The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system. Radiography of the breast

Device Description

The GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381). Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the GLORY mammography system, focusing on acceptance criteria and supporting studies:

Based on the provided documents, it's important to note that this is a 510(k) premarket notification for a modification of an already legally marketed device (MAM-CH22S). The submission focuses on demonstrating substantial equivalence rather than presenting an entirely new device with novel performance studies against specific acceptance criteria for a new indication.

Therefore, many of the typical elements of a detailed performance study proving a device meets acceptance criteria (like specific sensitivity/specificity thresholds, MRMC studies, or detailed ground truth establishment for a test set) are not present in these documents. Instead, the focus is on comparing the modified device's technical specifications and safety to the predicate device.

Here's the information extracted from the provided text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for a modification, the "acceptance criteria" is primarily demonstrating substantial equivalence in safety and effectiveness to the predicate device (MAM-CH22S). The performance metrics reported are primarily in terms of technical capabilities rather than clinical outcomes.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (GLORY vs. MAM-CH22S)
Effectiveness: Similar intended use and indications.	Identical intended use and indications.
Effectiveness: Equivalent diagnostic capability.	Significantly equivalent to MAM-CH22S. The GLORY system provides additional radiation (or mAs) for very thick or dense breasts and higher mA values with the small focal spot for magnification procedures. This suggests improved capability for specific challenging cases, rather than a degradation of performance.
Safety: Compliance with relevant safety standards.	Designed to comply with International Standard IEC 601-1, Medical Electrical Equipment, Part 1: General Requirements For Safety. Modifications were analyzed, and preventive measures were taken. No new significant risks were introduced.

Study Details

Given the nature of a 510(k) for a modification focused on substantial equivalence, a traditional "study proving the device meets acceptance criteria" in the sense of a large clinical trial with predefined performance metrics is not described here. The "study" is more of an engineering and comparative analysis.

Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not specified. The document does not describe a clinical "test set" of patient data used to evaluate diagnostic performance. The comparison is primarily at a technical specification level.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. No clinical test set with expert-established ground truth is mentioned.
Adjudication Method for the Test Set:
- Not applicable. No clinical test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned or described.
Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- No. This device is a mammography system (hardware), not an AI algorithm. Standalone algorithm performance is not relevant here.
Type of Ground Truth Used:
- Not applicable. For this type of 510(k), the "ground truth" for demonstrating equivalence largely relies on technical specifications, safety standard compliance, and the established performance of the predicate device.
Sample Size for the Training Set:
- Not applicable. This is a hardware system, not a machine learning model that requires a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set.

Summary of Approach:

The regulatory strategy for the GLORY Mammography System was to demonstrate substantial equivalence to a previously cleared predicate device (MAM-CH22S). The primary evidence for this was:

Identical Intended Use and Indications: The device performs the same diagnostic function.
Technical Enhancements: The modifications (additional mAs for dense breasts, higher mA for magnification) were presented as improvements for specific scenarios, not changes that altered the fundamental safety or effectiveness negatively.
Safety Compliance: Adherence to international safety standards (IEC 601-1) and an analysis of the modifications to ensure no new significant risks.

This type of submission relies on the established safety and effectiveness of the predicate device and the argument that the modifications do not introduce new questions of safety or effectiveness, effectively piggy-backing on the prior clearance. It does not involve de novo clinical studies to establish new performance metrics against specific acceptance thresholds.

Summary

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K9706.80

IIIN 20 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

The 510(k) premarket notification for the GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381).

The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system.

The effectiveness of the GLORY mammography system is significantly equivalent to that of the MAM-CH22S mammography system. Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.

With regards to safety, the GLORY mammography system was designed to comply with International Standard IEC (International Electrotechnical Commission) 601-1, Medical Electrical Equipment, Part 1: General Requirements For Safety. The modifications were analyzed and preventive measures were taken.

Based on this analysis, to the best of our judgment, the GLORY mammography system does not introduce new significant risks that could cause a safety hazard.

Based on the above, it is Elscint's opinion that the GLORY mammography system is substantially equivalent in safety and effectiveness to the legally marketed device, MAM-CH22S.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Coulevard Rockville MD 20850

.JUN 20 1997

Beny Sherer Safety Officer Elscint, Inc. Service Headquarters_ 86 Orchard Street Hackensack, NJ 07601 Re: K970680 Glory Mammography System Dated: May 15, 1997 Received: May 16, 1997 .. Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Sherer:

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We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 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 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 does not 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 marketing your device as described in your 510(k) premarket 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 80) and additionally 809.10 for in yritro 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 entilled, "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/dsmamain.html".

Sincerely yours,

William Y

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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510(k) Number (if known): K970680

Device Name: GLORY Mammography System

Indications For Use:

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Radiography of the breast

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

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

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use

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Daniel L. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 70680 510(k) Number _ y g

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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.