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BioHorizons CAD/CAM Bars are intended for use as superstructures of a multiple-unit endosseous dental implant system, attaching directly to implants or abutments, to support a prosthetic device in a partially or fully endentulous patient for the purpose of restoring chewing function. Implant-level bars are compatible with all BioHorizons Internal and Tapered Internal implant systems. Implant-level bars are compatible with Zimmer Dental Screw-Vent® and Tapered Screw Vent® implants with 3.5mm, 4.5mm internal hex connection mating platform diameters and are intended to be used with straight bar cylinders only. Abutment-level bars are compatible with BioHorizons Multi-unit Abutments.

All digitally designed BioHorizons CAD/CAM Bars are intended to be sent to a BioHorizons-validated milling center for manufacture.

The BioHorizons CAD/CAM Bars are computer aided designed (CAD), precision computer aided milled (CAM) superstructures manufactured for individual patients. The BioHorizons CAD/CAM Bars provide support for a fixed or removable prosthetic device. The BioHorizons CAD/CAM Bars will be provided in a fixed shape configuration (e.g. Dolder®, Hader, Round) or a free form shape configuration (e.g. Freeform/Milled, Hybrid, Montreal, Paris, Wrap Around), both configurations designed to fit the individual needs of the patient. The BioHorizons CAD/CAM Bars will be provided with either an implant-level or abutment-level connection interface. Implant-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the coronal (top) surface of the implant. Abutment-level CAD/CAM bars will include passive, non-indexing connection geometry with seating on the restorative platform of the abutment. The occlusal surface of the CAD/CAM bars may include connection geometry (e.g. female threads) to accept overdenture attachments. Bar material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The CAD/CAM Bars are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

When used with BioHorizons Internal and Tapered Internal implant systems, the BioHorizons CAD/CAM bars allow for up to 40° divergence between bar cylinders, with no individual bar cylinder angulated greater than 20° from the vertical axis. Only straight bar cylinders are compatible with the Zimmer Dent® and Tapered Screw Vent® implants with 3.5mm. 4.5mm and 5.7mm internal hex connection mating platform diameters.

The provided text is a 510(k) Summary for a dental device, the BioHorizons CAD/CAM Bars. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a performance study in the way a clinical trial for an AI/CADe device would.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or not provided in this type of regulatory document for a physical dental implant component.

However, I can extract information related to what aspects were tested and what was considered sufficient to demonstrate acceptable performance for this device, which serves as the "acceptance criteria" for a physical device in this context.

Here's a breakdown of the available information:

(N/A = Not Applicable or Not Provided in the document)

1. Table of Acceptance Criteria and Reported Device Performance

• Platform Seating Diameter: 3.0mm - 5.7mm
• Total Cylinders: 2 - 10
• Bar Span Between Cylinders: 0mm - 30mm
• Bar Height incl. Cylinder: 2.5mm - 11mm
• Maximum Angulation Per Cylinder: 0° - 20°
• Cylinder Diameter: 3.0mm - 10.0mm
• Distal Extension: 0mm - 1.5x AP Spread

Abutment Level Bars:

• Platform Seating Diameter: 4.8mm - 7mm
• Total Cylinders: 2 - 10
• Bar Span Between Cylinders: 0mm - 30mm
• Bar Height incl. Cylinder: 2.5mm - 11mm
• Maximum Angulation Per Cylinder: 0° - 20°
• Cylinder Diameter: 3.0mm - 10.0mm
• Distal Extension: 0mm - 1.5x AP Spread

These parameters were used for "worst-case" design validation. |
| 8. Fundamental Equivalence to Predicate Device
Focus: Bar base material, bar-implant/bar-abutment connection, prosthetic platform sizes, mode of prosthetic retention. | The fundamental scientific technology is substantially equivalent. Similar features exist, including:

• Bar base material (Titanium alloy as specified in ASTM F136 for subject device; ASTM F136 or Grade 4 Titanium for predicate).
• Bar-implant/bar-abutment connection tailored to implant/abutment component(s).
• Prosthetic platform sizes.
• Mode of prosthetic retention (screw-retained).
  Differences in bar shape, platform sizes, max implant span, etc., were mitigated by performance testing. |

2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in terms of number of devices tested for fatigue or dimensional analysis. The document refers to "a worst-case 3.0mm prosthetic platform, single-unit endosseous dental implant system test configuration" and "a representative subset of Zimmer® Screw-Vent® and Tapered Screw-Vent® implants". The exact number of units or datasets used in these "worst-case" or "representative" scenarios is not detailed.
• Data Provenance: N/A. This is bench testing data, not human patient data. The manufacturer is BioHorizons Implant Systems, Inc., based in Birmingham, Alabama, USA, so the testing was presumably conducted or overseen in the USA.

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)

• N/A. This is a physical dental implant component, not an AI/CADe device. The "ground truth" is based on engineering standards (ISO 14801, ASTM F136, BS EN ISO 17665-1:2006) and the device's functional performance against these standards and its intended use, rather than expert interpretation of images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. This process does not involve human adjudication in the context of diagnostic interpretation. Performance is assessed against quantitative engineering and material 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

• N/A. This is not an AI/CADe device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This is not an AI/CADe device. However, the performance testing described (fatigue, dimensional analysis, material compatibility) can be considered "standalone" in that it evaluates the device's intrinsic physical properties and functional compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For physical performance and material properties: Engineering Standards and Design Specifications.
  • Fatigue: Compliance with ISO 14801 and specific FDA Guidance Document.
  • Dimensionality: Comparison to existing, historically tested BioHorizons components and design specifications.
  • Material: Compliance with ASTM F136.
  • Sterilization: Compliance with BS EN ISO 17665-1:2006.
  • Biocompatibility: Historical testing on the same material shown to be non-cytotoxic, non-irritating, and negative for sensitization.

8. The sample size for the training set

• N/A. This is not an AI/CADe device that uses machine learning in the conventional sense requiring a training set based on data. The "training" here would refer to the engineering design and manufacturing processes development, which is not quantified by a "sample size" in this context.

9. How the ground truth for the training set was established

• N/A. As above, a training set with "ground truth" derived from expert consensus or pathology is not applicable for this physical medical device. The design and manufacturing processes are established based on established engineering principles, dental biomechanics, material science, and regulatory standards.

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