants.
  • Biocompatibility: ISO 10993-1, ISO 7405, ISO 10993-5.
  • Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST 79.
  • Materials: ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3.
  • The "ground truth" is adherence to these normative standards and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts.

Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.

The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device.

A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion.

The endosseous dental implants are available in a range of endosseous diameters and lengths.

The abutments are available in different versions including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

The following types of abutments will be available:

• . Cover screw
• Healing abutment
• Straight abutment ●
• Alligator abutment

The provided document is a 510(k) summary for a medical device called "Dental Implant System OKTAGON® Bone Level." It establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.

However, I can extract information related to performance testing that serves as the basis for demonstrating safety and effectiveness relative to established standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are the requirements outlined in the referenced international and national standards. The "reported device performance" is a statement of successful adherence to these standards.

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

• Sample Size: Not specified in the document. The performance tests (fatigue tests) are likely conducted on a sample of devices according to the requirements of the specified standards (e.g., ISO 14801).
• Data Provenance: Not specified. Standard performance testing is typically conducted in a laboratory setting, often by the manufacturer or a third-party testing facility. This is not "clinical data" in the sense of patient data.

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

• Not applicable. "Ground truth" in this context would refer to the established performance requirements outlined in the engineering and material standards. These are not established by clinical experts in the same way an AI/ML diagnostic output needs ground truth. Compliance to these standards is verified by testing engineers.

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

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations, primarily relevant for image-based diagnostic AI/ML. For a physical device, performance is measured against objective engineering metrics.

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

• Not applicable. This is a physical dental implant system, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device does not involve an algorithm.

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

• The "ground truth" here is the adherence to the engineering and material specifications defined by international standards (e.g., ISO 14801 for fatigue, ASTM F67 for material composition). These standards establish objective, measurable criteria for safety and performance.

8. The sample size for the training set

• Not applicable. This device does not use machine learning, so there is no training set. Design validation and verification are based on engineering principles and regulatory standards.

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

• Not applicable. As there is no training set, this question is not relevant.

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Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations.

The Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.

The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon and a metric thread.

Here is an analysis of the provided text regarding the acceptance criteria and study for the "Dental Endosseous Implant Abutment OKTAGON®":

1. Table of Acceptance Criteria and Reported Device Performance

• Identical intended use
• Equivalent material composition
• Equivalent connection to implants
• Identical principal design and measurements | "The intended use for Endosseous Dental Implant Abutment OKTAGON® is identical to the named predicated devices. The abutments have the same indications for use, material composition and the connection to implants is equivalent. In addition the principal design including measurements of abutments is identical to the previously cleared predicated devices." |

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

The provided text only explicitly mentions a "performance test (fatigue test)" conducted for the Dental Implant Abutments OKTAGON®. It does not specify a separate "test set" in the context of a statistical study with a specific sample size. The fatigue test itself would involve a sample of the abutments, but the exact number is not detailed.

• Sample Size for Test Set: Not explicitly stated for the fatigue test.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

This information is not applicable to the submission for a dental implant abutment, as the evaluation relies on physical performance testing against established engineering standards (ISO 14801) and comparison with predicate devices, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant for a dental implant abutment.

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. The device is a physical medical device (dental implant abutment), not an algorithm or AI system. Its performance is evaluated through physical tests like fatigue testing, not computational algorithms.

7. The Type of Ground Truth Used

For the fatigue test, the "ground truth" would be the objective mechanical properties and failure criteria defined by the ISO 14801 standard and the FDA's special controls guidance document. The abutments' ability to withstand specified cyclic loading without failure to a certain threshold is measured against these established engineering benchmarks.

For the substantial equivalence claim, the "ground truth" is the characteristics (intended use, material, connection, design, measurements) of the legally marketed predicate devices, which the OKTAGON® abutment is compared against.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable as the device is a physical medical device and does not utilize a training set or machine learning.

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Ask a specific question about this device