Allow the user to interactively indicate regions of detected calcification .
To allow the user to allocate each detected region to one of several coronary arteries .
To estimate algorithmically a score for the amount of detected calcification in each allocated . artery
To prepare reports including calcium score data, imagery, ECG traces, Comparison of score ◆ to cited literature and additional relevant information

The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium sconing may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.

Device Description

Calcium Scoring is a software package running on the 3Dvirtuoso workstation that allows the user to mark regions of detected calcification in CT cardiac images, to assign each region to a coronary artery, and to calculate the Agatston score and other information from the identified pixels. Film and paper reports of the results can also be prepared. Calcium Scoring is also a cost-effective alternative to Electron Beam CT (EBCT), since it produces calcium scores that correlates to the EBCT's gold standard, but at a much lower cost.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens Calcium Scoring Software Package (K990426). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria and a comprehensive study description. Therefore, some of the requested information, particularly regarding specific acceptance criteria, detailed study design, and sample sizes for testing and training, is not explicitly stated in the provided text.

Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or agreement thresholds. Instead, it describes the software's functionality and implies its performance by stating its ability to "calculate the Agatston score and other information from the identified pixels" and that it "produces calcium scores that correlates to the EBCT's gold standard." The primary "performance" mentioned is its correlation to a gold standard and its function as a cost-effective alternative.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to mark regions of calcification in CT cardiac images	Allows the user to interactively indicate regions of detected calcification.
Ability to assign calcifications to coronary arteries	Allows the user to allocate each detected region to one of several coronary arteries.
Ability to calculate Agatston score and related information	Algorithmically estimates a score for the amount of detected calcification in each allocated artery; calculates the Agatston score and other information from identified pixels.
Correlation of calculated calcium scores to EBCT gold standard	Produces calcium scores that correlates to the EBCT's gold standard.
Ability to generate reports	Prepares reports including calcium score data, imagery, ECG traces, comparison of score to cited literature, and additional relevant information.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions a correlation to "EBCT's gold standard" but doesn't elaborate on the study that established this correlation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The reference to "EBCT's gold standard" implies that Electron Beam CT was used as a reference, but it doesn't detail how this "gold standard" data was analyzed or confirmed by experts for the purpose of validating the software.

4. Adjudication method for the test set

The document does not specify any adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the software's functionality and its equivalence to predicate devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software is described as allowing the user to "interactively indicate regions of detected calcification" and "allocate each detected region." This implies a human-in-the-loop approach. While it then "estimates algorithmically a score," the initial steps involve user interaction. Therefore, a standalone (algorithm only) performance assessment as a primary validation step is not explicitly described or indicated by the software's interactive nature as presented.

7. The type of ground truth used

The primary ground truth referenced is "EBCT's gold standard." This implies that electron beam computed tomography results were considered the highly accurate reference for calcium scoring, against which the software's output was correlated.

8. The sample size for the training set

The document does not specify the sample size for a training set. Given the era (1999) and the nature of the submission (510(k) for substantial equivalence), detailed information on deep learning training sets is unlikely to be present.

9. How the ground truth for the training set was established

The document does not specify how ground truth for a training set was established, nor does it explicitly mention a distinct training set.

Summary

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K990426

MAY 1 2 1999

Attachment 11

510(k) Summary

Siemens Calcium Scoring Software Package

April 30, 1999

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information. I.
- Establishment

Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, NJ 08830
Contact Person:	Kathleen M. RutherfordManager, Regulatory Submissions(908) 321-4779 phone(908) 321-4841 fax
Device Name
Trade Name:	Calcium Scoring
Common Name:
Classification Name:	Picture Archiving and CommunicationSystem (PACS)
Classification:	Class II
Performance Standards:	None established under Section 514

II. Information Supporting Substantial Equivalence Determination.

· Device Description:

of the Food, Drug, and Cosmetic Act.

· Intended Use:

The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.

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· Technological Characteristics as compared to the Predicate Device:

As in the predicate devices UltraAccess and NetraMD, the Calcium Scoring software evaluates standard CT images for pixels above a given CT number threshold. These data are evaluated to calculate the Agatston score and other information. The results may be printed out to a paper report or to film.

· Substantial Equivalence:

Siemens Calcium Scoring is substantially equivalent to the following devices:

1. Imatron Ultra Access Device (K972903) cleared by FDA on 11/04/97
1. SCImage NetraMD Device (K960911) cleared by FDA on 05/29/96

Kathleen Rutherford

Manager, Regulatory Submitsions Imaging Systems Group, Siemens Medical Systems

4/30/99
Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1999

Alicia Juergensen Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 186 Wood Avenue Iselin. New Jersey 08830

Re:

K990426 Calcium Scoring Software Package Dated: April 30, 1999 Received: April 30, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Juergensen:

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 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/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting 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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นนักม พรรคที่ม

Attachment 1

Indications for Use

510(k) Number (if known) Calclum Scoring Software Package Device Name:

Indications For Use:

From user specified sets of CT cardiac images, Calcium Scoring can be used to: -

Allow the user to interactively indicate regions of detected calcification .
To allow the user to allocate each detected region to one of several coronary arteries .
To estimate algorithmically a score for the amount of detected calcification in each allocated . artery
To prepare reports including calcium score data, imagery, ECG traces, Comparison of score ◆ to cited literature and additional relevant information

(please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Jaris G. Elynor

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990426

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.