(17 days)
Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
Not Found
The input provided is a 510(k) clearance letter from the FDA for a surgical mesh device, Atrium C-QUR RPM Mesh. This document is related to medical device regulation and describes the process of obtaining clearance for a physical medical device (surgical mesh), not a software-as-a-medical-device (SaMD) or an AI-based diagnostic tool.
Therefore, the concepts of "acceptance criteria," "study," "sample size for test set," "ground truth," "MRMC study," "standalone performance," and "training set" as described in the prompt are not applicable to this type of device and document. These criteria are specifically for evaluating the performance of AI algorithms or diagnostic tools, which rely on data analysis and interpretation.
The provided document simply states that the Atrium C-QUR RPM Mesh is substantially equivalent to legally marketed predicate devices. This equivalence is typically established through preclinical testing (e.g., biocompatibility, material properties) and/or sometimes clinical use data if a novel feature is introduced, but not through the type of performance study outlined in the prompt for AI/diagnostic software.
In summary, none of the requested information regarding acceptance criteria, study details, and AI-specific performance metrics can be extracted from this document because it pertains to a physical surgical mesh, not an AI device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Atrium Medical Corporation % Mr. Joseph P. De Paolo VP Regulatory Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K121070
Trade/Device Name: C-QUR RPM Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXA Dated: April 3, 2012 Received: April 9, 2012
Dear Mr. De Paolo:
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.
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
APR 2 6 2012
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Page 2 - Mr. Joseph P. De Paolo
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/CDRH0ffices/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.
Mark A. Millhussen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1 510(k) Number (if known): Device Name: Atrium C-Qur RPM Mesh
Indications for Use:
Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
Prescription Use _ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kronefu MXM
(Division Blue Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121070
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.