Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

Filling of periodontal/infrabony defects .
Ridge augmentation .
Filling of extraction sites (implant preparation/placement) .
Sinus lifts .
Filling of cystic cavities

The device gradually resorbs and is replaced with bone during the healing process.

Device Description

Blue Sky Bio TCP Bone Graft Substitute is porous, resorbable, and biocompatible calcium phosphate ceramic consisting of ß-tricalcium phosphate. ß-tricalcium phosphate is an osteoconductive implant that is biodegradeable. Blue Sky Bio TCP Bone Graft Substitute is provided sterile in granular form, pyrogen-free and available in granule sizes up to 2000 μm.

AI/ML Overview

The provided text is a 510(k) summary for the Blue Sky Bio TCP Bone Graft Substitute, a Class II medical device. This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing acceptance criteria through a clinical study with performance metrics in the way an AI/ML device would.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why and what information is available:

Type of Device: The device is a bone grafting material, not an AI/ML diagnostic tool. Its clearance is based on demonstrating that it is as safe and effective as a legally marketed predicate device, not on specific performance metrics against a defined ground truth derived from a clinical dataset (like sensitivity, specificity, AUC).
Basis for Substantial Equivalence: The document explicitly states the "Basis for Substantial Equivalence" as meeting established standards for materials, biocompatibility, pyrogenicity, and sterilization. It also compares the device's composition (pure ß-tricalcium phosphate, compliance with ASTM F 1088-04), intended use, indications for use, anatomical site, and performance data to the predicate devices.
"Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are implied by meeting the standards and demonstrating equivalence to the predicates in terms of material properties, safety (biocompatibility, pyrogenicity), and indications for use.
"Study that proves the device meets the acceptance criteria": The "studies" mentioned are primarily pre-clinical tests for biocompatibility and material characterization, not patient-based clinical trials with performance metrics.

However, I can extract the following information that is somewhat related to your request, but understand it's not a direct fit for an AI/ML device performance evaluation:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Summary)
Material Composition	Pure ß-tricalcium phosphate, ≥95% phase purity
Material Standard Compliance	Complies with ASTM F1088-04
Biocompatibility	Pass (Cytotoxicity, Intracutaneous Irritation Test, Maximization Sensitization Test, Pyrogen Test, Acute Toxicity)
Sterilization	Provided sterile
Pyrogenicity	Pyrogen-free
Resorbability	Gradually resorbs and is replaced by bone during healing
Indications for Use (Equivalence)	Equivalent to predicate devices (Cerasorb® M Dental, ArrowBone-β) for: - Filling of periodontal/infrabony defects - Ridge augmentation - Filling of extraction sites (implant preparation/placement) - Sinus lifts - Filling of cystic cavities
Performance Data (Equivalence)	Demonstrates equivalence to predicates regarding dissolution testing and XRD profiles.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This document describes a new medical device seeking 510(k) clearance based on substantial equivalence to existing devices, relying on material characterization and biocompatibility testing, not on clinical performance data derived from a "test set" of patient data in the context of an AI/ML model. The biocompatibility tests would have involved in vitro and in vivo animal studies, but the sample sizes and detailed provenance are not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no "ground truth" established by human experts for a "test set" in the context of this device's submission. The "truth" for material properties is established by laboratory analytical methods.

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

Not applicable. No adjudication method for a test set of patient data is described because no such test set was used for performance evaluation in the AI/ML sense.

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-assisted device.

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

Not applicable. This is not an algorithm-based device.

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

Ground Truth (for material properties/safety): Material specifications (ASTM F1088-04), laboratory test results for chemical composition (XRD profiles), dissolution rates, and animal/cellular models for biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity, acute toxicity).

8. The sample size for the training set:

Not applicable. No training set for an AI/ML model.

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

Not applicable. No training set for an AI/ML model.

In summary, the provided document is a regulatory submission for a bone graft substitute, which is a different type of medical device than what your prompt anticipates for AI/ML performance evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 6, 2024

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

Re: K110198

Trade/Device Name: Blue Sky Bio TCP Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC

Dear Michele Vovolka:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 22, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under the product code LYC.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Andrew Steen, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6284, or andrew.steen@fda.hhs.gov.

Sincerely.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

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

Re: K110198

Trade/Device Name: Blue Sky Bio TCP Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LPK Dated: December 12, 2011 Received: December 17, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K110/98

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Blue Sky Bio TCP Bone Graft Substitute

Indications for Use: Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 . " · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · defects.

Filling of periodontal/infrabony defects .
Ridge augmentation .
Filling of extraction sites (implant preparation/placement) .
Sinus lifts .
Filling of cystic cavities 0

The device gradually resorbs and is replaced with bone during the healing process.

Susan Russe
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110988

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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. . .

K110198

510(k) SUMMARY 5

OWNER:

Blue Sky Bio, LLC 888 E. Belvidere Suite 212 Grayslake, IL 60030 Telephone: 847-548-8499 Fax: 888-234-3685

OFFICIAL CONTACT:

Michele Vovolka Vantage Consulting International P.O. Box 848 Grayslake, IL 60030 Telephone: 815-856-0355 Fax: 888-234-3685 Email: vantagemv(0)comcast.net

DEVICE NAME:

Trade Name: Blue Sky Bio TCP Bone Graft Substitute Bone Grafting Material, for Dental Bone Repair Common Name: Bone Grafting Material Bone Grafting Material, Synthetic Classification Name: Class: Class II Regulation Number: 21 CFR 872.3930 LYC Product Code:

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PREDICATE DEVICE(S):

Predicate 510(k)	Device Name	Indication	Clearance Date	Company
K051443	Cerasorb® MDental	Cerasorb® M DENTAL is recommended for:• Augmentation or reconstructive treatment of thealveolar ridge• Filling of infrabony periodontal defects• Filling of defects after root resection,apicoectomy, and cystectomy• Filling of extraction sockets to enhancepreservation of the alveolar ridge• Elevation of the maxillary sinus floor• Filling of periodontal defects in conjunction withproducts intended for Guided TissueRegeneration (GTR) and Guided BoneRegeneration (GBR)• Filling of perio-implant defects in conjunctionwith products intended for Guided BoneRegeneration (GBR)	22 July 2005	Curasan AG,Kleinostheim,Germany
K083372	ArrowBone-β	ArrowBone-β is intended for use in thereconstruction of natural or surgical periodontaldefects of the oral and maxillofacial region,including sinus floor elevation and augmentation ofthe alveolar crest.ArrowBone-β is intended for filling into the site of abony defect in combination with patient blood,autologous bone, membranes or sterile saline afterremoval of cysts or surgical removal of retainedtooth.	8 December2009	BrainBaseCorporation,Tokyo, Japan

DEVICE DESCRIPTION:

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STATEMENT OF INTENDED USE:

Blue Sky Bio TCP Bone Graft Substitute is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.

· Filling of periodontal/infrabony defects
· Ridge augmentation
· Filling of extraction sites (implant preparation/placement)
Sinus lifts
· Filling of cystic cavities

The device gradually resorbs and is replaced with bone during the healing process.

TECHNOLOGICAL CHARACTERISTICS:

The Blue Sky Bio TCP Bone Graft Substitute consists of pure ß-tricalcium phosphate as described in ASTM F1088-04, Standard Specification for ß-tricalcium Phosphate for Surgical Implants.

The following biocompatibility tests have been completed and results support that Blue Sky Bio TCP Bone Graft Substitute is compatible with surrounding tissues.

Biocompatibility Tests	Results
Cytotoxicity	Pass
Intracutaneous Irritation Test	Pass
Maximization Sensitization Test	Pass
Pyrogen Test	Pass
Acute Toxicity	Pass

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K110198

BASIS FOR SUBSTANTIAL EQUIVALENCE:

Blue Sky Bio TCP Bone Graft Substitute meets the requirements of established standards for materials, biocompatibility, pyrogenicity and sterilization.

Blue Sky Bio TCP Bone Graft Substitute is substantially equivalent to the currently marketed Cerasorb® M DENTAL and BrainBase Corporation ArrowBone-B, as a bone void filler for defects in the oral/maxillary and dental region. These bone graft materials are equivalent in that they consist of ß-tricalcium phosphate with a phase purity of more than 95% and comply with ASTM F 1088-04. The devices are substantially equivalent with regard to materials as demonstrated by comparison of XRD profiles and dissolution testing, intended use, indications for use, anatomical site and performance data.

The information provided in this submission demonstrates that the Blue Sky Bio TCP Bone Graft Substitute is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.