(343 days)
The ETIII SA Fixture System (03.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
The ETIII SA Fixture System (Ø3.2) is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
This document is a 510(k) premarket notification for the ETIII SA Fixture System (Ø3.2mm) to the FDA. It declares substantial equivalence to existing predicate devices, rather than presenting a study to prove a device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be found in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not present specific acceptance criteria or performance metrics for the ETIII SA Fixture System (Ø3.2mm) in the way one would expect for a new diagnostic or AI-driven device. Instead, it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. The "performance" is implicitly deemed equivalent to these predicates.
- The document does list various tests conducted, such as biocompatibility tests (Subchronic Toxicity, Bacterial reverse mutation, Chromosome aberration, Cytotoxicity, Skin sensitization, Oral Mucosa Irritation, Acute Systemic Toxicity, Pyrogen tests), sterility tests, and mechanical tests (adaptation accuracy, static and dynamic fatigue). However, it does not provide specific numerical outcomes or acceptance thresholds for these tests that could be presented in a performance table. It merely states that "All tests were conducted in accordance with relative standards without any discrepancies."
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a medical device (dental implant), not a software or AI device that would typically have a "test set" in the context of data analysis. The testing involved material properties, biocompatibility, and mechanical performance, not a clinical data set for algorithm validation.
- Therefore, there is no information on sample size for a "test set" as would be relevant for an AI study, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As this is a physical medical device (dental implant) and not an AI or diagnostic software, there is no "ground truth" established by experts in the context of data labeling or diagnosis for a test set. The validation relies on standard engineering, material, and biological safety testing.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method as typically defined for AI or diagnostic studies 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
- No. This document pertains to a physical dental implant, not an AI or diagnostic tool, so an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the physical properties and safety of a dental implant, the "ground truth" is established through adherence to recognized international standards (e.g., ISO, ASTM, USP) for material science, biocompatibility, and mechanical testing. There isn't a "ground truth" in the sense of clinical diagnosis or outcomes data detailed here for a study to prove acceptance criteria.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
Summary based on the document:
The document describes the ETIII SA Fixture System (Ø3.2mm) dental implant and seeks FDA clearance based on substantial equivalence to predicate devices. It references various non-clinical tests performed in accordance with international standards (ISO, USP) to demonstrate safety and performance, but does not provide the specific results or acceptance criteria values for these tests. It explicitly states, "No clinical studies are submitted." The focus is on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety and effectiveness as legally marketed predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel technology.
§ 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.