(57 days)
The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. 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.
The product (Mirage) is basically a camera driven acquisition, processing and postprocessing (visualization and analysis) software system with a Patient Data Management system, to which minimal processing (e.g. tomographic reconstruction) has been added.
The provided text describes a 510(k) submission for the "MIRAGE" Nuclear Medicine Planar and SPECT Image Processing Software by Segami Corporation. However, it does not contain the detailed information required to describe acceptance criteria and the extensive study methodologies you've requested.
The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.
Here's a breakdown of why the requested information cannot be fully extracted from the provided text:
- No specific acceptance criteria are listed for the device itself. The document states that "Substantial equivalence was shown non-clinically by demonstrating that Generic Image Operations, Generic Tomographic post-processing, First Pass Ventriculography and Planar Gated Blood-pool Analysis did not yield substantially different results from those of the predicate devices." It also mentions "Substantial equivalence was evidenced clinically by demonstrating that in the clinical applications (of current clinical cases or archival cases) the clinician's conclusion would not have differed substantially." This points to a comparative assessment against predicate devices, but not a set of predefined performance thresholds for MIRAGE itself.
- No specific study is described in detail. Instead, the document refers to "demonstrating" certain aspects for substantial equivalence. It doesn't outline a formal study design, sample sizes, ground truth establishment, or expert involvement as a typical performance study would.
Therefore, for most of your questions, the answer will be "Information not provided in the document."
Despite the limitations, here's what can be inferred or explicitly stated based on the provided text, aligned with your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Non-Clinical: Generic Image Operations yield results not substantially different from predicate devices. | MIRAGE's Generic Image Operations did not yield substantially different results from ICON COMPUTER SYSTEM (K914350) and SOPHY NXT (K913641). |
| Non-Clinical: Generic Tomographic post-processing yields results not substantially different from predicate devices. | MIRAGE's Generic Tomographic post-processing did not yield substantially different results from ICON COMPUTER SYSTEM (K914350) and SOPHY NXT (K913641). |
| Non-Clinical: First Pass Ventriculography yields results not substantially different from predicate devices. | MIRAGE's First Pass Ventriculography did not yield substantially different results from ICON COMPUTER SYSTEM (K914350) and SOPHY NXT (K913641). |
| Non-Clinical: Planar Gated Blood-pool Analysis yields results not substantially different from predicate devices. | MIRAGE's Planar Gated Blood-pool Analysis did not yield substantially different results from ICON COMPUTER SYSTEM (K914350) and SOPHY NXT (K913641). |
| Clinical: Clinician's conclusion in clinical applications (current/archival cases) would not differ substantially compared to predicate devices. | In clinical applications (of current clinical cases or archival cases), the clinician's conclusion would not have differed substantially when using MIRAGE vs. predicate devices. |
| Technical: Data validity and integrity in Patient Data Management. | The Patient Data Management went through a separate technical test in which the validity and integrity of the data was evaluated, and concluded to be similar to predicate devices. |
2. Sample sizes used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "current clinical cases or archival cases" but does not quantify the number of cases or images.
- Data Provenance: "Current clinical cases or archival cases." Country of origin is not specified. It is an unspecified mix of retrospective and potentially current cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document mentions "the clinician's conclusion." This implies that qualified clinical professionals (likely Nuclear Physicians, given the intended use) were involved in forming conclusions, but their specific qualifications or experience level are not detailed.
4. Adjudication method for the test set
- Adjudication Method: Not specified. The phrase "the clinician's conclusion would not have differed substantially" suggests a comparison, but the method of adjudication (e.g., 2+1, 3+1, or independent reviews) is not described.
5. 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
- MRMC Comparative Effectiveness Study: Not explicitly described. The study was focused on demonstrating "substantial equivalence" of the MIRAGE system (an image processing software) to predicate devices, rather than assessing human reader improvement with or without AI assistance. The MIRAGE system itself is an image processing tool, not an AI assistant in the modern sense.
- Effect Size: Not applicable/not measured.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The non-clinical demonstrations ("Generic Image Operations," "Generic Tomographic post-processing," etc.) suggest an assessment of the algorithm's output compared to predicate devices, implying a form of standalone evaluation. However, precise metrics for this standalone performance (e.g., accuracy, precision) relative to a true ground truth are not provided; the comparison is to the output of predicate devices. The "Patient Data Management" also underwent a "separate technical test" for validity and integrity.
7. The type of ground truth used
- Ground Truth Type:
- For non-clinical performance (image operations, tomographic processing, etc.): The 'ground truth' was effectively the output/results from the predicate devices (ICON COMPUTER SYSTEM and SOPHY NXT). The goal was to show MIRAGE's output was "not substantially different."
- For clinical conclusions: The 'ground truth' was "the clinician's conclusion" from using predicate devices in "current clinical cases or archival cases." The aim was to show the clinician's conclusion "would not have differed substantially" with MIRAGE.
- For Patient Data Management: "validity and integrity of the data" was evaluated, suggesting a comparison against expected data standards.
8. The sample size for the training set
- Training Set Sample Size: Not specified. As this is a 510(k) for an image processing system from 1997, the concept of a "training set" in the context of modern machine learning/AI might not be directly applicable in the same way. The software likely relied on established algorithms and mathematical models, rather than data-driven machine learning models requiring extensive training data.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not specified. (See point 8 regarding the applicability of "training set" in this context).
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Segami Corporation
×972886
10. 510K Summary
OCT - 1 1997
10.1. Identification
ﻟﻤﺴﺘﻘ
10.1.1 Date of Application:
10.1.2 Manufacturing Facility:
August 4, 1997
Segami Corporation, Inc. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: (410) 531-2357 fax: (410) 531-5029
10.1.3 Contact Person :
Philippe Briandet Ph.D. 12624 Golden Oak Drive Ellicott City, MD 21042 phone: (410) 531-2357 fax: (410) 531-5029
10.1.4 Signature
Philippe Briander
Date 08-04-97
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10. 2. Device Name
ﻴﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ
10.2.1 Classification Name:
10.2.2 Common/Usual Name:
Image Processing System
Nuclear Medicine Planar and SPECT Image Processing Software
10.2.3 Proprietary Name:
MIRAGE
10.3. Substantial Equivalence (Predicate devices)
The predicate devices are the ICON COMPUTER SYSTEM by Siemens Medical Systems, Inc.(Product code JWM, 510K # K914350) and SOPHY NXT by Sopha Medical Systems, Inc.(product code KPS and 501K# K913641).
Substantial equivalence was shown non-clinically by demonstrating that Generic Image Operations, Generic Tomographic post-processing, First Pass Ventriculography and Planar Gated Blood-pool Analysis did not yield substantially different results from those of the predicate devices.
Substantial equivalence was evidenced clinically by demonstrating that in the clinical applications (of current clinical cases or archival cases) the clinician's conclusion would not have differed substantially.
The technological characteristics which differ have no effect on the software's results: The Mirage system is based on the PC architecture (versus Macintosh and proprietary for predicate devices), the operating system is Windows NT (versus Macintosh and Forth), the software language is Visual C++ (versus Pascal and Forth).
The Patient Data Management went through a separate technical test in which the validity and integrity of the data was evaluated.
Conclusion:
The Mirage Software package is closely similar in intended use and technical characteristics to the predicate devices. The product raises no new questions regarding safety or effectiveness. Segami Corporation. Inc. concludes that the product is essentially equivalent to devices of the same classification previously approved.
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10.4 Description.
Camera driven acquisition software refers to the formatting of camera signals into spatial distributions, and producing timing signals allowing camera defined acquisition or motion to proceed. The term processing refers to all manners of data manipulation, following the acquisition. including the reconstruction of tomographic volume data from multiple projection acquisitions. The term post-processing refers to image manipulation and analysis which occurs after the image (planar or tomographic, static or dynamic) has been formed. Post-processing specifically includes display methods, which determine how the user can (re)view and interpret the data.
The most crucial component for a post-processing system, which should be able to receive and handle data (images) from different origins (acquisition systems), is the Patient Data Management.
The product (Mirage) is basically a camera driven acquisition, processing and postprocessing (visualization and analysis) software system with a Patient Data Management system, to which minimal processing (e.g. tomographic reconstruction) has been added.
10.5 Statement of Indication for use.
The intended use of the Mirage system of image acquisition, processing and analysis is to provide the Nuclear Physician with a tool to acquire, format and store the data acquired by a camera, to display in all the traditional manners, to add three-dimensional renderings to the displays, and to display some kinetic attributes of the imaged organs or systems. The major benefits are the ease of use, the speed of processing, and the variety of display alternatives.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized human figure with three arms raised in a wave-like pattern. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
Philippe Briandet, Ph.D. President Segami Corporation 12624 Golden Oak Drive Ellicott City, MD 21042
OCT - I 1997 Re: K972886 Mirage Nuclear Medicine Image Processing System Dated: August 4, 1997 Received: August 5, 1997 Unclassified/Procode: 90 LLZ
Dear Dr. Briandet:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Pracice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.J.Liau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K972886
Device Name: Mirage
Indications for Use:
The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy camera output data. 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)
Thavid A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).