(84 days)
The Select Components of the FRIALIT-2® Dental Implant System are indicated for use in the determination of implant placement, implant angle and to measure the available soft tissue height. The Select Components can also be used in determining the potential abutment angle and soft tissue height.
The FRIALIT-2 Select Components are part of the FRIALIT-2 Dental Implant System. The components consist if the FRIALIT-2 Select Sleeve, FRIALIT-2 Select Try-in Implant, and FRIALIT-2 Select try-in Abutment. The components come in the same diameters as the implant bodies and are color coded to correspond to size. The components can be used in the patient and/or the laboratory model to help in the determination of implant placement, abutment and implant angle and available soft tissue height.
This is a 510(k) premarket notification for a medical device, specifically dental implant components. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets pre-defined acceptance criteria in the same way a de novo or PMA submission might. Therefore, many of the requested elements regarding acceptance criteria and a study to prove meeting them are not typically part of a 510(k) notification from this era.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, and a "reported device performance" against those criteria, is not present in this 510(k) submission. A 510(k) primarily demonstrates substantial equivalence in design, material, and functionality to a predicate device.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied) |
|---|---|
| Design similar to predicate device | FRIALIT-2 Select Components are similar in design to the predicate. |
| Material similar to predicate device | FRIALIT-2 Select Components are similar in material to the predicate. |
| Functionality similar to predicate device | FRIALIT-2 Select Components are similar in functionality to the predicate. |
| Intended Use similar to predicate device | The intended use for the FRIALIT-2 Dental Implant System (which these components are part of) is for single tooth restorations, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures, and can be used for immediate, delayed immediate, or late implant placement. The Select Components specifically aid in the determination of implant placement, implant/abutment angle, and available soft tissue height. This is considered substantially equivalent to the predicate device. |
| Available in corresponding diameters | Components are available in diameters corresponding to the implant bodies. |
| Color-coded for ease of use | Components are color-coded for ease of use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a test set of data in the context of AI/software performance. It's a submission for physical dental components.
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)
Not applicable. As above, there is no study described that would involve establishing ground truth by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This is not an AI/software device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable to this submission for physical dental components. The "ground truth" in this context would be the predicate device's established safety and effectiveness.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm described.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
§ 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.