(7 days)
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:
- 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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- 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.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)