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ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.

This looks like a 510(k) premarket notification for a dental implant system. Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The application states that the new device, the ANKYLOS® C/X Implant 6.6 mm, is a line extension of an already cleared device and has largely similar characteristics to its predicate device (K083805 - ANKYLOS® C/X Dental Implant System). The primary acceptance criteria for this type of submission are typically demonstrating substantial equivalence to a legally marketed predicate device, especially in terms of safety and effectiveness.

Here's a table based on the provided "Similarities and Differences" section and the described non-clinical performance data to outline the criteria and the device's performance against them:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many implants were used for fatigue testing or CAD analysis. It simply states "Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device" and "surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively." For a 510(k) submission, especially for a line extension, the focus is often on representative samples demonstrating conformance to standards rather than large statistical cohorts typical of clinical trials.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of mechanical testing (fatigue, CAD), it's highly likely this was laboratory-based, prospective testing rather than clinical 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)

• This type of submission focuses on non-clinical performance (mechanical testing and CAD analysis). Therefore, no external experts or clinicians were explicitly used to establish ground truth for a "test set" in the way one might for a diagnostic AI device. The ground truth is established by an international standard (ISO 14801) for fatigue testing and engineering principles for CAD analysis, performed by the manufacturer's qualified personnel.

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

• None. As explained above, this is a non-clinical, engineering-focused evaluation based on established standards and calculations rather than subjective assessment requiring adjudication.

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

• No. This device is a dental implant, which is a physical medical device, not a diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

• No. This is a physical dental implant, not an algorithm or AI system.

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

• The ground truth for the non-clinical performance data (fatigue, surface area, bone-to-implant contact) is derived from engineering standards (ISO 14801) and CAD calculations based on the device's design specifications for the implant and comparison to the predicate. The "ground truth" for the FMEA is based on risk analysis methodologies.

8. The sample size for the training set

• Not applicable. This device is a physical dental implant. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and testing, not through training data in the AI sense.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for one. The "truth" about the device's functionality is established through its design, material properties, and adherence to performance standards.

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Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ANKYLOS® SynCone® Abutment 5°:

Acceptance Criteria and Study Details for ANKYLOS® SynCone® Abutment 5°

Based on the provided 510(k) summary, the device's acceptance criteria and the studies performed focus on demonstrating substantial equivalence to predicate devices. The primary criteria revolve around material composition, design, and performance characteristics compared to existing, legally marketed products.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for the test sets in the non-clinical performance data (fatigue testing, pull force testing). It mentions "Representative fatigue testing" and "Pull force testing."

The data provenance is non-clinical bench testing, meaning it's laboratory-generated data, not from human subjects. Therefore, country of origin and retrospective/prospective designations for human data are not applicable here.

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

This section is not applicable. The ground truth for this type of submission (demonstrating substantial equivalence through non-clinical bench testing) is defined by established international standards (like ISO 14801) and direct comparison to the performance characteristics of legally marketed predicate devices. It does not involve expert adjudication of human clinical data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation relies on objective measurements from bench testing following established standards and direct comparison to predicate device performance. No human adjudication of results is described.

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 relevant for diagnostic devices where human readers interpret medical images or data. The ANKYLOS® SynCone® Abutment 5° is a dental implant abutment, and its evaluation for this 510(k) submission relied on non-clinical performance data.

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

This section is not applicable. The device is a physical medical device (an implant abutment), not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, evaluated through bench testing, not through an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used for verifying the device's performance is established engineering and material science standards and metrics, and direct comparative performance against legally marketed predicate devices.

Specifically:

• ISO 14801: Dynamic fatigue test for endosseous dental implants.
• ASTM F136 and ASTM F67: Standard specifications for titanium alloys, defining acceptable material properties.
• Performance of predicate devices: The established and accepted performance of the ANKYLOS SynCone® Abutinents 4º and 6° (K041509) and Angled ANKYLOS® Balance Base Abutments (K122268) serve as the benchmark for equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. A training set is used in machine learning to teach an algorithm. This submission is for a physical medical device, not an AI/ML algorithm.

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

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

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The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.

The provided text describes a 510(k) summary for the ANKYLOS® C/X Dental Implant System, focusing on its substantial equivalence to predicate devices. However, the document does not contain the detailed study information typically associated with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.

The document states:

• "The results regarding the fatigue tests of the ANKYLOS® C/X Implant and the predicate devices were comparable. Therefore, it concluded that the ANKYLOS® C/X Implant performs as intended."

This is the only mention of performance data. It refers to a "fatigue test" and a "comparable" result. This does not provide specific acceptance criteria, numerical performance metrics, or details about the study design beyond stating "fatigue tests."

Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

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

• Cannot be determined from the provided text. The text only mentions "fatigue tests" without any details on the number of devices tested or the origin of the data.

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

• Cannot be determined from the provided text. This type of information is not present. The evaluation focuses on non-clinical performance (fatigue tests), not expert interpretation.

4. Adjudication method for the test set:

• Cannot be determined from the provided text. This is not relevant for the type of non-clinical testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study was not done. The document describes a non-clinical performance evaluation (fatigue tests) of a dental implant system.

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

• N/A. This question is typically relevant for AI/software devices. The device is a physical dental implant system, so "standalone" performance in this context would refer to its physical function, which was assessed via "fatigue tests."

7. The type of ground truth used:

• For the "fatigue tests," the "ground truth" would be the engineering standards for fatigue life or fracture resistance of dental implants. However, the specific standards or methods for establishing this "ground truth" are not detailed beyond the mention of "fatigue tests."

8. The sample size for the training set:

• N/A. This question is typically relevant for AI/machine learning models. The device is a physical dental implant system and would not have a "training set" in this context.

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

• N/A. (See point 8)

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The ANKYLOS® Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseus implant.

The ANKYLOS® Dental Implant System has been cleared for commercial distribution. The purpose of this application is to obtain clearance for additional marketing claims associated with the special features of the ANKYLOS® Dental Implant System.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the ANKYLOS® Dental Implant System. It primarily focuses on:

• Device Description and Intended Use: Explaining what the device is and what it's used for.
• Predicate Device Information: Stating that the current device is substantially equivalent to a previously cleared one.
• Technological Characteristics: Asserting that no changes have been made to the device itself, implying that previous safety and effectiveness data still apply.
• Regulatory Communication: Correspondence from the FDA affirming the substantial equivalence and permitting marketing.

There is no mention of:

• Specific performance metrics or acceptance criteria for the device (e.g., success rates, torque values, osseointegration rates).
• Any clinical or non-clinical study that was conducted to demonstrate performance against such criteria.
• Details about test sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested table or detailed information about a study based on the given text.

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The ANKYLOS® Temporary Abutment Balance is an anatomical abutment which is indicated for the fabrication of provisional crowns or bridges over max. 2 bridge pontics. The ANKYLOS® Temporary Abutment Balance is a short-term provisional for esthetic soft-tissue contouring.

The ANKYLOS® Temporary Abutment Balance is part of the ANKYLOS® Dental Implant System. The temporary abutment is available in the sizes "small" (D5.5) and "large" (D7) and with the gingival margins of 1.5 and 3. The ANKYLOS® Temporary Abutment Balance can be used in straight and angled implant positions. The ANKYLOS® Temporary Abutment Balance is made of plastic material.

The provided text is a 510(k) summary for the ANKYLOS® Temporary Abutment Balance, which is a dental implant component. This document focuses on demonstrating substantial equivalence to predicate devices based on material composition and prior use, rather than presenting a performance study with acceptance criteria in the context of AI/ML or diagnostic device evaluation.

Therefore, the requested information elements related to AI/ML study design (such as test set sample size, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract information regarding the device description, intended use, and the basis for the declaration of safety and effectiveness, which serves as the "study" in this context.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission is based on substantial equivalence through material and design comparison with predicate devices, not a performance study involving a "test set" in the diagnostic sense. The "data provenance" refers to the prior use of the materials and components in other legally marketed devices.

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

• Not Applicable. No "ground truth" establishment by experts for a test set was performed as part of this submission. The basis for safety and effectiveness relies on material properties and comparison to predicate devices, not a diagnostic assessment.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or adjudication method was used for this 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. This device is a physical dental implant component, not an AI/ML diagnostic or assistive device.

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

• Not Applicable. This device has no AI algorithm.

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

• Not Applicable. The "truth" in this context is the established safety and effectiveness of the component materials and design, demonstrated through prior use in legally marketed devices and successful biocompatibility testing of the material. There isn't a diagnostic "ground truth."

8. The sample size for the training set.

• Not Applicable. There is no AI training set for this physical device.

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

• Not Applicable. There is no AI training set or associated ground truth establishment for this physical device.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS® Dental Implant System consists of threaded dental implants in 3.5 - 7.0 mm diameters with 8 - 17 mm lengths. The implants are coated with the FRIADENT Surface. The ANKYLOS® Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. In the edentulous mandible, the ANKYLOS® dental implants are indicated for immediate loading procedures using the standard protocol.

The provided text is a 510(k) summary for the FRIADENT GmbH ANKYLOS® Dental Implant System. It outlines the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, F1-score, etc.).

Medical devices, especially hardware like dental implants, are regulated differently from AI/ML software. For devices like dental implants, "performance evaluation" typically refers to:

• Mechanical Strength and Durability Testing: Ensuring the implant can withstand masticatory forces over time.
• Biocompatibility Testing: Confirming the materials are safe for implantation in the human body.
• Sterilization Validation: Ensuring the device can be properly sterilized.
• Clinical Studies (if required): For novel designs or indications, clinical trials might be conducted to demonstrate safety and effectiveness in human subjects, often focusing on outcomes like integration success rates, survival rates, and complication rates.
• Comparison to Predicate Devices: Demonstrating that the new device performs "as well as" or "substantially equivalent" to a legally marketed predicate device, often through a combination of the above testing and analysis of existing literature on the predicate.

The document states: "Performance evaluations of the ANKYLOS® dental implant system show that the device performs as intended. Comparison of the ANKYLOS® dental implant system to the predicate devices shows that the device is substantially equivalent." This suggests that the "study" referred to is likely a compilation of engineering tests and comparative analysis rather than a human-in-the-loop AI performance study.

Therefore, I cannot provide the requested information for an AI/ML device performance study using this document. The questions you've asked are specific to AI/ML device validation, which is not covered in this 510(k) submission for a dental implant system.

To answer your request based solely on the provided text, I must state that the information is not present in the document.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.

This 510(k) submission (K040946) for the ANKYLOS® Dental Implant System does not contain a study to prove the device meets acceptance criteria related to performance metrics, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study. This submission is primarily focused on presenting additional instructions for use sheets for a device that has already been cleared (predicate 510(k) K012681).

Therefore, many of the requested elements for describing a study are not applicable to this particular submission. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through a new study.

Here's an breakdown based on the provided text, indicating what is present and what is not:

Acceptance Criteria and Device Performance

Summary of the "Study" (or basis for clearance):

This submission is a "Special 510(k)" or a similar type where the changes are minimal and do not impact safety or effectiveness. The "study" here is a comparison to a predicate device (Dentsply Ceramco ANKYLOS® Dental Implant System, K012681) to demonstrate substantial equivalence, particularly because the primary purpose of this specific application is to present "additional instructions for use sheets." The manufacturer asserts that design, materials, coatings, mechanical strength, prosthetic options, indications for use, system and methodology of implantation, and technological characteristics have not changed.

Non-Applicable or Not Provided Information from the Text:

Due to the nature of this 510(k) (updates to labeling for an already cleared device), the following information, which would typically be present for a clinical or performance study, is not provided in the given text:

2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable. No test set needing adjudication 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-based device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-based device, and no standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There's no performance evaluation generating new data that would require a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set: Not applicable. This is not an AI-based device, and no training set is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

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An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants

Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.

This document, K012681, is a 510(k) summary for a dental implant system. The purpose of a 510(k) is to demonstrate that a device is "substantially equivalent" to predicate devices already on the market. Therefore, the information provided focuses on this equivalence rather than a detailed study proving performance against defined acceptance criteria.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study for a novel device would. The document is a premarket notification to the FDA, stating the device's substantial equivalence to existing products. It does not contain details of a de novo study with acceptance criteria, sample sizes, or ground truth establishment.

Here's a breakdown of why the requested information cannot be fully provided from the given document, and what can be inferred:

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

• Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" for going to market is often demonstrating substantial equivalence to a predicate device. This is achieved by showing comparable technological characteristics and intended use, along with safety and effectiveness that are equivalent to the predicate.
• Reported Device Performance: Not explicitly reported in a quantitative manner against specific performance metrics. The document describes the device (uncoated pure titanium, rough threaded area, polished cervical margin, sterile packaging) and its intended use, implying its performance is similar to the identified predicate devices.

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

• Test Set Sample Size: Not applicable/not provided. This document is a 510(k) premarket notification, not a report of a new clinical or performance study where a test set would be used to evaluate novel performance. The FDA's substantial equivalence review is based on comparing the new device's characteristics and indications for use to legally marketed predicate devices.
• Data Provenance: Not applicable. The document refers to predicate devices (Straumann ITI Implant, Branemark System) but does not detail new data generation for the Ankylos system in the context of a "test set."

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 for a test set is not mentioned because no new performance study with such a test set is described.

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

• Not applicable. No test set or expert adjudication is described in this 510(k) summary.

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

• No. This is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• No. This is a physical medical device (dental implant), not an algorithm or software. Standalone algorithm performance is not applicable.

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

• Not applicable. No new "ground truth" was established in the context of demonstrating performance as described in a clinical study. The "truth" for a 510(k) centers around the established safety and effectiveness of the predicate devices and demonstrating that the new device is substantially equivalent.

8. The sample size for the training set

• Not applicable. This relates to machine learning models, which is not relevant for a dental implant 510(k) submission.

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

• Not applicable. As above, this pertains to machine learning and not to this type of medical device submission.

Summary of what is provided:

• Device Name: Ankylos Implant System
• Intended Use: Surgical placement in upper/lower jaw arches to provide root-form means for prosthetic appliance attachment, restoring chewing function. Can be placed via 2-stage or single-stage (immediate loading, restricted to anterior mandible based on 4 interforaminal placed implants, not single unsplinted implants).
• Predicate Devices:
  • Straumann ITI Implant (510k - 984104)
  • Branemark System (510k - 992937)
• Device Description: Uncoated pure titanium (grade 2 per ISO 5832/II), threaded area with rough structure, polished cervical margin, sterile packaged.
• Substantial Equivalence: The FDA's letter (K012681) confirms that they reviewed the 510(k) and "determined the device is substantially equivalent...to legally marketed predicate devices." This is the "acceptance" in the context of a 510(k) for market clearance.

In essence, the document serves as evidence of the FDA's decision regarding market clearance based on substantial equivalence, not as a detailed report of a performance study with specific acceptance criteria and ground truth methodologies.

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