The Advanced Automatic Detector Selection (AADS) option is used with the automatic exposure control of the GLORY mammography system. With the AADS option, the legally marketed GLORY system can determine exposure parameters automatically from a detector located beneath the densest breast tissue.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes an "Advanced Automatic Detector Selection (AADS) option for the GLORY Mammography System" and focuses on its substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (If Stated)	Reported Device Performance
Not explicitly stated	"the ADDS option does not result in any new potential safety risks and does not significantly change the effectiveness of the GLORY system."

Comment: The document does not define specific quantitative acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the AADS option's performance. Instead, it makes a qualitative statement about its safety and effectiveness relative to the predicate device.

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

Sample Size for Test Set: Not provided.
Data Provenance: Not provided. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study.

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

This information is not provided as the document does not describe a performance study with a test set requiring ground truth established by experts.

4. Adjudication method for the test set

Not applicable as no performance study with a test set is 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

No MRMC comparative effectiveness study is mentioned. The device is an "Advanced Automatic Detector Selection" option, implying an automated function during image acquisition, not necessarily an AI-assisted interpretation tool for human readers.

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

The device is an "option" for an existing mammography system, designed to "determine exposure parameters automatically from a detector located beneath the densest breast tissue." This implies a standalone algorithmic function within the system for exposure control. However, the document does not contain data to describe its standalone performance in terms of specific metrics. It's an enhancement to the existing automatic exposure control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable as no performance study requiring "ground truth" to evaluate diagnostic accuracy is described. The device's function is exposure control, not diagnosis.

8. The sample size for the training set

Not applicable. The document describes a device option, not a machine learning model that would typically have a training set.

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

Not applicable. As above, this device is not presented as a machine learning model requiring a training set with ground truth.

Summary

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DEC 1 1 1998 Elscint, Inc. Corporate Headquarters 22 Paris Avenue Rockleigh, NJ 07647 Tel. 201 750-3240 1-800-ELSCINT Fax 201 750-3232 Elscint Web Site: http://www.elscint.co.il

983313

510(k) Summary

This 510(k) Summary provides the information required by 21 CFR 807.87(h).

Submitter's Name and Address: 1.

Elscint Inc., 22 Paris Avenue, Rockleigh, NJ 07647

Contact Person and Telephone No .:

Steven M. Kay, Director, Regulatory Affairs and Quality Assurance, (201) 750-3240.

Date of Summary:

17 September 1998

2. Product Identification

Trade/Proprietary Name: Advanced Automatic Detector Selection (AADS) option for the GLORY Common Name: Option Classification Name: Mammographic X-Ray System (21 CFR 892.1710/Procode: 90 IZH)

3. Predicate Device(s):

GLORY (K970680) mammography system

4. Device Description:

5. Intended Use:

The intended use and the indications for use of the GLORY mammography system (Screening and diagnostic breast radiography) are unchanged.

6. Safety and Effectiveness:

The GLORY is designed to comply with IEC Electrical (601-1) and Mechanical (601-2) international standards. Potential electrical, mechanical, radiation and software hazards are identified through hazard analysis. Product safety and quality are maintained by:

Adherence to Federal and International standards .
System verification and validation, continuing review of user requirements and the . implementation of a Quality System that conforms to Federal OSR and ISO requirements.

To the best of our judgement, the ADDS option does not result in any new potential safety risks and does not significantly change the effectiveness of the GLORY system.

7. Equivalency Information Summary:

It is the opinion of Elscint, Inc. that the ADDS option is of a comparable type and substantially equivalent to the currently marketed GLORY mammography system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Steven M. Kay Director of Regulatory Affairs Elscint, Inc. 22 Paris Avenue Rockleigh, NJ 07647

Re: K983313

Advanced Automatic Detector Selection Option for Glory Mammography System (ADDS Option) Dated: September 18, 1998 Received: September 21, 1998 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Kay:

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 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 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 intro disgnostic 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 Compirance 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/cdrivdsmardsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa 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: Advanced Automatic Detector Selection Option for GLORY Mammography System

Indications For Use:

Radiography of the breast Preoperative wire localization and stereotactic biopsy procedures

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

(Concurrence of CDRH, Office of Device Evaluation(ODE)
Signature
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K983313
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Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.