(14 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.