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AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.

AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.

The AccuFit" Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

The AccuFit" Dental Abutments and Screws are designed for use with commercially available dental implant systems. The abutments will seat directly on implants and are secured by screws to become sub-structure of prosthesis. These abutments are offered in a straight body with a straight or scalloped prosthetic margin and are made of Titanium alloy Ti6AlV4.

A list of dental implant systems, which the AccuFit™ family of products is compatible with, is shown in tables within this document. The abutments and screws of the compatible systems are listed as the predicates for this filing.

The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:

Table A. Compatible Commercial Implant Manufacturers

This document is a 510(k) Premarket Notification for the AccuFit™ Dental Implant Abutments and Screws. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria implicitly through the comparison to predicate devices and the process of ensuring compatibility. The primary acceptance criterion is substantial equivalence to existing legally marketed dental implant abutments and screws.

The "reported device performance" is not quantified in terms of specific performance metrics (like wear resistance, fracture strength in controlled studies, etc.) in this submission. Instead, performance is demonstrated by adhering to material standards and ensuring a precision fit with compatible implant systems.

Study Information

The document describes a bench study/testing rather than a clinical trial or a study involving human subjects or AI performance.

1. Sample size used for the test set and the data provenance:

   • Test Set Description: The "test set" consists of commercially available implant components from various manufacturers (Zimmer Dental, Nobel-Biocare, Biomet 3i, Lifecore Biomedical) that the AccuFit™ system is designed to be compatible with.
   • Sample Size: The document does not specify a numerical sample size (e.g., how many units of each compatible implant system were purchased for testing). It ambiguously states, "The commercially available implant components are purchased as samples."
   • Data Provenance: The data provenance is described as "commercially acquired samples" from various implant companies. This implies the data is retrospective in the sense that the compatible implants are pre-existing, but the testing performed by Berkeley Implant would be prospective for their device. The country of origin of these commercial implants is not specified, but they are recognized manufacturers in the dental implant market.

2. 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 submission does not involve medical image analysis or interpretation, and therefore, there are no "experts" in the sense of clinical specialists establishing a "ground truth" for a diagnostic task. The ground truth for device compatibility and performance is established through engineering measurements and material standards. The expertise involved would be in manufacturing, quality control, and metrology, but no specific number or qualifications of "experts" are listed in this context.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable to the type of study described. There's no clinical "adjudication" of results in a diagnostic or therapeutic sense. The "adjudication" of fit is based on optical measurements and cross-assembly, which are objective engineering assessments.

4. 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. An MRMC study is relevant for evaluating diagnostic systems, especially those involving human interpretation (e.g., radiologists reading images with and without AI assistance). This submission is for a physical medical device (dental implant abutments and screws) and does not involve AI or human "readers" of any kind in a diagnostic capacity.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an algorithm or AI-based device. It is a physical dental implant component.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" in this context is based on engineering specifications, material standards (ASTM F136-08e1), precise measurements (using high-precision optical equipment), and successful physical cross-assembly with predicate devices/compatible implant systems. The compatibility is determined by mating diameters, lead-in bevels, internal/external hex sizes, and internal threads.

7. The sample size for the training set:

   • This document describes the manufacture and testing of a physical medical device. It does not involve a "training set" in the context of machine learning or AI algorithms. The manufacturing process itself (machining, quality control) is analogous to "training" in that it produces the intended device, but it's not a data-driven training set.

8. How the ground truth for the training set was established:

   • As there is no "training set" in the AI/machine learning sense, this question is not applicable. The "ground truth" for the device's design and manufacturing is established by engineering design specifications derived from the compatible predicate devices and relevant material standards. The manufacturing process aims to meet these specifications.

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