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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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The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, 5.0mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.

Inclusive® Implant Bridge Framework attaches to implants. The Implant Bridge Framework is intended to be finished into a dental prosthesis using standard laboratory materials. The Inclusive® Implant Bridge Framework is customized by following instructions and models specific to each patient.

The Inclusive® Implant Bridge Framework is made of titanium and shipped non-sterile. The Inclusive® Implant Bridge Framework will be attached with titanium screws.

Here's a breakdown of the acceptance criteria and the study information for the Inclusive® Implant Bridge Framework, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a sample size in terms of number of manufactured devices or clinical cases used for the performance testing. It refers to "various static and fatigue tests."
• Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. The tests were laboratory-based (material and mechanical testing).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable as the study described is a laboratory-based mechanical and material performance study, not a clinical study involving expert interpretation of data or images. Ground truth for material and mechanical properties is established through adherence to international standards (e.g., ASTM F136, ISO 14801:2007).

4. Adjudication Method for the Test Set

• This information is not applicable as the study described is a laboratory-based mechanical and material performance study. Adjudication methods are typically used in clinical studies or studies involving human assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance testing only. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The device is a physical dental implant bridge framework, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

• The ground truth used for this device's performance assessment is based on:
  • International Standards: Adherence to material specifications (ASTM F 136 for Ti-6Al-4V ELI Alloy) and mechanical testing standards (ISO 14801:2007 for dynamic fatigue testing).
  • Guidance Documents: Following the FDA's "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for implant to abutment compatibility.
  • Validated Sterilization Protocols: Adherence to ANSI-AAMI ST79-2006 for sterilization.

8. Sample Size for the Training Set

• This information is not applicable. As the device is a physical medical device and the study is for performance testing, there is no "training set" in the context of machine learning or AI models. The "training" for the manufacturing process would be established through quality control and process validation, which is not detailed in terms of sample size in this summary.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the same reasons as #8. Ground truth for manufacturing processes is established through engineering specifications, validated manufacturing procedures, and quality control checks, not through a "training set" in the AI sense.

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