(211 days)
BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.
All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.
BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BioHorizons CAD/CAM Abutments:
The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k)). This means the "acceptance criteria" are largely based on showing the device performs comparably to existing, legally marketed devices, rather than establishing de novo performance targets. The "studies" are tests conducted to support this claim of equivalence.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list numerical acceptance criteria in a typical pass/fail format with specific thresholds. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant industry standards. The reported device performance is demonstrated through various tests designed to show that the BioHorizons CAD/CAM Abutments perform in accordance with their intended use and are substantially equivalent to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Fatigue Strength (per ISO 14801 & FDA Guidance) | "Results of the testing demonstrate that the fully milled, worst-case 30° angled configurations of both the 3.0mm and 3.5mm prosthetic platform abutments and the titanium bases with bonded zirconia superstructure perform in accordance with their intended use." (Implies meeting or exceeding the performance established by the standard and predicate devices for similar angled abutments). |
| Implant Compatibility | "Compatibility testing was performed on a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants... This testing verifies compatibility of BioHorizons Abutments for Zimmer® with all Zimmer® Screw-Vent® and Tapered Screw-Vent® items based on equivalent mating platform geometry." (Implies successful and reliable fit/function with listed implant systems). |
| Sterilization Efficacy (for non-sterile devices requiring sterilization by user) | "Steam sterilization validation testing was performed new in accordance with AAMI/ANSVISO 17665-1:2006... Test results demonstrate a sterility assurance level (SAL) of 10⁻⁶." (Implies achievement of the industry-standard sterility level after a validated sterilization process). |
| Software Validation (for CAD/CAM design parameters) | "Software intended use validation testing of the software systems utilized in the manufacture of the CAD/CAM abutments was performed to ensure that the program design limitations prevent the user from milling abutments that do not fulfill the BioHorizons design criteria." (Implies the software correctly enforces design constraints to ensure proper abutment manufacturing). |
| Substantial Equivalence (Overall Safety & Effectiveness) | "The data presented in this submission demonstrates that the proposed devices are substantially equivalent with respect to performance and intended use. The proposed devices perform as well as the legally marketed predicate devices. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices." (This is the overarching conclusion of the submission, supported by all the aforementioned tests and comparisons). |
Further Details on the Study:
Given the nature of this 510(k) submission for a dental abutment, it's highly unlikely that components like "test sets," "ground truth experts," "adjudication methods," or "MRMC comparative effectiveness studies" were part of the presented data. These concepts are more typically associated with diagnostic imaging AI/ML devices or clinical trials involving complex human interpretation.
Therefore, many of the requested items below will be marked as "Not Applicable" or "Not Provided" based on the document's content and the typical scope of device approval for implant components.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for compliance with the respective standards (e.g., ISO 14801 typically requires 12 samples per group for fatigue testing). The document mentions "worst-case 30° angled configurations" and "representative subset" for compatibility testing.
- Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The document does not indicate data from human subjects or clinical sites.
- Retrospective or Prospective: Not applicable as these are laboratory and validation tests, not clinical studies involving patient data.
-
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. The "ground truth" for mechanical and sterilization testing is defined by the physical properties measured against engineering standards (e.g., fracture strength, SAL level). For software validation, it's the correct implementation of defined design parameters. No human expert "ground truthing" in the sense of clinical interpretation is relevant here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Adjudication methods are relevant for ambiguous human interpretations, which is not the case for material property or mechanical performance testing.
-
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
- No. This is not a diagnostic device involving human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Directly Applicable. While software validation for the CAD/CAM milling process was performed (an "algorithm only" component), this isn't a standalone diagnostic AI. Its "performance" is about correctly enforcing design parameters, not making a diagnosis or prediction. The core device is a physical product, not a software algorithm presented for standalone performance evaluation in a clinical context.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards / Defined Specifications:
- For Dynamic Mechanical Fatigue: ISO 14801 standards and BioHorizons' internal performance specifications for expected strength and durability.
- For Compatibility: Physical fit and function with the specified implant systems.
- For Sterilization: AAMI/ANSVISO 17665-1:2006, specifically achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
- For Software: BioHorizons' allowable range of design parameters and criteria.
- Engineering Standards / Defined Specifications:
-
The sample size for the training set
- Not Applicable. As a physical medical device submission, there is no "training set" in the context of machine learning algorithms. The design process for the abutments is based on engineering principles and existing product lines, not data training.
-
How the ground truth for the training set was established
- Not Applicable. (See above, no training set for this type of device submission).
§ 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.)