(15 days)
The Modified M-IV Mammography System is intended to produce radiographic images of the breast. It is suitable for reasons of images for initial examination for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for reasons of images for initial examination for Screening mainmography inverves the production of magnified images for more thorough examination of areas of the breast determined suspicious mages for more morough oxamilasses in the sampression views, and the unrough sereening manilies are . . . . . . . production of images used by a physician in preparation for biopsy.
Modified M-IV Mammography System
This document (K011987) is a 510(k) summary for a Modified M-IV Mammography System. It primarily focuses on regulatory compliance and the intended use of the device, rather than detailed performance studies and acceptance criteria typically associated with algorithm-driven devices.
Based on the provided text, the device is a mammography system, which is a hardware device for producing radiographic images, not an AI-enabled diagnostic algorithm. Therefore, many of the requested categories for AI device studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The "acceptance criteria" discussed are primarily regulatory and operational standards for the mammography system itself, not performance metrics of an AI algorithm.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Compliance/Design) |
|---|---|
| Classification to UL Standard 187 | Designed for classification to UL Standard 187 |
| Classification to Canadian Standards Association, CSA Standard C22.2 No. 114 | Designed for classification by Underwriters Laboratories, Inc. to Canadian Standards Association, CSA Standard C22.2 No. 114 |
| Certification to International Electrotechnical Commission Standard IEC-601-1 | Designed for certification to International Electrotechnical Commission Standard IEC-601-1 |
| Conformity to Federal Performance Standards for Ionizing Radiation Emitting Products (21CFR 1000) | Tested and conforms to 21CFR 1000 |
| Meet requirements for American College of Radiology (ACR) accreditation (for image quality and radiation dose limits) | Designed to meet the requirements for ACR accreditation |
| User-friendly and comprehensive Operator's Manual (for safe and effective operation) | Comprehensive Operator's Manual provided, ensuring safe and effective operation |
Regarding the other requested information (which are largely not applicable to this type of device submission):
2. Sample sized used for the test set and the data provenance:
- Not Applicable. This submission is for a physical mammography system, not an AI algorithm. There is no "test set" of images or patient data in the context of an algorithm's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI, refers to expert consensus on disease presence/absence. This is not relevant for a hardware device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is discussed as this is not an AI algorithm submission.
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:
- Not Applicable. This is a hardware device. No AI component is mentioned, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be performed or reported in this type of 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device. "Standalone performance" in the context of an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the context of disease diagnosis is not relevant for the regulatory acceptance of a mammography image acquisition system. The "ground truth" for this device is its adherence to technical standards and its ability to produce images, not the diagnostic accuracy of those images themselves.
8. The sample size for the training set:
- Not Applicable. This submission is for a physical mammography system. There is no AI training set involved.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI training set, there's no ground truth establishment for it.
Summary Explanation:
This 510(k) submission (K011987) for the "Modified M-IV Mammography System" focuses on demonstrating the safety and effectiveness of the physical device itself, not on the performance of a diagnostic algorithm or AI. The "acceptance criteria" are therefore centered on compliance with established engineering, electrical safety, radiation emission, and imaging quality standards for mammography equipment (e.g., UL, CSA, IEC, 21CFR 1000, ACR guidelines). The document indicates that the device has been "designed for" these classifications/certifications and "tested and conforms" to the federal standards, suggesting internal testing and design verification were performed to meet these criteria.
The absence of information regarding test sets, training sets, expert review, or AI performance studies is entirely consistent with a 510(k) submission for a non-AI-enabled hardware device like a mammography machine.
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Safety and Effectiveness 510(k) Summary Section 5.0
- The Modified M-IV Mammography Systems have been designed for 1. classification to Underwriters Laboratories, Inc. (UL) to Standard 187.
- The Modified M-IV Mammography Systems have been designed for 2. classification by Underwriters Laboratories, Inc. to Canadian Standards Association, CSA Standard C22,2 No. 114.
- The Modified M-IV Mammography Systems have been designed for 3. certification to International Electrotechnical Commission Standard IEC-601-1
- The Modified M-IV Mammography Systems are tested and conform to the 4. Federal Performance Standards for Ionizing Radiation Emitting Products, defined in 21CFR 1000.
- The American College of Radiology (ACR) in Reston, Virginia, conducts a રે. nationwide program that accredits providers of mammography services. To qualify for ACR accreditation, the mammography device at a provider site must meet ACR standards for image quality and operation within radiation dose limits. The Modified M-IV Mammography Systems have been designed to meet the requirements for ACR accreditation.
- A comprehensive Operator's Manual provided with each system is user friendly 6. and comprehensive, thus ensuring safe and effective operation of the Modified M-IV Mammography Systems.
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2001
Mr. Roaida Rizkallah Regulatory Specialist Lorad, A Hologic Company 36 Apple Ridge Road DANBURY CT 06810
Re: K011987
Modified M-IV Mammography System Dated: June 22, 2001 Received: June 26, 2001 Regulatory Class: II 21 CFR 892.1710/Procode: 90 IZH
Dear Mr. Rizkallah:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section JTQ(F) notifications for use stated in the enclosure) to legally marketed predicate devices device is substantially colurations 16, 1976, the enactment date of the Medical Device Amendments, or to devices marketed in meestale continetec provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recassified in accordance will the provisions of the Act. The general controls provisions of the Act include requirements for annual registration of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval) it may be subject 11 your device is classince (SC ubove pairs offecting your device can be found in the Code of Federal Regulations, to such additional controls. Existing major regulations areemination assumes compliance with the Current Cood Manufacturing I tue 21, Patis 600 to 693. A Subsamany equintion (QS) for Medical Devices: General regulation (21 CFF Part Practice requirentents, as set tour in the Quality Dystom togeneral (FDA) will verify such assumptions. Friday 620) and that, through periodic Q5 mispection. In addition, FDA may publish further announcements to comply with the Use in the Federal Register. Please note: this response to your premarket notification submission does not concerning your device in the Pockal Register. Trease nown response 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 THIS leder will allow you to ocgally 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 vitin If you desire specific advice to your device of Compliance at (301) 594-4639. Additionally, for questions on the promotion undentising 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" (21CFR 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) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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510(k) Number (if known):
Device Name: Modified M-IV Mammography System
Intended Use:
The Modified M-IV Mammography System is intended to produce radiographic images The Modifical M-1 v Wianinograpily of of or screening and diagnostic mammography. of the breast. Tits specific meetable as to reasons of images for initial examination for Screening mainmography inverves the production of magnified images for more thorough examination of areas of the breast determined suspicious mages for more morough oxamilasses in the sampression views, and the unrough sereoning manilies are ... . . . .
production of images used by a physician in preparation for biopsy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 21 CFR 801.109
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
David C. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
00 4
§ 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.