These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including

. Periodontal defects;
. Alveolar ridge augmentation;
Extraction sockets (ridge preservation, implant preparation/ placement); .
. Maxillary sinus floor elevation;
Craniofacial augmentation; .
Root resection, apicoectomy and cystectomy; .
Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Device Description

Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.

AI/ML Overview

This document K080418 is a 510(k) premarket notification for bone grafting materials. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific quantitative acceptance criteria for device performance in a clinical trial.

Here's a breakdown based on the provided text:

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

The document does not present specific quantitative acceptance criteria in a typical "performance metrics" table format as one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices. The "performance" reported is the finding of this equivalence based on technological characteristics and results from animal and clinical studies.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence in Design, Function, and Intended Use	The proposed devices (Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with cortical cancellous chips, BioSet™, BioSet™ IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM) are stated to be substantially equivalent to GRAFTON PLUS® DBM Paste, GRAFTON® DBM, Accell Connexus, and DBX® Demineralized Bone Matrix in design, function, and intended use.
Substantial Equivalence in Design, Function, Materials and Processing	The proposed devices are stated to be substantially equivalent to RTI Allograft Paste and RTI Allograft Paste IC in design, function, materials, and processing.
Same Technological Characteristics (Design, Material, Chemical Composition)	The devices containing DBM in a gelatin carrier (Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, Osteofil®) have the same technological characteristics (design, material, chemical composition) as the predicate RTI Allograft Paste. The devices containing DBM and cortical-cancellous bone chips in a gelatin carrier (Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, Osteofil® ICM) have the same technological characteristics (design, material, chemical composition) as the predicate RTI Allograft Paste IC.
Safety and Effectiveness for Dental Bone Void Filling Applications	"Results from animal and clinical studies demonstrate that these products are safe and effective for use in dental bone void filling applications." (Note: A footnote clarifies that findings from animal models are not necessarily predictive of human clinical results).
Osteoinductivity	Finished product from each lot is evaluated for osteoinductivity using the modified athymic nude rat assay. (No specific pass/fail rate or quantitative result is provided in this summary, but the method is stated).

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

The document mentions "animal and clinical studies" but does not provide details on the sample size for these studies, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on the conclusion of safety and effectiveness rather than the specifics of the underlying studies.

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)

This information is not provided in the document. The studies mentioned (animal and clinical studies) would typically involve experts to assess outcomes, but the submission does not detail their involvement or qualifications.

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

This information is not provided as the document doesn't detail the methodology of the "clinical studies" or how ground truth was established.

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

This is not applicable. The device is bone grafting material, not an AI or imaging device that would involve human "readers" or AI assistance. Therefore, an MRMC study and effect size in human improvement with AI are not relevant to this submission.

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

This is not applicable. The device is not an algorithm.

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

For osteoinductivity, the ground truth is established through a "modified athymic nude rat assay."
For the general claims of safety and effectiveness, the document refers to "animal and clinical studies." These would likely involve outcomes data such as bone formation, integration, healing, and potentially histological/pathological assessment, but the specifics are not detailed.

8. The sample size for the training set

This is not applicable. The device is bone grafting material. There is no "training set" in the context of an AI/machine learning model. The relevant "training" relates to the development of the bone graft material, which is a manufacturing and biological process, not an algorithmic one.

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

This is not applicable for the same reasons as #8.

Summary

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K080418

Image /page/0/Picture/1 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a stylized graphic on the left, followed by the word "Regeneration" in bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in a smaller font size. The logo appears to be for a technology company.

Date: February 15, 2008

Submitted by: Lisa Simpson

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 www.rtix.com

APR 3 0 2008

Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-418-1627

Trade Names:

Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with cortical cancellous chips, BioSet™, BioSet™ IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM

Classification Name and Code: bone grafting material, human source (21 CFR 872.3930, product code NUN)

Substantial Equivalence:

The proposed devices are substantially equivalent to GRAFTON PLUS® DBM Paste, GRAFTON® DBM, Accell Connexus, and DBX® Demineralized Bone Matrix in design, function and intended use, and substantially equivalent to RTI Allograft Paste and RTI Allograft Paste IC in design, function, materials and processing.

Description:

Indications for Use:

. Periodontal defects;
. Alveolar ridge augmentation;
Extraction sockets (ridge preservation, implant preparation/ placement); .
. Maxillary sinus floor elevation;
Craniofacial augmentation; .
Root resection, apicoectomy and cystectomy; .
Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

{1}------------------------------------------------

K'080418

Image /page/1/Picture/1 description: The image shows the logo for Regeneration Technologies, Inc. The logo features a stylized graphic to the left of the company name. The company name is written in a bold, sans-serif font, with the word "Regeneration" appearing in a larger font size than "TECHNOLOGIES, INC." The logo is simple and modern, and it is likely used on the company's website, marketing materials, and other branding materials.

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 www.rtix.com

Summary of Technological Characteristics:

These devices are composed of demineralized and non-demineralized allograft bone in a gelatin carrier matrix. Finished product from each lot is evaluated for osteoinductivity using the modified athymic nude rat assay. These devices have the same technological characteristics (i.e., design, material, and chemical composition) as the respective predicate device as listed in the table below:

Device Name	Predicate Name	TechnologicalCharacteristics Comparison
Regenafil®Altiva DBM PasteBioSet™RTI Allograft PasteOsteofil®	RTI Allograft Paste	Same technologicalcharacteristics (i.e., design,material, and chemicalcomposition) as the predicate
Regenaform®Altiva DBM with cortical cancellous chipsBioSet™ ICRTI Allograft Paste ICOsteofil® ICM	RTI Allograft Paste IC	Same technologicalcharacteristics (i.e., design,material, and chemicalcomposition) as the predicate

Performance Data Supporting Substantial Equivalence Determination:

The proposed products are equivalent to RTI Allograft Paste and RTI Allograft Paste IC, but have different specific clinical indications. Results from animal and clinical studies demonstrate that these products are safe and effective for use in dental bone void filling applications.

1 Findings from an animal model are not necessarily predictive of human clinical results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2008

Mr. Travis Arola Regulatory Affairs Manager Regeneration Technologies, Incorporated 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650

Re: K080418

Trade/Device Name: Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with Cortical Cancellous Chips, BioSet™, BioSet™, IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: February 15, 2008 Received: February 15 2008

Dear Mr. Arola:

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 -Mr. Arola

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Syitte y. Michàu Oms.

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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271

K0804/8

Indications for Use

510(k) Number (if known):

Device Names:

Regenafil® Regenaform® Altiva DBM Paste Altiva DBM with cortical cancellous chips BioSet™ BioSet™ IC RTI Allograft Paste RTI Allograft Paste IC Osteofil® Osteofil® ICM

Indications for Use:

Periodontal defects; �
Alveolar ridge augmentation; .
Extraction sockets (ridge preservation, implant preparation/ placement); .
. Maxillary sinus floor elevation:
. Craniofacial augmentation;
Root resection, apicoectomy and cystectomy; ●
Tumor resection. .

One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Prescription Use Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Susan Ryare

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices,

510(k) Number:__

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.