(134 days)
The angled XiVE® MP and angled ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws, immediate loading is possible using a minimum of 4 implants. Implants may be tilted up to 45°. When used with angulations between 30°and 45° in edentulous arch, a minimum of four implants must be used and splinted.
The straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments are indicated for use in prosthetic restorations with XiVE®, FRIALIT® and ANKYLOS® implants, respectively, and bridges or bar overdentures using a minimum of 2 implants. In edentulous jaws. immediate loading is possible using a minimum of 4 implants.
The Angled XiVE® MP and ANKYLOS® Balance Base Abutment are endosseous dental implant abutments which provide a platform for prosthetic restoration with bridges or bar constructions in conjunction with XiVE and ANKYLOS® implants. The abutments are provided with an angulation of 15° and 30° at gingival heights ranging from 2.0mm - 5.0 mm for angled XiVE® MP abutments and from 3.0mm - 4.5mm for angled ANK YLOS® Balance Base abutments, respectively. The angled ANK YLOS® BalanceBase Abutments are offered in 3.45mm diameter (compatible with all ANKYLOS® implants). The angled XiVE® MP Abutments are offered in diameters ranging from 3.4mm (compatible with 3.4mm diameter XIVE® implants) to 3.8mm (compatible with XiVE® implants of 3.8mm - 5.5mm diameter). The abutments are connected to the corresponding implants by a central screw which mates with the internal thread of the implant. The abutments and the abutment screws are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial Alloy for Surgical Implant Applications).
The Angled XiVE® MP and ANKYLOS® Balance Base Abutments facilitate the SmartFixTM treatment concept in which the angled abutments are used in combination with straight abutments on a of minimum four (4) implants (with two posterior implants placed at an angle of up to 45° in the posterior region) to support prosthetic restorations.
In addition to the introduction of the Angled XiVE® MP and ANK YLOS® Balance Base Abutments, a modification to the indications for use statements of the currently marketed straight FRIADENT® MP and straight ANKYLOS® Balance Base Abutments is implemented as part of this premarket notification.
The provided text is a 510(k) summary for dental implant abutments and does not contain information about a study that proves the device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a clinical trial with human subjects.
Instead, the document details the substantial equivalence of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments to legally marketed predicate devices. The "performance data" mentioned refers to non-clinical, engineering-focused testing, specifically fatigue data, to demonstrate the structural integrity and durability of the device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the type of information presented in this 510(k) summary.
Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Material Equivalence: Device material conforms to established standards and is equivalent to predicate device material. | The abutments are machined from Titanium Alloy (Ti6AL4V ELI) conforming to ASTM F 136, which is the same material used in the legally marketed predicate device. |
| Design and Technological Equivalence: Device design, angulations, sizes, and technological characteristics are similar to predicate devices. | The proposed devices are similar in terms of design, angulations (15° and 30°), sizes (gingival heights 2.0mm-5.0mm for XiVE, 3.0mm-4.5mm for ANKYLOS; diameters 3.45mm for ANKYLOS, 3.4mm-3.8mm for XiVE), and indications for use. They incorporate the same technological characteristics as the predicate devices. |
| Safety - Risk Assessment: No unacceptable risks identified regarding the function of the device. | A failure mode, effect, and criticality analysis (FMECA) was performed. "There were no unacceptable risks regarding the function of the Angled XiVE® MP and ANKYLOS® Balance Base Abutments." |
| Mechanical Integrity/Durability: Device can withstand intended forces and has adequate fatigue life. | "Representative fatigue data from testing is included and the results support substantial equivalence." (Specific quantitative acceptance criteria for fatigue and the exact data are not provided in this summary but would have been part of the full submission). |
| Substantial Equivalence: Demonstrated equivalence to predicate devices based on indications for use, technological characteristics, and non-clinical testing. | "Based on the comparison of the indications for use, the technological characteristics and the non-clinical testing it can be concluded that the Angled XiVE® MP and ANKYLOS® Balance Base Abutment are substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this is non-clinical engineering testing (fatigue testing). The "sample size" would refer to the number of abutments tested for fatigue. This information is typically proprietary and not fully disclosed in a public 510(k) summary.
- Data Provenance: Not specified, but generally, such engineering tests are conducted in a controlled laboratory environment, often by the manufacturer or a contracted lab. The document does not indicate country of origin of data or whether it was retrospective or prospective, as these terms are not applicable to non-clinical device testing in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context is related to engineering specifications and performance standards (e.g., ASTM standards for materials, recognized test methods for fatigue). Clinical expert consensus is not used to establish this type of "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical studies with subjective interpretations. This document describes objective non-clinical performance 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:
- No. This is a medical device (dental abutment), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of submission is based on established engineering standards, material specifications (e.g., ASTM F 136), and recognized test methods for mechanical performance (e.g., fatigue testing protocols). The implicit ground truth is that the device must meet or exceed the performance characteristics of the predicate devices according to these objective engineering metrics.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" in the AI/ML sense.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)