(13 days)
OsteoGraf/D-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
The OsteoGraf/D-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
The provided text is a 510(k) summary for the OsteoGraf/D-300 bone grafting material. This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than on a study proving the device meets specific performance acceptance criteria through clinical or AI-based evaluations.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-driven devices, cannot be found in this 510(k) summary.
Here's an breakdown of what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not define specific quantitative acceptance criteria or provide performance metrics (e.g., sensitivity, specificity, accuracy) for the OsteoGraf/D-300. The device is a bone grafting material, and its approval is based on substantial equivalence to an existing predicate device (OsteoGraf/P, K891173).
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Available: This type of information would be relevant for a study evaluating a diagnostic device or an AI model. For a bone grafting material seeking 510(k) clearance, performance is typically demonstrated through biocompatibility, material characterization, and comparison to a predicate, not through a "test set" in the sense of a diagnostic evaluation. The summary states, "the performance data provided," but does not detail what this data entails or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Available: Ground truth in this context (for a material) is not established by a panel of experts in the way it would be for a diagnostic image or clinical outcome assessment.
4. Adjudication method for the test set
- Not Applicable/Not Available: No test set or adjudication method is described.
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 type of study is relevant for AI-assisted diagnostic devices. The OsteoGraf/D-300 is a physical bone grafting material, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: The device is not an algorithm.
7. The type of ground truth used
- Not Applicable/Not Available: The concept of "ground truth" as pathology, outcomes data, or expert consensus used for evaluating diagnostic performance does not apply directly to the clearance of a bone grafting material. The "truth" for this device relates to its material properties, biocompatibility, and clinical performance as observed in studies for the predicate device, but these are not detailed as "ground truth" in this context.
8. The sample size for the training set
- Not Applicable/Not Available: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable/Not Available: No training set.
Summary of available information relevant to regulatory submission principles:
- Device Approval Type: 510(k) Premarket Notification.
- Basis for Clearance: Substantial Equivalence to a predicate device.
- Predicate Device: OsteoGraf/P, K891173.
- Key Argument for Equivalence: "All of the components found in OsteoGraf/D-300 have been used in legally marketed devices and/or were found safe for dental use. The modifications made to the legally marketed device do not affect biocompatibility."
- Intended Use Claimed: Identical to the predicate device.
- Performance Data Mentioned: "performance data provided" and "biocompatibility support", but specific details or metrics are not included in this summary.
In essence, this document is a regulatory announcement demonstrating that a new medical device is sufficiently similar to an already approved device that it does not require a new, extensive clinical trial demonstrating novel performance against defined acceptance criteria.
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1671
510(k) SUMMARY
AUG - 8 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
CONTACT: Helen Lewis
DATE PREPARED: July 18, 2007
TRADE OR PROPRIETARY NAME: OsteoGraf/D-300
CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930
PREDICATE DEVICES: OsteoGraf/P, K891173
DEVICE DESCRIPTION: The OsteoGraf/D-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
INTENDED USE: Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in OsteoGraf/D-300 have been used in legally marketed devices and/or were found safe for dental use. The modifications made to the legally marketed device do not affect biocompatibility. Therefore, it was determined that biocompatibility testing was not necessary. OsteoGraf/D-300 conforms to applicable industry standards.
We believe that the prior use of the components of OsteoGraf/D-300 in legally marketed devices. the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/D-300 for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract representation of an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2007
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K072052
Trade/Device Name: OsteoGraf/D-300 Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 18, 2007 Received: July 26, 2007
Dear Ms. Lewis:
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 - Ms. Lewis
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 vours.
Chiu Lin, Ph.D.
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: OsteoGraf/D-300
Indications for Use:
OsteoGraf/D-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
These are the same indications for use previously cleared for K891173.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off
Susa Putt
Civision of Anesthesiology, General Hospital Infaction Control, Dental Device
510(k) Number: K672352
§ 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.