(87 days)
The CalScoR Software is intended to be used with the Rapidia software by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.
CalScoR is a Windows-compatible software program that runs with the previously cleared Rapidia Software (K012290). The Rapidia Software is a fast, practical, and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics-rendering technology.
CalScoR can specify the location of calcium in images, calculate the calcium score based on Agaston's method display the percentile of the score with the graph, and issue reports.
Here's a summary of the acceptance criteria and study details for the 3DMed Co., Ltd. CalScoR software, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Scores obtained from CalScoR and predicate device (AccuScore) are similar. Linear regression slope = 1, intercept = 0. | Linear regression demonstrated the scores were similar, with a calculated slope of 1 and intercept of 0. |
| Scores obtained from CalScoR and predicate device (AccuScore) are essentially identical. | F-test resulted in an F-value of 13742853.39, showing the two scores are identical within 0.0001 (0.01%) error level. |
| CalScoR performs all functions according to the functional requirements specified in the Software Requirements Specifications. | Testing demonstrated that the CalScoR performs all functions according to the functional requirements. |
Study Information
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Tests were performed to compare the accuracy," but does not specify the number of cases or the origin of the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as the comparison was against a predicate device's output, not expert-established ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as the comparison was against a predicate device's output.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The study focused on comparing the algorithm's output to a predicate device's output.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the testing compared the CalScoR software's output directly to the predicate device's output, indicating a standalone algorithm comparison.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this study was the output of a legally marketed predicate device, AccuScore/Accuview Software (K990241), which also calculates calcium scores based on Agaston's method.
- The sample size for the training set: Not applicable. The document does not describe a machine learning model that would require a distinct training set. The device's algorithm for calculating calcium score is stated to be based on Agaston's method.
- How the ground truth for the training set was established: Not applicable.
Overall, the study focused on demonstrating substantial equivalence to a predicate device by comparing the outputs of the two software programs using statistical methods (linear regression and F-test), rather than directly validating against clinical outcomes or a human expert standard.
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6 2002 SEP
510(k) Summary for 3DMed Co., Ltd. CalScoR
1. Submitter Name and Address
Jae Choi, PhD 3DMed Co., Ltd. 940-319 Research Park SNU, San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 REPUBLIC OF KOREA
Telephone: 82-2-889-1764
Date Prepared: June 10, 2002
2. Device Name
Proprietary Name: CalScoR Software Common/Usual Name: Calcium scoring software Picture archiving and communications system Classification Name:
3. Predicate Device
Accuview/AccuScore Software (K990241)
4. Intended Use
The CalScoR Software is intended to be used by a trained physician with the Rapidia software for the review and analysis of CT images as an aid in cardiac analysis.
5. Device Description
CalScoR is a Windows-compatible software program that runs with the previously cleared Rapidia Software (K012290). The Rapidia Software is a fast,
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practical, and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics-rendering technology.
CalScoR can specify the location of calcium in images, calculate the calcium score based on Agaston's method display the percentile of the score with the graph, and issue reports.
Technological Characteristics 6.
The CalScoR Software and the predicate device are both software programs that can be used for measuring calcium scores from CT images. The CalScoR software can be operated from a personal computer. The algorithm for calculating calcium score is based on Agaston's method.
7. Performance Testing
Tests were performed to compare the accuracy of the CalScoR's calcium score with that of the predicate device. A linear regression was used to demonstrate that the scores obtained from the AccuScore and CalScoR were similar. The slope was set to 1 and the intercept was set to 0. Additionally, an F-test was used to show that the two scores are essentially identical. The F-value of the experimental results was 13742853.39, which means that the two scores are identical within 0.0001(0.01%) error level
The testing demonstrated that the CalScoR performs all functions according to the functional requirements specified in the Software Requirements Specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.
od and Drug Administration rate Boulevard
3DMed Co., Ltd. % Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K021913
Trade/Device Name: CalScoR Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 10, 2002 Received: June 11, 2002
Dear Ms. McNamara-Cullinane:
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 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
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21 CFR 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,
Nancy C. Snogdon
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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510(k) Number (if known):
Device Name: CalScoR Software
Indications for Use:
The CalScoR Software is intended to be used with the Rapidia software by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Siegmann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
§ 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).