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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 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:

• Standard/Standard Plus RN Ø 4.1/4.8 (platform Ø 4.8)
• Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5)
• Tapered Effect RN Ø 4.1 (platform Ø 4.8)
• Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3)
• Bone Level/ Bone Level Tapered RC Ø 4.1, 4.8 (platforms Ø 4.1 and 4.8)

The Panthera Dental Milled Bar is a metallic dental restorative device that 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 patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. 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.

This document, a 510(k) Premarket Notification for the Panthera Dental Milled Bars, describes the device and its claimed substantial equivalence to a predicate device. However, it does not contain information about a study that measures the device's performance against specific acceptance criteria for AI/algorithm-based medical devices.

The provided text focuses on the device's design, materials, manufacturing process, and non-clinical testing (sterilization, biocompatibility, FEA, fatigue testing, reverse engineering, process capability) to demonstrate its mechanical and physical properties. It explicitly states that "Panthera Dental Inc. did not performed clinical testing" and "Human clinical study was not deemed necessary to support substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and performance data for an AI/algorithm-based medical device, as this document pertains to a physical dental device and does not involve AI or an algorithm requiring such a study.

To directly answer your specific points based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes non-clinical engineering and material tests, not performance metrics of an AI/algorithm.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/algorithm study. The non-clinical tests involved physical samples of the dental bars (e.g., for fatigue testing, sterilization validation). Data provenance relates to the testing conducted by Panthera Dental Inc. in Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/algorithm performance is irrelevant for this physical device.
4. Adjudication method for the test set: Not applicable.
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 document explicitly states no clinical testing was performed, and this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical dental device, not an algorithm.
7. The type of ground truth used: Not applicable for an AI/algorithm. For the physical device, "ground truth" would relate to engineering specifications and material properties, validated through established standards (e.g., ISO 14801 for fatigue testing, USP for sterility).
8. The sample size for the training set: Not applicable. There is no AI/algorithm training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device and does not involve the type of AI/algorithm performance studies you are inquiring about.

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Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.

Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.

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

The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.

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)

This information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical bench testing.

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

This is not applicable. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

This is not applicable as the device is a physical medical device, not a software algorithm.

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

The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

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