(34 days)
The QBrain software has been developed for the objective and reproducible analysis of MR images of the brain. It performs quantitative analysis of MR brain images based on automatic segmentation. More specifically, it quantifies the volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions). These parameters should only be used by trained medical professionals in clinical practice and to reach conclusions in clinical trials.
The QBrain software has been developped for the onalyses on MR brain images of based on automatic segmentation. More specifically, it quantifies the volumes of based on automatic segmentation: more openiture, more openiture (CSF), and white matter hyperintensities (lesions).
The provided text (K050703) describes the QBrain software, which performs automatic quantitative analysis of MR brain images, specifically quantifying the volumes of intracranial cavities, cerebrospinal fluid (CSF), and white matter hyperintensities (lesions).
However, the provided document does not contain information regarding traditional acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or a formal study designed to demonstrate performance against such criteria.
Instead, the submission emphasizes substantial equivalence to an existing predicate device (IQuantify workstation software, K011196). The "Summary of Safety and Effectiveness" primarily focuses on the device description, intended use, and a declaration of safety based on internal development, risk analysis, and validation tests. There is no detailed study methodology, test set characteristics, or a table of acceptance criteria with reported performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported performance, sample sizes used, number of experts, adjudication methods, MRMC study details, or standalone performance. The document only implicitly "proves" acceptance by asserting substantial equivalence and stating that "validation and validation tests" were performed, but without detailing their scope or results.
Here's a breakdown of what can be extracted from the provided text based on your questions, with the understanding that robust study details are absent:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy thresholds, sensitivity, specificity). The primary "acceptance" mechanism implied is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: No specific performance metrics (e.g., percentages, F1 scores, absolute error) are reported in the document.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
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, as no formal ground truth establishment for a test set is detailed.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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 Study: Not mentioned or described. The document states a primary use is "quantitative values support the diagnostic and/or therapy response" and "should only be used by trained medical professionals in clinical trials," but does not present a study comparing human performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No specific standalone performance study is described or reported with metrics. The device's function is "automatic segmentation," implying standalone capability, but its performance is not quantified.
7. The type of ground truth used:
- Type of Ground Truth: Not specified in detail for any study. The document mentions "mask data, generated by automatic segmentation and/or manual editing" as input for results, but does not clarify how a "ground truth" for evaluating the system's accuracy was established.
8. The sample size for the training set:
- Sample Size (Training Set): Not specified.
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not specified.
Summary based on available information:
The K050703 submission for QBrain primarily relies on demonstrating substantial equivalence to a predicate device (IQuantify workstation software, K011196) rather than providing detailed performance studies with quantitative acceptance criteria, test sets, and ground truth methodologies. The document emphasizes the device's functionality (automatic quantification of brain structures) and its intended use by trained medical professionals in clinical trials, but it lacks the specific data points requested in your prompt regarding detailed study designs and outcomes.
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12. SUMMARY OF SAFETY AND EFFECTIVENESS
- SUMMARY OF SAFETY AND E. F 20.000.01.2019 Part 807.87(h)
| • SubmitterAddress | : Medis medical imaging systems b.v.: Schuttersveld 9: 2316 XG Leiden, The Netherlands |
|---|---|
| Telephone | : +31 71 522 3244 |
| Fax | : +31 71 521 5617 |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : March 03, 2005 |
| • Device Name | : Automatic quantitative analysis of MR brain images |
| Common Name | : QBrain |
| Device Class. Name | : Class II; PACS software |
| Regulation Number | : 21 CFR 892.2050 (90 LLZ) |
| • Predicate Device(s) | : IQuantify workstation software, K011196 |
· Device Description and indications for Use · Device Description and indications for of other MRI vendors. Mask data, generated by automatic segmentation and/or manual editing, and quantitative results from different users generated by automatic segmentation aftarer manality of results from different users and easy export to standard spreadsheet software.
and easy export to standard spreadsheer onliners.
Neuro-(radio)logists in hospitals and specialists in core labs use the understing, and Neuro-(radio)logists in nospitals and specialists in the provided objective and analytical soliware package in image pot. process or are used in the quantitative Values Support the utagnostic und / or therapy response.
· Intended use
• Intended use The QErain sonware has been developped for the onalyses on MR brain images of based on automatic segmentation. More specifically, it quantifies the volumes of based on automatic segmentation: more openiture, more openiture (CSF), and white matter hyperintensities (lesions).
nyperimenties (lesions).
These parameters should only be used by trained medical professionals in alinian trials These parameters should only be used by trained weach conclusions in clinical trials.
• Substantial equivalence Information
· Substantial equivalent to the Predicate Device of Insightful Corporation QBRAIN IS substantially equivalent to the Products annique for the same intended use.
Conclusion
It is our opinion, QBrain is safe because during the development ond rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, and rick, It is our opinion, QBrain is sale because canning and hazard and risk analyses,
were controlled by a risk management plan, including hazard and risk andyses, were controlled by a fisk management partic partic and literature support this verticalion and validation tests. Endinone if will not have any adverse effects on statement. The solware package QDrain noon will not have any any any and chooses to accept or reject the results.
accept of reject the results.
In current thinking, the level of concern for the standalone software in image post-In current thinkling, the lever of QBrain does not change the intended use of MRI processing is "Minor and the use result in any new potential hazard.
scanners in practice, nor does the use roour in any conclude that the subject device is Based of the information ouplikalent to the predicate device.
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing left and appears to be in flight. The logo is black and white.
Public Health Service
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems bv Schuttersveld 9, 2316 XG Leiden THE NETHERLANDS
Re: K050703 Trade/Device Name: QBrain Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: March 3, 2005 Received: March 18, 2005
Dear Mr. Hollander:
Doar Mr 2001
We have reviewed your Section by the time to maket the indications for use stated in We have reviewed your Section 510(K) premainst interested (for the indications for use stated in
above and have determined the device is substantially equival in interests pr above and have determined the devices is substances marketed in interstate commerce prior to
the enclosure) to legally marketed predicated in interstate or to devices that ha the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device and Cosmetic Act (Act) the May 28, 1976, the enactment date of the Necded Dely, and Cosmetic Act (Act) that reclassified in accordance with the provisions of and of the A. You may, therefore, market the do not require approval of a premarket approval application (The eyeneral controls provisions of the Act
device, subject to the general controls provisions of the Act manufac device, subject to the general controls provisions of devices, good manufacturing practice, labeling, metude requirements iss misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket
) (Special Control (States (Altimal and Prel - Evicting major regul If your device is classified (see above) into crails . Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulation in the Federal Register device can be found in the Code of I edolar regulation of the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualice of a substances with other requirements of the Act or any
FDA has made a determination that your device complies. You must comply with FDA has made a determination inal your device whales what agencies. You must comply with all the Federal statutes and regulations administered by enistration and listing (21 CFR Part 807); labeling
Act's requirements, including, but not limited to registration as as fort Act's requirements, including, but not mined to registed to the the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quali (21 CFR Part 801); good manuacium production in a sectronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radia (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)
Children and construction of alience frame faulicatial equivalence of your devic This letter will allow you to begin marketing your also as as as your device of your device to a legally
premarket notification. The FDA indine of substantial equivalence of premarket notification. The FDA finding of substantial equivalence of 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
r and the may of the filler following numbers, hased on the regulation numb If you desire specific advice for your device on our labeling regaration (even and 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 while for stime of researce to premarket notification" (21 CFR Also, please note the regulation entitled, Misolaning on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility and its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistanc Division of Small Manafastarana, at its Internet address.
638-2041 or (301) 443-6597 or at its Internet address 038-2041 of (501) +15 -0/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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Indications for Use
510(k) Number (if known): K050703
Device Name: QBrain
Indications For Use: The QBrain software has been developed for the objective and Indications For USe. The Qurain soltware from In Marc one offically analysis of MR
reproducible analysis of MR images of the brain. It performs quantities the reproducible analysis of Mrs images of the brain. More specifically, it quantifies the brain images based on adtomatic segmentation more opening ;
volumes of intracranial cavities, areas that contain cerebrospinal fluid (CSF), and white matter hyperintensities (lesions).
matter nypermiensities (tesions).
These parameters should only be used by trained conclusions in clinical trials These parameters should only be used by trained model practice and to reach conclusions in clinical trials.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Snowdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).