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The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

DIO Protem Implant System is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.0 and 2.5mm, and lengths from 8mm to 14mm. It is placed via one stage surgery and the functional loading can be from immediate to delay.

The provided 510(k) submission for the DIO Protem Implant System (K070568) does not contain information regarding objective acceptance criteria, a specific study proving the device meets those criteria, or details of a clinical performance study.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Mega'Gen Co., Ltd. Intermezzo ™ Implant System, K051018) through comparative analysis of technological characteristics and intended use. The performance section explicitly states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates a focus on engineering specifications rather than a clinical performance study with predefined acceptance criteria for clinical outcomes.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

• No specific acceptance criteria for clinical performance are mentioned.
• No reported clinical device performance is detailed in this document. The submission only mentions that "laboratory testing was conducted to determine device functionality and conformance to design input requirements." This likely refers to mechanical or material testing, not clinical outcomes.

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

• Not applicable. The document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy or clinical outcomes. The "laboratory testing" mentioned does not provide details on sample size or data provenance.

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

• Not applicable. No clinical ground truth establishment is described in this submission.

4. Adjudication method for the test set

• Not applicable. No clinical ground truth establishment or adjudication is described in this submission.

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

• No MRMC comparative effectiveness study was done. This device is a dental implant, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a dental implant, not an algorithm.

7. The type of ground truth used

• Not applicable for clinical performance. For the substantial equivalence claim, the "ground truth" implicitly relies on the safety and effectiveness of the predicate device. For the laboratory testing, the ground truth would be the engineering design input requirements.

8. The sample size for the training set

• Not applicable. This device is a dental implant; there is no "training set" in the context of machine learning or AI.

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

• Not applicable.

Summary of what the submission does say about "performance":

The submission states:

• "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (Section 13-8. Performance)
• The overall strategy for regulatory clearance is Substantial Equivalence to the Mega'Gen Co., Ltd. Intermezzo ™ Implant System (K051018). The substantial equivalence comparison table focuses on:
  • Intended Use (Identical to predicate)
  • Material (Titanium alloy vs. Commercially pure titanium GR. 3)
  • Screw Threads (YES for both)
  • Implant Thread Diameter (2.0 and 2.5 mm vs. 1.6, 2.0, 2.5, 3.1 mm)
  • Lengths (8-14 mm vs. 10.0, 13.0, 15.0 mm)
  • Surface Treatment (Machined for both)
  • Sterilized (YES for both)

To receive 510(k) clearance, the manufacturer demonstrates that the new device is as safe and effective as a legally marketed device (the predicate). For devices like this dental implant, the "performance" demonstrated for substantial equivalence often involves showing that material properties, mechanical strength, biocompatibility, and manufacturing processes are comparable to the predicate, and that the intended use is the same or very similar. This typically relies on engineering and biological testing, rather than extensive clinical efficacy trials with specific clinical acceptance criteria.

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