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THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH ABUTMENTS LABORATORY-AND CUSTOM RESTORATIONS, CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.

The FRIALIT-2® AuroBase abutment is a one part abutment with two working areas, a gold cvlinder and a plastic sleeve. The gold cylinder has as the rotational securing device a hexagon, which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The plastic sleeve molded around the gold cylinder and is color-coded in order to differentiate the different diameters. The diameters of the FRIALIT-2® AuroBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: Ø3.8 mm. Ø4.5 mm, Ø5,5 mm and Ø6,5 mm. The FRIALIT-2® AuroBase gold cylinder is manufactured out of a commercial gold alloy. The FRIALIT-2® AuroBase plastic sleeve is manufactured out of a burnable commercial plastic.

This looks like a 510(k) premarket notification for a dental implant abutment, not a medical device that would involve a study with a test set, ground truth, or human readers as described in your request. The document describes a medical device, but it appears to be a physical component (an abutment for dental implants) rather than an AI/software-based medical device that would require the types of studies you've inquired about.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable to the provided 510(k) summary for the FRIALIT-2® AuroBase abutment.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (3i UCLA abutment) through:

• Description of Technological Characteristics: Comparing design features like working areas, rotational securing mechanisms (hexagon), and materials.
• Material Composition Comparison: A table showing the chemical composition of the gold cylinder for both the proposed device and the predicate device, indicating very similar percentages of Au, Pd, Pt, and Ir.
• Preclinical Testing Results: A table comparing static shear strength and dynamic fatigue strength, showing the FRIALIT-2® AuroBase met or exceeded the predicate device's performance.

This type of 510(k) submission typically relies on engineering and material testing to show that the new device is as safe and effective as a legally marketed predicate, rather than clinical trials or AI performance studies.

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Fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.

The FRIALIT-2® CeraBase abutment is a two part abulment. It consists of the titanium insert and the caramic sleeve. The titanium insert has as the rotational securing device a hexagon. which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The ceramic sleeve is blaced on top of the titanium insert where it is rotationally secured by a slot and key connection. The titanium insert is color-coded in order to clearly differentlate the different diameters. The diameters of the FRIALIT-2® CeraBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: D3,8 mm, D4,5 mm, D5,5 mm and D6,5 mm. The FRIALIT-2® CaraBase titanium insert is manufactured out of pure titanium grade II material which is in accordance to ASTM F 67 'Standard Specification for Unalloyed Titanium for Surgical Implant Application'. The FRIALIT-209 CeraBase ceramic sleeve is manufactured out of medical grade aluminumdioxid ceramic which Is In accordance to ASTM F 603 'Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application'.

The provided text describes the FRIALIT-2® CeraBase abutment and compares it to a predicate device, the NobelBioCare CeraOne abutment, to demonstrate substantial equivalence for a 510(k) submission. This type of submission focuses on comparing a new device to an existing, legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria in the way a clinical trial for a new drug or novel medical device would.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, while standard for certain device evaluations, is not explicitly detailed or applicable in the provided 510(k) summary. This document is a summary demonstrating substantial equivalence based on technological characteristics and preclinical testing, not a report of a full clinical trial or a diagnostic algorithm validation.

However, I can extract the relevant information presented and explain why other points are not directly addressed by this document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implied by the comparison to the predicate device. The performance metrics are technological properties and preclinical testing results, demonstrating that the new device is "substantially the same" or performs at least as well as the predicate.

Explanation: In a 510(k) submission, the "acceptance criteria" for performance are broadly to demonstrate that the new device is as safe and effective as a legally marketed predicate device. For technical characteristics, this often means demonstrating similar properties or improved performance where applicable. For static shear strength, the FRIALIT-2® CeraBase significantly exceeds the predicate, and for dynamic fatigue strength, it matches the predicate's "runout" performance. The ceramic properties (Al2O3 content, crystallogical phase, grain size) are presented for comparison to show fundamental similarity in material.

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

The provided document describes preclinical testing results, not a clinical test set in the sense of patient data. The "samples" would refer to test pieces or prototypes of the abutments used in mechanical testing.

• Sample Size for Test Set: Not explicitly stated as a numerical value for each test (e.g., how many abutments were tested for static shear strength or grain size). It's typical for such engineering tests to use a statistically sound number of samples, but the specific count is not in this summary.
• Data Provenance: The tests are preclinical, conducted by the manufacturer (FRIATEC AG, Germany). Thus, the "country of origin of the data" is Germany. It is not retrospective or prospective patient data.

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

This point is not applicable to this type of submission. "Ground truth" established by experts typically refers to clinical diagnoses or pathological findings in a diagnostic device study. This document concerns the physical, mechanical, and material properties of an implant abutment, which are measured using objective laboratory methods and engineering standards, not clinical expert consensus.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated in point 3. Adjudication methods (like 2+1 or 3+1 consensus) are used to resolve discrepancies among expert opinions when establishing ground truth for diagnostic or prognostic tasks, which is not the nature of this pre-clinical engineering data.

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. This submission is for a physical medical device (dental abutment), not a diagnostic algorithm or AI-assisted system for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this document.

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

This is not applicable for the same reasons as point 5. No algorithm is being submitted or evaluated.

7. The Type of Ground Truth Used

The "ground truth" here is based on objective engineering measurements and material science standards. For example:

• Al2O3 content: Measured using chemical analysis.
• Crystallographical phase: Determined by techniques like X-ray diffraction.
• Grain size parameters: Measured using microscopy and image analysis.
• Static shear strength and dynamic fatigue strength: Determined using standardized mechanical testing procedures (e.g., ISO, ASTM standards relevant to dental implants).

It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an engineering evaluation for a physical device like this, which would be relevant for machine learning algorithms.

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

This is not applicable as there is no training set.

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The Friatec Bone Shield is indicated for use for insuring three dimensional alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

The document is a 510(k) clearance letter from the FDA to FRIATEC AG for their device called "Frios Boneshield." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. The "Indications For Use" provided describe the purpose of the device (insuring three-dimensional alveolar bone defects and facilitating augmentation), but not its performance metrics or acceptance criteria from a study.

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The FRIALIT-2 ProTect Abutment is intended for use as a temporary abutment system for short and longer term provisionilization of the FRIALIT-2 implant system, and a provisional abutment for screw. retained crowns or bridges.

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The provided document is a 510(k) clearance letter from the FDA for the FRIALIT-2 ProTect Abutment. This type of document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) clearance process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than rigorous performance testing and clinical trials that would be described by the questions you've posed. The letter confirms that the device is substantially equivalent for its stated indications for use (as a temporary abutment system for provisionalization of the FRIALIT-2 implant system, and a provisional abutment for screw-retained crowns or bridges).

Therefore, I cannot answer any of your questions based on the provided text. The requested information is not present in this regulatory document.

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FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous bridget.orn, to outments supporting a full arch fixed prosthesis in the totally edentulous mandibite or maxila.

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This document is a 510(k) clearance letter from the FDA for a dental implant device, Frialit-2 Screw. It states the device is substantially equivalent to a legally marketed predicate device but does not contain information about acceptance criteria, study details, or device performance data. Therefore, I cannot extract the requested information from the provided text.

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FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

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I am sorry, but based on the provided document, the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria is not available.

The document is an FDA 510(k) clearance letter for the "Frialit-2 Cylinder" device. It indicates that the device has been found substantially equivalent to pre-amendment devices for the stated indications for use. However, it does not include details on:

• Specific acceptance criteria (like performance metrics, thresholds, etc.)
• Any performance study results (e.g., accuracy, sensitivity, specificity, etc.)
• Sample sizes for test sets or training sets
• Data provenance
• Details about experts or ground truth establishment
• MRMC studies or standalone algorithm performance.

The letter focuses on the regulatory clearance based on substantial equivalence, not on the detailed technical or clinical study outcomes that would typically define and demonstrate meeting acceptance criteria for an AI/device performance study.

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