The Glotto RT is intended to provide film-screen X-ray imaging of the breast and other soft-tissue organs that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto HT can also be used as the imaging device for sterotactic needle biopsy.

Device Description

The Giotto HT 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 HT 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

The provided document, K973d56, describes a 510(k) submission for a conventional film-screen x-ray mammographic device named Giotto HT. As a premarket notification for a medical device cleared through the 510(k) pathway, it primarily focuses on demonstrating substantial equivalence to a predicate device, not on specific clinical study results proving performance against acceptance criteria in the way a new, high-risk device might.

Therefore, the information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, as requested, is largely not present in this type of 510(k) summary. This document operates under the assumption that if the device is substantially equivalent to a legally marketed predicate device, its safety and effectiveness are established.

However, based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (which in this context refers to the substantial equivalence comparison).

Here's the breakdown of the requested information, with acknowledgements of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance
Safety	No adverse effect on patient/operator	Same materials (paddles, supports, holders, Bucky) as predicate Giotto HF, which is considered safe. Differences do not affect safety.
Effectiveness	Produce high-resolution images of the breast; Detect non-palpable lesions.	Operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Giotto HF. Designed to meet or exceed all ACR requirements (e.g., image resolution, contrast resolution, dose, kV accuracy).
Technological Characteristics	Substantial equivalence to predicate in materials, technology, functional methodology.	All characteristics of Giotto HT compare substantially with Giotto HF.
Intended Use	Identical to predicate device	Intended uses are identical to the Giotto HF predicate device.
Regulatory Compliance	Meet MQSA and ACR requirements	Designed to meet or exceed all ACR requirements.

Explanation:
The document doesn't list explicit "acceptance criteria" in a quantitative, measurable format as might be found in a clinical trial protocol. Instead, for a 510(k) device like this, the primary "acceptance criterion" is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device. The "reported device performance" is essentially the claim of substantial equivalence and adherence to established standards (like ACR).

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

Sample Size: Not applicable/Not mentioned. This document describes a comparison to a predicate device and adherence to industry standards, not a specific clinical study with a defined test set of patients or images.
Data Provenance: Not applicable/Not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable/Not mentioned. The 510(k) process for this type of device does not typically involve independent expert review of a clinical test set for ground truth establishment.
Qualifications: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not mentioned. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

MRMC Study Done? No. This device is a conventional mammographic x-ray system, not an AI-powered diagnostic aid. The concept of "human readers improve with AI" is not relevant to this device.
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study Done? No. This device captures images; it is not an algorithm that performs a standalone diagnostic function.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate device and the ACR accreditation program requirements. The claim is that the Giotto HT meets or exceeds these established standards.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is a conventional imaging device, not an AI/machine learning product that requires a training set.

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

How Ground Truth Established: Not applicable, as there is no training set for this type of device.

Summary regarding the "study that proves the device meets the acceptance criteria":

The "study" in this 510(k) submission is the comparison to the predicate device (Giotto HE, K901558) and the demonstration of compliance with ACR requirements and the MQSA program. The manufacturer asserts that:

The Giotto HT's function, scientific concepts, physical and performance characteristics are substantially equivalent to the predicate device.
The device is designed to meet or exceed all ACR requirements for mammography equipment (e.g., image resolution, contrast resolution, dose, kV accuracy).
The materials in patient contact are the same as the predicate, ensuring biocompatibility.
The intended uses are identical to the predicate.

The FDA's allowance to market the device signifies their agreement that sufficient evidence was provided to demonstrate substantial equivalence, thus inherently accepting that the device meets the necessary safety and effectiveness criteria as established by the predicate device and relevant standards in 1997.

Summary

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K973d56

510(k) Summary

Submitter Information: 1.

1.1. Submitter: SITCO Incorporated 25663 Hillview Ct. Mundelein, IL 60060 Phone: (847) 438-1855 FAX: (847) 438-1862
Manufacturing Facility: 1.2. Internazionale Medico Scientifica S.r.I. Via Pila, 1/8 - 40044 Pontecchio Marconi Bologna, Italy
1.3. Contact: Robert H. McCarthy
Date: September 29, 1997 1.4.

Device Name 2.

2.1.	Classification Name:Classification Number:	System Mammographic901ZH
2.2.	Trade/Proprietary Name:	Giotto HT
2.3.	Predicate Device:	Giotto HE (DC K901558)

Device Description 3.

3.1. Function

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Optional accessories allow both prone and seated breast needle biopsy.

3.2. Scientific Concepts:

X-ray imaging began in the late nineteenth century with the discovery of x-rays 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 the ionizing radiation, was quickly recognized and 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, resulting in 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.

3.3. Physical And Performance Characteristics:

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 vears 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 HT has been designed to meet or exceed all the ACR requirements.

Device Intended Use: 4.

The intended uses of the Giotto HT are identical to the intended 4.1. uses of the Giotto HF predicate device (Premarket notification K901558)..

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Device Technological Characteristics: 5.

The characteristics of the Giotto HT system compare substantially 5.1. with the Giotto HF, 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 HF.

5.2. Biocompatibility

The components of the Giotto HT that come in direct contact with the patient (paddles, supports, holders, Bucky) are of the same materials as the the Giotto HF predicate device (Premarket notification K901558)

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert H. McCarthy Vice President SITCO Incorporated 25663 Hillview Court Mundelein, Illinois 60060 Re: K973856

Giotto HT Mammographic System Dated: September 29, 1997 Received: October 9, 1997 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

21 1997 NOV

Dear Mr. McCarthy:

い

We have reviewed your Section 510(k) notification of intent to market the device 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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 in with diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 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

h. William Hsiau Yu

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_off

510(k) Number (if known):_K973856

Giotto HT Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﮐﺎ Prescription Use (Per 21 CFR 801.109) ાવ

Over-The-Counter Use_

(Optional Format 1-2-96)

David h. Sorum

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K973856

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.