(158 days)
The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional 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 Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. 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. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tapered Screw-Vent® M Implant:
This document describes a 510(k) premarket notification for a medical device (dental implant). For such submissions, the primary "acceptance criterion" is Substantial Equivalence to a predicate device, rather than specific performance metrics like sensitivity, specificity, or accuracy which are common for diagnostic or AI-driven devices. Therefore, the information requested in the prompt (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) is largely not applicable in this context.
The study described is a non-clinical study focused on demonstrating mechanical equivalence, not a clinical study assessing patient outcomes or an AI performance study.
Acceptance Criteria and Reported Device Performance (Non-Applicable for this 510k)
For this 510(k) submission, the "acceptance criteria" and "reported device performance" are framed around demonstrating Substantial Equivalence to legally marketed predicate devices. The core of the "study" is a comparison of technological characteristics and non-clinical mechanical similarity.
| Criterion Type | Acceptance Criteria (for Substantial Equivalence) |
|---|---|
| Primary Goal: | Demonstrate Substantial Equivalence to Predicate Devices |
| Device Comparison | The Tapered Screw-Vent® M Implant must be shown to be substantially similar to its predicate devices (Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant) in: |
| - Implant/abutment connection | The new device features the "Internal Hex" implant interface, which is identical to both predicate devices. |
| - Implant body design | The new device has been modified to add a 1mm machined collar and small grooves to the top, and is tapered with triple-lead threads. These features are either identical to or variations seen in the predicate devices (e.g., machined collar similar to Predicate 2, grooves identical to Predicate 1, triple-lead threads same as both predicates). The document states the new device is "mechanically similar" with the "same internal hexagon interface, triple lead threads of the same size and depth, and the same diameter internal thread" as the predicate Tapered Screw-Vent implant. |
| - Materials | The new device is made of "Titanium 6Al-4V," which is identical to both predicate devices. It is also stated that "Both are fabricated from the same material" (referring to the new device and predicate Tapered Screw-Vent). The new device uses "MTX Surface equivalent to existing Zimmer Dental implants," and the "MTX Surface" is identical across all three devices. |
| - Manufacturing | The document states, "The Tapered Screw-Vent® M Implant is the same as the predicate Tapered Screw-Vent® T Implant and Tapered Screw-Vent® Implant in the... manufacturing." It also notes that both the predicate Tapered Screw-Vent T and the new device Tapered Screw-Vent M utilize the "same lower level drawing for the machined component." |
| - Indications for Use | The stated Indications for Use for the new device are consistent with typical uses for endosseous dental implants for which the predicates are used. ("designed for use in the maxilla or mandible for immediate loading or for loading after a conventional 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"). |
| Mechanical Equivalence | The Tapered Screw-Vent® M Implant must be shown to be mechanically equivalent to the predicate design, indicating that mechanical testing is not necessary. |
| Performance: The device is deemed "mechanically equivalent to the predicate design" due to the shared internal hexagon interface, triple lead threads (same size and depth), same internal thread diameter, same titanium alloy material (with same mechanical properties), and same MTX grit blasted surface (with minor exception of a 0.5mm machined collar finish). This mechanical equivalence means performance is expected to be similar/equivalent to the predicate, making it "as safe and effective for its intended use." |
Since this is a 510(k) submission primarily relying on substantial equivalence through design and material comparison, many of the typical questions for AI/diagnostic devices are not applicable.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No formal 'test set' in the sense of patient data for performance evaluation was used. The evaluation was based on design specifications, material properties, and comparison to predicate devices. This is a non-clinical submission.
-
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):
- N/A. No ground truth was established by external experts for a test set in this context. The "truth" is established by the manufacturer demonstrating equivalence to legally marketed predicates.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication of a test set occurred.
-
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:
- N/A. This is not an AI device, and no MRMC study was conducted. No human readers or AI assistance are involved in the function or evaluation of this dental implant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices. The new device is demonstrated to be substantially equivalent to these predicates based on design, materials, and intended use, eliminating the need for new complex ground truth determination.
-
The sample size for the training set:
- N/A. No training set was used as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- N/A. No training set or associated ground truth was established.
§ 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.