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The Maestro System™ endosseous implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention.

The 7mm and 10.5mm length Maestro System dental implants are a machined titanium. screw-form implant supplied in diameters of 3.5mm, 4mm and 5mm. Implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surqical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137. Sterilization of healthcare products - Requirements for validation and routine control - Radiation sterilization.

The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.

This document describes a Special 510(k) Notification for a device modification, specifically the addition of new sizes (7mm and 10.5mm lengths) to the existing BioHorizons Maestro System™ screw-type dental implants. This type of submission focuses on demonstrating substantial equivalence to a predicate device and typically does not involve new clinical studies or detailed performance acceptance criteria, as the fundamental technology and indications for use remain unchanged. Therefore, a direct response to many of the requested categories (acceptance criteria, specific study details, sample sizes, expert involvement, ground truth, etc.) is not applicable or cannot be extracted from the provided text.

Here's an analysis based on the provided text:

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

This information is not provided in the document. Special 510(k) applications for minor modifications like adding new sizes generally rely on demonstrating that the new sizes have the same technological characteristics and intended use as the predicate device, implying that the established performance of the predicate device applies. There is no new performance data or acceptance criteria presented for the modified device sizes.

2. Sample sized 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/provided. The submission is a Special 510(k) for a device modification, not a submission based on new clinical testing that would involve a test set. The focus is on demonstrating equivalence of the new sizes to the existing, predicate device.

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/provided. As explained above, no new clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable/provided. No test set or associated adjudication methods are 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

This information is not applicable/provided. This is a submission for a dental implant, not an AI-powered diagnostic device. Therefore, MRMC studies or AI assistance are not relevant to this submission.

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

This information is not applicable/provided. This is a submission for a dental implant, not an algorithm or AI device.

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

This information is not applicable/provided. No new ground truth establishment is described as the submission focuses on demonstrating equivalence of new sizes to an already approved predicate device. The "ground truth" for this modification essentially relies on the established safety and effectiveness of the existing Maestro System implants.

8. The sample size for the training set

This information is not applicable/provided. No training set is described as this is not an AI/algorithm submission, nor does it include a de novo clinical study requiring a training set.

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

This information is not applicable/provided. As above, no training set is described.

Summary of the K030463 Application:

The BioHorizons Implant Systems, Inc. K030463 submission is a Special 510(k) Notification for a Device Modification. The modification involves adding new lengths (7mm and 10.5mm) to the existing Maestro System™ screw-type dental implants.

The core argument for acceptance is Substantial Equivalence to the predicate device (The Maestro System™ already marketed by BioHorizons, with various K-numbers listed).

The justification for substantial equivalence is based on the following:

• No change in fundamental scientific technology: The implants are still machined titanium, screw-form.
• Same materials: Titanium alloy (ASTM F136 - 6AL-4V ELI) and surface treatments (RBM or HA) remain unchanged.
• Same suppliers, processing, packaging, and sterilization methods.
• No change in intended use or indications for use: The implants are for single tooth replacement or as abutments for fixed bridgework and dental retention in the mandible and maxilla.

Because this is a submission for a modification to an existing, approved device, and not a de novo device or a significant change requiring new clinical data, the acceptance criteria are implicitly that the new sizes do not introduce new questions of safety or effectiveness and maintain the same technological characteristics as the predicate. The "study" proving this is the comparative analysis of technological characteristics and intended use against the predicate device, which is documented in the 510(k) submission itself. No new clinical trials or performance studies with specific acceptance criteria are mentioned or required for this type of submission.

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The Maestro System™ may be used in the mandible or maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

The Maestro System is a comprehensive system containing implants, surgical components, and prosthetic components. This 510(k) submission notification is for the purpose of obtaining authorization to offer Ti-N coated prosthetic abutments as part of The Maestro System. The abutments will continue to be machined from titanium alloy but will undergo a Ti-N coating process. BioHorizons proposes to coat all exposed surfaces of the implant abutments during the coating process; current dimensional characteristics and specifications for abutments coated with Ti-N do not change. Cleaning, packaging and sterilization operations will be the same for the Ti-N coated abutments as for the non-coated abutments. In clinical practice, the implant and abutments surgical placement and restorative procedures will not change. The purpose of Ti-N coating implant abutments is two-fold: first, the yellow color of the Ti-N coating presents an esthetically-pleasing tint when visible through tissue, compared with the gray tint of uncoated titanium; second, the yellow color provides a distinct demarcation line at the interface of the implant body and the abutment, which will provide a visual aide in determining implant depth during the placement process. The product is packaged using materials known in the industry to be appropriate for medical device packaging and will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10-6.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified information points, based on the provided text.

Here's why:

The provided text is a 510(k) summary for a device modification (adding a Titanium-Nitride coating to existing dental implant abutments). This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving that a new device meets specific, pre-defined acceptance criteria through a comprehensive performance study with statistical endpoints.

Here's a breakdown of why each requested point cannot be fully addressed:

1. A table of acceptance criteria and the reported device performance: The document does not define specific quantitative "acceptance criteria" for the performance of the Ti-N coated abutments in a clinical or functional sense. It primarily discusses the characteristics of the coating itself (adhesion, thickness, elemental composition) and its biocompatibility. It does not provide performance metrics like success rates, fracture rates, or patient outcomes that would be compared against acceptance criteria.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of clinical or performance data for the Ti-N coated abutments. The non-clinical testing refers to material property tests of the coating.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there's no clinical "test set" requiring expert ground truth establishment for diagnostic or outcome assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as 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 is entirely unrelated to the device described. The device is a physical dental implant component, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the device type or the nature of the 510(k) submission. The "ground truth" for the material tests would be the established scientific methods for measuring adhesion, thickness, and elemental composition.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "studies" and "acceptance":

The document focuses on demonstrating that the modification (the Ti-N coating) does not alter the safety or effectiveness of the previously cleared predicate device. This is achieved through:

• Predicate Device Comparison: The core of a 510(k) is showing substantial equivalence to existing, legally marketed devices.
• Biocompatibility Testing: The text explicitly states, "Biocompatibility testing has been conducted on Ti-N using the International Organization for Standardization (ISO 10993-1) guidelines. This testing, and subsequent clinical applications, has demonstrated that titanium nitride is biocompatible and appropriate for human use in implant medical devices that come in contact with bone, skin, tissue, or blood." This is a crucial "study" showing the material's safety.
• Non-Clinical Material Property Testing: "Ti-N coating applied to The Maestro System abutments was assessed in a number of tests, including adhesion and coating thickness to IonBond specification MS 70-722, and elemental composition using Energy Dispersive Spectroscopy in a scanning electron microscope at the University of Alabama at Birmingham School of Dentistry." These tests confirm the physical properties of the coating meet a specified standard (IonBond MS 70-722) and its chemical composition is as expected. This represents the "acceptance criteria" for the coating itself, not the overall device performance.

In summary, this 510(k) demonstrates the modified device is substantially equivalent by confirming the new material (Ti-N) is biocompatible and has appropriate physical properties, and that these changes do not alter the intended use or fundamental technological characteristics of the existing, cleared device. It is not a clinical effectiveness study with performance acceptance criteria for the entire device.

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The Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention. The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed.

The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 4.0 mm and 5.0 mm, and in active thread area lengths of 9 mm, 12 mm, and 15 mm. The implant will have a polished collar length of 2 mm. The implant raw material is titanium alloy as specified in ASTM F136 -Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). The product is packaged using materials known in the industry to be appropriate for medical device packaging and will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10°. The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality. Following five years of clinical use, this submission proposes offering an additional polished collar length and threaded area length to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information, formatted as requested.

Important Note: The provided document (K020645) is a 510(k) summary for a dental implant. These summaries are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed clinical study proving specific acceptance criteria in the way a novel AI or diagnostic device might. Therefore, many of the requested fields (like sample size, number of experts, adjudication methods for ground truth, MRMC studies, standalone performance details, training set specifics) are not typically found in this type of document for a dental implant and are marked as "Not Applicable," "Not Provided," or "Not Relevant" below. The primary "study" for this device is testing to demonstrate equivalence in mechanical properties and biocompatibility.

Acceptance Criteria and Device Performance

There are no explicit "acceptance criteria" tables with numerical targets and corresponding "reported device performance" in the sense of a diagnostic algorithm's sensitivity or specificity. Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device. This substantial equivalence is established by showing that the modified device (The Maestro System™ with a 2mm polished collar length) has the same intended use, fundamental scientific technology, and similar technological characteristics (materials, design principles, manufacturing, sterilization) as the predicate. The "performance" is implicitly deemed acceptable if this substantial equivalence is established and the device maintains safety and effectiveness.

The document highlights the following characteristics of the proposed device, which, by virtue of being similar to the predicate, establish its "performance" for substantial equivalence:

Study Details

1. 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 applicable/Not provided. This 510(k) is for a dental implant, not a diagnostic algorithm. The "test set" would primarily refer to bench testing for mechanical properties and biocompatibility. Details of such testing (e.g., number of implants tested for fatigue or tensile strength) are not included in this summary document.
   • Data Provenance: Not applicable/Not provided in this summary. Bench testing data is typically generated in a lab setting. Clinical data, if any were submitted (which is generally not required for 510(k) substantiation based on minor design changes and substantial equivalence), would need specific provenance.

2. 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):

   • Number of Experts: Not applicable/Not provided. For a dental implant's mechanical and material properties, "ground truth" is established through standardized engineering tests and material specifications, not expert consensus on interpretations. The regulatory body (FDA) evaluates the submitted test data and documentation.

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

   • Adjudication Method: Not applicable/Not relevant. This type of adjudication is typically used for reconciling differing expert opinions in labeling or image interpretation, which is not the primary mode of evaluation for a physical medical device like an implant in a 510(k).

4. 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:

   • MRMC Study: No. This is a physical dental implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI improvement metrics are not applicable.

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

   • Standalone Performance: No. This is a physical dental implant, not an algorithm.

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

   • Ground Truth Type: For a dental implant, the "ground truth" for demonstrating safety and effectiveness for a 510(k) typically involves:
     • Biocompatibility: Conformance to ISO 10993 series through testing or material equivalency.
     • Mechanical Performance: Bench testing (e.g., fatigue, static strength, torque strength) according to relevant ISO/ASTM standards, demonstrating performance equivalent to or better than the predicate.
     • Material Specifications: Conformance to ASTM or ISO standards for the raw materials.
     • Sterilization Validation: Conformance to ISO 11137.
     • The "Type of Ground Truth" here is primarily the adherence to these recognized standards and demonstrated performance in engineering and biological testing.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/Not relevant. This is not a machine learning or AI device that requires a training set.

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

   • Training Set Ground Truth Establishment: Not applicable/Not relevant. As this is not an AI device, there is no training set or associated ground truth.

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The Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and dental retention. The Indication/Intended use of the modified device, the Maestro System™, as described in its labeling has not changed.

The 15 mm length Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied in diameters of 3.5 mm , 4.0 mm and 5.0 mm, and in lengths of 9 mm, 12 mm, and15 mm. The implant raw material is titanium alloy as specified in ASTM F136 - Specification for Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM) or coating with synthetic hydroxylapatite (HA). The product is packaged using materials known in the industry to be appropriate for medical device packaging and will be provided sterile, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products -- Requirements for validation and routine control - Radiation Sterilization, with a minimum sterility assurance level of 10-

The Maestro System ™ is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This is achieved by optimizing implant designs based on bone quality.

Following four years of clinical use, this submission proposes altered sizing to assist the dental practitioner in treatment planning and ease of use with the product. Three base implant designs, corresponding to each bone density classification (D1/D2, D3 and D4) will be available in 3.5 mm, 4.0 mm and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, will be available in three lengths and may feature a Resorbable Blast Media (RBM) surface treatment, or hydroxylapatite (HA) coating.

This document is a 510(k) premarket notification for a medical device called "The Maestro System™," a screw-type dental implant. The purpose of this submission is to introduce altered sizing for existing implants and reintroduce a 15mm length implant. It claims substantial equivalence to previously cleared Maestro System implants.

Based on the provided information, there is no study described that demonstrates and provides acceptance criteria for device performance based on objective measures, such as a diagnostic accuracy study. The entire submission focuses on establishing substantial equivalence to previously cleared predicate devices through similarities in design, material, and intended use, rather than presenting a performance study with specific acceptance criteria.

The acceptance criteria for this 510(k) submission are implicitly tied to the concept of substantial equivalence to the predicate device. This means the device must be demonstrated to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Here's an analysis of the provided information in the context of your request, explicitly noting where information is not available in the document:

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

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

• Not applicable / Not provided. This document does not describe a performance study with a test set. The submission relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

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 / Not provided. There is no test set or ground truth described in this submission.

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

• Not applicable / Not provided. There is no test set or adjudication method 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 / Not provided. This device is a physical dental implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely outside the scope of this submission.

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

• Not applicable / Not provided. This device is a physical dental implant, not an algorithm or software. No standalone performance study for an algorithm is relevant here.

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

• Not applicable / Not provided. No specific "ground truth" for a performance study is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate devices based on their legal marketing history and previous FDA clearances.

8. The sample size for the training set

• Not applicable / Not provided. There is no training set described. This is not a machine learning or AI device.

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

• Not applicable / Not provided. As there is no training set, this information is not relevant.

Summary of the "Study" (Implicit)

The "study" presented in this 510(k) is a comparative analysis against predicate devices to demonstrate substantial equivalence. It's not a clinical trial or a performance study with a test set in the traditional sense you might expect for a diagnostic or AI device. The evidence for "meeting acceptance criteria" is the comprehensive argument that the modifications to the Maestro System do not raise new questions of safety or effectiveness when compared to the already cleared versions of the Maestro System. The FDA's decision to clear the device (K020133) indicates that they accepted this argument for substantial equivalence.

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