(302 days)
The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforaminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.
The DIO STEADY External Implant System is comprised of dental implants, and superstructures. The DIO STEADY External Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The provided 510(k) submission for the DIO STEADY External Implant System is for a dental implant, which is a physical device, not an AI/ML-driven medical device. Therefore, a significant portion of the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable in this context.
However, I can extract and present the relevant information regarding the performance and testing conducted for this traditional medical device.
Device Name: DIO STEADY External Implant System
Predicate Device: SM Internal/External Implant System (510(k) No: K070569)
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Compliance with applicable International and US regulations | Biocompatibility performed, confirming compliance. |
| Functional Performance | Fatigue testing according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" | Fatigue test results similar to previously cleared predicate devices, using the worst-case scenario (DIO STEADY External Fixture and an angled abutment). |
| Design Conformance | Conformance to design input requirements | Device functionality and conformance to design input requirements were determined through laboratory testing. |
| Substantial Equivalence | Demonstrates equivalence to predicate device (SM Internal/External Implant System K070569) in material, intended use, and similar design/technological characteristics. | Evaluation concluded that the DIO STEADY External Implant System is substantially equivalent to its predicate device. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This is a physical device, and the performance evaluation involved laboratory testing for mechanical and material properties, rather than testing on a dataset.
- Data Provenance: Not applicable. The testing was conducted in a laboratory setting by the manufacturer (DIO Corporation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to annotated data. For a physical dental implant, performance is validated through engineering tests and adherence to standards, not through expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert annotations for datasets, which is not pertinent to the mechanical and material testing of a dental implant.
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. This is a physical dental implant, not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance would be established by:
- Engineering Standards: Adherence to recognized international and US standards for medical device materials (e.g., ASTM F67 for CP Ti Gr4) and performance (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
- Laboratory Measurements: Direct measurements of material properties and mechanical performance (e.g., fatigue strength) under controlled laboratory conditions, compared against established benchmarks or predicate device performance.
8. The sample size for the training set
Not applicable. This is a physical device, and no training set (in the AI/ML sense) was used. The device design and manufacturing processes are developed through traditional engineering methods and quality controls.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device. The "ground truth" for its design and manufacturing is based on established engineering principles, material science, and regulatory requirements for medical devices.
§ 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.