(123 days)
The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). 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 triple-lead threads.
The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.
This document describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Implant. For medical devices, "acceptance criteria" and "device performance" are typically related to the physical and mechanical properties of the device, and the "study" proving these are usually non-clinical (laboratory) tests. Clinical studies (with human subjects) are often not required for 510(k) clearances, especially if substantial equivalence to a predicate device can be demonstrated through non-clinical testing.
Here's the breakdown of the requested information based on the provided text, focusing on the absence of typical "AI/software algorithm" acceptance criteria and studies, as this is a dental implant:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format as might be seen for software performance metrics (e.g., sensitivity, specificity thresholds). Instead, it refers to performance standards for mechanical properties.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Fatigue Testing | Meets standards in accordance with FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. |
| Compression Testing | Meets standards in accordance with FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. |
| Mechanical Strength | Demonstrated improvements over the predicate device. |
| Torque Testing (Apical Tip Strength) | Indicator that the strength at the apical tip of the implant is greater than the stress the implant will see in dense cortical bone, in accordance with internal Zimmer Research Protocols. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. Non-clinical mechanical testing typically uses a certain number of samples, but the exact count is not provided in this summary.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no mention of country of origin for data as it's not patient data, nor is there a retrospective or prospective nature to the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for non-clinical mechanical testing of a dental implant. "Ground truth" in this context refers to established engineering standards and guidelines for mechanical performance, not expert medical consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical imaging studies. This document describes mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study is a clinical study comparing human reader performance, often with and without AI assistance. This document explicitly states: "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No. This device is a physical dental implant, not a software algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for non-clinical testing is based on established engineering principles, industry standards (e.g., ISO standards for dental implants), and FDA guidance documents (specifically, the Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The device's ability to resist fatigue, compression, and maintain torque strength constitutes the "truth" against these predefined benchmarks.
8. The Sample Size for the Training Set
No. This is not applicable to the development and testing of a physical medical device like a dental implant. "Training set" refers to data used to train machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this relates to machine learning models, not physical device engineering.
§ 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.