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Intended Use for Two-Piece Implant Systems

• For implantation into any area of the fully 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 .
• 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.
• Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. .
• . Taper Hex Implant System is compatible with NobelActive implants and prosthetics
• Double Hex Implant System is compatible with Astra double hex implants and prosthetics .
• Square Taper Implant System is compatible with Straumann Bone-Level implants and . prosthetics

Intended Use for One-Piece Implant System

• For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis
• For single tooth or multiple unit prosthesis ●
• For single stage surgical procedure .
• 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. In edentulous cases four or more implants must be used
• Overdenture Implants are intended for support of removable prosthesis. .

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained , screw retained and overdenture-type restorative options. The implants and abutments are made out of Ti6Al4V titanium alloy and have an internal anti-rotational geometry or have a one-piece design with the abutment portion being an integral part of the implant. The device also includes exempt accessories such as laboratory analogs and drivers for insertion of the implants. and The activFluor surface treatment of the implants is the same as on Blue Sky Bio's predicate devices and is performed by blasting the surface and chemically etching to enhance the surface roughness for apposition of bone to the implant surface. The implants and components are supplied sterile or not sterile and are labeled accordingly.

The provided text describes the "Blue Sky Bio Dental Implant System" and its modifications. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and results in the way typically seen for AI/ML-driven medical devices.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as it pertains to a traditional medical device (dental implants). There is no mention of an algorithm, AI, human-in-the-loop, or a test set with ground truth established by experts.

However, I will extract the information that is available and indicate when information is not present.

Acceptance Criteria and Device Performance for Blue Sky Bio Dental Implant System

This device is not an AI/ML device, so typical performance metrics like sensitivity, specificity, or AUC are not applicable, nor are direct comparisons of human performance with and without AI. The acceptance is based on demonstrating substantial equivalence to predicate devices through material, technological, and safety comparisons, as well as performance testing for compatibility and fatigue.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a traditional medical device (dental implant). The "test set" and "data provenance" as understood in AI/ML studies are not relevant here. Performance was assessed through compatibility and fatigue testing of the physical device, not on a dataset of patient information.

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

Not applicable. This is a traditional medical device. Ground truth, in the context of expert review of data, is not established for this type of device submission. The assessment relies on engineering and material standards, and clinical experience with predicate devices.

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

Not applicable. This is a traditional medical device. No adjudication method for a test set of data is mentioned.

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 a traditional medical device. No AI assistance or human reader studies are mentioned.

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

Not applicable. This is a traditional medical device. There is no algorithm or standalone performance to evaluate.

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

Not applicable. For this device, ground truth as typically understood in AI/ML studies (e.g., confirmed diagnoses) isn't directly relevant. The "truth" or acceptance is based on:

• Compliance with manufacturing specifications.
• Material properties meeting standards.
• Mechanical performance (compatibility, fatigue) meeting or exceeding predicate device performance and industry standards (e.g., ISO 14801).
• Demonstration of substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.

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

Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.

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• 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
• 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.
• Abutments are intended for use in conjunction with compatible Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.

The modification of the Blue Sky Bio Dental Implant System consists of angled abutments and abutments to be custom milled to a specific angle to allow restoration of implants which are placed at an off-axis. A line of UCLA type straight abutments is introduced. In addition, an implant with a length of 8mm is introduced. A ceramic surgical osteotomy drill is also introduced.

The provided text is a 510(k) summary for the Blue Sky Bio Dental Implant System. It describes the device, its indications for use, and the regulatory approval process. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This document is a regulatory submission for a medical device that outlines its description and intended use, and confirms its substantial equivalence to a predicate device. It is a design and manufacturing document, not a performance study report.

Therefore, I cannot populate the table or answer the other questions based on the provided text because the required information is not present.

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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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• 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 root form dental implants of various lengths and diameters and associated abutment systems, which provide the cliniaian with cement retained and overdenture-type restorative options. 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.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "Blue Sky Bio Dental Implant System." The document is a 510(k) summary and FDA clearance letter, which primarily focuses on substantial equivalence to a predicate device, regulatory classifications, and intended use. It does not include details about specific performance metrics, clinical studies, or the types of information you've requested regarding acceptance criteria and study design.

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• 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 root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol.

This submission is for a Traditional 510(k) for a Class II medical device, specifically a "Blue Sky Bio Dental Implant System." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials to establish de novo safety and efficacy criteria. Therefore, the information typically requested in your prompt (such as acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is generally not part of a Traditional 510(k) submission.

Explanation Based on Document Content:

The provided document (K051507) is a 510(k) summary and the FDA's clearance letter for the "Blue Sky Bio Dental Implant System." Here’s why it doesn't contain the requested information in the typical format for device performance studies:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It does not usually require de novo clinical studies with specific acceptance criteria and performance metrics against a defined standard.
• "Modification of the Blue Sky Bio Dental Implant System": The device description explicitly states, "The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems... Modifications to the existing system do not introduce new issues of safety or efficacy." This further reinforces that the submission is for a modification of an already cleared device, making extensive new performance studies unlikely to be required.
• FDA Letter Confirmation: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device... We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the basis of the clearance, not evidence of meeting specific numerical performance criteria from a clinical study.
• Lack of Performance Data Section: Traditional performance data sections, including benchmarks, study designs, sample sizes, and ground truth methods, are absent from the provided document, as they are not standard requirements for this type of submission unless specific new safety/efficacy questions are raised by the modification, which the submitter explicitly denies.

Therefore, based on the provided document, I cannot fulfill your request for the following reasons:

1. No explicit acceptance criteria or reported device performance table: The submission relies on substantial equivalence to a predicate device, not on meeting new quantitative acceptance criteria from a performance study.
2. No sample sizes, data provenance, or details on ground truth for test/training sets: These are components of clinical or performance studies, which are not detailed in this 510(k) submission.
3. No information on experts for ground truth or adjudication methods: Again, related to detailed studies which are not present.
4. No MRMC comparative effectiveness study or related effect size: This type of study is not mentioned or required for a 510(k) submission focused on substantial equivalence for this device.
5. No standalone (algorithm-only) performance data: The device is a physical dental implant system, not a software algorithm, so this concept is not applicable.
6. No specific type of ground truth mentioned: Directly related to the absence of detailed performance studies.
7. No sample size for the training set or how ground truth for the training set was established: These details pertains to the development and validation of machine learning algorithms or specific clinical trials, neither of which are described here.

This document describes a regulatory filing for a medical device that relies on demonstrating equivalence to an existing device rather than presenting new clinical study data with specific performance metrics and acceptance criteria.

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