The Biopsy Digit-AM is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy, and guide wire placement.

Device Description

The BIOPSY DIGIT-AM device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the BIOPSY DIGIT-AM they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.

AI/ML Overview

The provided text describes a medical device called BIOPSY DIGIT-AM, which is a mammographic system intended for stereotactic guidance in breast biopsy procedures. However, the document is a 510(k) summary for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device (BIOPSY DIGIT).

It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of an AI/algorithm-focused performance study. The document primarily asserts equivalence based on "materials used, technology applied, and functional methodology" and states that "Differences of note do not affect safety and effectiveness of the device, intended use, or application methods."

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. The document is about a mechanical/imaging system rather than an AI or algorithm-driven diagnostic tool that would typically have the kind of performance metrics you've asked for.

Here's an attempt to address your request based on the absence of information and the nature of the device described:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Typically for AI/Algorithm)	Reported Device Performance (from text)
Quantitative Performance Metrics (e.g., Sensitivity, Specificity, AUC, Accuracy for lesion detection/classification)	Not reported. The document describes a stereotactic guidance system for biopsy, not a diagnostic algorithm. The performance is assessed in terms of substantial equivalence to a predicate device for its intended use (accurate lesion localization for biopsy).
Localization Accuracy (e.g., mean error in mm for biopsy target)	Not explicitly stated with a specific numerical threshold or result. The device operates on the principle of accurately determining 3D lesion coordinates using stereo imaging. It states "the tip will be precisely positioned at the pre-determined coordinates," implying sufficient accuracy for its purpose, but no quantitative performance study is detailed here.
Precision/Reproducibility	Not explicitly stated.
Clinical Efficacy (e.g., reduction in false positives/negatives, improved biopsy yield)	Not reported for this specific device in this document. It mentions mammography having a "high rate of false positive examinations" and stereotactic needle localization being a "minimally invasive procedure for obtaining the tissue sample needed determining the lesion type for a positive mammography examination," but these are general statements about the procedure, not performance metrics of the BIOPSY DIGIT-AM itself.
Safety (e.g., adverse event rates)	Not reported in this summary, beyond the statement that differences from the predicate "do not affect safety."

2. Sample size used for the test set and the data provenance:
Not provided. The document describes a physical medical device, not an AI/algorithm trained on a dataset. Substantial equivalence for such devices often relies on engineering specifications and preclinical testing, rather than large clinical test sets with ground truth labels in the way AI algorithms do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/algorithm performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No expert adjudication for 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:
Not applicable. This device is a stereotactic guidance system, not an AI assistant for human readers. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a "System Mammographic" and "uses two stereo images... to determine the location of a lesion." While it uses a calculated determination, it's a physical system for guidance, not a standalone diagnostic algorithm. Its function is to determine coordinates for physical needle placement, which is then performed by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of an AI/algorithm performance study. For a stereotactic biopsy device, the "ground truth" would implicitly be the actual pathological confirmation of the lesion's presence and type, and the device's accuracy would be measured by how closely the needle tip reaches the target. However, no such specific study or ground truth methodology for performance validation is described in this document.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established:
Not applicable.

Summary of what the document does indicate regarding "performance":

Principle of Operation: It works like human binocular vision to determine 3D coordinates from two stereo X-ray images.
Intended Use: Identical to the predicate device (BIOPSY DIGIT, K990192) for mammographic stereotactic guidance (fine needle aspiration, needle biopsy, guide wire placement).
Substantial Equivalence: The BIOPSY DIGIT-AM is described as substantially equivalent to the predicate BIOPSY DIGIT in "materials used, technology applied, and functional methodology." The submission asserts that "differences of note do not affect safety and effectiveness of the device, intended use, or application methods."
Performance Claim: The device "performs as well as the predicate BIOPSY DIGIT." The predicate itself was implicitly deemed safe and effective for its intended use through its prior clearance.

In essence, this 510(k) submission is a declaration of equivalence to an already cleared device, arguing that the new device has no new questions of safety or effectiveness. It does not present novel performance data against specific, defined acceptance criteria in the way a new AI algorithm might.

Summary

{0}------------------------------------------------

(062039

Submitter Information 1.

1.1. Submitter: GIOTTO USA, LLC 1822 East 1st Street Wichita, KS 67214 Phone: 316-393-5966 Fax. 316-263-4686
1.2. Manufacturing Facility: Internazionale Medico Scientifica S.r.l. Via Sagittario, 5 - 40044 Pontecchio Marconi Bologna, Italy
1.3. Contact: Robert Rusk
1.4. Date: 17-Jul-06

2. Device Name

2.1.	Classification Name:Classification Number:	System Mammographic90IZH
2.2.	Trade/Proprietary Name:	BIOPSY DIGIT-AM
2.3.	Predicate Device:	BIOPSY DIGIT (DC K990192)

3. Device Description

3.1. Function

3.2. Scientific Concepts:

The BIOPSY DIGIT-AM works on the same principle as human binocular vision. Two images of the same object are taken with the x-ray source in two different

SEP 1 1 2006

{1}------------------------------------------------

510(k) Summary

K62039

positions. Objects between the source and film plane appear at a different location as the source is moved from position A to B as shown in the figure below. Since the geometry of the system is fixed and knew, given the apparent position of the object in the two views, shown as C and D in the figure, the true position of the object can be calculated.

Image /page/1/Figure/3 description: The image shows a diagram of an X-ray imaging system. The diagram includes an X-ray source labeled "X-ray Source" with points A and B indicating the source's extent. An object is positioned between the source and the image detector plane, and the image detector plane is labeled "Image detector plane" with points C and D indicating the plane's extent.

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 years of age. Mammography, however, has been shown to have a high rate of false positive examinations.

Stereotactic needle localization has been shown to be a minimally invasive procedure for obtaining the tissue sample needed determining the lesion type for a positive mammography examination. The procedure removes much less tissue and produces much less scar tissue than conventional surgical biopsy.

Device Intended Use 4.

4.1. The intended uses of the BIOPSY DIGIT-AM are identical to the intended uses of the BIOPSY DIGIT predicate device (Premarket notification K990192),

Device Technological Characteristics 5.

5.1. The characteristics of the BIOPSY DIGIT-AM system compare substantially with the BIOPSY DIGIT, 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 BIOPSY DIGIT.

{2}------------------------------------------------

K062039

The components of the BIOPSY DIGIT-AM that come in direct contact with 5.2. the patient (paddles, supports, holders, digital camera) are of the same materials as the BIOPSY DIGIT predicate device (Premarket notification K990192).

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Giotto USA c/o Ms. Allison Scott Consultant The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032

Re: K062039

Trade/Device Name: Biopsy Digit-AM Regulation Number: 21 CFR §892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Scott:

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 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) 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.

SEP 1 1 2006

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/8 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.

Protecting and Promoting Public Health

{4}------------------------------------------------

Page 2 -

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 orth 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.

This letter will allow you to begin marketing your device as described in your Section 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

K04 2039

Biopsy Digit-AM Device Name:

Indications For Use:

The Biopsy Digit-AM is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy, and guide wire placement.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Simpson

(Division Sign-Of Division of Reprodu and Radiological D 510(k) Number

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.