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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Burn-out Cylinder is a component of a dental implant abutment used in the process of fabricating the dental abutment and the prosthetic restoration. The Burn-out Cylinders are modified by the dental lab and incorporated into the wax framework pattern which is cast into a final gold alloy form. Burn-out Cylinder is made with PMMA (Poly(Methyl Methacrylate)) and is available in three cylinder diameters (4.5mm, 5.5mm and 6.5mm) with two connection designs (Hex and Non-Hex).

Angled Screw Abutment is a dental abutment intended for multi-unit loaded restorations and combined with the burn-out cylinder for increasing the post height to be 4mm at minimum when used for single-unit loading. Angled Screw Abutment is fabricated from Grade 4 pure titanium and partially TiN coated. Angled Screw Abutments in this submission are available in three connection designs (Hex, Long Hex and Non-Hex), two diameters (4.5mm and 5.5mm) and two angulations (15° and 30°). The Dentium angled screw abutments were originally cleared under 510(k) K141457. All subject device abutments are compatible with Implantium dental implants of Dentium Co., Ltd. Abutments are supplied non-sterile and autoclaved by the end user.

This document is a 510(k) summary for a medical device called "Burn-out Cylinder and Angled Screw Abutments." It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is a dental implant component, a class II device under regulation 21 CFR 872.3630. The acceptance criteria and the study proving it meets these criteria are primarily based on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with human readers or a standalone AI algorithm.

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the relevant FDA guidance and ISO standards for dental implants, specifically demonstrating mechanical performance equivalent to or better than predicate devices.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the precise number of devices or components used for each individual mechanical test (e.g., how many abutments were subjected to fatigue testing). It refers to "testing finished assembled implant/abutment systems of the worst case scenario," implying a selection of configurations that would be most challenging.

• Sample Size: Not explicitly stated as a number of units. The testing is described qualitatively ("worst case scenario") rather than quantitatively with specific sample sizes per test type.
• Data Provenance: The tests are "Non-clinical testing performed in accordance with FDA Guidance" and ISO standards. This indicates laboratory testing, likely conducted by the manufacturer or a contracted testing facility. There is no mention of country of origin for mechanical testing data, but the manufacturer is based in Korea. This is not retrospective or prospective data in the clinical sense, but rather bench testing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device submission. The "ground truth" for this device's performance is established by objective physical measurements and engineering standards (e.g., whether a device fractures under a certain load, or passes a specified number of fatigue cycles). Expert review in the context of imaging or diagnostic accuracy is not relevant here.

4. Adjudication Method

This information is not applicable. Adjudication methods are typically used in clinical trials involving human interpretation of data, such as medical images, where there might be disagreement among experts. For mechanical testing, the failure or success is objectively determined by the test apparatus and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic device or AI algorithm, often in the context of human interpretation of medical data, which is not relevant for a dental implant abutment.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (referring to an algorithm's performance) was not done. This device is a physical medical component, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Objective Engineering Standards: Adherence to ISO 14801:2007 (for fatigue and static load failure).
• Absence of Failure: The primary ground truth is the absence of fracture, cracks, or severe distortion under specified mechanical loading conditions, and the ability to withstand 5,000,000 cycles without failure at the fatigue limit.
• Predicate Device Equivalence: The ultimate ground truth for regulatory purposes is demonstrating substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as existing devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical testing for this type of medical device. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned or implied for this device's evaluation.

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