(90 days)
The intended use of the Sulzer Dental Ceramic System-HexLock is for anterior single unit restoration cases. This system is intended to improve esthetics in anterior cases by replacing the metal substructure within a restoration with a tooth color ceramic structure.
The Ceramic System-HexLock uses a titanium hex core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is cemented to the core for a final restoration. The core will be offered in two implant interface diameters, 3.5mm, and 4.5mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.
The provided text is a 510(k) summary for the Sulzer Dental Ceramic System-HexLock. It primarily focuses on comparing the new device to predicate devices to establish substantial equivalence, rather than detailing a study with specific acceptance criteria and performance data in the typical sense of a clinical trial or algorithm validation.
However, based on the information provided, we can infer the "acceptance criteria" through the comparison analysis and the "study" demonstrating that the device meets these criteria is the comparison itself, which aims to show substantial equivalence.
Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text for a direct fit:
Acceptance Criteria and Device Performance
The core "acceptance criteria" here is that the Sulzer Dental Ceramic System-HexLock is substantially equivalent to existing, legally marketed predicate devices. The "reported device performance" is demonstrated by the comparison of its technological characteristics and intended use to these predicates.
Key Implicit Acceptance Criterion: Substantial Equivalence to predicate devices (HexLock Abutment (K953101) and FRIALIT®-2 CeraBase Abutment (K980630)).
| Feature (Comparison Point) | Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (Sulzer Dental Ceramic System-HexLock) |
|---|---|---|
| Intended Use | Primarily Anterior Single-Unit Restoration Cases (FRIALIT®-2 CeraBase Abutment) or broader Anterior/Posterior Single-Unit and Multi-Unit Restoration Cases (Sulzer Dental HexLock Abutment) | Intended for anterior single unit restoration cases. (Stated in 510(k) summary and recognized by FDA in clearance letter). This aligns with the FRIALIT®-2 CeraBase Abutment. |
| Abutment Body Geometry | Tapered Retentive Wall (specific to the new device, but compared against Straight Retentive Wall of predicates). The acceptance is that this design is similar enough or provides comparable function. | Tapered Retentive Wall |
| Abutment Diameters | 3.5mm & 4.5mm (Sulzer Dental HexLock) and 3.4mm, 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT®-2 CeraBase) | 4.5mm (as a body diameter) and 3.5mm & 4.5mm for abutment/implant diameter. This falls within the range and specific sizes of the predicate devices. |
| Abutment/Implant Diameter | 3.5mm & 4.5mm (Sulzer Dental HexLock) and 3.4mm, 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT®-2 CeraBase) | 3.5mm & 4.5mm. This matches the Sulzer Dental HexLock and is covered by the FRIALIT®-2 CeraBase. |
| Abutment Body Material | Titanium Alloy (Ti-6Al-4V) (Sulzer Dental HexLock) or Pure Titanium grade II (FRIALIT®-2 CeraBase) | Titanium Alloy (Ti-6Al-4V). This is identical to one of the predicate devices. |
| Implant/Abutment Interface | Hex anti-rotational interface (both predicates) | Hex anti-rotational interface. This is identical to both predicate devices. |
| Ceramic Coping Material | N/A for Sulzer Dental HexLock; Aluminum Oxide for FRIALIT®-2 CeraBase | Zirconia Toughened Alumina. The document highlights this as a key differentiating feature intended to "improve esthetics." The acceptance criteria implicitly allow for material differences if safety and effectiveness are maintained, likely supported by material testing data (though not detailed here). |
| Sterility | Sterile (Sulzer Dental HexLock) or Not Sterile (FRIALIT®-2 CeraBase) | Not Sterile. This aligns with one of the predicate devices. |
| Overall Safety & Effectiveness | Demonstrated by substantial equivalence to predicate devices, ensuring equivalent performance regarding mechanical properties, biocompatibility, and intended clinical outcome. | FDA clearance (K014175) confirms substantial equivalence, implying the device is as safe and effective for its intended use as the predicate devices. This process typically involves demonstrating that any differences do not raise new questions of safety or effectiveness. |
Study Details:
It's important to clarify that this document is a 510(k) summary for regulatory clearance, not a research paper detailing a specific clinical study with granular data. The "study" here is implicitly the substantial equivalence comparison performed by the manufacturer and reviewed by the FDA.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a traditional test set for performance parameters. The "test set" is the Sulzer Dental Ceramic System-HexLock itself, and its characteristics are compared against the established characteristics of the predicate devices.
- Data Provenance: The data provenance is from the specifications and characteristics of the new device and the predicate devices (Sulzer Dental HexLock Abutment and FRIALIT®-2 CeraBase Abutment). The manufacturing site for the new device is listed as Carlsbad, CA (USA), and for one predicate as Meinnheim, Germany. This is a retrospective comparison based on existing device specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no "ground truth" expert consensus established for a test set in this 510(k) summary. The ground truth for the predicate devices' safety and effectiveness was established when they received their own regulatory clearances. For the new device, its specifications are provided by the manufacturer.
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Adjudication method for the test set:
- Not applicable. The process is a regulatory review by the FDA (specifically the Division of Dental, Infection Control and General Hospital Devices), comparing the new device's documentation to predicate devices. It is not an adjudication based on multiple expert opinions on a specific test set.
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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:
- Not applicable. This device is a dental implant abutment and ceramic coping system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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The type of ground truth used:
- The "ground truth" in this context refers to the established safety, effectiveness, and regulatory clearance of the predicate devices based on their inherent characteristics, testing, and clinical track record. The new device's ground truth for approval is its "substantial equivalence" to these predicates. This involves comparing engineering specifications, materials, and intended use, likely supported by bench testing (though not detailed in the summary).
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.)