(70 days)
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw type endosseous dental implant design for bone level placement and can be used in a single or two stage protocol. Refer to Figure 1, product renderings. The implant will have a straight body with an external single lead thread design. The new device implant body, fabricated from 6Al-4V titanium alloy, features single lead threads that begin 0.75mm apical of the base of the implant Spline tines and continue to the apex of the implant. The flute are formed by a helical cuts that "twist" or spiral the cutting flutes around the long axis of the implant in the same sense as the threads. The flutes tend to pull the implant into the site and present a positive rake andle to the osteotomy in a manner similar to a spiral flute thread tap. It has a Spline interface that consists of six tines. These tines interdigitate with like tines on abutments used in the system to create an anti-rotation interface. The new device will feature hydroxylapatite (HA) coating , hydroxylapatite coating with additional Zimmer Dental MP-1® processing equivalent to existing Zimmer Dental implants (K953101, K011028, K013227, K061410, K072589),
The provided text describes a 510(k) premarket notification for a dental implant and focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new device.
Therefore, the requested information cannot be fully extracted from the provided document as it does not contain details about a study that proves the device meets specific acceptance criteria in the format requested. Specifically:
- Acceptance Criteria and Device Performance Table: The document does not provide a table of acceptance criteria and reported device performance metrics in the context of a performance study. It discusses similarity to predicate devices.
- Sample size for test set and data provenance: No test set is described.
- Number of experts and their qualifications: Not applicable, as no ground truth establishment for a test set is mentioned.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned. The document is about establishing substantial equivalence, not conducting a comparative effectiveness study.
- Standalone (algorithm only) performance: Not applicable as this is a physical dental implant, not an algorithm.
- Type of ground truth used: Not applicable, as there's no diagnostic or screening study described.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document is a regulatory submission for a dental implant (3.25mm Spline® Twist™ Implant, HA Coated), asserting its substantial equivalence to existing predicate devices (Integral VI Biointegrated Dental Implant System, Small Diameter Spline Twist Implant, and Calcitek HA-Coated Endosseous Dental Implants). This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device.
The "study" in this context is the comparison made for substantial equivalence, which primarily focuses on design, materials, indications for use, and a comparison of their characteristics to demonstrate that the new device does not raise new questions of safety or effectiveness.
Key information from the document related to comparison/equivalence:
- Device Description: The 3.25mm Spline Twist Implant, HA Coated is a self-tapping, screw-type endosseous dental implant for bone level placement. It features a straight body, external single lead thread design, helical cuts (flutes) for self-tapping, a Spline interface with six tines for anti-rotation, and a hydroxylapatite (HA) coating.
- Comparison Statement: "The new device is substantially equivalent to the predicate devices. The device's, general structure, and function in the endosseous implant system remains the same as the predicate devices." (Page A5-3)
- Specific Similarities Highlighted:
- Design: Similar to the previously cleared Small Diameter Spline Twist Implant, including the Spline interface and its tines.
- Body Dimensions: Body is "identical" to the Small Diameter Spline Twist Implant, with a .1240" (3.15mm) major diameter for single lead threads.
- Material: Fabricated from the same 6AL-4V titanium alloy as the Small Diameter Spline Twist Implant and the Integral VI Biointegrated Dental Implant System, specified to ASTM B328 and ISO 5832-3.
- HA Coating: Features the same HA coating as the predicate Integral VI Biointegrated Dental Implant System, applied via plasma spray and processed with hydro-thermal treatment (MP-1) similar to Calcitek HA-Coated Endosseous Dental Implants.
- Prosthetics: Uses the same prosthetics (engaging and non-engaging abutments, copings) as the predicates, made from titanium alloy, gold alloy, and plastic.
- Surgical Instruments: Will use similar surgical instruments, with an added 2.7 mm intermediate drill and utilizing existing taps and driving tools.
- Indications for Use: The stated Indications for Use on page A5-2 are consistent with general dental implant applications (edentulous mandibles/maxillae for denture prostheses, bridgework, single tooth replacement, immediate or conventional loading under appropriate conditions).
In summary, the document serves as evidence for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study against predefined acceptance criteria for a novel device.
§ 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.