(181 days)
The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.
The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches. The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm. The surface is SA: Sand blasted and Acid etched.
The provided text describes the ET IV SA Dental Implants, a dental implant system. The document is a 510(k) premarket notification summary from the FDA.
Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:
Key Takeaway: This document does not contain specific acceptance criteria or an independently conducted study to prove the device directly meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study. Instead, it argues for substantial equivalence to previously cleared predicate devices based on non-clinical testing and comparison of characteristics. Therefore, many of your requested points are not applicable or cannot be extracted directly from this type of FDA submission.
However, I will extract relevant information where available and note when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific performance acceptance criteria and direct performance metrics in comparison to those criteria are not provided in this 510(k) submission. The document focuses on showing the new device is substantially equivalent to predicate devices. The "reported device performance" is essentially that it performs equivalently to the predicate devices in the tested categories.
| Acceptance Criteria Category | Reported Device Performance (as argued for substantial equivalence) |
|---|---|
| Intended Use | The modifications do not affect the intended use of the device. Same indications for use as predicate devices. |
| Surgery Type | Same surgery type (one or two-stage surgery) as predicate devices. |
| Structure | Similar structure to predicate devices (internal hex connection, submerged fixture, tapered body shape, 3 sided cutting edge with self-tapping). The revision relates to the tapered body and thread compared to the primary predicate. |
| Material | Same material (Pure Titanium Grade 4 per ASTM F67) as predicate devices. |
| Surface | Same SA (Sand blasted and Acid etched) surface treatment as predicate devices. |
| Sterilization Method | Same radiation sterilization method as predicate devices. |
| Shelf Life | Same shelf life (8 years) as predicate devices. |
| Biocompatibility | Deemed not necessary to re-test due to same manufacturing process and material as predicate K140934, indicating biological safety is equivalent. |
| Sterilization Validation | Deemed not necessary to re-validate due to same manufacturing process, material, sterile barrier system, and gamma irradiation conditions as predicate K140934, indicating sterilization validity is equivalent. |
| Fatigue Testing | Deemed not necessary to re-test. Applicable fatigue test data of ø 3.5 Hiossen Implant System (K140934) conducted per ISO 14801:2007 is relied upon, as there is no new worst-case compared to K140934. This implies the device meets the fatigue performance standards of ISO 14801:2007 as demonstrated by the predicate. |
The subsequent points (2-9) are largely for studies involving AI/ML algorithms or clinical trials with ground truth establishment, which are not present in this document. However, I will address them to indicate their absence or provide the most relevant information given the context.
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided: This document describes a medical device (dental implant) that underwent non-clinical performance testing (biocompatibility, sterilization validation, fatigue testing) based on existing data from predicate devices, rather than a new "test set" of patient data in the context of an algorithm or diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided: Ground truth establishment by experts is typically relevant for diagnostic or AI/ML device studies. The assessments here are based on engineering comparisons and material properties, referencing established standards (e.g., ISO 14801:2007 for fatigue testing) rather than adjudicated expert interpretations of a dataset.
4. Adjudication method for the test set
- Not applicable / Not provided: No multi-reader adjudication process is mentioned, as this is not a study involving interpretations by multiple readers.
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: No MRMC study was conducted or is relevant for this type of dental implant submission. This device does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical dental implant, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Indirectly: For the non-clinical tests referenced:
- Biocompatibility: Ground truth is established by compliance with biocompatibility standards (e.g., ISO 10993 series), and relying on the predicate device's compliance.
- Sterilization Validation: Ground truth is compliance with sterilization standards (e.g., ISO 11137 for radiation sterilization), relying on the predicate device's compliance.
- Fatigue Testing: Ground truth is established by meeting the requirements of ISO 14801:2007 for dental implants, relying on the predicate device's test data.
8. The sample size for the training set
- Not applicable / Not provided: This device did not involve a "training set" in the context of AI/ML or statistical modeling. The "data" relied upon consists of design specifications, material properties, manufacturing processes, and non-clinical test reports from the predicate devices.
9. How the ground truth for the training set was established
- Not applicable / Not provided: As there is no training set mentioned in the context of an algorithm, there's no ground truth established for it. The ground truth for the non-clinical tests is based on established scientific and engineering principles and international standards.
§ 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.