(81 days)
Zimmer® One-Piece 3.7mm, Angled implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm, Angled implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® One-Piece 3.7mm, Angled implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The Zimmer One-Piece Implant, 3.7mm, Angled is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion is angled by 17 degrees. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.
This document (K061717) describes a 510(k) premarket notification for a new dental implant, the Zimmer® One-Piece Implant, 3.7mm, Angled. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics are not available in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. This document does not describe specific performance-based acceptance criteria beyond demonstrating substantial equivalence and meeting general mechanical testing requirements. There are no quantitative performance metrics reported for the device in a clinical context within this submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. The document states "mechanical testing" was performed to demonstrate substantial equivalence to a predicate device. However, it does not specify the sample size for this mechanical testing, the type of data (e.g., in-vitro, in-vivo), or its provenance. This is a premarket notification, not a clinical trial report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable/Not Available. The concept of "ground truth" established by experts for a test set (as would be relevant in an AI/diagnostic device study) is not applicable here. This submission is for a physical medical device (dental implant) and focuses on mechanical equivalence rather than diagnostic accuracy or expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. As explained above, the type of "test set" and "adjudication" typically associated with AI or diagnostic studies is not relevant to this 510(k) submission for a physical implant.
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
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This is a 510(k) submission for a physical dental implant, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical dental implant and does not involve an algorithm, AI, or standalone performance evaluation in the context of a software or diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For this type of device, "ground truth" would typically relate to in-vitro mechanical properties, biocompatibility, and potentially long-term osseointegration and clinical outcomes from existing data on similar devices or post-market surveillance. The document focuses on showing mechanical substantial equivalence, implying that accepted standards and performance of the predicate devices serve as an indirect "ground truth" for the new device's expected physical behavior. No specific "ground truth" methodology as used in diagnostic studies is described.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device (dental implant), not a machine learning model or AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no "training set" for this physical device, the establishment of ground truth for such a set is not relevant.
Summary of available information from the document:
- The document, K061717, is a Special 510(k) for a device modification: the Zimmer® One-Piece Implant, 3.7mm, Angled.
- Device Description: It's a one-piece endosseous dental implant made of titanium alloy with an angled (17 degrees) abutment portion. The implant section is designed for osseointegration with a treated surface and tapered, double-lead threads.
- Intended Use: Support and retention of fixed single tooth and fixed partial denture restorations in specific regions of partially edentulous jaws. It can be immediately loaded in the anterior mandibular arch if four are splinted and immediately restored with a temporary prosthesis not in functional occlusion.
- Substantial Equivalence: The device is deemed substantially equivalent based on mechanical testing comparing it to the Zimmer® Screw Vent® Mini™/ Contour Hex-Lock™ Abutment, 3.5mm, Angled assembly and the Zimmer® One-Piece, 3.7mm, Straight implant. The primary difference is a dimensional modification (17-degree angle), while materials, general structure, and function remain the same as the predicate device.
In essence, this 510(k) relies on demonstrating that the new angled version is mechanically equivalent to existing, legally marketed predicate devices, and therefore does not require a new extensive clinical study with the type of acceptance criteria and performance data requested above.
§ 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.