(153 days)
BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prositiesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3:5mm, 4.5mm and 5.7mm internal hex-connection, mating platform diameters.
BioHorizons Simple Solutions with Laser-Lok is an abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm with collar heights of 0.8mm, 1.8mm and 2.8mm. 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.
The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. 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 with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products - Radiation -- Part 2: Establishing the sterilization dose.
The provided document describes the BioHorizons Simple Solutions with Laser-Lok, an abutment system for dental implants. This 510(k) submission (K100985) focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for device performance.
Therefore, the information requested in the prompt, which typically applies to medical devices seeking approval based on performance metrics against specific acceptance criteria (often for diagnostic devices or those with quantifiable outcomes), is largely not applicable in the context of this 510(k) for an implant abutment system.
However, I can extract information related to the study that supports the technological characteristics and substantial equivalence claim, which is the closest available data.
Here's the breakdown of what can be found or inferred from the provided text, and what is not available for this type of device submission:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: This device is an implant abutment system, which is typically cleared based on substantial equivalence to existing devices, materials, and biomechanical properties, rather than specific performance metrics like sensitivity/specificity for a diagnostic device. The study described focuses on biological response (bone and soft tissue healing) which is a qualitative outcome demonstrating equivalence or superiority to the predicate's biological interaction, not a quantitative performance metric against a pre-defined acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: "Each group received nine implants with abutments placed at the time of surgery."
- Since there are four cohorts (Group A, B, C, D), the total number of implants in the study would be (4 cohorts * 9 implants/cohort) = 36 implants.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "A prospective study was conducted in a canine model..."
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)
- Not Provided / Not Applicable: The study was a canine model investigating bone and soft tissue healing. The "ground truth" here would be the biological response observed in the animal tissue, which is typically analyzed by veterinary pathologists or histologists. The document does not specify the number or qualifications of experts involved in the analysis of the canine tissue samples. It references "Nevins et al concluded...", implying an external study or expert opinion was cited.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided / Not Applicable: Adjudication methods like 2+1 or 3+1 are common in reader studies (e.g., for diagnostic imaging devices where human readers interpret results). This was a preclinical in vivo animal study; adjudication in this context refers to the process by which biological samples (e.g., histological slides) are interpreted, which is not detailed.
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
- No: This is entirely Not Applicable. An MRMC study is relevant for diagnostic devices involving human interpretation of clinical cases, often with AI assistance. This submission pertains to a dental implant abutment and involves a preclinical in vivo study, not a human reader study or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is entirely Not Applicable. This device is a physical dental implant component, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Pathology/Histology of Biological Responses: The study evaluated "bone and soft tissue healing patterns." The results described "significant improvement in peri-implant hard and soft tissue healing" and "intense fibroblastic activity to occur on the abutment-grooved surface, resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration." This indicates that the "ground truth" was derived from histological or pathological analysis of the tissue samples obtained from the canine model.
8. The sample size for the training set
- Not Applicable: This was a preclinical in vivo study, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
Summary of the Study that Proves (or supports) the Device's Claims:
The device's claims are primarily related to substantial equivalence in design, materials, and intended use, with an added "Laser-Lok" feature for improved biological integration. The study cited supports the effectiveness of this Laser-Lok feature.
Study Description:
- Name of Study: A prospective study conducted in a canine model.
- Objective: To evaluate bone and soft tissue healing patterns when Laser-Lok microgrooves are applied to dental implant abutments.
- Design: The study consisted of four cohorts:
- Group A: Laser-Lok healing abutment on an RBT implant
- Group B: Laser-Lok healing abutment on an RBT implant with a machined area
- Group C: Machined healing abutment on an RBT implant
- Group D: Machined healing abutment on an RBT implant with a machined area
- Methodology: Laser-Lok and machined-surface healing abutments were randomly assigned to internal-connection implants that were either fully RBT treated or RBT-treated with a 0.3mm machined collar. Abutments were placed at the time of surgery.
- Sample Size: 9 implants per group (total of 36 implants across four groups).
- Results (Reported Device Performance): The study demonstrated "significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces." Specifically, it facilitated "intense fibroblastic activity" and the formation of a "physiologic barrier to apical JE migration."
- Ground Truth: Histopathological analysis of bone and soft tissue healing patterns in the canine model.
This preclinical study supports the biological benefits of the Laser-Lok feature, contributing to the overall claim of substantial equivalence and safety/effectiveness for the BioHorizons Simple Solutions with Laser-Lok abutment system.
§ 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.)