(198 days)
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.
| Properties / Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (FRIALIT-2® CeraBase) |
|---|---|---|
| Al2O3 content | 99.0 weight-% (NobelBioCare CeraOne) | 99.6 weight-% |
| crystallogical phase | α-aluminumdioxide (NobelBioCare CeraOne) | α-aluminumdioxide |
| grain size parameters [µm] | d10: 0.9, d50: 2.2, d90: 3.8 (NobelBioCare CeraOne) | d10: 1.3, d50: 3.9, d90: 7.7 |
| static shear strength [lbs] | 74.5 lbs (NobelBioCare CeraOne) | 99.2 lbs |
| dynamic fatigue strength [lbs] | runout at 35 lbs (NobelBioCare CeraOne) | runout at 35 lbs |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.