Search Results

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.

Ask a specific question about this device

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform Fixtures. They include Abutments, Healing Abutments, Hand Instruments, Impression Copings and Machine Instruments.

This document is a 510(k) summary for a medical device submitted in 1996. It does not contain any information about acceptance criteria, device performance, results of any studies, or ground truth establishment.

The document is a pre-market notification that primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc.
• Device Description: Accessories for the BRANEMARK SYSTEM® - Wide Platform Fixtures (e.g., Hand Instruments, Healing Abutments, Impression Copings, Machine Instruments).
• Predicate Product: Other existing components marketed by Nobelpharma.
• Intended Use: To be used as accessories with the Wide Platform endosseous implant system, in the same manner as predicate products.
• Comparison of Technological Characteristics: States that the technological characteristics are "identical" to the corresponding predicate products.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your questions, I would need a document that describes the design verification and validation testing performed for the device, including:

• Specific acceptance criteria (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
• Results of tests demonstrating compliance with these criteria.
• Details about the study design (e.g., sample sizes, methods for establishing ground truth, expert qualifications, adjudication methods).

Ask a specific question about this device