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BioHorizons Implant Site Dilators are indicated for use to aid in the placement of root form implants in soft maxillary bone. Rather than removing valuable bone from the surgical site, the function of these instruments is to manually form the osteotomy by compressing the bone laterally, causing a denser bone to implant interface.

The Implant Site Dilators are hand-operated instruments which provide an aid in the placement of root form implants in soft maxillary bone. All components are made from surgical grade stainless steel.

The provided 510(k) notification for the BioHorizons Implant Site Dilators (K980874) does not contain detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the way typically expected for submissions involving AI/Machine Learning devices. This document is for a medical device (surgical tools), not a software device, and therefore the evaluation methods are different.

However, based on the information provided, here's a breakdown of what can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document. For a physical device like surgical instruments, "acceptance criteria" would typically relate to factors like material strength, sterility, biocompatibility, and functional performance (e.g., ability to expand bone without breaking, ease of use). The document indicates a general "safety and effectiveness" evaluation.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The term "test set" in the context of this document would refer to the physical devices that were evaluated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document states: "These evaluations indicate that the Implant Site Dilators should be safe and effective when used as intended." The evaluations were conducted by:

• "consulting implantologists"
• "oral and maxillofacial surgeons"

The number of experts is not specified. Their qualifications are given by their titles: "implantologists" and "oral and maxillofacial surgeons," implying they are qualified medical professionals with expertise in dental implant procedures. Specific experience (e.g., "10 years of experience") is not mentioned.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a physical instrument evaluation, adjudication would likely involve expert opinion and potentially subjective assessment of performance during simulated or actual use.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, as this type of study is primarily relevant for diagnostic imaging systems and AI algorithms where multiple human readers interpret cases. This document is for surgical hand instruments.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This device is a manual surgical instrument, not an algorithm, so there is no "standalone" algorithm performance to evaluate. Its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for safety and effectiveness would have been established through a combination of:

• Expert Consensus/Opinion: The evaluations by consulting implantologists and oral and maxillofacial surgeons.
• Laboratory Conditions: Testing to ensure material properties, dimensions, and perhaps simulated functional performance (e.g., ability to withstand forces during bone compression).

There is no mention of pathology or outcomes data in this summary.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a training set as it is not an AI/Machine Learning algorithm.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set.

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