(21 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.
Model CAC-127-8 Cardiac Array Coil
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided text, it is a 510(k) clearance letter for a medical device: Model CAC-127-8 Cardiac Array Coil. This document is a regulatory clearance and does not contain the detailed study information typically found in a clinical study report or a scientific publication.
Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study designs (MRMC, standalone) cannot be extracted from this 510(k) clearance letter.
The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technical characteristics and performance being similar to existing devices, implying that it meets the same safety and effectiveness standards. However, the specific details of how that performance was proven are not included.
Here's what can be inferred or directly stated from the document, along with what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in this document. A 510(k) clearance letter does not detail specific acceptance criteria or quantitative performance metrics. It confirms that the device has been reviewed and found substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
Not available in this document. The letter does not describe any specific test set or the characteristics of the data used for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not available in this document. The letter does not mention ground truth establishment or the involvement of experts in a testing phase.
4. Adjudication Method
Not available in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not available in this document. The letter does not discuss MRMC studies or the effect size of human readers with/without AI assistance. Given the device is a cardiac array coil (a hardware component for an MRI scanner), it's highly unlikely that an MRMC study for AI assistance would be relevant or performed for this specific device.
6. If a Standalone Performance Study Was Done
Not available in this document. The letter does not provide details of any standalone performance study. For a hardware component, standalone performance would likely relate to signal-to-noise ratio, homogeneity, artifact levels, etc., which are not detailed here.
7. The Type of Ground Truth Used
Not available in this document.
8. The Sample Size for the Training Set
Not available in this document. This device is a hardware component and not an AI/ML algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not available in this document. (Not applicable for this type of device and document)
Summary of what is known from the document:
- Device Name: Model CAC-127-8 Cardiac Array Coil
- Intended Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician."
- Regulatory Status: Substantially Equivalent (K051512) to a predicate device.
- Regulatory Class: Class II
- Product Code: MOS
- Date of Clearance: June 28, 2005
To obtain the detailed information you are requesting (acceptance criteria, study design, sample sizes, ground truth, expert qualifications), you would typically need to consult:
- The original 510(k) submission document: This document, submitted by Invivo Corporation to the FDA, would contain the technical specifications, performance data, and comparison to predicate devices. These are usually not publicly available in their entirety.
- Publicly available summaries of 510(k)s: The FDA sometimes publishes summaries, but often these do not include granular study details.
- Scientific publications: If the performance data was significant enough, it might have been published in a peer-reviewed journal.
- Clinical trial reports: If any specific trials were conducted beyond typical substantial equivalence testing, their reports would contain this data.
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Image /page/0/Picture/1 description: The image is a 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 an emblem of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Schubert Chief Technology Officer Invivo Corporation N27 W23676 Paul Rd PEWAUKEE WI 53072
Re: K051512 Trade/Device Name: Model CAC-127-8 Cardiac Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 1, 2005 Received: June 7, 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 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 (Premarket Approval), 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.
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.
JUN 2 8 2005
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reteet notification. The FDA finding of substantial equivalence of your device to a legally premained noticale 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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Section C – Statement of Indications for Use:
Applicant: Invivo Corporation Kor 1512 510(k) number (if known):_ Device Name: Model CAC-127-8 Cardiac Array Coil
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| ------------------ | -- |
$\checkmark$
Over-The-Counter or Use
Nancy brondon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K057512
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
510(k) Number _
N/A