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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.

The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement.

The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

The provided text is a 510(k) summary for a medical device (Panthera Dental Milled Bars), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for an AI/CADe device.

Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/CADe device.

Here's why and what kind of information would be needed:

• Acceptance Criteria & Reported Device Performance: This document only provides a comparison of design specifications between the applicant's device and a predicate device (Tables 5.1, 5.2, 5.3) for physical dimensions and material. It does not list "acceptance criteria" in the way one would for an AI/CADe system (e.g., sensitivity, specificity, AUC thresholds).
• Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "Human clinical study was not deemed necessary to support substantial equivalence." and "Panthera Dental Inc. performed no clinical testing." It discusses non-clinical testing like fatigue testing, biocompatibility, and process capability for the physical dental bar, not an AI algorithm.
• Missing Information for AI/CADe devices: The document lacks all the specific details you requested for an AI/CADe study, such as:
  • Sample sizes for test sets (it mentions "thirty (30) cylinders" for process capability testing, not an AI test set).
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone algorithm performance.
  • Type of ground truth (pathology, outcomes data, etc.).
  • Training set sample size and ground truth establishment for the training set.

In summary, the provided document describes a physical dental device, not an AI/CADe system, and thus does not contain the information requested about AI performance metrics or related studies.

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