(21 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Models HRS-63-8 and HRS-127-8 Shoulder Array Coils
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (MRI coils). This type of document does not contain information regarding software-related acceptance criteria, study details, or AI performance metrics.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements for the physical device, but it does not include any performance data or studies that would address the points in your request related to acceptance criteria for software, AI, or human reader performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts for ground truth, or adjudication methods for a test set.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set or how its ground truth was established.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health and Human Services - USA. The seal features the department's emblem, which is a stylized representation of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2005
Mr. Thomas Schubert Chief Technology Officer Invivo Corporation N27W23676 Paul Road PEWAUKEE WI 53072
Re.: K053017 Trade/Device Name: Models HRS-63-8 and HRS-127-8 Shoulder Array Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: MOS Dated: October 25, 2005 Received: October 26, 2005
Dear Mr. Schubert:
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 (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 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 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.
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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(K) Application, Device Modification Models HRS-63-8 and HRS-127-8 Shoulder Array Coils, October 25, 2005
Section C - Statement of Indications for Use
Applicant: Invivo Corporation K053017 510(k) number (if known): Device Name: Models HRS-63-8 and HRS-127-8 Shoulder Array Coils
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Nancic Brogdon
(Division Sign-Off)
Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053017
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Over-The-Counter Or Use Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Page 3
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.