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The BellaTek Bars are indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The BellaTek Bars are intended for attachment to a minimum of two (2) abutments.

All digitally designed BellaTek Bars are intended to be sent to Biomet 3i for manufacture.

The BellaTek Bars are indicated for compatibility with the following abutment systems:

· Universal Multi-Unit Abutments manufactured by Terrats Medical SL., 2.9-5.7mm, Angled, max 30 degrees

• · ZimVie Eztetic Implant System
• · ZimVie TSX Implant System
• · ZimVie Tapered Screw-Vent System
• · ZimVie Low Profile Abutments, 3.4-6.0mm, Angled, max 30 degrees
  • · ZimVie Osseotite Implant System
  • ZimVie T3 and T3 PRO Implant System
• · ZimVie Tapered Abutments, 3.5-5.7mm, Angled, max 30 degrees
  • · ZimVie TSX Implant System
  • · ZimVie Tapered Screw-Vent Implant System .

The BellaTek Bars are intended to disperse the load of a prosthesis across dental implant-abutment assemblies. They also provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The subject devices are identical to the reference predicate device CAM StructSURE Precision Milled Bars cleared in K080864 (SE 07/21/2008) with the only addition of the new connection geometry. The subject device has a new bar-to-abutment connection tailored to the multi-unit restorative abutment component(s) with which the device is intended to be used. Similar to the primary predicate device (K233083), the BellaTek Bars are manufactured out of commercially pure titanium per ASTM F67 or Titanium Alloy per ASTM F136. The BellaTek Bars are placed in a nylon bag and sealed in same manner as the reference predicate device (K080864). A label is applied to the bag.

Like the primary predicate device (K233083), the BellaTek Bars are offered in two types. A Type I Bar is a Titanium Alloy bar designed for use with removable overdentures. A Type II Bar is a Pure Titanium or Titanium Alloy bar designed for fixed prosthesis. All BellaTek Bars (Dolder, Primary, Hader, Hybrid, Freeform, Canada, Wraparound and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CAD/CAM software system in accordance with customer specifications, within the limits of design defined in tables below. The subject devices are provided non-sterile in same manner as the predicate devices.

The BellaTek Bars are dental implant abutments intended to restore chewing function in partially or fully edentulous jaws by attaching to a minimum of two abutments.

Here's an analysis of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily aligned with demonstrating substantial equivalence to a predicate device through materials, design specifications, and performance bench testing. Specific quantitative performance targets are not explicitly listed in an "acceptance criteria" table format in the provided document, but rather implied through comparison to existing standards and predicate devices.

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

• Sample Size: Not explicitly stated as a number of devices or cases. The document refers to "worst case design" being validated. For sterilization, the validation process implies testing units to demonstrate SAL. For biocompatibility, "representative Biomet 3i patient-specific bar devices" were used. For MRI review, it was a "non-clinical worst-case MRI review... based on the entire system including all variations." This suggests a methodology of evaluating design limits and material properties rather than a large clinical test set.
• Data Provenance: The studies are non-clinical (bench testing, material analysis, literature review, MRI rationale). No specific country of origin for non-clinical data is mentioned, but the standards followed (e.g., ASTM, ISO, EN ISO) are international. The studies are by nature prospective as they are conducted to support the specific device submission, but they leverage established scientific literature and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that the studies are non-clinical bench tests, material characterizations, and literature reviews, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense does not directly apply. The "ground truth" for these types of studies is established by:

• Regulatory Standards: Adherence to recognized standards like ASTM F136, ASTM F67, ISO 10993-1, ISO 10993-5, EN ISO 17665-1, and FDA guidance documents.
• Engineering and Scientific Expertise: The performance of bench tests, material analysis, and MRI safety assessments would be conducted by engineers, material scientists, and physicists with expertise in these areas. While individual names or specific numbers aren't listed, this expertise is inherent in conducting such tests.
• Literature: The MRI safety assessment explicitly mentions using "published literature" as part of its scientific rationale, implying leveraging the consensus of experts in that field.

No specific number of experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") are provided in the context of establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies where subjective interpretation is involved (e.g., image reading). The studies described here are non-clinical, objective evaluations (bench testing, material analysis).

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

No. The provided document states: "No clinical data were included in this submission." Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical dental implant bar, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Regulatory Standards and Specifications: Adherence to performance parameters detailed in FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments"), and international standards (ASTM, ISO, EN ISO).
• Material Properties: Data derived from chemical and mechanical testing of the materials (ASTM F136, ASTM F67).
• Biocompatibility Endpoints: Established biological safety endpoints defined by ISO 10993 standards.
• MRI Safety Rationale: Scientific principles and published literature related to magnetic fields and medical devices.
• Demonstration of Substantial Equivalence: Direct comparison of technological characteristics and performance to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed through traditional engineering methods and validated through the testing described.

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

Not applicable. There is no training set for this device.

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