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The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.

The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.

This document is a 510(k) premarket notification for a dental abutment system. It does not describe a study involving device performance concerning AI or reader performance. Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

1. Comparison of technological characteristics: This involves comparing material, angle, geometry, socket heights, surface treatment, sterilization, and accessories between the new device and predicate devices.
2. Non-clinical testing: This includes validation of sterilization, packaging validation (aging studies), and surface analysis (cytotoxicity and cleaning validation).
3. Engineering studies: Fatigue testing was conducted according to ISO 14801:2003 (E).

Here is a summary of the provided information related to the device and its testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in the form of a table that would be common for AI/diagnostic devices. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting relevant ISO standards for dental implants.

• Material: Predicate has Titan Grade 1 for straight abutments vs. New device: All Titanium Grade 5.
• Socket heights: Predicate offers more options (1.5, 2.5, 3.5, 4.5 mm) vs. New device (1.5, 3 mm).
• Surface treatment: New device has anodization in implant-connecting-area; predicate has pure machined surface. |
  | Sterilization Validation | - Microbiological Performance MDS Test 103706-10 (Submitted Oct. 19, 2011)
• Dose mapping (Submitted Dec 04, 2012) |
  | Packaging Validation | - Ageing Study over 5 years by MDS, Test 094466-10 (Submitted Oct. 19, 2011)
• Ageing Study real time aging 5 years by MDS, Test 142775-10 (dye penetration test) (Submitted June 04, 2014)
• Ageing Study real time aging 5 years by MDS, Test 151504-10 (microbial properties) (Submitted April 09, 2015) |
  | Surface Analysis | - Test Cytotoxicity abutments, MDS report no. 123335-20 (Submitted July 30, 2012)
• Report cleaning validation_2013RV02-2010 (Submitted Sept 18, 2013) |
  | Engineering Studies (Fatigue) | Conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested. |

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

• Test Set Sample Size: Not applicable in the context of an AI/diagnostic device. For the non-clinical and engineering studies, specific sample sizes are not explicitly stated, but the studies refer to standard tests (e.g., ISO 14801 for fatigue testing, MDS reports for cytotoxicity, sterilization, and packaging). These typically involve a defined number of units to meet statistical significance for the specific test.
• Data Provenance: The document is a submission to the FDA from a German company (OT medical GmbH, Bremen, Germany). The non-clinical and engineering study reports are listed with submission dates, indicating they were conducted retrospectively for the purpose of this 510(k) submission.

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

Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for a test set. The validation relies on laboratory and engineering testing standards.

4. Adjudication method for the test set

Not applicable. This is not an AI/diagnostic device that involves human reader adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This is not an AI/diagnostic device; therefore, an MRMC study related to AI assistance for human readers was not performed.

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

No. This is not an AI algorithm.

7. The type of ground truth used

For the engineering studies, the "ground truth" is adherence to the performance requirements outlined in the ISO standard (ISO 14801:2003 (E)) for fatigue testing, aiming to demonstrate a "stable screw joint." For non-clinical tests, the ground truth relates to meeting established criteria for sterilization effectiveness, packaging integrity, cytotoxicity, and cleaning validation as per relevant standards and test methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; there is no training set in the conventional sense.

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

Not applicable.

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The Natural Line abutment is indicated for use in cases where the placement of the implant requires an angled reconstruction for an esthetic result. The abutment can be used to restore crowns for single tooth replacement and bridges for bound situations

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "NaturalLine Abutment" does not contain the information necessary to describe acceptance criteria and a study proving a device meets those criteria, as typically required for AI/ML medical devices.

This document is a standard FDA clearance letter for a dental implant abutment, which is a mechanical device. It outlines the regulatory classification, product code, and basic indications for use. It confirms that the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance.

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

1. AI/ML Device Context: The NaturalLine Abutment is a physical medical device, not an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, AUC) are not applicable here.
2. Performance Data: The letter states the device is substantially equivalent to predicates but does not provide specific performance data (like sensitivity, specificity, accuracy, or any clinical trial results) that would be evaluated against acceptance criteria. The clearance is based on comparison to existing legally marketed devices, not on de novo performance metrics.
3. Ground Truth, Experts, Sample Sizes, Adjudication: These terms are relevant to the validation of AI/ML models, where data is used to train and test the algorithm's diagnostic or predictive capabilities. For a mechanical dental abutment, the "ground truth" would be related to its mechanical properties, biocompatibility, and fit, which are assessed through engineering tests and material science, not through expert consensus on image interpretation or pathology.
4. MRMC Study/Standalone Performance: These are specific types of studies for AI/ML performance evaluation, which are not relevant for a dental abutment.

In summary, the provided FDA document is for a traditional mechanical medical device and does not contain any of the information requested regarding acceptance criteria and performance studies for an AI/ML device.

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The OT-F2 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The OT-F3 Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

The OT-F implants are available in the diameters 3.8, 4.1 and 5.0mm. For the diameter 3.8 and 4.1mm there are 5 lengths: 8, 10, 12, 14 and 16 mm, for the diameter 5.0mm only 4 lengths: 8, 10, 12 and 14 mm. The implants are made from titanium grad 4 acc. to ASTM F-67. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All abutments are made from titanium grad 5 acc. to ASTM F-136.

The OT-F3 implants are available in the diameters 4.1 and 5.0mm. For each diameter there are 3 lengths: 5, 7 and 9 mm. For prosthetic construction we offer a temporary abutment CreativeLine, titanium abutments straight NaturalLine, ball head abutments TecLine and a bar connection with ProfiLine. All implants are made from titanium grad 5 acc. to ASTM F-136.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) premarket notification summary for dental implants, not a clinical study report for an AI device. Therefore, many standard AI study criteria will not be applicable.

The document discusses two distinct dental implant systems: the OT-F2 and the OT-F3, each with its own predicate device comparison. I will treat them separately for clarity, as the provided text presents them as essentially two separate 510(k) submissions consolidated under the same K-number.

OT-F2 Dental Implant System (K113113 - Part 1)

1. Table of Acceptance Criteria and Reported Device Performance

For the OT-F2 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate device (Pitt-Easy Dental Implant System, K053242). The reported device performance is presented as a comparison of technological characteristics.

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

• Sample Size for Test Set: Not applicable in the context of an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
• Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2") and external lab reports (e.g., MDS, Duddeck, IGMHS). The tests listed are for material properties, sterilization validation, aging, and fatigue.

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

This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI device.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI device.

7. Type of Ground Truth Used

The ground truth for the OT-F2 system is established through:

• Comparison of technological characteristics to a legally marketed predicate device (510(k) pathway).
• Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
• Results from non-clinical tests on material properties, sterilization efficacy, and aging.

8. Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

OT-F3 Dental Implant System (K113113 - Part 2)

1. Table of Acceptance Criteria and Reported Device Performance

For the OT-F3 system, the acceptance criteria are implicitly defined by substantial equivalence to the predicate devices (K926354, K971196, K032140 Endopore Dental Implant System). The reported device performance is presented as a comparison of technological characteristics.

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

• Sample Size for Test Set: Not applicable for an "AI device" test set. For the engineering studies, standard test samples were used per ISO 14801:2003, but specific numbers are not provided.
• Data Provenance: The document is from Germany (OT medical GmbH, Bremen/Germany). The non-clinical testing appears to be a mix of internal testing ("SEM Pictures F2", "IfW Report 4451 Metallographie") and external lab reports (e.g., MDS, Duddeck, Endolab, IMA Test Report). The tests listed are for material properties, sterilization validation, aging, and fatigue.

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

This information is not applicable. The device is a physical dental implant, not an AI diagnostic tool. Ground truth is established through engineering and material testing standards, and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable in the context of expert adjudication for an AI device. Compliance is assessed against established engineering standards and comparison to a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI device.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI device.

7. Type of Ground Truth Used

The ground truth for the OT-F3 system is established through:

• Comparison of technological characteristics to legally marketed predicate devices (510(k) pathway).
• Compliance with international standards for dental implants (e.g., ISO 14801:2003 for fatigue testing).
• Results from non-clinical tests on material properties, sterilization efficacy, aging, surface analysis, shear bonding strength, tension testing, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Overall Note: The provided text is a 510(k) Premarket Notification Summary for dental implants, which are physical medical devices, not AI-powered software or diagnostic tools. As such, the typical "acceptance criteria" and "study types" for AI devices (like sample size for test sets, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) are not relevant to this document. The "study" here refers to non-clinical engineering and materials testing, and the "acceptance criteria" are demonstrating substantial equivalence to predicate physical devices.

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