(256 days)
3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
The Certain PREVAIL Implants are parallel walled, straight collared internally connected implants with a lateralized seating surface. They will be available in lengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameters will be 4.0 and 5.0mm. The collar diameters will be 4.1mm for the 4.0mm diameter implants and 5.0mm for the 5.0mm implants. The seating surface will lateralize back to 3.4mm for the 4.0mm diameter implants, and 4.1mm for the 5.0mm implants. The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136.
The provided text is a 510(k) premarket notification for a medical device (Certain™ PREVAIL™ Implants). It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one would find in a clinical trial or a standalone AI/software device submission.
Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is not present in the provided document.
However, I can extract the information that is available and highlight what is missing based on the nature of this type of submission.
Here's the breakdown of what can be inferred or explicitly stated:
Acceptance Criteria and Device Performance
This submission is a 510(k) for an implantable dental device, not a software or AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device (OSSEOTITE® IOL Dental Implants), rather than meeting specific numerical performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
The device performance is described in terms of its technological characteristics being similar to the predicate.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Technological Characteristics: The device's design, materials, and intended function should be similar to the predicate device to ensure safety and effectiveness. | "The Certain™ PREVAIL™ Implants contain features Technological and functions which are similar to the currently available OSSEOTITE® IOL Implants." |
| "The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136." | |
| Indications for Use: The device should have the same indications for use as the predicate, or minor differences that do not raise new questions of safety or effectiveness. | The Indications for Use are provided and deemed substantially equivalent to the predicate, including specific details regarding immediate loading. |
| Mechanical/Physical Properties: While not explicitly detailed as acceptance criteria here, dental implants typically require demonstrating properties like strength, fatigue resistance, and biocompatibility, often through testing to established standards or comparison to predicate device data. (No specific data tables provided in this excerpt) | The device is described as "parallel walled, straight collared internally connected implants with a lateralized seating surface." It specifies available lengths, diameters, and collar diameters. |
| Conclusion of Substantial Equivalence: The FDA's ultimate agreement that the device is substantially equivalent to a legally marketed predicate. | "The Certain PREVAIL Implants are substantially Conclusion equivalent to the legally marketed OSSEOTITE® IOL Implants." (Submitter's conclusion) |
| "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA's conclusion) |
Study Details (as applicable for this type of submission)
Given this is a 510(k) for a physical implant, the concept of a "study" with test sets, ground truth, and experts as if it were an AI/software device is not directly applicable. Substantial equivalence for such devices often relies on comparisons of design, materials, manufacturing processes, and potentially non-clinical testing (e.g., mechanical, biocompatibility) rather than clinical studies in the sense of comparing performance characteristics against a ground truth dataset.
- Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of data. The "test" is demonstrating equivalence through a comparison of device characteristics, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set of data is established in this summary. The FDA reviewers (experts in regulatory review) assess the submission for substantial equivalence.
- 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. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in a 510(k) for a physical device is generally the established safety and effectiveness of the predicate device. The new device is compared against this standard.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
- 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.