(11 days)
OsteoGraf/LD-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
The OsteoGraf/LD-300 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
This 510(k) summary (K072057) is for a medical device called OsteoGraf/LD-300, which is a bone grafting material. The provided document does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study proving device performance as it pertains to AI/ML device evaluation.
Here's a breakdown of why and what information can be extracted:
Reasoning for missing information:
- Type of Device: OsteoGraf/LD-300 is a physical bone grafting material, not an AI/ML powered device, an imaging device, or a diagnostic tool that would typically have performance metrics like sensitivity, specificity, or AUC based on algorithmic output.
- 510(k) Summary Nature: A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics, intended use, and sometimes bench/animal testing or clinical data for safety and efficacy. It rarely includes detailed algorithmic performance metrics, ground truth establishment for AI, or MRMC studies.
- Date: This 510(k) is from 2007, a period before AI/ML in medical devices was prevalent and before specific FDA guidance for AI/ML device evaluation was established.
Information that can be extracted or inferred from the document:
Since this device is not an AI/ML device, the requested tabular format for AI/ML performance metrics and many of the specific questions are not applicable. However, I can still provide relevant information from the document in the context of device acceptance.
Device Acceptance (Based on 510(k) Summary Principles for Non-AI/ML Devices):
For a traditional device like OsteoGraf/LD-300, acceptance criteria and proof of meeting them are primarily demonstrated through:
- Substantial Equivalence: The primary means of "acceptance" in a 510(k) is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This involves comparing intended use, technological characteristics, and performance data (if applicable for non-clinical studies) to show that it is as safe and effective.
- Safety and Effectiveness: Performance data usually refers to non-clinical testing (e.g., biocompatibility) and, in some cases, clinical data if necessary to address new questions of safety or effectiveness not raised by the predicate.
Analysis of the Provided Text (K072057):
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Inferred from 510(k) Process) Reported Device Performance (Summary in K072057) Substantial Equivalence to Predicate Devices The device is deemed substantially equivalent to predicate devices OsteoGraf/LD-300 (K960353, K942212). This is the core "acceptance criterion" for a 510(k). Safety & Effectiveness (via predicate model) "We believe that the prior use of the components of OsteoGraf/LD-300 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/LD-300 for the indicated uses." Biocompatibility "The modifications made to the legally marketed device do not affect biocompatibility. Therefore, it was determined that biocompatibility testing was not necessary." (Implies previous biocompatibility for predicate was acceptable and modifications didn't change this). Conformity to Industry Standards "OsteoGraf/LD-300 conforms to applicable industry standards." Intended Use Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites. (Same as predicate devices). Technological Characteristics High purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite. Components used in legally marketed devices. -
Sample size used for the test set and the data provenance: Not applicable. This is a material, not an AI/ML algorithm or a diagnostic test with a test set of data. The "performance data provided" mentioned likely refers to non-clinical data or general accumulated knowledge/literature supporting the material's properties or clinical use, not a specific "test set" in the context of AI/ML validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" establishment in the context of expert review for data labeling, as this is not an AI/ML device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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 material, not designed to assist human readers or interpreted with AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. For a material like this, "ground truth" regarding its effectiveness would typically come from clinical outcomes data from studies (for PMA devices or some clinical studies supporting 510k) or established scientific understanding of the material's properties and clinical performance (for 510k based on substantial equivalence). The statement "prior use of the components... in legally marketed devices" and "performance data provided" serves as the basis for claiming safety and effectiveness by substantial equivalence.
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The sample size for the training set: Not applicable. This is a material device.
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How the ground truth for the training set was established: Not applicable.
Summary:
The provided 510(k) clearance document for OsteoGraf/LD-300 (K072057) is for a traditional bone grafting material, not an AI/ML-powered medical device. Therefore, the questions related to AI/ML specific performance metrics, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this device or its clearance pathway. The acceptance criteria for this device were primarily based on its substantial equivalence to existing predicate devices regarding intended use, technological characteristics, and safety and effectiveness, supported by the known properties of its components and existing performance data (likely non-clinical or historical clinical evidence from its predicate).
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510(k) SUMMARY
AUG - 6 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/LD-300 |
| CLASSIFICATION NAME: | Bone Grafting Material 21 CFR 872.3930 |
| PREDICATE DEVICES: | OsteoGraf/LD-300, (K960353, K942212) |
DEVICE DESCRIPTION: The OsteoGraf/LD-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/LD-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/LD-300 conforms to applicable industry standards.
We believe that the prior use of the components of OsteoGraf/LD-300 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/LD-300 for the indicated uses.
000009
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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 features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 2007
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K072057
Trade/Device Name: OsteoGraf/LD-300 Regulation Number: 21 CFR 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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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" (21 CFR 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,
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
K072057 510(k) Number (if known):
Device Name: OsteoGraf/LD-300
Indications for Use:
OsteoGraf/LD-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 K960353 and K942212.
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)
Super Pump
(Division Sign-Utt) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072032
000008
Premarket Notification
OsteoGraf/LD-300
DENTSPLY International
§ 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.