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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 consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm). The superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.

The provided text describes a 510(k) premarket notification for the "DIO Protem Implant System (2.0/2.5mm)". This submission is for a medical device (endosseous dental implant system) and not for an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) and associated studies (MRMC, standalone, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods) is not applicable here.

Instead, the "acceptance criteria" for a medical device like this in a 510(k) submission typically revolves around demonstrating substantial equivalence to a previously legally marketed predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to performance testing (bench testing) and a thorough comparison against the predicate device to show that the new device is as safe and effective.

Here's how to interpret the information provided in the context of a traditional medical device 510(k) submission:

Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The "acceptance criteria" for the DIO Protem Implant System (2.0/2.5mm) is demonstrating substantial equivalence (SE) to its predicate device, the DIO Protem Implant System (K06710568). This is the primary criterion for clearance under a 510(k).

The "study" or evidence provided to prove the device meets this acceptance criterion is a substantive comparison of its technological characteristics and intended use to the predicate device, supported by laboratory testing.

1. Table of Acceptance Criteria and the Reported Device Performance (interpreted for medical devices, not AI):

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

Not applicable for this type of medical device submission. The evaluation relies on the physical and material characteristics of the device, as well as bench testing to verify performance, rather than a "test set" of patient data.

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

Not applicable. Ground truth for AI/ML device performance is not relevant here.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established by engineering specifications, material science standards, and performance test results. For instance, the stated dimensions (e.g., diameter, length) are verified directly against engineering drawings and manufacturing tolerances.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm being "trained."

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

Not applicable.

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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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