(169 days)
The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.
The Sterngold 3.25mm ERA Dental Implant System consists of a threaded, external-hex, self-tapping, rootform endosseous implant with integral female insert (abutment). The thread major diameter is 3.25 mm; available implant lengths will be 10, 13 & 15 mm. The implants will be available in straight and anglecorrection (5°, 11° & 17°) versions with cuff heights ranging from 0.76-4mm. The implants are manufactured from pure, implant-grade titanium alloy. The external surface of the implants (excluding the neck and the implant head) is lightly acid etched to remove any surface contaminants remaining from the manufacturing operation, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The female insert is titanium nitride coated.
The provided text is a 510(k) summary for the Sterngold 3.25mm ERA Dental Implant System, and a letter from the FDA confirming its substantial equivalence. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert adjudication, or MRMC studies for AI devices. Instead, it relies on demonstrating equivalence to existing predicate devices and compliance with relevant standards.
Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I will populate the table and answer the questions based on the information provided, or indicate when the information is not present.
Acceptance Criteria and Device Performance
As this is a 510(k) submission for a dental implant, the "acceptance criteria" are not reported in terms of statistical metrics (like sensitivity, specificity, etc.) for an AI device. Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices and compliance with FDA guidance and standards for endosseous implants.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The Sterngold 3.25mm ERA Dental Implants are stated to be substantially equivalent to other currently marketed dental implant systems cleared by FDA through the 510(k) process, including the Sterngold ERA Dental Implant System and the Sterngold Narrow Platform Hex Screw Implants. |
| Compliance with Regulatory Standards and Guidance Documents | The submission provided information to demonstrate conformity with: |
- Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants (FDA Guidance)
- Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996) |
| Safety and Effectiveness for Intended Use (based on above criteria) | The conclusion states: "Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold 3.25mm ERA Dental Implant System has been shown to be safe and effective for the product's intended use." |
Since this is a 510(k) for a physical medical device (dental implant), not a software or AI device, the following questions are not applicable to the submitted document. The document describes a traditional device clearance pathway, not a performance study for an AI algorithm.
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm requiring a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical properties, biocompatibility, mechanical strength, and successful osseointegration over time, which are typically assessed through material testing, pre-clinical studies, and clinical experience with predicate devices, rather than a "ground truth" for an algorithmic output.
- The sample size for the training set: Not applicable.
- 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.