Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for:
Filling of large oral and maxillofacial intra-osseous cavities.

Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection, apicectomy, and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

Device Description

Osta Maxigro™ and Osta Regigro™ are natural bone minerals which have been derived from a bovine extract. The material is essentially free from collagen and comprises of a highly purified mineral structure with micropores and trabecules which is comparable to that of human bone. The materials are prepared by extracting the fat and removal of the collagen, thereby resulting in a pure bone mineral that is sintered in block form and then crushed to form powder granules. This natural sponge like geometry comprising of Hydroxyapatite nano-crystalls results in a high internal surface area scaffold that typically exceeds 100m /g for Osta Maxigro™ and 80m /g for Osta Regigro™. The high surface area properties of these materials make them ideal for allowing blood flow to the wound site where bony contact is established during the bone remodeling process. Osta Maxigro™ and Osta Regigro™ have low crystallinities comparable to that of human bone which is completely resorbed and replaced by host bone during bone regeneration process. The materials support bone formation but do not induce bone formation. Osta Maxigro™ are available in powder or block form and both undergo final sterilization by y- radiation of Osta Maxigro™ blocks and granules can be utilized for the indications shown below depending on the defect size. Osta Maxigro™ Blocks is ideally recommended for filling of large bone cavities with limited bone height and or wall thickness.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Osta Maxigro™ and Osta Regigro™ devices:

The provided text describes a 510(k) premarket notification for Osta Maxigro™ and Osta Regigro™ (anorganic bovine bone grafting material), claiming substantial equivalence to the predicate device Bio Oss (K033815).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets. Instead, the submission relies on demonstrating similarity and no significant difference compared to the predicate device, Bio Oss (K033815). The "acceptance criteria" are implied to be achieving equivalence to the predicate in key characteristics.

Acceptance Criterion (Implied)	Reported Device Performance (Osta Maxigro™ & Osta Regigro™)
Effectiveness: In vitro dissolution rate comparable to predicate	"no significant difference in the dissolution rates of the devices (in either form powder or block) to the predicate" at 99% confidence. This is considered indicative of comparable in vivo resorption rates.
Safety: Biocompatibility according to ISO standards	Cytotoxicity: Conformed to ISO 10993-5. (Both individually and in combination).Intracutaneous Injection: Conformed to ISO 10993-5 (The document states ISO 10993-5 for Intracutaneous Injection initially, but then lists ISO 10993-10 under Standards Met, implying it aligns with the correct standard).Sensitization: Conformed to ISO 10993-10.Genotoxicity: Conformed to ISO 10993-3.In vivo implantation: "no significant difference regarding inflammation, encapsulation and angiogenesis with respect to the predicate as per ISO10993-6" at 99% confidence in a muscle pouch study.Sterility: Conformed to ISO 11137, achieving a Sterility Assurance Level (SAL) of 1x10⁻⁶.Prion reduction: Hydrogen peroxide gas treatment incorporated in the process as per published data.
Material Characteristics: Similar to predicate	Design: Similar, Osta Maxigro™ has higher surface area due to more micropores (closer to natural bone), which was verified not detrimental to performance. Osta Regigro™ has identical surface area.Materials: Similar (sourced from bovine femurs, similar thermal treatments).Mechanical Safety: Similar in Compressive Strength and Young's Modulus (though not intended for loading).Chemical Composition: Similar (based on Chemical Analysis, XRD, FTIR, Crystallinity, and dissolution performance).
Indications for Use: Identical to predicate	Identical: Augmentation or reconstructive treatment of alveolar ridge; Filling of periodontal defects; Filling of defects after root resection, apicectomy, and cystectomy; Filling of extraction sockets; Elevation of maxillary sinus floor; Filling of periodontal defects in conjunction with GTR/GBR products.
Target Population: Identical to predicate	Identical. Not for patients who exhibit Hyperthyroidism, Osteoporosis, Osteomalacia, Liver disease and renal dysfunction, diabetes and acute or chronic infections.
Anatomical Sites: Identical to predicate	Identical: Periodontal and Maxillo Facial.

2. Sample Size Used for the Test Set and Data Provenance

Dissolution Study: The text mentions "no significant difference in the dissolution rates of the devices (in either form powder or block) to the predicate" at 99% confidence, but does not specify the sample size for this test.
Biocompatibility Studies (in vitro/in vivo): The text mentions these tests were performed and conformed to ISO standards.
- Cytotoxicity, Intracutaneous Injection, Sensitization, Genotoxicity: These are in vitro or local toxicity tests. The document does not specify the number of samples or batches tested.
- Implantation Study (in vivo): An "in vivo implantation muscle pouch study" was conducted. The sample size is not specified. Given it's an animal study, the sample size would typically refer to the number of animals.
Data Provenance: The document does not explicitly state the country of origin for the data (e.g., if the dissolution or implantation studies were performed in South Africa where Osta Technologies is based, or elsewhere). The studies are described in a retrospective manner within the 510(k) submission, confirming tests were completed before submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The "ground truth" here is the established safety and effectiveness profile of the predicate device (Bio Oss) and the performance standards defined by ISO for various biological and material characteristic tests. The studies are laboratory-based and animal-based, not involving human expert assessment of clinical cases for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. The studies described are objective laboratory and animal tests, not clinical studies requiring human adjudication of results. "Adjudication method" primarily applies to clinical studies where human readers (e.g., radiologists) interpret images or clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices assisting human interpretation of medical images, which is not the nature of this bone grafting material device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as this is a medical device (bone grafting material), not an algorithm or AI software. All performance tests performed are inherently "standalone" in the sense that they assess the material itself without human interpretation as part of a diagnostic or therapeutic workflow.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established benchmarks and scientific principles:

Predicate Device Performance: The primary ground truth for substantial equivalence is the known performance and safety profile of the legally marketed predicate device, Bio Oss (K033815).
ISO Standards: International Organization for Standardization (ISO) standards (e.g., ISO 10993 series for biocompatibility, ISO 11137 for sterilization) serve as the ground truth for biological safety tests.
Scientific Understanding: The understanding that in vitro dissolution rates are indicative of in vivo resorption rates serves as a scientific ground truth for the effectiveness claim.

8. The Sample Size for the Training Set

This is not applicable. This submission describes a physical medical device (bone grafting material), not an AI/ML algorithm that requires a training set. The term "training set" is generally used in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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1091424

As Required by 21 section 807.92 ( c )

1-Submitter Name: Osta Technologies 19 Virgo Road. Farrarmere. Benoni 1518. South Africa 2-Address: 3-Phone: +27-11-425-1071 4-Fax: +27--866-407-469 5-Contact Person: Mr Dimitri Markoulides (Managing director) 6-Date summary prepared: 29 July, 2010

7 - Official Correspondent: Mansour Consulting LLC

8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA

9- Phone: 678-908-8180

10- Fax: 678-623-3765

11- Contact Person: Jay Mansour, President

12-Device Trade or Proprietary Name: Osta Maxigro™ and Osta Regigro™

13-Device Common or usual name: Anorganic Bovine Bone grafting material

14-Device Classification Name: Bone Filling Material

15-Substantial Equivalency is claimed against Bio Oss, cleared under K033815

16-Description of the Device:

17-Intended Use:

Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for:

Filling of large oral and maxillofacial intra-osseous cavities .

AUG 1 8 2010

ﻟﻠﺘﻨﺘ

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2074

18-Indications for Use: (refer to FDA form attached)

1. Augmentation or reconstructive treatment of alveolar ridge
1. Filling of periodontal defects
1. Filling of defects after root resection, apicectomy, and cystectomy
1. Filling of extraction sockets to enhance preservation of the alveolar ridge
1. Elevation of maxillary sinus floor
1. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

19-Technological Characteristics

TECHNOLOGICALCHARACTERISTICS	Comparison between K091424 and K033815	Location of justificationwithin K091424submission
Indications for use	Identical-See above	510k Summary
Target population	Identical- Not for patients who exhibitHyperthyroidism, Osteoporosis, Osteomalacia,Liver disease and renal dysfunction, diabetes andacute or chronic infections.	Device Labeling
Design	Similar, the only slight difference being is thatOsta Maxigro has higher surface area than thepredicate due to a higher volume of microporeswhich is closer to mimicking that of natural bone.The higher surface area of the device is notdetrimental to the performance characteristics ofthe device relative to the predicate as verified bydissolution and implantation tests. Osta Regigrohas an identical surface area to the predicate andhas the same volume of micropores.	Original SubmissionTab15 pp4-11
Materials	Similar, both devices are sourced from bovinefemurs and are treated with similar thermaltreatments.	S2-Tab 3
Performance	Similar, there is no statistical difference betweenthe dissolution characteristics or immunogenicresponses from implantation testing.	S2-Tab GOriginal Submission Tab F
Sterility	Similar both conform to ISO11137 in using asterilization cycle validated sterility assurancelevel (SAL) of 1x10-6	Original Submission Tab P
Biocompatibility	Similar both conform to the requirements of thebluebook memorandum G95-1 whichencompasses the following:Cytotoxicity testing ISO 10993-5Intracutaneous Injection ISO 10993-5Sensitization testing ISO 10993-10Genotoxicity Testing ISO 10993-3	Original Submission Tab 18Original Submission Tab 18Original Submission Tab 18S2 Tab AOriginal Submission Tab B-F
	K091424	3074

Mechanical safety	Similar in Compressive Strength and Young'sModulus, however Osta Maxigro & Osta RegigroAre not intended for loading.	Original Submission Tab 15
Chemical composition	Similar, based on Chemical Analysis, XRD, FTIRand Crystallinity analysis. The similar dissolutionperformance characteristics are evidence that thechemical composition is very similar.	Original Submission Tab 15
Chemical safety	Not applicable
Anatomical sites	Identical- Periodontal and Maxillo Facial
Human factors	Not applicable
Energy used and/ordelivered	Not Applicable
Compatibility withenvironment and otherdevices	Not Applicable.
Where used	Identical, both devices have the same intendeduses except for implant loading	510k Summary
Standards met	Similar, they comply withCytotoxicity testing ISO 10993-5Intracutaneous Injection ISO 10993-10Sensitization testing ISO 10993-10Genotoxicity Testing ISO 10993-3Implantation Testing ISO 10933-6
Electrical safety	Not applicable
Thermal safety	Not applicable
Radiation safety	Not applicable

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19- Brief discussion of the non clinical tests submitted, referenced or relied on in this 510k submission.

Effectiveness discussion

Assessment of the performance characteristics of the Osta Maxigro™ and Osta Regigro™ was carried out by a full chemical and physical characterization of the test devices relative to the predicate. The physical and chemical characteristics of the devices were comparable to the predicate; however, the key performance output that has a direct link to the chemical and physical characteristics was the dissolution performance of the devices relative to the predicate. It is well accepted that the in vitro dissolution rate comparisons of the devices relative to the predicate would be indicative of the in vivo resorption rates which would demonstrate substantially equivalence to the predicate. Given that at 99% confidence there was no significant difference in the dissolution rates of the devices (in either form powder or block) to the predicate, it follows that from a performance characteristic point of view, the devices would be as effective as that of the predicate.

Safety discussion

From a biological tolerance point of view the Osta Maxigro™ and Osta Regigro™ devices were tested individually regarding cytotixicity according to ISO 10993-5 and intracutaneous injection (ISO 10993-5) and in combination testing for cytotoxicity, sensitization testing ISO10993-10 and genotoxic screening (ISO 10993-3). It should be borne in mind that both Osta Maxigro™ and Osta Regigro™ devices are exposed to the same chemical treatments for the same times during processing. The Osta Maxigro™ and Osta Regigro™ devices conformed to all the standards mentioned above regarding safety. An in vivo impiantation muscle pouch study also concluded that at 99% confidence there was no significant difference, regarding inflammation, encapsulation and angiogenesis with respect to the predicate as per ISO10993-6. From a sterility point of view the devices also conformed to ISO 11137 in terms of achieving a sterility level SAL 1x10 °. In terms of mitigating the potential

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

K 091424

presence of prions, a hydrogen peroxide gas treatment was incorporated in to the process to reduce the potential presence of prions on the devices as per published data. Based on the biological screening, sterility tests and prion reduction initiatives as described above, the fact that the Osta Maxigro™ devices complies to all safety standards for biological tolerance means that the devices are as safe as that of the predicate.

20-Safety and Effectiveness of the devices:

Based on the summaries in (18 &19) above it is demonstrated that Osta Maxigro™ and Osta Regigro™ devices are substantially equivalent to the predicate Bio Oss™ and effective regarding the indications for use.

Page.

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

Osta Technologies C/O Mr. Jay Mansour Mansour Consulting, LLC 845 Aronson Lake Court . Roswell, Georgia 30075

AUG 1 8 2010

Re: K091424

Trade/Device Name: Osta Maxigro ™ and Osta Regigro Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: July 30, 2010 Received: August, 02, 2010

Dear Mr. Mansour:

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- Mr. Mansour

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,

Wh 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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K09/424

Indications for Use

171

510(k) Number (if known): K091424

Device Name: Osta Maxigro™ and Osta Regigro™

Indications For Use:

Augmentation or reconstructive treatment of alveolar ridge
Filling of periodontal defects
Filling of defects after root resection apicocectomy, and cystectorny
Filling of extraction sockets to enhance preservation of the alveolar ridge
Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

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

Over-The-Counter Use (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)

Rai Mreby for MSN

(Division Sign-Off)

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

Page 1 of

510(k) Number: _ KO91 424

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.