(84 days)
The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:
- Support of fixed (cemented) restorations utilizing multiple abutments; .
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ●
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
- Terminal or interniedlate abutment support for fixed bridgework; .
- Free standing restorations without involvement of adjacent dentition.
The abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures.
This document is a 510(k) summary for the Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment, overdenture abutments used with endosseous implants. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/Software as a Medical Device submission would.
Based on the provided text, the device is a physical medical device (dental abutment) and the submission is a premarket notification (510(k)) seeking clearance for substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise new questions of safety and effectiveness.
Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth, and AI performance metrics is not available in the provided document.
However, I can extract what is explicitly stated about the basis for market clearance, which effectively serves as the "proof" for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal, quantitative acceptance criteria or detailed performance metrics in the way a software or diagnostic device would.
Instead, the "acceptance criteria" for a 510(k) in this context are based on demonstrating "substantial equivalence."
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use | Implant systems are for use in edentulous mandibles and maxillae as a support or attachment for prosthetic restoration. The Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment are for overdenture retention. |
| Technological Characteristics | "The technological characteristics of the modified versions of the o-ring and dalla bona abutments and the earlier versions are identical. The titanium used in both devices is the same. Manufacturing processes are also the same as is general shape and structure." |
| Safety and Effectiveness | "no new types of technology and no new technological questions are involved." (by demonstrating identical technology and manufacturing to a legally marketed predicate) |
| Substantial Equivalence to Predicate Device | The device is substantially equivalent to the commercially marketed products known as Lifecore Overdenture Abutments Systems (K921764, K924190). |
2. Sample Size used for the test set and the data provenance: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device through description of technological characteristics, not on a clinical "test set" in the context of performance evaluation.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth as typically understood for diagnostic or AI devices is not part of this 510(k) submission for a physical implant accessory.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is a 510(k) submission for a physical device, not an AI or diagnostic tool requiring such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.
7. The type of ground truth used: Not applicable in the context of clinical performance data. The "ground truth" for this submission is the established safety and effectiveness of the predicate device(s) through their prior market clearance and historical use.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided text is a standard 510(k) summary for a physical medical device (dental abutments). It seeks market clearance by demonstrating substantial equivalence to already cleared predicate devices. The "study" proving the device meets the (implicit) acceptance criteria is the comparison of its technological characteristics and intended use to those of legally marketed predicate devices, and the conclusion that no new questions of safety or effectiveness are raised. There are no performance data, clinical trials, or AI-related metrics discussed because the device, and the regulatory pathway chosen, do not require them.
§ 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.