(184 days)
As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation.
As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.
Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.
The provided text describes a 510(k) premarket notification for a medical device called "Immix™ Bone Graft Extender." It outlines the device's purpose, comparison to a predicate device, and the FDA's decision regarding its substantial equivalence. However, the document does not contain any information about acceptance criteria, detailed study designs, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.
The 510(k) summary focuses on establishing substantial equivalence to a legally marketed predicate device (HTR Polymer, U. S. Surgical). This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs at least as safely and effectively as the predicate, often through comparisons to existing data or general performance characteristics rather than new, extensive clinical trials with specific acceptance criteria as might be seen for novel devices requiring PMA approval.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Table of Acceptance Criteria and Reported Device Performance: This information is completely absent. The document states "The results of performance and biocompatibility testing show that the Immix™ polymer material is safe and effective for its intended use and performs at least as well as legally marketed predicate devices," but it does not specify what those performance criteria were or the actual results.
- Sample Size and Data Provenance for Test Set: Not mentioned. It's unclear if any specific "test set" in the context of AI model evaluation was used, as this is a medical device, not an AI algorithm.
- Number and Qualifications of Experts for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned. The device is a "bone graft extender," not an imaging or diagnostic AI tool that would typically involve human readers.
- Standalone Performance Study (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of Ground Truth Used: Not mentioned. As it's a physical implant, "ground truth" would likely refer to clinical outcomes, histological analysis, or imaging results from biocompatibility and performance studies, but these details are not provided.
- Sample Size for Training Set: Not applicable/not mentioned. This is not an AI model requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable/not mentioned.
In summary, the provided 510(k) document is a regulatory submission for a physical medical device and does not contain the type of detailed performance study information, especially related to AI model evaluation, that your request specifies. The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to a predicate device, meaning it performs "at least as well" as the predicate based on unspecified performance and biocompatibility testing.
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510 (k) SUMMARY
l. ADMINISTRATIVE
Osteogenics Biomedical, Inc. Submitter: 3234 - 64th Street Lubbock, Texas 79413 (806) 792-2311
Contact Person: Chad Bartee
Date of Preparation: November 12, 2001
DEVICE NAME II.
Proprietary Name: Immix ™ Common Name: Bone Graft Extender Classification Name: Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction
PREDICATE DEVICE .
HTR Polymer, U. S. Surgical (K904111)
IV. DEVICE DESCRIPTION
Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.
V. INTENDED USE
As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation.
COMPARISON TO PREDICATE DEVICE vi.
The Immix™ polymer material is similar in composition, and identical in function and intended use to legally marketed devices such as HTR Polymer, U. S. Surgical.
The results of performance and biocompatibility testing show that the Immix™ polymer material is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the HTR Polymer material.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
16 2002
Osteogenics BioMedical, Incorporated C/O Richard A. Hamer Richard Hamer Associates, Incorporated 6401 Meadows West Drive Fort Worth, Texas 76132
Re: K013764
Trade/Device Name: Immix Bone Graft Extender Regulation Number: 878.3500 Regulation Name: Polytetrafluoroethylene with Carbon Fibers Composite Implant Material Regulatory Class: Unclassified Product Code: LYC and KKY Dated: February 21, 2001 Received: February 25, 2002
Dear Mr. Hamer:
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 - Mr. Hamer
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Patricia Cicconte/foe
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name: Immix™ Bone Graft Extender
Indications for Use:
As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _ OR
Swoon Rogers
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number - ( 0 ) 3
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.