RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

Device Description

Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.

AI/ML Overview

This is a 510(k) premarket notification for "RegenerOss Allograft Putty Plus Mineralized." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a standalone clinical study report with detailed acceptance criteria and performance metrics typically seen for de novo devices or PMA applications. Therefore, many of the requested points related to device performance in a clinical setting and expert involvement in ground truth establishment are not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that a "rigorous design control process is the basis for a substantial equivalence determination" and that "verification and validation activities have been performed successfully, as identified by the risk analysis, ensuring the modified device is as safe and effective as the predicate device. The predetermined acceptance criteria have been met."

However, specific numerical acceptance criteria and reported device performance (e.g., success rates, effect sizes) for clinical use are not explicitly provided in the given text. The study primarily focuses on demonstrating comparable characteristics to a predicate device through non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance:

Assessment Area	Acceptance Criteria (Implied)	Reported Device Performance
Osteoinductive Potential	Comparable levels of osteoinductive performance to the predicate device (InterGro Oral) in an ectopic bone growth model.	Results indicate comparable levels of osteoinductive performance (as indicated by histological scoring of new bone formation) of the predicate device compared to the modified device in the athymic rat ectopic bone growth model.
Product Functional Testing (Solubility, Handling)	Comparable solubility, extrudability, moldability, and disintegration characteristics to the predicate device (InterGro Oral).	Solubility testing: Results indicate that the solubility characteristics of the modified device are comparable to that of the predicate device. Handling evaluation (extrudability, moldability, disintegration): Results indicate that the handling characteristics of the modified device are comparable to that of the predicate device.
Safety and Effectiveness	Device is as safe and effective as the predicate device.	"The safety and effectiveness of RegenerOss Allograft Putty Plus Mineralized was verified and documented through Biomet's design control process. Substantial equivalence to the predicate device is based on the same intended use and base material... and verification and validation of selected performance properties and acceptance criteria."
Radiopacity and Structural Strength	Improved radiopacity, osteoconduction, and structural strength compared to DBM only, and comparable to the predicate device's use of Pro Osteon.	"Cancellous Bone Chips are added for radiopacity, osteoconduction, and to enhance the structural strength of the product." The use of cancellous bone chips "serves the same purpose as the Pro Osteon calcium salt granules, to improve the radiopacity, osteoconduction, and structural strength of the product." (Comparison is implied to be met).

Study Details:

Sample size used for the test set and the data provenance:
- The primary "test set" for the osteoinductive potential evaluation was conducted in an athymic rat ectopic bone growth model. The specific sample size (number of rats or implants) is not provided in the document.
- The functional testing (solubility, handling) would have involved samples of the device material itself, but the number of samples is not specified.
- The data provenance is from non-clinical laboratory studies (animal model and in-vitro material testing) conducted by Biomet/Biomet Interpore Cross. It is retrospective in the sense that it's part of a design control process validation for a modification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment of osteoinductive potential involved "histological scoring of new bone formation." This typically involves trained pathologists or histologists, but their number and qualifications are not disclosed in this 510(k) summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a 510(k) submission focused on substantial equivalence through non-clinical testing, formal clinical adjudication methods are not typically detailed.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a bone grafting material, not an imaging analysis AI or a diagnostic tool that involves human readers. Therefore, this question is not applicable to the submitted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the osteoinductive potential, the ground truth was based on histological scoring of new bone formation in the animal model. This implies a pathological assessment.
- For functional testing, the "ground truth" refers to the measured physical and chemical properties of the material, which are scientifically quantifiable.
The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning model, so there is no "training set." The development process involved design inputs and verification/validation, but not machine learning training.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model.

Summary

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Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralızed

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JAN 2 0 2012

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Section 6 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Sponsor/Applicant	Biomet 3i4555 Riverside DrivePalm Beach Gardens, Florida 33410
Number	1-800-342-5454Fax: 561-514-6316www.biomet3i.com
Establishment Registration	1038806
Sponsor/Applicant Contact	Mayank ChoudharyRegulatory Affairs SpecialistMayank.choudhary@biomet.com561-776-6831
Date Prepared	December 10, 2012
Preparer	Biomet Interpore Cross181 Technology DriveIrvine, California 92618949-453-3200Fax: 949-453-3225Establishment Number: 2029012
Contact for Review/Questions	Kathleen Olivares, Regulatory Affairs AssociateKathleen.olivares@biomet.com949-453-3200, extension 104
Trade/Proprietary Name	RegenerOss Allograft Putty Plus Mineralized
Common/User Name	Demineralized Bone Matrix (DBM) with MineralizedCancellous Chips in a Lipid Carrier
Classification Name	Class II
Legally Marketed Devices to WhichSubstantial Equivalence is Claimed	510(k) K070147- InterGro Oral
Other Marketed Devices in the Same	510(k) K080418- Regenaform; Altiva DBM with Cortical

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K113645

Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralized

Classification Using Cancellous Bone Cancellous Chips; Regeneration Technologies Inc. Chips 510(k) K060332- OrthoBlast II DBM Paste and Putty with Cancellous Chips; IsoTis OrthoBiologics, Inc. Description of the Device Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier. How the Device Functions A resorbable, osteoconductive bone graft substitute with osteoinductive potential that promotes bone formation. The implant is resorbed and is replaced with bone during the healing process. Scientific Concepts and Significant Demineralized cortical bone matrix, (DBM) is derived from Characteristics donated human tissue allograft bone which has been granulated, demineralized, and lyophilized and contains various growth factors including osteoinductive proteins. Mineralized cancellous bone chips from the same donor as the DBM are added for radiopacity, osteoconduction, and to enhance the structural strength of the product. An added carrier is a resorbable, biocompatible, semi-viscous lipid. By combining the DBM and cancellous chips with the carrier it allows for easier intra-operative handling and improves holding properties of the DBM at the site of transplantation. Intended Use of the Device The indication for use statement is the same as the predicate device, InterGro Oral, legally marketed by Biomet 3i. RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including:localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects. Summary of New Device Comparison to The technological characteristics of the new device are the Predicate Device same in comparison to those of the predicate. RegenerOss Allograft Putty Plus Mineralized Cancellous Bone Chips is a modification of a Biomet cleared device, InterGro Oral. The difference between the two devices, or change, is to a secondary material ingredient. For marketing purposes one

source of calcium salt granules, a hydroxyapatite material

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(Pro Osteon), is being replaced with another source of calcium salt or hydroxyapatite material, Cancellous Bone Chips, from the same donor as the DBM. The use of cancellous bone chips serves the same purpose as the Pro Osteon calcium salt granules, to improve the radiopacity, osteoconduction, and structural strength of the product.

Cancellous Bone Chips are legally marketed in other devices within the same classification regulation, for the same intended use.

A rigorous design control process is the basis for a substantial equivalence determination. This well defined modification to the currently marketed Biomet device followed a predetermined set of requirements and activities in the management of the design and development of the product. The process included documentation of design inputs, risk analysis, design output, test procedures, generation and completion of verification and validation steps, and the completion and documentation of formal design reviews.

All verification and validation activities have been performed successfully, as identified by the risk analysis, ensuring the modified device is as safe and effective as the predicate device. The predetermined acceptance criteria have been met.

Additional testing was performed in accordance with the risk analysis and design control process to characterize RegenerOss Allograft Putty plus Mineralized and to demonstrate substantial equivalence to the predicate device.

Osteoinductive potential of the modified device compared to the predicate device has been evaluated in the athymic rat ectopic bone growth model. Results indicate comparable levels of osteoinductive performance (as indicated by histological scoring of new bone formation) of the predicate device compared to the modified device in this model.

Product functional testing was performed, including solubility testing in an aqueous environment and handling evaluation (extrudability, moldability and disintegration). Results indicate that the solubility and handling characteristics of the modified device are comparable to that of the predicate device.

Substantial Equivalence

Non-Clinical Studies

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Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralized

Conclusion

The safety and effectiveness of RegenerOss Allograft Putty Plus Mineralized was verified and documented through Biomet's design control process. Substantial equivalence to the predicate device is based on the same intended use and base material, (DBM and Carrier) of the Biomet cleared device, Intergro Oral; use of a secondary material ingredient cleared as part of other legally marketed devices within the same classification and same intended use; and verification and validation of selected performance properties and acceptance criteria.

113645

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

Ms. Kathleen Olivares Regulatory Affairs Associate Biomet Interpore Cross 181 Technology Drive Irvine, California 92618

JAN 2 0 2012

Re: K113645

Trade/Device Name: RegenerOss Allograft Putty Plus Mineralized Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: January 18, 2012 Received: January 19, 2012

Dear Ms. Olivares:

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. Olivares

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 /ucm 1 1 5809.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,

Nh 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

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Image /page/6/Picture/0 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '113645'. The characters are written in a clear, sans-serif font, and they appear to be part of a code or identification number.

Indications for Use

KI13645 510(k) Number (if known): ,

Device Name: RegenerOss Allograft Putty Plus Mineralized

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: K113645

Page 1 of 1

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.