(53 days)
The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.
ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.
This document is a 510(k) Pre-market Notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the new device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of algorithmic performance metrics (like sensitivity, specificity, etc.) is not applicable or available in this submission.
Here's a breakdown based on the provided text, addressing what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not outline specific performance acceptance criteria for the ScrewVent® and Tapered ScrewVent® implants in the way one would for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices.
The "performance" is implicitly demonstrated through the comparison of technological characteristics and intended use, asserting that the new device performs similarly to or no worse than the predicate devices for their stated intended uses.
| Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (ScrewVent® & Tapered ScrewVent®) |
|---|---|---|
| Intended Use | Must be the same as or very similar to predicate devices: "Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement." | "Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement." (Matches predicate) |
| Technological Characteristics | Must be similar to predicate devices (design, material, diameter, length, surface, packaging, sterilization). Any differences must not raise new questions of safety or effectiveness. | Similar overall design to predicate implants. No modifications to ScrewVent and Tapered ScrewVent implants. No change to implant materials or implant/abutment interface. (See Table 1 for detailed comparisons). |
| Material | Commercially Pure Titanium (Branemark), Commercially Pure Titanium (ITI) | Titanium alloy |
| Sterilization | Dry heat (Branemark), Gamma irradiation (ITI) | Gamma irradiation |
Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a demonstration of similarity in design and function to legally marketed devices, ensuring safety and effectiveness are maintained.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of an AI/ML device. It is a 510(k) submission for a physical medical device (dental implants). Therefore, concepts like "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.
The "comparison" is based on the technical specifications and intended uses of previously cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to a 510(k) submission for a dental implant. There is no "ground truth" establishment by experts in the context of a dataset for algorithmic evaluation. The safety and effectiveness are established through material compatibility, mechanical testing (which is not detailed here but implied by substantial equivalence), and historical clinical use of similar devices.
4. Adjudication Method for the Test Set
Not applicable. There is no test set adjudication for a physical dental implant in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This document concerns a physical dental implant and therefore an MRMC study was not conducted or is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML device.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI performance evaluation (e.g., pathology, outcomes data for diagnostic accuracy) is not directly applicable here.
For a physical device like a dental implant, the "ground truth" for its safety and effectiveness is established through:
- Established clinical practice and long-term outcomes of very similar predicate devices.
- Material properties and biocompatibility testing (implied, not detailed).
- Mechanical performance such as strength, fatigue, and interface stability (implied, not detailed).
- Adherence to recognized standards (implied).
The document states, "There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface." This statement and the comparison table are the primary "evidence" presented for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device and therefore does not have a "training set."
9. How the Ground Truth for the 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.