The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

AI/ML Overview

This document is a 510(k) premarket notification for Elscint Inc.'s "Cardiac Scoring option," a software feature for CT scanners. It focuses on the device's substantial equivalence to a predicate device, rather than providing a detailed study proving its meeting of specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs, and quantitative performance metrics is not present in the provided text.

Based on the provided information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like sensitivity, specificity, or accuracy. The "Effectiveness" section broadly states:

Criterion Type	Acceptance Criteria	Reported Device Performance
Functionality	Quantification of calcifications by a weighted number.	"Quantifies calcifications by a weighted number instead of manual calculation of area x density products."
Ease of Use	Easier to use than manual calculation.	"As such it is easier to use."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. There is no mention of a test set, patient data, country of origin, or retrospective/prospective nature of any data related to performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. The document makes no mention of experts or a process for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Since no test set or ground truth establishment is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The document does not describe any study comparing human readers with and without AI assistance, nor does it mention any effect size.

6. Standalone (Algorithm Only) Performance Study

This information is not provided. The document describes the software's functionality but does not present data from a standalone performance study in terms of quantifiable metrics. The "Effectiveness" section is descriptive rather than quantitative.

7. Type of Ground Truth Used

This information is not provided. As no specific study data is presented, the type of ground truth used is not described.

8. Sample Size for the Training Set

This information is not provided. There is no mention of a training set or its size.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Since no training set is mentioned, the method for establishing its ground truth is also not described.

Summary of what the document does claim regarding "effectiveness":

The core claim for effectiveness is that the "Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use." The basis for this claim, and the overall "effectiveness" of the device, is its substantial equivalence to predicate devices (specifically, the Histogram and ROI functions of the CT Twin flash, K945512). The document suggests that the device performs a similar function (quantifying high-density structures) but in a more user-friendly way. The effectiveness is therefore asserted through a comparison to a known, legally marketed predicate device rather than through a rigorous, quantitative study with specific acceptance criteria.

Summary

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Summary of Safety and Effectiveness

1. Device Name

MAY 2 9 1997

K970980

Cardiac Scoring option

2. Submitter

Elscint Inc., 505 Main Str. Hackensack, NJ 07601.

3. Description of Main Features

The Cardiac Scoring option is a software option based on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries.

4. Predicate Devices

CT Twin flash, K945512,

5. Safety

The Level of Concern of the Cardiac Scoring was determined to be minor.

The safety of this software option is assured by the company procedures that conform to accepted practices. The key process stages are:

· Definition of Requirements
· Design
· Implementation
Verification and Validation .

Good quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

6. Effectiveness

The Cardiac Scoring option quantifies calcifications by a weighted number instead of manual calculation of area x density products. As such it is easier to use.

7. Substantial Equivalency Statement

Based on the above considerations, it is Elscint's opinion that the Cardiac Scoring option is substantially equivalent in safety and effectiveness to the Histogram and ROI functions of the predicate device, CT Twin flash, K945512.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three curved lines that resemble a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1997

Thomas J. Spackman, M.D., F.A.C.R. President and Chief Executive Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601

Re: K970980 Cardiac Scoring for CT Scanners Dated: March 11, 1997 Received: March 18, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Dr. Spackman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desermined 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 Devices that have been reclassified in scoordance 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 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 and be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 some affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin markeing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 ensided, "Misbonading 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/cdrtv/dsmamain.html".

Sincerely yours,

Williamy

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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Page 1 of 1

510(k) Number (if known): K970980

Device Name: Cardiac Scoring for CT Scanners

Indications For Use: Cardiac scoring from whole body computed tomography derived measurements

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

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

Vinh h. Saygon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices K970980 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

4 . . Over-The-Counter Use

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.