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BioHorizons Tapered Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

The BioHorizons Tapered Internal Implants are machined titanium, screw-form endosseous dental implants supplied in 3.4mm and 4.6mm diameters. The 3.4mm diameter implant includes lengths of 9mm, 10.5mm, 15mm and 18mm while the 3.8mm and 4.6mm diameter implants include an 18mm length option to complement currently cleared implant lengths within those implant body diameters. Implant 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 roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser• Lok® microchannels, to the implant collar of select models. 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 10-6, validated in compliance with ANSVAAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part I: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) premarket notification for a medical device called "BioHorizons Tapered Internal Implants." It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria and performance through a clinical study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of submission. The document primarily focuses on technical characteristics and mechanical testing to justify equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a substantial equivalence claim, not a de novo clearance with specific acceptance criteria from a clinical trial. The "acceptance criteria" here relate to demonstrating equivalence in design, materials, and mechanical performance to predicate devices. The performance reported is that the device "performs as well as the referenced predicate device."

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

• Sample Size: Not specified for a "test set" in the context of a clinical study. The testing refers to "Mechanical testing of the 3.0mm implant-abutment connection... in conjunction with angled prosthetic abutments representative of the worst-case scenario." This implies an engineering test, not a clinical trial with human subjects. Thus, the "sample size" would refer to the number of devices mechanically tested, which is not detailed but is typically a small number for such engineering tests.
• Data Provenance: The 'data' generated is from mechanical testing conducted according to ISO 14801 and FDA guidance documents. This is laboratory-based engineering data, not clinical data from countries of origin.

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

Not applicable. This submission relies on engineering and material standards (ASTM, ISO) and comparison to predicate devices, not on expert consensus for ground truth on clinical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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

Not applicable. This device is a dental implant, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a dental implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) is based on:

• Established engineering standards (e.g., ISO 14801 for fatigue testing, ASTM F136 for material).
• Performance of legally marketed predicate devices (K071638 and K093321), which have already demonstrated safety and effectiveness through their own clearance/approval processes.
• Physical and chemical properties of the materials and design features.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning/AI sense.

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

Not applicable. As above, no training set for an AI algorithm is involved.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a dental implant, not a study evaluating acceptance criteria for a diagnostic device or AI software. The "study" referenced is mechanical testing to demonstrate substantial equivalence to existing devices.

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