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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.

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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InstaFix™ Shape Memory Fixation System is intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
InstaFix™ Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs

InstaFix™ Shape Memory Fixation System is a set of dynamic compression implants made from shape memory metal nickel-titanium alloy called NiTinol. The staples are available in sizes 8mm to 30mm. The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. InstaFix™ Shape Memory Fixation implants are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process. Each staple is packaged sterile along with the corresponding drill guide and implant holder. The one time use Accessory Kit and the Sizer Kit are packaged sterile to assist in the procedure. The Accessory Kit contains one drill and two locating pins. The Sizer Kit contains samples of the available staple sizes.

Here's a breakdown of the acceptance criteria and the study information for the InstaFix™ Shape Memory Fixation System, based on the provided document:

This document is a 510(k) summary for a medical device. For such submissions, the primary "study" proving acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device. This typically involves non-clinical testing to show that the new device performs at least as well as the predicate device in relevant performance areas. There isn't usually a clinical study with human patients and outcomes data for this type of submission.

Therefore, many of the requested categories related to clinical studies, human readers, and training data will not be applicable or will have limited information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly that the device performs functionally equivalent or better than the predicate device in key mechanical and material characteristics. The reported device performance is presented as successful completion of these non-clinical tests, demonstrating equivalence. Specific quantitative acceptance targets are not explicitly stated in a table within this summary, but rather are inherent in demonstrating performance comparable to the predicate.

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

• Sample Size: Not explicitly stated for each non-clinical test (e.g., how many staples were tested for fatigue life). However, this refers to numbers of physical devices tested, not human subjects or patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are benchtop, non-clinical studies performed on the physical device itself. The data is generated from laboratory testing of the InstaFix™ devices.

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

Not applicable. This is a non-clinical device performance study. "Ground truth" in this context refers to established engineering standards or the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices or devices where human interpretation plays a significant role. The InstaFix™ system is a surgical fixation device.

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

Not applicable. This device does not involve algorithms or human-in-the-loop performance in the sense of AI. Its "performance" is based on its mechanical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through bench-top engineering tests designed to evaluate the mechanical and material performance of the device against a known predicate device's performance standards/characteristics and relevant industry standards for orthopedic implants.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this non-clinical submission, as it does not involve machine learning or AI.

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

Not applicable. There is no training set.

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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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