DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

Device Description

DSM is comprised of a workstation, monitor, trackball, keyboard, computer and digital image receptor.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Lorad Digital Spot Mammography System (DSM). It details the device's characteristics and compares them to a previously cleared predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the typical sense of quantitative thresholds for performance metrics. Instead, the "acceptance" for this 510(k) seems to be based on demonstrating substantial equivalence to a predicate device.

The tables within the document compare the specifications of the new DSM to the predicate DSM (K030666). The acceptance is implicitly that the new device's specifications are "Same" or functionally equivalent to the predicate, with the primary new feature being DICOM capabilities.

Feature / Acceptance Criteria (Implicit)	Reported Device Performance (New DSM)
Intended Use (Same as K030666)	"...application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination." (Same as predicate)
General Configuration (Same as K030666)	Described as "workstation, monitor, trackball, keyboard, computer and digital image receptor." (Same as predicate)
Principles of Operation (Same as K030666)	Uses a Charge-Coupled Device (CCD) for image capture. (Same as predicate)
Operating Parameters (Similar to K030666)	- Tissue Imaging Area: 5.0 cm x 5.0 cm - Operator control of Image contrast & luminance: Choice of 512 or 1024 pixel resolution - Monitor: Large 18 in. high resolution, gray scale flat screen monitor - Near Real-Time Image Display: 512 Mode - approx. 4 seconds; 1024 Mode - approx 8 seconds - Image Device: Charge-Coupled Device (CCD) - Display Area: 18 in. diagonal (minimum) 160° viewing angle (minimum) - Computer Microprocessor: Intel CPU - Archive Media: DVD + R/RW, CD - R/RW - Operating System: Only recognizes disks, DVD/CD formatted with DOS, Windows 9X/NT/2000 - User Controls: Power, Brightness, Contrast, Picture Tilt, Height Vertical Position, Horizontal Position - Approvals: UL 1950, FCC-A, DHHS, CSA-950, IEC 950
Added Functionality	DICOM Query/Retrieval Operations

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

The provided text does not contain information about a specific "test set" for performance evaluation in the context of clinical accuracy or diagnostic efficacy. This 510(k) seems to be primarily focused on demonstrating substantial equivalence in physical and functional specifications to a predicate device, rather than new clinical validation. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

Since there is no mention of a clinical test set or performance study to evaluate diagnostic accuracy, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

Given the absence of a clinical test set for performance evaluation, there is no information about an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or is not reported in this document. The purpose of this 510(k) is to modify an existing device and demonstrate substantial equivalence, not to conduct a new clinical effectiveness study comparing human readers with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Based on the document, no standalone algorithm performance study was done or is reported. The device described (Digital Spot Mammography System) is a hardware and software system used by a physician for localization and biopsy procedures. It's an imaging and guidance tool, not an AI diagnostic algorithm operating independently.

7. The Type of Ground Truth Used

As no clinical performance study is described, there is no information on the type of ground truth used. The "ground truth" for this 510(k) process is the predicate device's established performance and safety, to which the new device is compared in terms of its specifications.

8. The Sample Size for the Training Set

No information is provided regarding a training set. This document describes a medical imaging device's hardware and software specifications for a 510(k) submission, not the development or validation of an AI algorithm which would typically involve training sets.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

Summary

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Summary of Safety and Effectiveness
K040884		APR 2 3 2004
Submitter:	Hologic, Inc.35 Crosby DriveBedford, MA 01730
Contact Person:	Gail Yaeker-DaunisSr. Regulatory Specialist
Date Prepared:	April 1, 2004
Common Name:	DSM
Proprietary Name:	Digital Spot Mammography System
Predicate Devices:	Lorad DSM K921962A & K030666
Intended Use:	DSM as part of a standard x-ray mammography unit is part of astereotactic lesion localization system that has the application oflocalizing, and then giving a physician the capability of performingfine needle aspiration or core biopsy of lesions determined to besuspicious through prior mammographic examination

Compliance Statement:

The DSM has been designed for certification to International Electrotechnical Commission Standard IEC-601-1, IEC 601-1-x, IEC 601-2-xx

cUL 187, UL 1950, FCC-A, DHHS, CSA-950, IEC 950

A comprehensive Operator's Manual provided with each system is user friendly and comprehensive, thus ensuring safe and effective operation of the DSM.

This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).

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General Information Section 1.0

Ko4o884

Introduction 1.1

The purpose of this Special 510(k) is to modify the Lorad Digital Spot Mammography System which was originally cleared for market as 510 (k) # K921962A At that time, DSM was cleared for use on the Lorad Mammography systems and the Lorad StereoGuide Stereotactic Breast Biopsy System for use in localization and stereotactic procedures.

DSM was last modified as part of the Lorad MultiCare Platinum System (formerly StereoGuide) with Digital Spot Mammography as 510 (k) # K030666.

At this time, Lorad wishes to modify DSM to include DICOM capabilities and to provide capability for use with both the MultiCare Platinum Breast Biopsy System and Lorad Mammography Systems.

1.2 Indications for Use

The indications for use of the DSM are the same as submitted in the Lorad MultiCare Platinum System, 510 (k) # K030666, and repeated below:

DSM as part of a standard x-ray mammography unit is part of a stereotactic lession localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

1.3 Substantial Equivalence

The DSM and the predicate device DSM as cleared in MultiCare Platinum 510(k) # K030666 have the same intended use, the same general configuration, the same principles of operation, and similar operating parameters. The DSM is now available for use with both Lorad MultiCare Platinum Breast Biopsy Table System and M-IV Mammography System. The addition of DICOM capability is considered the only significant change to the device.

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DSM is comprised of a workstation, monitor, trackball, keyboard, computer and digital image receptor.

Image /page/2/Picture/3 description: In the image, a computer is sitting on a desk. The computer has a monitor, keyboard, and tower. The desk is made of wood and has a simple design. The computer is likely used for work or school.

Table 1 below compares the current DSM to the predicate DSM cleared on February 27, 2003 as 510(k) # K030666.

DSM Console	DSM (K030666) Lorad Multicare	DSM
	Platinum
Tissue Imaging Area	5.0 cm x 5.0 cmOperator control of Image contrast &luminance: Choice of 512 or 1024pixel resolutionLarge 18 in., high resolution, grayscale flat screen monitor	Same
Near Real-TimeImage Display	512 Mode - approx. 4 seconds1024 Mode - approx 8 seconds	Same
Image Device	Charge-Coupled Device (CCD)	Same
Monitor	Flat Panel	Same
Display Area	18 in. diagonal (minimum) 160°viewing angle (minimum)	Same
ComputerMicroprocessor	Intel CPU	Same
Archive Media	DVD + R/RW, CD - R/RW	Same
Operating System	Operating system will only recognizedisks, DVD/CD formatted with DOS,Windows 9X/NT/2000	Same
User Controls	Power, Brightness, Contrast, PictureTilt, Height Vertical Position,Horizontal Position	Same

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Section 1.0

DSM Console	DSM (K030666) Lorad MulticarePlatinum	DSM
Approvals	UL 1950, FCC-A, DHHS, CSA-950,IEC 950	Same
DICOM	DICOM Query/Retrieval Operations	Same

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2004

Ms. Gail Yaeker-Daunis Sr. Regulatory Specialist Hologic, Inc. 36 Apple Ridge Road DANBURY CT 06810

Re: K040884 Trade/Device Name: Lorad Digital Spot Mammography System (DSM) Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: 90 IZH Dated: April 2, 2004 Received: April 6, 2004

Dear Ms. Yaeker-Daunis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.

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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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 the 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" (21CFR Part 807.97) you may obtain. 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,

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

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510(k) Number (if known):

Device Name: Lorad Digital Spot Mammography System (DSM)

Indications for Use:

DSM as part of a standard x-ray mammography unit is part of a stereotactic lesion Down as part of a standad as the application of localizing, and then giving a physician the location 37 stem that has the uppers aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V 21 CFR 801.109

Over-the-Counter Use

David h. leppmm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 14008 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.