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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:

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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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.

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.

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