(86 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.