Search Results

The BioHorizons Maestro System 3.0 mm Diameter Implant may be used

• (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
• (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
• (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM). 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 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components.

This document is a 510(k) summary for a dental implant, not a study report for a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not present in the provided text.

Based on the provided text, here is what can be extracted and what cannot:

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

• Cannot be provided. The document describes a medical device (dental implant) and its substantial equivalence to predicate devices for regulatory clearance. It does not detail specific acceptance criteria or performance metrics in the way a clinical or technical performance study would. It focuses on the device's characteristics and intended use.

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

• Cannot be provided. This document is not a study report. It does not mention any test sets, sample sizes, or data provenance.

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)

• Cannot be provided. No ground truth establishment for a test set is mentioned in this regulatory submission document.

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

• Cannot be provided. No adjudication method is mentioned as there is no test set or study 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

• Cannot be provided. This device is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not applicable to this submission.

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

• Cannot be provided. This device is a dental implant, not an algorithm.

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

• Cannot be provided. No ground truth is described in the context of a performance study.

8. The sample size for the training set

• Cannot be provided. This document is not about an AI device with training sets.

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

• Cannot be provided. Not applicable to this type of device and document.

Summary of what is present:

The document is a 510(k) Pre-market Notification for a dental implant, demonstrating substantial equivalence to previously cleared predicate devices. The focus is on the physical characteristics, materials, manufacturing processes, and intended use being similar to existing, legally marketed devices. The "study" here is essentially the comparison to predicate devices, asserting that its "Technological Characteristics" are "identical or very similar" and "substantially equivalent to all features of the predicate devices which could affect safety or effectiveness because of the similarities in design, material and intended use."

The regulatory body (FDA) reviewed this claim and, in the letter, indicated that the device is "substantially equivalent" for the stated indications for use. This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, implying that if the new device is as safe and effective as a legally marketed predicate, it can be marketed. No new clinical trials or performance studies against specific numerical acceptance criteria are detailed in this type of submission.

Ask a specific question about this device

Ask a specific question about this device

The BioHorizons Maestro System™ is indicated for use as an artificial root structure for single tooth replacement or as abutments for bridgework and denture retention in the mandible and maxilla.

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 bone growth and interface maintenance over the long-term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, and D4) and bone volume classification (Division A, B, and C-h) in the mandible and maxilla. Four implant designs, corresponding to each bone density and bone volume classification, are available in 3.5, 4.0,and 5.0 mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in several lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating.

The provided text describes a 510(k) premarket notification for the BioHorizons Maestro System™, an endosseous implant system. The evaluation details focus on mechanical testing, not on clinical performance or AI algorithm effectiveness. Therefore, many of the requested criteria cannot be directly addressed.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes product evaluation consisting of "mechanical testing of the implant and bioactive coating mechanical tests." It then states that these analyses "indicate The Maestro System™ should be safe and effective when used as intended."

However, the document does not explicitly state specific acceptance criteria in a quantitative or qualitative manner (e.g., minimum tensile strength, maximum wear rate). It also does not provide a table of reported device performance metrics against such criteria. The closest information to performance is the general statement about biomechanical performance optimization, but no specific data is presented.

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

The document mentions "mechanical testing of the implant and bioactive coating mechanical tests."

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This question is not applicable in this context. The "ground truth" for mechanical testing in device evaluation would typically refer to established engineering standards and measurements, not expert clinical interpretation.

4. Adjudication Method for the Test Set:

This question is not applicable in this context as the evaluation involved mechanical testing, not human-read test sets requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The device is a physical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone algorithm performance study was done. The device is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device evaluation would be based on engineering standards and measurements derived from mechanical testing, ensuring the implant meets specified strength, fatigue, and other material properties for its intended use. The document doesn't explicitly name the specific standards or measurements used (e.g., ASTM standards for implant materials), but implies their use through the mention of "mechanical testing."

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical implant; there is no "training set" in the context of AI development. The design of the implants is based on biomechanical principles and bone density classifications, which would stem from scientific understanding and potentially prior clinical data, but not in the sense of an AI training set.

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

This question is not applicable for the same reason as above.

Summary of what cannot be addressed from the provided text:

Due to the nature of the device (a physical endosseous implant) and the type of evaluation described (mechanical testing for safety and effectiveness), most of the questions relating to AI performance metrics, expert adjudication, ground truth establishment for AI models, and training/test set sample sizes (in the context of AI) are not applicable. The document focuses on the physical and material properties of the implant system and its substantial equivalence to previously cleared devices.

Ask a specific question about this device