(132 days)
Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.
Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices with performance metrics like sensitivity, specificity, or AUC.
Instead, this document is a 510(k) Summary for a dental implant system (Intermezzo™ Plus), which is a physical medical device. For such devices, "acceptance criteria" are usually related to manufacturing quality, material properties, mechanical performance, and demonstrated equivalence to a predicate device. The "study" typically refers to laboratory testing and comparison to an already approved device.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device (Intermezzo™ Implant Systems, K051018) in terms of indications for use, fundamental scientific technology, materials, size, and safety/effectiveness.
| Characteristic | Acceptance Criteria (Based on Predicate) | Reported Device Performance (Intermezzo™ Plus) |
|---|---|---|
| Indications for Use | Mandible and Maxilla, Endosseous Dental Implant, Support for overdentures | Mandible and Maxilla, Endosseous Dental Implant, Support for overdentures |
| Endosseous Implant Material | C.P Titanium Gr.3 | C.P Titanium Gr.3 |
| Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Implant Diameters | 1.6 – 3.1 mm (Predicate ranges from 1.6mm) | 2.5 – 3.1 mm (Within the range of the predicate's larger diameters) |
| Implant Lengths | 10.0 – 15.0 mm | 10.0 – 15.0 mm |
| Fundamental Scientific Technology | Threaded, root form implants constructed of titanium | Threaded, root form implants constructed of titanium (Implicitly confirmed by "similar in fundamental scientific technology") |
| Safety and Effectiveness | No new questions of safety or effectiveness raised compared to the predicate | "Any differences between the two devices do not raise new questions of safety and effectiveness." |
| Functionality & Design Conformance | Conforms to design input requirements | "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not specified in the provided text. The "test" in this context refers to laboratory testing of the physical implant device, not a test set of data for an algorithm.
- Data provenance: Not explicitly stated for specific test raw data. The manufacturer is Mega'Gen Co., Ltd., located in Gyeongsan, Gyeongbuk, South Korea. The testing would presumably have been conducted there or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable to this type of device and submission. "Ground truth" established by experts in this manner (e.g., for diagnostic imaging) is not a component of a 510(k) for a dental implant. The "ground truth" for a physical device like this is objective measurements from laboratory tests and conformance to material standards, typically verified by engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of medical data, particularly in AI algorithm validation. This document describes a physical medical device.
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:
- This is not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance in diagnostic tasks. This document is for a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this physical device, the "ground truth" (or basis for verification) isn't established by expert consensus on medical images or pathology in the typical sense. Instead, it would be based on:
- Engineering specifications and standards: Material properties, dimensions, mechanical strength, biocompatibility, sterility.
- Performance metrics derived from laboratory testing: For example, fatigue testing, torque resistance, surface roughness, integration with bone (though this is more of an in-vivo outcome, the design facilitates it).
- Demonstrated equivalence to a legally marketed predicate device: This is the primary "ground truth" for a 510(k) submission like this, meaning it performs as safely and effectively as the existing device.
8. The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical dental implant device.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set.
Summary of the "Study" mentioned:
The document states:
- "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (Section 13-8)
- The comparison data in Section 13-13 provides evidence for "substantial equivalence" to the predicate device (Intermezzo™ Implant Systems, K051018). This comparison serves as a key part of the "study" demonstrating the device meets the regulatory acceptance criteria for 510(k) clearance. The comparison focuses on:
- Indications for Use
- Material (C.P Titanium Gr.3)
- Sterility and Sterilization Method (Gamma)
- Dimensions (Implant Diameters and Lengths)
- Fundamental technology (threaded, root form)
In essence, the "study" for this dental implant is primarily laboratory-based physical testing and a detailed comparison against an already approved predicate device to demonstrate that it is equally safe and effective.
§ 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.