(134 days)
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients
Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.
The provided text describes a 510(k) submission for the "Secure Implant System (2.5/3.0mm)", which is an endosseous dental implant system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving efficacy through clinical studies with acceptance criteria and device performance metrics in the way a new drug or novel medical device might.
Therefore, the document does not contain information on:
- Acceptance criteria tables with reported device performance: This submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than meeting specific performance metrics derived from a clinical study.
- Sample sizes used for a test set or data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm-only) performance
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
The study section of the document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that testing was performed internally by the manufacturer to ensure the device met its design specifications and performed as intended, which is standard for medical device development. However, specifics of this laboratory testing (e.g., acceptance criteria, test results) are not detailed in the provided 510(k) summary.
The primary method for demonstrating "device meets acceptance criteria" in this context is through substantial equivalence to predicate devices. The table provided in Section 14-12, "Substantial Equivalence Comparison," outlines the characteristics of the subject device (Secure Implant System) against two predicate devices (IntermezzoTM Plus and Zimmer One-Piece Implant System, though only IntermezzoTM Plus is detailed in the table). This comparison acts as the "study" proving the device's acceptability by showing it is similar enough to already-approved devices, rather than a clinical trial with specific performance metrics.
Summary of available information:
| Category | Information from Document |
|---|---|
| Acceptance Criteria & Reported Device Performance Table | Not applicable in the context of this 510(k) summary. The "acceptance criteria" here is substantial equivalence to predicate devices. The "performance" is implied by the similarity in design and materials. The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," but does not provide specific criteria or results of this testing. |
| Sample Size (Test Set) & Data Provenance | Not applicable. There is no mention of a clinical test set in the provided text. The device is cleared based on substantial equivalence to predicate devices and laboratory testing to design inputs. |
| Number & Qualifications of Experts for Ground Truth | Not applicable. |
| Adjudication Method | Not applicable. |
| Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No MRMC study was conducted or reported. |
| Standalone Performance | The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This is typically a standalone assessment against predetermined design specifications, but no specific performance results are provided in this summary. |
| Type of Ground Truth Used | Not applicable in the context of clinical performance evaluation. The "ground truth" for a 510(k) is the established performance and safety of the predicate device(s). |
| Sample Size for Training Set | Not applicable. This is not an AI/Machine Learning device. |
| How Ground Truth for 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.