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The Dentium Co., Ltd Implantium is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

The Dentium Co., Ltd Implantium is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide. The Dentium Co., Ltd Implantium are available in four diameters (3.4, to 4.8 mm) and four lengths (8, 10, 12 and 14 mm)

The provided text describes a 510(k) premarket notification for the Dentium Co., Ltd Implantium, a dental implant device. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details the device's general information, indications for use, device description, and the FDA's determination of substantial equivalence to a legally marketed predicate device (Astra Tech Implants-Dental System K012965). The substantial equivalence determination is based on the primary function, technological characteristics, and a comparison to the predicate device, concluding that it "raises no new questions of safety and effectiveness."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets such criteria because this information is not present in the provided text.

Here is a breakdown of what can be inferred or directly stated from the text regarding the lack of such information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided documents. The FDA's acceptance is based on "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as the predicate, not necessarily against pre-defined quantitative performance metrics for the new device.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, osseointegration percentages) are reported for the Dentium Co., Ltd Implantium itself in this document. The equivalence claim infers its performance is similar to the predicate.

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

• Sample Size: Not applicable. No "test set" in the context of a performance study (e.g., clinical trial data) is mentioned or used for this 510(k) submission as described. The determination is based on comparison to a predicate.
• Data Provenance: Not applicable. No study data (retrospective or prospective) from a particular country of origin is referenced for the Dentium Co., Ltd Implantium's performance.

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" establishment by experts is mentioned as part of this 510(k) submission for performance evaluation.

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

• Not applicable. There is no test set or adjudication process described.

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 is a dental implant, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

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

• Not applicable. This is a physical medical device (dental implant), not an algorithm or AI.

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

• Not applicable. No "ground truth" used for a performance evaluation study is mentioned. The ground for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. See point 8.

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