(42 days)
The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Cbyon System with Image Enhanced Fluoroscopy Module." This type of document primarily confirms that a new device is substantially equivalent to a predicate device already on the market, rather than detailing clinical study results or performance criteria for a novel AI/ML device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this FDA clearance letter.
The letter focuses on regulatory approval based on substantial equivalence, and not on a detailed performance evaluation as would be required for a novel AI/ML diagnostic or prognostic device.
Here's what can be extracted:
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A table of acceptance criteria and the reported device performance:
- This information is not present in the 510(k) clearance letter. The letter confirms substantial equivalence, not detailed performance metrics against specific acceptance criteria.
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Sample sizes used for the test set and the data provenance:
- Not applicable/Not found in this document. This document is not a clinical study report.
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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/Not found in this document.
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Adjudication method for the test set:
- Not applicable/Not found in this document.
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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/Not found in this document. The device is a "computer-aided, image-guided system," which implies human interaction, but MRMC study details are not provided.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not found in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not found in this document.
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The sample size for the training set:
- Not applicable/Not found in this document.
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How the ground truth for the training set was established:
- Not applicable/Not found in this document.
Summary based on the provided document:
The provided text is an FDA 510(k) clearance letter for the Cbyon System with Image Enhanced Fluoroscopy Module. This document serves as regulatory approval based on demonstrating substantial equivalence to a legally marketed predicate device. It does not contain the detailed clinical study results, performance metrics, sample sizes, ground truth methodologies, or expert qualifications that would be typically found in a clinical study report or a premarket approval (PMA) submission for a novel device, especially an AI/ML product.
Therefore, none of the specific questions regarding acceptance criteria and study details can be answered based solely on the provided FDA 510(k) clearance letter. The letter simply states the device is "substantially equivalent" to predicate devices for its stated "Indications for Use," which are for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2001
Ms. Krishna Sudhakaran Regulatory Compliance Manager Cbyon, Inc. 2275 E. Bayshore Road, Suite 101 Palo Alto, California 94303
Re: K012886
Trade/Device Name: Cbyon System with Image Enhanced Fluoroscopy Module Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 8, 2001 Received: September 10, 2001
Dear Ms. Sudhakaran:
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.
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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Page 2 - Ms. Krishna Sudhakaran
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) 594-4659. 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,
Susan Walker, MD
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Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Indications for Use Statement
510(k) # 0001714
Device Name: CBYON System with Image Enhanced Fluoroscopy Module
Indications for Use: The CBYON System with Image Enhanced Fluoroscopy Module intended use is as a computer-aided, image-guided system intended for planning and intraoperative navigation for cranial, spinal, and cranial biopsy procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
Signature Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
4 Number is for the predicate device, the CBYON System
A
510(k) Number K012886
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).