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BioHorizons Single-stage 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.

BioHorizons Single-stage Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

BioHorizons Single-stage Implants are machined titanium, screw-form endosseous implants supplied in 3.5mm, 4.0mm, 5.0mm, 6.0mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant material is titanium alloy as specified 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 surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. 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 to 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.

The BioHorizons Single-stage Implant System includes a series of implant catalog item numbers with Laser-Lok® technology applied to the implant collar to provide additional treatment options for the dental implant clinician.

The provided document is a 510(k) Premarket Notification for the BioHorizons Single-stage Implant System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed study results as one might find for a novel drug or a high-risk medical device.

Therefore, the document does not contain the specific information requested regarding acceptance criteria, a standalone study to prove meeting acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Metrics: For a 510(k) submission, the primary goal is to show that the new device (BioHorizons Single-stage Implant System in this case) is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (materials, design, intended use, sterilization methods) and citing existing regulatory approvals for the predicate device, rather than setting and meeting new performance acceptance criteria through a specific study in the way a drug or novel biologic might.

• No Dedicated "Study" in the Requested Format: The document doesn't describe a stand-alone prospective or retrospective study designed to test the device against specific performance acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate devices.

Let's address the specific points based on what can be inferred or what is explicitly stated in the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent points (2-9) are largely not applicable in the context of this 510(k) submission, as it isn't a clinical trial demonstrating performance against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No dedicated "test set" or clinical study with a specific sample size is mentioned. The submission relies on the established performance of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set was established as part of this submission framework.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or expert adjudication process is described here.

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-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a new performance study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and clinical use.

8. The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an algorithm being developed.

9. How the ground truth for the training set was established: Not applicable. Same as above.

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