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STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.

STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function.
STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.

The provided document is a 510(k) summary for the STERI-OSS Implant System, which is a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets pre-defined acceptance criteria for performance in a clinical setting. For medical devices undergoing 510(k) clearance, the primary goal is to show that the new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific novel performance acceptance criteria through clinical studies.

Therefore, the requested information elements such as "acceptance criteria and the reported device performance," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are typically not applicable in the context of a 510(k) substantial equivalence submission for a device like a dental implant. These elements are more commonly associated with clinical trials or performance studies for novel devices or software with AI/ML components requiring new clinical evidence.

The document describes non-clinical testing to demonstrate that the differences between the subject device and predicate devices do not affect substantial equivalence.

Here's a breakdown of the available and non-applicable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the format typically used for performance studies with defined acceptance criteria for clinical outcomes. The document instead presents a comparison of technological characteristics with predicate devices and reports on non-clinical engineering and materials testing to support substantial equivalence.

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

This information is not applicable as the document describes non-clinical engineering and material testing rather than clinical trials with patient data. The "test set" would refer to the physical devices or materials used for the non-clinical tests (e.g., fatigue testing samples, sterilization samples), but specific sample sizes for these are not detailed in this summary for each test, only that they were conducted according to specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. Ground truth is not established by experts in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence through non-clinical testing of materials, design, and manufacturing processes, rather than diagnostic accuracy or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable. No adjudication method is described because there is no "test set" in the context of human interpretation or diagnostic agreement.

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:

This information is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices, which is not the nature of the STERI-OSS Implant System (a dental implant).

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

This information is not applicable. The STERI-OSS Implant System is a physical medical device, not an algorithm or AI software. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

This information is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission focuses on adherence to engineering standards, material specifications, and comparative characteristics with predicate devices. For example, for biocompatibility, the "ground truth" is established by the specified ISO standards for biological evaluation. For fatigue, it's defined by the ISO standard for endosseous dental implants.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/ML device requiring machine learning model training.

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

This information is not applicable for the same reason as point 8.

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