(31 days)
The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
Not Found
The provided document is a 510(k) clearance letter for the "Mirage Cedars Option" device, which is a Picture Archiving and Communications System (PACS) for scintigraphy camera output data. It does not contain a detailed study report or specific acceptance criteria with reported device performance. Therefore, I cannot provide the requested information based solely on the text provided.
However, based on the nature of a 510(k) submission for a PACS device, I can infer some general aspects and typical requirements. For a complete answer, one would need to access the full 510(k) summary or the original study data submitted to the FDA.
From the given document, I can only extract these pieces of information:
- Trade/Device Name: Mirage Cedars Option
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Picture archiving and communications system
- Regulatory Class: II
- Product Code: LLZ
- Indications for Use: The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
- 510(k) Number: K070683 (also K07106 is mentioned, but K070683 is the primary one in the letter header).
Regarding the specific questions you asked, here's an explanation of why the information is not present in this document and what would typically be expected for a PACS system:
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A table of acceptance criteria and the reported device performance:
- Information in document: Not present.
- Typical for PACS: For a PACS system, acceptance criteria usually relate to image display accuracy (e.g., adherence to DICOM Part 14 grayscale display function standard), image retrieval speed, data integrity, security, and functionality as described in the indications for use. Performance would be assessed against these functional and technical specifications rather than diagnostic accuracy (as it's a display/archiving tool, not a diagnostic AI algorithm).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information in document: Not present.
- Typical for PACS: A "test set" in the context of an algorithm's diagnostic performance isn't directly applicable here because the device is a PACS, not an AI diagnostic algorithm. Testing would involve system validation and verification with various types of scintigraphy images (DICOM compliance, correct display, retrieval) rather than a diagnostic evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Information in document: Not present.
- Typical for PACS: Ground truth in the diagnostic sense is not relevant for a PACS. Instead, validation would involve technical experts (e.g., medical physicists, IT professionals) to verify system functionality and adherence to standards, and potentially clinical users (e.g., nuclear medicine physicians) to confirm aesthetic and functional usability.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information in document: Not present.
- Typical for PACS: Adjudication is not typically used for PACS validation.
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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:
- Information in document: Not present.
- Typical for PACS: An MRMC study is not relevant for a PACS, as it's not a diagnostic AI tool intended to assist readers with interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information in document: Not present.
- Typical for PACS: Not applicable. A PACS is a system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information in document: Not present.
- Typical for PACS: Not applicable in the diagnostic sense. The "ground truth" would be technical specifications and clinical expectations for image display and archiving.
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The sample size for the training set:
- Information in document: Not present.
- Typical for PACS: Not applicable. PACS systems are not typically "trained" in the machine learning sense. They are engineered software systems.
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How the ground truth for the training set was established:
- Information in document: Not present.
- Typical for PACS: Not applicable.
In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical and clinical study results that would typically be found in a 510(k) summary or the full submission. For a PACS device like the "Mirage Cedars Option," the focus of testing and acceptance criteria would be on system functionality, compliance with standards (e.g., DICOM), data integrity, and display accuracy, rather than diagnostic performance metrics of an AI algorithm.
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Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be a stylized eagle or bird-like figure composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 2 2007
Philippe Briandet, Ph.D. President Segami Corporation 8325 Guilford Road, Suite B COLUMBIA MD 21046
Re: K070683
Trade/Device Name: Mirage Cedars Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2007 Received: March 13, 2007
Dear Dr. Briandet:
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.
Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo.
Protesting and Promoting Public Health
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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), 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litml.
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) Mirage Cedars Option
070683 510(k) Number (if known):_
Device Name: Mirage Cedars Option .
Indications for Use:
The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.
(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)
(Division Sign-Off) Division of Reproxime :: sodominal, and Radiological Device
§10(k) Number K07106
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Appendix II-2
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).