(132 days)
The FRIALIT-2® MH-2 Abutment is intended for use in multiple unit bridges and bar overdentures.
The FRIALIT-2® MH-2 Abutment is part of the FRIALIT-2® Dental Implant System. The MH-2 Abutment is designed to support multiple unit bridges and bar overdentures. The MH-2 Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each MH-2 Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The 3.8 and 4.5mm abutments are also available with a 9mm gingival cuff height.
The provided text describes the FRIALIT-2® MH-2 Abutment, a component of a dental implant system. The document is a 510(k) premarket notification for this device.
However, the documentation does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission. This 510(k) is for a physical medical device (a dental abutment), and its clearance is based on demonstrating substantial equivalence to predicate devices, not on performance metrics against predefined acceptance criteria for a software algorithm.
Therefore, I cannot populate the table or answer the specific questions related to AI/SaMD studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) as this information is not present in the provided document.
The core of this submission is a comparison to predicate devices to demonstrate similar material, design, function, and intended use, thereby establishing substantial equivalence.
Here's how I can address the request based on the provided text, while highlighting the absence of AI/SaMD-specific study details:
This 510(k) submission for the FRIALIT-2® MH-2 Abutment is for a physical dental device and does not involve AI/SaMD. Therefore, the typical acceptance criteria and study designs associated with AI/SaMD (e.g., performance metrics, ground truth, training/test sets, MRMC studies) are not applicable or detailed in this document.
The primary "acceptance criterion" for this type of submission is Substantial Equivalence to legally marketed predicate devices.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (for Substantial Equivalence Evaluation) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Material: Constructed of biocompatible material (CP-2 titanium) | Material is CP-2 titanium, similar to predicate devices. |
| Design: Similar design characteristics for dental abutments. | Design is similar to predicate devices (original MH-2 Abutment and Nobel BioCare Abutment). |
| Functionality: Designed to support multiple unit bridges and bar overdentures. | Functionality is similar to predicate devices, intended for multiple unit bridges and bar overdentures. |
| Intended Use: For use in multiple unit bridges and bar overdentures. | Intended use matches predicate devices: for multiple unit bridges and bar overdentures. |
| Technological Characteristics: Correspond to implant bodies, available in various gingival cuff heights. | Technological characteristics (diameters corresponding to implant bodies, various gingival cuff heights) are similar to or consistent with predicate devices. |
Study that proves the device meets the acceptance criteria:
The "study" or justification for meeting acceptance criteria for this conventional medical device is the "Substantial Equivalence" comparison to predicate devices, as detailed in sections 16.5 and 16.7 of the submission. The argument is that because the new device is fundamentally similar in material, design, function, and intended use to already cleared devices, it is equally safe and effective.
Regarding the specific questions related to AI/SaMD, the information is not applicable or available in this document:
- Sample size used for the test set and the data provenance: Not applicable as this is not an AI/SaMD study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/SaMD study requiring expert consensus for ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable as this is not an AI/SaMD study with a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.