(135 days)
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants and mating abutments for screw-retained, multi-unit prostheses.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to approximately 2.3 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5. 35. 37.5. 40. 42.5.45. 47.5. 50. 52.5.57.5. and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).
The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 1.5, 2.0, and 2.5 mm. The prosthetic post is angled 52° or 60° to the long axis of the implant. These components are used with previously cleared abutment screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA100 surface treatment, identical to that cleared in K231127. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants and abutments are provided sterile to the end user.
The provided text is a 510(k) Summary for a dental implant system. It explicitly states that no clinical data were included in this submission to support substantial equivalence (see "No clinical data were included in this submission." on page 6 of 9).
Therefore, it is not possible to provide specific details about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as这些 types of studies were not conducted or reported in this 510(k) submission.
The "Performance Data" section (pages 6-7 of 9) refers to non-clinical data only:
- mechanical testing
- gamma irradiation sterilization
- bacterial endotoxin testing
- MR environment evaluation
- sterile barrier shelf life data
- biocompatibility data
These tests are typically conducted to assess the physical and biological characteristics of the device, not its clinical performance in patients as would be measured in an AI/MRMC study.
In summary, based on the provided document, no study was conducted to prove the device meets acceptance criteria related to AI/MRMC performance as outlined in your request. The submission relies on substantial equivalence to predicate devices, supported by non-clinical performance data.
§ 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.