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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred from Substantial Equivalence Basis)
Material Composition: Biocompatibility of implant materials for endosseous use.	Materials are consistent with legally marketed predicate devices, previously demonstrated to be safe and effective.
Mechanical Properties: Sufficient strength and durability for dental implant applications.	Mechanical properties are consistent with legally marketed predicate devices, previously demonstrated to be safe and effective.
Surface Properties: The two new surfaces must be safe and not introduce new issues of safety or efficacy.	New surfaces are substantially equivalent to those of predicate devices, or their safety/efficacy has been addressed through comparison.
Design Dimensions: Implant length of 8mm is safe and effective when used as intended.	The 8mm length is deemed appropriate for its intended use, comparable to predicate devices in form and function.
Sterilization: Maintenance of sterility or appropriate labeling for non-sterile components.	Sterilization methods and labeling are consistent with accepted standards and predicate devices.
Intended Use Safety & Efficacy: The system performs safely and effectively for stated indications (edentulous/partially edentulous, single/multiple units, one/two-stage protocol, immediate placement/loading).	No new issues of safety or efficacy are introduced by the modifications, implying performance similar to predicate devices.

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.

Summary

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K063874

Blue Sky Bio, LLC

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 847-548-8499 Fax: 847-548-849 Email: azickmann@blueskybio.com

510(K) Summary

General Information

MAR 2 9 2007

Classification Name:	Endosseous Implant
Common Name:	Prosthetic Dental Implant System
Trade Name:	Blue Sky Bio Dental Implant System
Submitter's Name:	Blue Sky Bio, LLC
Address:	888 E Belvidere Rd., Suite 212
	Grayslake, IL 60030
Telephone:	847-548 8499
Fax:	847-548 8491
Contact:	Michele Vovolka
Date of Summary	December 2006

Device Description

Intended Use

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

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michele Vovolka Blue Sky Bio, LLC 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030

MAR 2 9 2007

Re: K063874

Trade/Device Name: Blue Sky Bio Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 28, 2006 Received: December 29, 2006

Dear Ms. Vovolka:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Vovolka

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Soufte y. Michael Dmd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Blue Sky Bio, LLC

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 847-548-8499 Fax: 847-548-849 Email: azickmann@blueskybio.com

Indications for Use Statement

510(k) Number (if Known):_____________________________________________________________________________________________________________________________________________________

Device Name: Blue Sky Bio Dental Implant System

Indications for Use:

. 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.

Prescription Use
(21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey for MSR

nesthesiology,

510(k) Number: K063874

Page_1_of_1

December 2006

Blue Sky Bio, LLC 510(k)

Page 9□
Proprietary & Confidential

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.