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The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.

The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).

Here's an analysis of the provided text regarding the DIO Biotite-H Implant Systems:

Acceptance Criteria and Study for DIO Biotite-H Implant Systems

The provided 510(k) summary for the DIO Biotite-H Implant Systems indicates that the device's performance was evaluated through laboratory testing to determine functionality and conformance to design input requirements. However, the document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., accuracy, sensitivity, specificity, or failure rates). Instead, the primary "acceptance criteria" appear to be focused on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.

The study presented is a substantial equivalence comparison rather than a traditional clinical or performance study with defined numerical acceptance criteria for device efficacy or safety. The document aims to show that the new device is as safe and effective as previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for performance are not provided. The "reported device performance" is essentially a statement of comparability to the predicate device in several key aspects.

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

• Test set sample size: Not applicable in the context of this 510(k) summary. The "test set" for demonstrating substantial equivalence is the predicate device's existing performance data and regulatory history, along with the results of the manufacturer's internal laboratory testing. No specific number of implants or "test cases" for a human-in-the-loop or standalone study are mentioned.
• Data provenance: The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" (Section 15-8). This implies internal testing by the manufacturer (DIO Department, DSI, Inc. in South Korea). The specific country of origin for the data generated from this testing is South Korea, as that is the submitter's location. The testing would be prospective in the sense that it was performed on the specific new device for this submission, but its purpose was to uphold the claim of equivalence to existing devices.

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

• This question is not applicable to the provided 510(k) summary. The submission is for a medical device (dental implant), not an AI/software as a medical device (SaMD) that typically requires expert-established ground truth for performance studies. The "ground truth" for this device's safety and effectiveness is primarily established through its physical and material properties, design specifications, and comparison to existing, legally marketed predicate devices.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no mention of a traditional "test set" involving human interpretation or expert review for a clinical performance study. The evaluation method described is a comparison of technological characteristics and intended use to predicate devices, supported by internal laboratory testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, and its effect size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The DIO Biotite-H Implant System is a physical dental implant, not an AI/SaMD.

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

• No, a standalone performance study (in the context of AI algorithms) was not done. Again, this is a physical medical device. The "standalone performance" was evaluated through laboratory testing of the implant's physical properties and functionality. The document does not provide details of these tests, only that they were conducted.

7. The Type of Ground Truth Used

• For the substantial equivalence comparison, the "ground truth" is the established regulatory clearance and safety/effectiveness profile of the predicate device (IMPLANT INOVATION, INC. (K 955428) and other listed predicates), as well as recognized industry standards (e.g., ASTM-F-67, ASTM-F-136) for material properties.
• For the laboratory testing mentioned, the "ground truth" would be the predefined design input requirements and functional specifications for the implant, often derived from engineering standards and clinical expectations for dental implants.

8. The Sample Size for the Training Set

• This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• This question is not applicable as there is no training set for an AI model.

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