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The Blue Sky Bio Dental Implant System is intended for use in either partially or fully edentulous mandibles and maxillae to give support to single or multiple units fixed dental prosthesis. It is also intended to give support to overdentures by means of o-ring abutments or bar-attachments. The system is suitable for a one-stage and two-stage protocol. Immediate placement and loading is indicated following certain restrictions.

The Blue Sky Bio Drills are intended to make ostotomies in the mandible or maxilla to accept dental implants.

• . For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
• . For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
• . For single tooth or multiple unit prosthesis
• . For single stage or two stage surgical procedure
• One piece implants for single stage procedure only .
• For immediate placement and immediate function when multiple units are splinted and for single . units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.

The modification of the Blue Sky Bio Dental Implant System consists of two new surfaces. An implant length of 8mm is introduced. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly.

This is a dental implant system. The provided text contains a 510(k) summary and an FDA clearance letter. It does not describe any specific studies performed to establish acceptance criteria or device performance in the way that would typically be done for an AI/ML medical device.

Key points from the provided text:

• Device: Blue Sky Bio Dental Implant System (consisting of implants, components, and drills).
• Modification: Two new surfaces and an 8mm implant length were introduced.
• Claim: "Modifications to the existing system do not introduce new issues of safety or efficacy." This suggests that the 510(k) relies on the substantial equivalence principle rather than new performance studies.
• FDA Decision: The FDA determined the device to be "substantially equivalent" to legally marketed predicate devices. This means they evaluated the device based on its similarity to existing devices and existing standards, not typically through a new, comprehensive clinical or performance study with detailed acceptance criteria as one would find for an AI algorithm.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable or not present in the provided document because this is a mechanical dental device undergoing a 510(k) submission based on substantial equivalence, not an AI/ML device requiring performance studies against a ground truth.

However, to address the prompt as best as possible given the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. The submission is for a physical medical device (dental implants) and relies on substantial equivalence to predicate devices, not on a "test set" of data in the context of an AI/ML algorithm. There are no mentions of a specific test set, data provenance, or data collection. The submission likely includes engineering testing (e.g., mechanical, fatigue, surface characterization) whose "sample size" would relate to the number of implants/materials tested for those specific properties, but this is not detailed in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2. There's no mention of experts establishing ground truth for a test set in the context of this 510(k) submission. FDA reviewers (experts in medical device evaluation) review the submission against regulatory requirements and predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. See point 2. No test set or adjudication method is described.

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 is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable in the traditional sense. For a physical device, "ground truth" equates to established engineering standards, biocompatibility requirements, pre-clinical testing results (e.g., mechanical strength), and comparison to the known safety and efficacy profiles of predicate devices. The "truth" is that the device, with its modifications, is as safe and effective as existing, marketed devices for its intended use.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of device submission.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set" for this type of device submission.

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