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Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.

This document describes a 510(k) premarket notification for the "Premilled Titanium Block System" by InnoBioSurg Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than conducting a de novo study to establish new performance criteria. Therefore, the information provided below is extracted based on the principles of substantial equivalence as demonstrated by the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify general "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy for the device itself, as this is a dental abutment system and not an AI/diagnostic device. Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence with the predicate device. The performance is assessed against established standards for dental implants and abutments.

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

For the fatigue tests performed on the subject device:

• Sample Size: The document indicates that fatigue tests were conducted "under the worst-case scenario." While a specific number isn't given, standard ISO 14801 testing protocols usually involve a predefined number of samples (often 10 for each test condition) to establish fatigue limits. It specifies only the "worst-case scenario" (smallest diameter with maximum angulation) was tested for the new device.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a non-clinical, mechanical test, not patient data. The study type is a laboratory-based equivalency testing study, not retrospective or prospective clinical data.

For biocompatibility and sterilization validation tests:

• These tests were leveraged from predicate devices (K152520, K173120, K192197). This means new tests with a specific sample size for the subject device were not performed for these aspects. The sample sizes and provenance for these predicate studies are not detailed in this document.

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

N/A. This document describes a submission for a mechanical dental device (abutment system) based on substantial equivalence and non-clinical testing, not an AI/diagnostic device that requires expert-established ground truth for a test set. There were no human readers or expert panels involved in determining the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/diagnostic device, no adjudication method (e.g., 2+1, 3+1) was used for a test set in the context of clinical or diagnostic performance. The evaluation was based on adherence to ISO standards for mechanical and material properties.

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

No. An MRMC study is not applicable to this type of device. This is a physical dental abutment system, and its performance is evaluated through engineering and materials testing, not through reader perception or diagnostic accuracy.

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

No. This is not an AI algorithm or a software-only device. The evaluation focuses on the physical properties and performance of the dental abutment system itself.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests (fatigue, biocompatibility, sterilization) is defined by the successful adherence to the specified international standards (ISO, ANSI/AAMI). For example, for fatigue, the "ground truth" is that the device withstands a certain number of load cycles at a specified force without failure, as per ISO 14801. For biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. This submission is for a physical medical device (dental abutment system) and does not involve AI or machine learning algorithms that require a "training set."

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

N/A. Not applicable, as there is no training set for this type of device submission.

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