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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

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.

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