The Giotto Image X-ray Mammographic System is intended to provide filmscreen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.

Device Description

The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto Image allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information based on the provided text:

Key Takeaways:

This 510(k) summary is for a conventional film-screen X-ray mammographic device, not an AI-powered system.
The primary method for demonstrating equivalence is by showing the device meets or exceeds existing regulatory and accreditation standards for mammography equipment and that its performance is substantially equivalent to a predicate device (Giotto HT).
The text does not describe a study involving an AI algorithm or human readers interpreting images with or without AI assistance. Therefore, most of the requested AI-related information (MRMC study, standalone AI performance, training set details) is not applicable or cannot be extracted from this document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (What the device must meet)	Reported Device Performance (How the device performs)
Overall Performance & Standards	Meet or exceed all requirements set forth by the ACR (American College of Radiology) accreditation program, which is adopted by the FDA's MQSA program.	"The Giotto Image has been designed to meet or exceed all the ACR requirements." (Implies it does perform at this level, though specific numbers aren't provided).
Image Resolution	ACR requirements for image resolution.	"The Giotto Image has been designed to meet or exceed all the ACR requirements."
Contrast Resolution	ACR requirements for contrast resolution.	"The Giotto Image has been designed to meet or exceed all the ACR requirements."
Dose	ACR requirements for patient dose.	"The Giotto Image has been designed to meet or exceed all the ACR requirements."
kV Accuracy	ACR requirements for kV accuracy.	"The Giotto Image has been designed to meet or exceed all the ACR requirements."
Functionality	Generate high-resolution images of the breast on film using an x-ray source.	"The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film..."
Technological Characteristics	Substantially compare in materials, technology, and functional methodology to the predicate device (Giotto HT).	"The characteristics of the Giotto Image system compare substantially with the Giotto HT, in both materials used, technology applied, and functional methodology."
Safety and Effectiveness Impact	Differences from predicate device do not affect safety and effectiveness, intended use, or application methods.	"Differences of note do not affect safety and effectiveness of the device, intended use, or application methods."
Patient Contact Materials	Components in direct contact with the patient are of the same materials as the predicate device.	"The components of the Giotto Image that come in direct contact with the patient... are of the same materials as the Giotto HT predicate device."

Study Information (Based on provided text)

Sample size used for the test set and the data provenance:
- The document does not describe a specific "test set" in the context of an algorithm or human reader study. It refers to meeting ACR accreditation standards for mammography equipment. These standards generally involve phantom imaging and calibration tests, not a clinical study with a patient dataset.
- No data provenance (country of origin, retrospective/prospective) is mentioned, as a clinical study with a patient test set isn't detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for an image-reading test set is described. The "ground truth" here is adherence to engineering and performance specifications defined by the ACR.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication is described.
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. This is a conventional X-ray mammography device, not an AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and is not mentioned).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device for image acquisition, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth in this context is the adherence of the device's physical and performance characteristics (image resolution, contrast, dose, kV accuracy, etc.) to established industry and regulatory standards (ACR requirements adopted by MQSA) for mammography equipment. This is assessed through physical measurements and phantom tests, not clinical outcomes or expert consensus on patient images.
The sample size for the training set:
- Not applicable. This document describes a physical imaging device, not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is described.

Summary

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NOV 30 2001

510(k) Summary

K012953
page 1 of 2

Submitter Information 1.

Submitter: 1.1. MEDX Incorporated 3456 N. Ridge Ave., #100 Arlington Heights IL 60004 Phone: (847) 463-2020 Fax. (847) 463-2019
Manufacturing Facility: 1.2. Internazionale Medico Scientifica S.r.l. Via Sagittario, 5 - 40044 Pontecchio Marconi Bologna, Italy
1.3. Contact: Floyd Rowan
Date: August 30, 2001 1.4.

Device Name 2.

2.1.	Classification Name:Classification Number:	System Mammographic90IZH
2.2.	Trade/Proprietary Name:	Giotto Image
2.3.	Predicate Device:	Giotto HT (DC K973856)

Device Description 3.

3.1. Function

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510(k) Summary

K012953
Page 2 of 2

Scientific Concepts: 3.2.

X-ray imaging began in the late nineteenth century with the discovery of xrays by William Conrad Roentgen. X-ray imaging of the human anatomy, including the breast, began immediately after this discovery. The danger of x-ray exposure, tissue damage caused by ionizing radiation, was quickly x ray expectand today is known to be a major limitation of x-ray imaging. It was not until the 1980's that the unique requirements of x-ray mammography for the detection of non-palpable lesions were realized, manimography the development of specialized x-ray mammographic units. These devices incorporate special x-ray tubes and low ripple x-ray generators producing much lower energy x-rays than conventional x-ray systems. These low energy x-rays allow penetration of the breast tissue while at the same time producing sufficient contrast on the film to detect non-palpable breast lesions. Film screen systems for mammography have been optimized to produce the high resolution images required by mammography while at the same time minimizing dose to the patient.

Physical and Performance Characteristics: 3.3.

Mammography has been demonstrated to be the best imaging choice for screening of women for breast cancer by many studies and is currently recommended as a routine procedure for women over 50 years of age. The FDA has introduced the MQSA program to ensure consistent quality among mammography providers. The MQSA has adopted the accreditation program administered by the American College of Radiology (ACR). This program sets forth requirements for mammography equipment including image resolution, contrast resolution, dose, kV accuracy, etc. The Giotto Image has been designed to meet or exceed all the ACR requirements.

Device Intended Use 4.

The intended uses of the Giotto Image are identical to the intended uses of 4.1. the Giotto HT predicate device (Premarket notification K973856).

Device Technological Characteristics 5.

The characteristics of the Giotto Image system compare substantially with 5.1. the Giotto HT, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Giotto HT.
The components of the Giotto Image that come in direct contact with the 5.2. patient (paddles, supports, holders, Bucky) are of the same materials as the Giotto HT predicate device (Premarket notification K973856).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2001

Mr. Floyd R. Rowan Executive Vice President Medx, Inc. 3456 N. Ridge Ave., #100 ARLINGTON HEIGHTS IL 60004 Re: K012953 Trade/Device Name: Giotto Image Mammographic x-ray system Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: August 30, 2001 Received: September 4, 2001

Dear Mr. Rowan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the exercised of 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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), please 11 you desire of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Yancy C. Snigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Giotto Image X-ray Mammographic System

Indications For Use:

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Optional Format 3-10-98)

Prescription Use

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.