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The proposed Blue Sky Bio TAD is intended to provide a fixed anchorage point for attachment of orthodonic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

The Blue Sky Bio TAD is fabricated from titanium Alloy without surface treatment, which meets the material requirements specified in the standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the Blue Sky Bio TAD in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head.

The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed Blue Sky Bio TAD is threaded for quick insertion and provides stability and biomechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing.

The Blue Sky Bio TAD is an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The provided text describes the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance.

Therefore, the requested information specifically on acceptance criteria and a study proving the device meets those criteria, as well as details like sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone performance, cannot be extracted from this document as these types of studies were not conducted or reported for this submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Blue Sky Bio TAD to its predicate device."

However, I can provide a summary of the non-clinical tests performed, the general purpose of these tests, and the ground truth used for materials, which is documented in the provided text.

Summary of Non-Clinical Testing for Blue Sky Bio TAD

The Blue Sky Bio TAD was deemed substantially equivalent to predicate devices based on non-clinical performance tests, material equivalence, and manufacturing process equivalence. Clinical testing was not required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and reported performance values are not detailed in the provided text for most tests, a table format for "acceptance criteria" and "reported device performance" as typically seen in clinical studies or detailed engineering reports cannot be fully constructed. However, the document outlines the types of tests performed and the standards they followed, which imply that the results met the requirements of those standards.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified for any of the non-clinical tests (Axial Pull-out, Peak Torque, Insertion Torque, Sterilization, Shelf Life). These tests are typically conducted on a small number of samples representative of the manufactured device.
• Data Provenance: Not specified. These are non-clinical lab tests, likely performed internally or by a contracted lab. There's no mention of country of origin or whether data is retrospective or prospective as these terms are more relevant to clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (e.g., ASTM, ISO) or published scientific methodologies. There is no mention of expert consensus for these specific tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic outcomes. These are not relevant for the engineering and material performance tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not reported. The document explicitly states that clinical testing was not required. These studies are relevant for evaluating the performance of AI-assisted diagnostic devices with human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Standalone Performance: No, a standalone performance study was not reported. This is a physical medical device (dental implant), not a software algorithm that would have standalone performance metrics.

7. Type of Ground Truth Used

• Ground Truth for Non-Clinical: The ground truth for the non-clinical tests is based on established international standards (e.g., ASTM, ISO) and published scientific literature/methodologies (e.g., "Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics" for peak torque). For biocompatibility, the ground truth is based on the material's conformance to ASTM F136 and its long history of safe use in similar implant applications.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

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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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