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Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.

Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.

Implant Direct Custom Bars are computer-aided design/computer-aided manufacturing, individually designed prosthetic devices for partially or fully edentulous restorations. The bars and fixation screws are made from Wrought Titanium Alloy conforming to an FDA recognized consensus standard ASTM F136. The Custom Bars consist of two device types: fixed-detachable frameworks and overdenture bars. The bar systems consists of the bars as well as fixation screws to facilitate the attachment to the dental implants.

Implant Direct Custom Bars are attached directly to an implant to provide support for the fabricated denture. The implant specific interfaces on the Custom Bars are designed and manufactured with precise mating features in order to the mating surfaces of the implants or abutments.

The Implant Direct Custom Bars are designed and produced at Implant Direct under the direction of clinical professionals. The patient requirements and implant locations are obtained conventionally or digitally and a bar is designed, using CAD software, according to established customization parameters. Once the design is finished, the bar design is sent to the clinician for approval before manufacture. After bar design approval is received, the bar design is milled using a precise CAM system, inspected, cleaned, packaged non-sterile, and shipped to the customer where it is finished into the final restoration.

This document describes the premarket notification for "Custom Bars" (K162633), which are patient-specific dental devices. The device is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.

However, I can extract information related to the performance data and the study conducted for this non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information, since this is not an AI/ML medical device, the following points are not applicable or not provided in the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of mechanical and biocompatibility testing. The testing was performed on "worst-case configurations" and "worst-case sample" as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic/screening devices, not for physical dental prosthetics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device performance testing against laboratory standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (ISO 14801, ASTM F382, ISO 10993-1, ISO 10993-5, ISO 17665-1, ISO 17665-2) and equivalence to predicate devices, as demonstrated through non-clinical laboratory testing.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Additional Information from the document:

• Study Type: Non-clinical testing (mechanical, biocompatibility, and cleaning/sterilization validation). Clinical performance testing was not performed and was deemed not required to support substantial equivalence.
• Predicate Device for Comparison: Dentsply International ISUS Implant Suprastructures (K122424) was the primary predicate. Nobel Biocare NobelProcera Overdenture Bar (K132749) and Biomet 3i CAM StructSURE Overdenture Bars (K101582) were used as references.
• Conclusion: The studies concluded that the Custom Bars are substantially equivalent to the legally marketed predicate devices based on the non-clinical testing performed.

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