(88 days)
The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.
The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.
The provided document is a 510(k) summary for a dental implant abutment (Sulzer Dental Ceramic System - Spline) seeking substantial equivalence to existing predicate devices. It does not describe a study involving algorithms, AI, or performance metrics typically associated with device acceptance criteria in the context of AI/ML.
Instead, this document focuses on demonstrating that a new medical device (a physical dental implant component) is substantially equivalent to legally marketed predicate devices. The "acceptance criteria" here refer to the criteria for substantial equivalence under FDA regulations, which involve comparing the new device's intended use, technological characteristics, and safety/effectiveness concerns to those of existing devices.
Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, or training set details because this submission is not about an AI/ML device.
The "acceptance criteria" in this context are established by the FDA's regulatory framework for 510(k) submissions, primarily evaluating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the document, which argues for substantial equivalence based on a comparison to predicate devices, rather than a clinical trial or AI model validation study.
Here's a breakdown of what the document does provide, reframing the request to fit the content:
1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance (Characteristics):
| Feature | Acceptance Criteria (Predicate Characteristics) | Reported Device Performance (Sulzer Dental Ceramic System-Spline Characteristics) |
|---|---|---|
| Intended Use | Anterior/Posterior Single-Unit and Multi-Unit Restoration Cases (Gold Coping) OR Anterior Single Unit Restoration Cases (FRIALIT-2® CeraBase) | Anterior and premolar, single-unit cement-retained restorations |
| Abutment Body Geometry | Straight Retentive Wall | Tapered Retentive Wall |
| Abutment/Implant Interface Diameter | 3.25mm, 4.0mm, and 5.0mm (Gold Coping) OR 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT-2® CeraBase) | 3.25mm, 4.0mm, and 5.0mm |
| Abutment Cuff Flare Dimater | 4.5mm and 6.5mm (Gold Coping) OR Variable (FRIALIT-2® CeraBase) | 4.5mm |
| Abutment Body Material | Gold Alloy (Gold Coping) OR Pure Titanium grade II (FRIALIT-2® CeraBase) | Titanium Alloy (Ti-6A1-4V) |
| Implant/Abutment Interface | Spline anti-rotational interface (Gold Coping) OR Hex anti-rotational interface (FRIALIT-2® CeraBase) | Spline anti-rotational interface |
| Ceramic Coping Material | N/A (Gold Coping) OR Aluminum Oxide (FRIALIT-2® CeraBase) | Zirconia Toughened Alumina |
| Manufacturing Site | Carlsbad, CA (Gold Coping) OR Meinnheim, Germany (FRIALIT-2® CeraBase) | Carlsbad, CA |
| Packaging | PETG tray and Tyvek® lid (Gold Coping) OR Blister pack combined w/ cardboard outer wrap (FRIALIT-2® CeraBase) | PETG tray and Tyvek® lid |
| Sterile | No | No |
The "study" demonstrating this device meets "acceptance criteria" is the comparison analysis itself, which asserts that differences do not raise new questions of safety or effectiveness.
The following points are not applicable to this document as it pertains to a physical device approval based on substantial equivalence, not an AI/ML model.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of AI/ML validation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML-based test set is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the substantial equivalence claim is the performance and characteristics of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.
§ 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.