(88 days)
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.
§ 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.