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The ETII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intend for delayed loading.

The ETII Bio-SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface treatment is Bio-SA. ETII Bio-SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has Bio-SA surface treatment. ETIII Bio-SA Fixture is coated with nano thickness calcium phosphate on the SA surface of Al2O3 blasting & acid etching.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ETIII Bio-SA Fixture System:

Based on the provided 510(k) summary (K112532), this document does not describe a study that uses acceptance criteria related to typical performance metrics like sensitivity, specificity, accuracy, or other statistical measures often associated with medical device performance studies (e.g., for diagnostic algorithms or imaging devices).

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here are defined by the regulatory requirements for showing that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, intended use, and non-clinical testing.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission as they are for a different kind of device performance evaluation.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the device and studies for typical AI/algorithm performance (which are not in this document):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical laboratory testing of a physical implant, not an AI/algorithm-driven device evaluated with patient data.
3. 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): Not applicable. Ground truth for this device involves material properties, mechanical strength, and biocompatibility, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests mentioned:
   • Fatigue Testing: Ground truth is established by engineering standards and specifications, i.e., whether the implant can withstand specified forces for a certain number of cycles without failure.
   • Biocompatibility Testing: Ground truth is established by the pass/fail criteria defined in the ISO 10993 series of standards for assessing biological effects (e.g., cytotoxicity, irritation, sensitization).
8. The sample size for the training set: Not applicable. This isn't an AI/machine learning device. The "training" for a physical device like this involves designing and manufacturing processes to meet specifications.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study Information Provided in the 510(k):

The device (ETIII Bio-SA Fixture System) demonstrated "acceptance" by establishing substantial equivalence to three predicate devices (ETII SA Fixture System K101096, NanoTite PREVAIL Implant K072363, and Dio Biotite-H Implant System K073070) through:

• Comparison of Intended Use: Shown to be identical.
• Comparison of Design and Materials: Material (Pure Titanium Grade 4), diameter, length, structure (single thread, taper body type, self-tapping, submerged), and connection (internal hex) were shown to be the same or similar to the predicates.
• Surface Treatment: While different from one predicate (ETIII SA Fixture, which was RBM), the Bio-SA surface treatment was deemed similar to another predicate (NanoTite PREVAIL Implant) which used NanoTite, and the manufacturing process was similar to the Dio Biotite-H Implant System. The key here is that the new surface did not raise new questions of safety or effectiveness.
• Non-Clinical Testing:
  • Fatigue Testing: Performed with a representative worst-case scenario using a "GSIII Fixture and an angled abutment" (a system with similar material and design to the ETIII Bio-SA Fixture). The results from this predicate/similar device were used as proof for the new device.
  • Biocompatibility Testing: Performed according to ISO 10993 standards (ISO 10993-5, -6, -10, -11) and demonstrated compliance.
• No Clinical Testing: The submission explicitly states "No clinical studies are submitted," indicating that the regulatory pathway required only non-clinical data for substantial equivalence.

This is a common approach for demonstrating the safety and effectiveness of new medical devices that are similar to existing ones, particularly Class II devices like dental implants.

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