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510(k) Data Aggregation
(302 days)
Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.
Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.
Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.
Blue Sky Bio PEEK abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).
The subject device 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). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:
- Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
- Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.
Here's a summary of the non-clinical performance and the basis of equivalence:
| Acceptance Criteria (Implied / Indirect) | Reported Device Performance (as stated in submission) |
|---|---|
| Fatigue Resistance (ISO 14801:2016 for Endosseous Dental Implants) | "Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry - Dynamic loading test for Endosseous Dental Implants and following FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." (Implies satisfactory performance, no specific values given). |
| Biocompatibility (Cytotoxicity, per ISO 10993-1, 10993-5, 10993-12 for PEEK abutments) | "Cytotoxicity testing was performed on representative Temporary PEEK abutments (ASTM F2026-17) according to ISO 10993-1, ISO 10993-5, ISO 10993-12." (Implies satisfactory performance, no specific values given). |
| Packaging and Shelf-Life Stability | "The packaging for the subject device is the identical to the sponsor's own prior clearances as referenced in K102034 and K073713 in which accelerated aging testing was presented and leveraged for the subject devices." (Leveraged from predicate devices). |
| Sterilization (SAL of 10^-6 for sterile components) | "Test results and Sterilization Validations performed for the sponsor's own reference devices is also leveraged demonstrate suitable sterilization of the subject device sterile components with demonstration of a sterility assurance level (SAL) of 10-6." (Leveraged from predicate devices). |
| Pyrogenicity (LAL Endotoxin Analysis with testing limit of 20 EU/device) | "Pyrogenicity information provided is based on FDA Guidance... The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." (Implies compliance). |
| End-user Sterility Validation (ISO 17665-2 for PEEK abutments) | "End-user sterility validation was conducted according to ISO 17665-2 for subject Temporary PEEK Abutments." (Implies compliance). |
| MRI Safety (Magnetically Induced Displacement Force and Torque) | "Non-clinical worst-case MRI review to evaluate the metallic devices in the MRI environment using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance..." (Implies safety based on rationale and literature). |
| Clinical Safety/Effectiveness for Pterygoid Placement and Long Implants (Implied from clinical literature) | Clinical literature supports high success rates (e.g., 90.7% to 99%) for implants with similar dimensions and angulations in the pterygoid region and for the TILT procedure. The subject device's dimensions (10-25mm length, up to 45° angulation) fall within this window and are considered to not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
- Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.
4. Adjudication Method for the Test Set
Not applicable, as there was no dedicated clinical "test set" requiring adjudication.
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 dental implant system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device (dental implant).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(76 days)
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).
The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.
I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a dental implant modification, focusing on material changes and substantial equivalence to a predicate device. It discusses:
- Device Identification and Modification: B.A.S.I.C. Dental Implant System, modified to use stronger titanium.
- Intended Use: Identical to the predicate device, for replacing missing teeth.
- Comparison to Predicate Device: Argues substantial equivalence based on identical dimensional characteristics and indications for use. Mentions other predicate devices with similar dimensions and titanium alloy materials.
- Testing: States that "the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints."
- Sterilization and Biocompatibility: Confirms the sterilization process remains the same and references ISO standards.
- Conclusion: Reaffirms substantial equivalence.
- FDA Letter and Indications for Use: The official FDA clearance letter and the stated indications for use.
Crucially, it does not provide details about acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers (MRMC studies). The mention of "testing revealed... better shear/lateral forces" is too high-level to infer specific acceptance criteria or detailed study methodologies.
Therefore, I cannot populate the requested table or answer the specific questions about the study design, ground truth, or expert involvement based on the provided text.
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