(165 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) 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.
The purpose of this submission is to expand the Blue Sky Bio Zygomatic Implant System cleared in K153064. This submission includes abutments with two interface connection designs for attachment to the previously cleared zygomatic implants: an internal hexagon connection (with a 45° bevel) and a tapered internal hexagon connection (with a 12° taper). The internal hexagon connection abutments are provided in platforms of 3.5 mm and 4.5 mm. The tapered internal hexagon connection abutments are provided in platforms of 3.5 mm (NP) and 4.3 mm (RP). All subject abutments have an angulation of 45° and are for support of screw-retained overdenture prosthetic restorations. Except for the angulation, the subject device abutments have the same designs as corresponding abutments cleared in K153064. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device abutments are made of titanium alloy conforming to ASTM F136. The previously cleared abutment screws also are made of material conforming to ASTM F136.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document is a 510(k) Premarket Notification from the FDA for the Blue Sky Bio Zygomatic Implant System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily related to non-clinical performance testing to support this equivalence, particularly for an expanded indication (new abutment angulation).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance testing performed to demonstrate equivalence to the predicate device. For devices like this, the "acceptance criteria" generally align with established standards for dental implants and their components.
| Acceptance Criteria (Implied Standard) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (conformance to relevant standards for implantable materials) | Biocompatibility (referenced from K153064) |
| Sterilization Validation (effective sterilization method) | Sterilization validation according to ISO 17665-1 and ISO 17665-2 (referenced from K153064 and K073713) |
| Mechanical Strength/Fatigue Life (sufficient strength for intended use, especially under dynamic loading) | Dynamic compression-bending testing of the 45° NP (3.5 mm platform) abutment on a compatible tapered internal hexagon connection 4.3 mm body diameter implant according to ISO 14801. |
| Result: The fatigue limit data demonstrated that constructs of the subject device abutments in combination with the previously-cleared compatible zygomatic implants, and used according to the proposed labeling, have sufficient strength for their intended use. | |
| Engineering Analysis (structural integrity and design suitability) | Engineering analysis |
| Material Conformance (materials meet specified standards) | Abutments made of titanium alloy conforming to ASTM F136; abutment screws also conform to ASTM F136. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise sample size in terms of number of abutments or implants tested for the mechanical performance data. It mentions "constructs" for dynamic compression-bending testing. For ISO 14801, a typical number of samples for fatigue testing is outlined in the standard, usually involving multiple samples at different load levels to determine a fatigue limit. However, the exact number is not explicitly stated in this summary.
- Data Provenance: The data is non-clinical performance testing performed by the manufacturer (Blue Sky Bio, LLC) or a contracted lab. It is inherently prospective in the sense that the tests were conducted specifically for this submission. There is no mention of country of origin for the data, but it can be assumed to be from a lab adhering to the relevant ISO standards typically accepted in the US for regulatory submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are non-clinical (mechanical and material testing), not clinical studies involving patient data or expert interpretation of medical images/outcomes. Ground truth in this context is established by adherence to specified engineering standards (e.g., ISO 14801, ASTM F136).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or outcome assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "No clinical data were included in this submission." MRMC studies typically assess the diagnostic performance of a device or algorithm in a clinical context, often with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable here. This device is a physical dental implant system, not a software algorithm. The "standalone" performance relates to the mechanical integrity of the physical components.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data primarily consists of established engineering standards and material specifications.
- For mechanical testing, the ground truth is the pass/fail criteria defined by ISO 14801 (e.g., meeting a certain fatigue limit without failure).
- For material composition, the ground truth is conformity to ASTM F136 specifications for titanium alloy.
- For sterilization, the ground truth is validation against ISO 17665-1 and ISO 17665-2.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.)