(45 days)
The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The Legacy System consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of mini-threads near the top of each implant, are manufactured using the same medical grade titanium allov material and are coated with the same soluble blast media (SBM) blasted surface treatment or HA plasma sprayed. The HA coated variety of these implants are the subject of this submission
The provided text is a 510(k) summary for a dental implant device (Legacy System Dental Implants With HA Coating). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics typically seen for AI/ML-driven devices or diagnostics.
Therefore, the requested information elements related to specific acceptance criteria, study design (sample size, data provenance, expert consensus, adjudication, MRMC, standalone performance, training set details), are not available in the provided document.
The document primarily addresses the following for the Legacy System Dental Implants With HA Coating:
- Device Description: Tapered screw-type endosseous implants with specific thread configurations, made of medical grade titanium alloy, with soluble blast media (SBM) blasted surface treatment or HA plasma sprayed.
- Intended Use: Identical to predicate devices, for single-stage or two-stage surgical procedures in the mandible and maxilla, supporting single/multiple-unit fixed restorations and retention of overdentures, including immediate placement and function.
- Device Comparison: Found to be favorably comparable to predicate devices (Zimmer Dental Tapered Screw-Vent Dental Implant System K013277 and Implant Direct's Spectra-System K061319) in terms of function, technological characteristics, intended use, and materials.
- Substantial Equivalence: The FDA determined the device to be substantially equivalent to legally marketed predicate devices. This means it has the same intended use and technological characteristics as the predicate devices, or if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
Without the specific study results, acceptance criteria, and performance metrics, it is impossible to complete the table or answer most of your detailed questions.
However, I can provide a general interpretation based on the document's content:
Implied Acceptance Criteria (based on 510(k) process):
For a traditional 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as the predicate. This is typically achieved by comparing:
- Intended Use: Must be the same as the predicate.
- Technological Characteristics: Must be the same, or if different, must not raise new questions of safety and effectiveness.
- Performance: While not explicitly detailed with specific metrics in this summary, the safety and effectiveness of the traditional dental implant are implied to be "acceptable" if they are equivalent to the predicate. This would typically involve biocompatibility testing, mechanical testing (fatigue strength, torque, etc.), and potentially animal or clinical studies if new questions of safety or effectiveness arise.
Since this is a traditional 510(k) for a physical medical device (dental implant) and not an AI/ML diagnostic tool, many of your questions regarding AI-specific criteria (MRMC, standalone performance, training sets, expert adjudication methods) are not applicable to the information provided.
Summary of what can be gleaned (or inferred) from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device: | Achieved: FDA determined substantial equivalence (DEC 10, 2007). |
| Same Intended Use | "identical to the intended use of the predicate abutments" |
| Similar Technological Characteristics | "nearly identical technological characteristics" |
| Similar Materials | "same medical grade titanium alloy material" |
| Similar Principle of Operation | "used in an identical function as the cited predicates" |
| As Safe and Effective as Predicate | Implied by substantial equivalence finding. |
2. Sample size used for the test set and the data provenance: Not applicable/Provided. This document does not detail a clinical study with a "test set" in the context of diagnostic performance. Any testing (e.g., mechanical, biocompatibility) would have been internal and compared to standards or predicate device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring ground truth from experts in a test set.
4. Adjudication method for the test set: Not applicable.
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 a physical medical device, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML or diagnostic performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by engineering tests and clinical outcomes, compared to established standards and predicate devices.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model for which a training set is relevant.
9. 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.