ReOss" Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Device Description

ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue.

ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.

Products are provided in sterile packaging in various dosage volumes.

AI/ML Overview

This 510(k) summary (K082419) pertains to the ReOss™ Products, which are bone grafting materials. Based on the provided text, the submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents instead of new clinical study data to demonstrate substantial equivalence. Therefore, the information requested regarding acceptance criteria, device performance, and study details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within this document.

Here's why and what can be inferred:

Abbreviated 510(k): The document explicitly states: "This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This means the manufacturer is demonstrating substantial equivalence by showing conformity to recognized standards or guidance documents, rather than conducting new clinical performance studies specifically for this device.
Safety and Performance: The document states that Intra-Lock International "has provided information to demonstrate conformity with FDA's guidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045." This implies that the device's design and manufacturing meet the safety and performance requirements outlined in those guidance documents. However, the specific acceptance criteria and performance data from a dedicated study of the ReOss™ device itself are not presented here.
Conclusion: The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock ReOss" products have been shown to be safe and effective for its intended use." This re-iterates the substantial equivalence claim without detailing specific study results.

Therefore, the table and detailed study information requested cannot be fully populated from the provided text.

Here's a breakdown of what can be stated, acknowledging the limitations:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for a new clinical study. Instead, the acceptance criteria are implicit in the conformity to FDA guidance documents (Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045) and the equivalence to predicate devices. These guidance documents likely outline performance characteristics (e.g., biocompatibility, biodegradation rate, osteoconductivity) that the device implicitly meets by design and material composition.
- Reported Device Performance: No specific performance metrics (e.g., success rates, bone regeneration volume, adverse event rates from a study of ReOss™) are reported in this summary. The device's performance is inferred to be "safe and effective" based on its similarity to legally marketed predicate devices and compliance with relevant guidance.

Acceptance Criterion (Implicit from Guidance/Predicate)	Reported Device Performance (as inferred)
Biocompatibility	Assumed to meet standards of predicate devices and FDA guidance for bone grafting materials.
Resorbability	Confirmed by material description and classification as a "Resorbable calcium salt bone void filler device."
Osteoconductivity	Claimed by material description ("permeated with osteoconductive sub-micron particles of Hydroxyapatite") and intended use.
Safety & Effectiveness for Intended Use	Concluded to be "safe and effective" through comparison to predicate devices and conformity with FDA guidance.

Sample size used for the test set and the data provenance: Not applicable or provided, as no new clinical test set data from a study of ReOss™ is presented. Data provenance relates to predicate devices, but specific details are not given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided, as no new clinical test set requiring ground truth establishment for ReOss™ is described.
Adjudication method for the test set: Not applicable or provided.
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 device is a bone grafting material, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone grafting material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study of ReOss™. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by their previous regulatory clearances and real-world use overseen by FDA.
The sample size for the training set: Not applicable or provided, as no new clinical study data from a training set for ReOss™ is presented. (This question is typically relevant for AI/ML devices).
How the ground truth for the training set was established: Not applicable or provided.

In summary: This 510(k) summary demonstrates substantial equivalence by referencing existing FDA guidance and comparing the ReOss™ products to predicate devices, rather than presenting results from a de novo clinical study of the device's performance against specific acceptance criteria.

Summary

{0}------------------------------------------------

K082419

510(k) Summary

Establishment:

Intra-Lock International, Inc. 6560 West Rogers Circle Suite 24 Boca Raton, FL 33487

MAY 27 2009

Proprietary Name: ReOss™ Products

Classification Name: Bone Grafting Materials, 872.3930 Resorbable calcium salt bone void filler device 888.3045

Device Classification: Class Il

Predicate Devices:

Granular	Manufacturer	ProductCode	K#
Copios BVF	Kensy Nash/Zimmer	MQV	K071237
Eovia	Orthotec	MQV	K040514
OsSatura	Isotis	LYC	K042706
Bioscaff Alvelac	Bio-ScaffoldInternational Pte Ltd.	LYC	K080308
Putty	Manufacturer	ProductCode	K#
Stryker TCP	Stryker	MQV	K060061
Optimum DBM	LifeNet	MQV	K053098
Actifuse ABX E-Z fil	Apatec	MQV	K071206
Dynagraft	Isotis	MQV	K040419
Putty	Manufacturer	ProductCode	K#
Optimum DBM	LifeNet	MQV	K053098
DynaGraft	Isotis	MQV	K040419

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

K0802419

Material Description:

ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.

Products are provided in sterile packaging in various dosage volumes. ReOss

Intended Use:

Dental Applications

TM are indicated for filling and/or augmenting ReOss Granules intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation graffing.

Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's quidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045. In addition, theses guidance documents were also consulted during our preparation of this application for permission to market these products.

{2}------------------------------------------------

K082419

Conclusion:

Based on the indications for use, technological characteristics, and
comparison to predicate devices, the Intra-Lock ReOss" products have been shown to be safe and effective for its intended use.

{3}------------------------------------------------

Image /page/3/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffery Sakoff Vice President, Director of Operations Intra-Lock International, Incorporated 6560 West Rogers Circle, Suite 24 Boca Raton, Florida 33487

Re: K082419

Trade/Device Name: ReOss Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: MQV, LYC Dated: May 12, 2009 Received: May12, 2009

Dear Mr. Sakoff:

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 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.

{4}------------------------------------------------

Page 2- Mr. Sakoff

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Runner
Susan Runner, D.D.S., M.A.

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K082419

Indications for Use

510(k) Number (if known): K082419

Device Name: ReOss

Indications For Use:

Over-The-Counter Use Prescription 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey for MSN

Page 1 of 1

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

KO8241 510(k) Number:

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.