(83 days)
Implant Innovation, Inc., 3i, Dental Implants and Accessories are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.
Dental implants are surgically inserted into the upper and/or lower jawbone and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or an emergence profile (EP) healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention.
Implant Innovation's dental accessories are available in a wide range of sizes; and are manufactured from various materials.
This premarket notification relates to marketing previously non-sterile 31 dental accessories as sterile for user convenience. The devices are packaged in sterilizationcompatible packaging (heat-sealed nylon pouch) and sterilized by gamma irradiation.
There are no changes to the design, materials, or the Indications for Use for the accessories.
The provided text describes a 510(k) premarket notification for "3i Dental Accessories" seeking to market previously non-sterile dental accessories as sterile for user convenience. The acceptance criteria and the study to prove the device meets these criteria are outlined in the "PERFORMANCE DATA" section.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength after multiple exposures to gamma irradiation. | An analysis of the data demonstrated there were no significant differences in the materials pre- vs. post-sterilization. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The text mentions "multiple exposures of gamma irradiation" and "an analysis of the data," implying a set of accessories were tested, but the specific number (sample size) is not provided.
- Data Provenance: This was an internal study conducted by the manufacturer, Implant Innovations, Inc., as part of their premarket notification. It's a prospective study designed to evaluate the impact of sterilization on their existing accessories. The country of origin is implicitly the USA, where the company is based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study focused on the mechanical strength of the dental accessories after sterilization, not on interpreting diagnostic images or clinical outcomes that would require expert consensus for ground truth. The "ground truth" here is the objective measurement of mechanical strength.
4. Adjudication method for the test set
Not applicable. Since the study involves objective mechanical testing rather than interpretation by human readers, no adjudication method was used.
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 not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software device, but a physical medical device (dental accessories). The performance evaluation was a physical test on the devices themselves.
7. The type of ground truth used
The ground truth used was objective mechanical strength measurements. The "no significant differences in the materials pre- vs. post-sterilization" implies that the mechanical properties of the accessories before sterilization served as the baseline or ground truth against which the post-sterilization properties were compared.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set." The study involved testing the physical properties of the dental accessories.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and study.
§ 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.