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IS-III active Short Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed loading.

IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.

The provided text describes a 510(k) premarket notification for a medical device (IS-III active Short Implant) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with specific acceptance criteria as you might find for a new diagnostic device or a drug. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to a diagnostic AI/ML device or a drug is not directly applicable in the same way here.

However, we can infer "acceptance criteria" from the performance characteristics and safety evaluations that the FDA requires for substantial equivalence, and "the study" refers to the non-clinical testing performed to meet these requirements.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as the performance and safety benchmarks for substantial equivalence and "study" as the non-clinical testing conducted.

1. A table of (inferred) acceptance criteria and the reported device performance

Since this is a 510(k) for an endosseous dental implant, the acceptance criteria are primarily focused on mechanical performance, biocompatibility, and sterility, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

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

The document describes non-clinical bench testing. For such tests, the "sample size" refers to the number of physical device samples tested.

• Fatigue Testing: "under the worst-case scenario" implies specific configurations were chosen for testing, but a numerical sample size is not explicitly stated. Typically, multiple samples (e.g., n=5, n=10) would be tested per configuration to ensure statistical robustness.
• Axial Pull-Out Testing: "under the worst-case scenario" implies specific configurations were chosen, but a numerical sample size is not explicitly stated.
• Biocompatibility Testing: The biocompatibility testing was performed on a "reference device, K181138." The sample size for that testing is not specified in this document.
• Sterilization Validation: Tests would involve multiple samples to validate the process to achieve SAL 10^-6, but numerical sample size is not specified.
• Shelf Life Testing: "The worst-case construct was tested," implying specific samples of the device and packaging system were aged and then tested. Numerical sample size is not specified.
• Surface Area Analysis / Comparative Bone to Implant Contact Surface Area Analysis: These are analytical comparisons, likely involving measurements on a set number of devices or designs, but a specific numerical sample size is not given.

Data Provenance: All testing is non-clinical (bench testing), not human data. The data originates from the manufacturer's internal testing and analysis or contracted laboratories, performed to comply with international standards (ISO, ASTM) and FDA guidance documents.

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

This section is not applicable. The evaluations are based on internationally recognized standards (ISO, ASTM) and FDA guidance for medical device performance (mechanical, material, sterility). There isn't a "ground truth" established by human experts in the context of diagnostic interpretation for these types of non-clinical tests. The "truth" is whether the device meets the specified standard (e.g., maximum load before fracture in fatigue testing, or specific material properties).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpreters are evaluating diagnostic images or clinical outcomes, and their interpretations need to be reconciled to establish a consensus ground truth. Here, the "test set" consists of physical devices subjected to mechanical, chemical, and biological tests governed by objective, quantitative standards.

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 section is not applicable. MRMC studies are specific to diagnostic performance evaluations, particularly when assessing the impact of AI on human reader performance for tasks like image interpretation. This submission is for an endosseous dental implant, which is a physical device, not an AI/ML diagnostic tool.

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

This section is not applicable. There is no AI algorithm being evaluated in this submission. The device is a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As mentioned in point 3, the concept of "ground truth" in the context of diagnostic performance (like pathology or expert consensus) is not directly applicable here. The "truth" or reference for evaluating performance of the dental implant consists of:

• International Standards: e.g., ISO 14801 (dental implant fatigue), ASTM F543-17 A3 (mechanical testing), ISO 10993 series (biocompatibility), ISO 11137-1:2006 (radiation sterilization), ASTM F1980 (accelerated aging/shelf life).
• Manufacturer Specifications: Ensuring the device meets its design specifications (e.g., dimensions, material composition).
• Existing Predicate Device Performance: The primary "ground truth" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by matching or exceeding its established performance in relevant tests.

8. The sample size for the training set

This section is not applicable. There is no AI/ML model for which a "training set" would be used.

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

This section is not applicable, as there is no AI/ML model or corresponding training set.

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