(190 days)
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.
This is a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.
The document mainly focuses on comparing the new device's characteristics to those of predicate devices and showing that any differences do not raise new questions of safety or effectiveness.
Here's a breakdown of the information that is available or applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, formal "acceptance criteria" in the sense of predefined thresholds for clinical performance against a disease are not provided. Instead, the device demonstrates performance through engineering analysis, dimensional analysis, and dynamic compression-bending testing to show it is comparable to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Referenced from predicate devices K102034 and K060957, implying the new device materials are biocompatible. |
| Dimensional Analysis | Compared to predicate devices. The subject device implants are in the same overall length range as the primary predicate K141777 (35 mm to 52.5 mm), and the 55 mm length is supported by reference predicate K093562. Smaller body diameter (4.3 mm) is supported by reference predicate K093562 (4.05 mm) and dynamic compression-bending testing. Abutment platform diameters (3.5, 4.3, 4.5 mm) and angulations (17°, 30°) are presented. |
| Dynamic Compression-Bending Testing (Fatigue Performance) | According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). Demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777, especially for worst-case constructs (smallest diameter implant - Taper Hex 4.3 mm body diameter - and largest angulation - 30°). This implies meeting or exceeding the predicate's fatigue resistance as tested per the standard. |
| Material Composition | Ti-6Al-4V conforming to ASTM F136, same as previously cleared components in K102034 and K060957. |
| Surface Finish | Grit blasted and acid etched for endosseous surface, same as predicate implants in K102034 and K060957. |
| Sterilization & Packaging | Similar materials and processes as described in K102034 and K060957 (implants sterilized, abutments provided non-sterile for sterilization by user). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "number of cases" or "number of patients" as this was a non-clinical submission. For the dynamic compression-bending testing per ISO 14801, the standard typically specifies the number of samples required for fatigue testing, but the exact number used in this specific test is not provided in the summary.
- Data Provenance: Non-clinical (lab-based engineering and material testing). Not applicable in terms of country of origin or retrospective/prospective for clinical data.
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 a clinical sense (e.g., disease presence/absence determined by expert radiologists) is not relevant for this type of non-clinical device submission.
4. Adjudication method for the test set:
Not applicable. No expert adjudication process as this was a non-clinical submission.
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 device is a physical dental implant system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For Biocompatibility: Material specifications (ASTM F136) and prior clearance of similar materials in predicate devices (K102034 and K060957).
- For Dimensional Analysis: Engineering drawings and measurements, compared against predicate device specifications.
- For Dynamic Compression-Bending Testing: The performance requirements of the ISO 14801 standard and the comparative performance of the primary predicate device (K141777).
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.