(140 days)
The Tapered Screw-Vent® X 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 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
The Tapered Screw-Vent®X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. 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 Tapered Screw-Vent X implants will be offered in 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 will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. 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.
The provided text describes a dental implant device, the Tapered Screw-Vent® X Implant, and outlines its characteristics, comparison to predicate devices, and testing performed. However, it does not contain information regarding acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML algorithm or software.
The document is a 510(k) summary for a medical device (endosseous dental implant) and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing (mechanical performance) and some clinical data on safety and basic performance.
Therefore, for the requested information related to acceptance criteria and an AI/ML study, the answer is: Not applicable / Not provided in the document.
Here’s a breakdown based on the document's content, highlighting why the requested information for AI/ML performance is not available:
1. A table of acceptance criteria and the reported device performance:
- Not applicable for AI/ML performance. The document does not mention any AI/ML components or software.
- The "Non-clinical Testing" section states: "Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.' Performance testing demonstrated that the device performs appropriately for the proposed indications for use." This general statement refers to mechanical and material performance, not AI/ML metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for AI/ML test sets. The document refers to clinical studies for human subjects, not a dataset for software testing.
- Clinical Study Sample Size (for device performance): Not explicitly stated in terms of number of patients for the studies, only that a "controlled population" and "normal patients and subjects with elevated risk factors" were included.
- Data Provenance (for clinical studies): Not specified (e.g., country of origin).
- Study Type: "A prospective clinical study" and "A second, longitudinal data collection study" were conducted.
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 for AI/ML ground truth. The document describes clinical studies evaluating implant performance in patients, where "ground truth" would likely be clinical outcomes observed by treating clinicians, not expert consensus on an image or data set for an AI algorithm. No information is provided about expert panels or their qualifications for establishing ground truth as requested for AI/ML evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for an AI/ML test set is mentioned.
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:
- Not applicable. No MRMC study is mentioned, as this device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. No AI algorithm is part of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML context. For the clinical studies mentioned, the "ground truth" would be related to clinical outcomes such as implant loading success, osseointegration, absence of adverse events, etc. The document states: "No device related adverse events were reported in either study to date." This implies observed clinical outcomes.
8. The sample size for the training set:
- Not applicable. No AI training set is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No AI training set is mentioned.
In summary: The provided document is for a physical medical device (dental implant) and does not contain any information related to AI/ML algorithms, their acceptance criteria, performance studies, or associated ground truth establishment.
§ 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.