The Lorad M-Ille Mammography System is intended to produce radiographic images of the breast. Its specific intended use is screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

Screening and diagnostic mammography, including magnification studies, special views, spot compression views, as well as images used by a physician in preparing for a biopsy.

Device Description

The Lorad M-IIIe mammoqraphy system is based on Lorad's currently marketed M-III, with changes to add features of Lorad's M-IV. The mechanical package, layout and basic electrical design of the M-III are used, but the x-ray tube of the M-IV, as well as the M-IV user interface and several M-IV software feature algorithms are incorporated. The changes made to the M-III to create the M-IIIe are summarized in the table below.

The Lorad M-Ille is a stand alone mammography device, mounted on a base with casters which allow positioning in the room where it is installed. A foot-operated mechanical lock prevents movement during clinical use of the device. The unit is AC powered, and must be connected to a 220 VAC/50-60 hertz (nominal) line to operate.

The standalone unit has two major assemblies: the C-arm and the Control Console. An M-Ille configuration tree, identifying the major components and subassemblies that comprise the M-IIIe, is provided in Attachment 1. The C-arm, which contains an x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the machine. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The bottom panel of the C-arm is spring loaded and attached to a safety switch which disables C-arm vertical movement downward should it contact an object, such as a wheelchair.

The C-arm is attached by a locking pivot mechanism to the Control Console. The pivot allows the C-arm to be manually rotated about its central axis. The pivot mechanism is attached to the control console via a vertically moving carriage. This carriage is screw mounted to the base of the Control Console. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage which, in its actuated condition, prevents rotation. The brake is de-actuated to release the C-arm for movement. The Control Console is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. At the top of the Control Console, an operator station, consisting of a keyboard, a panel of individual pushbuttons and a Liquid Crystal Display (LCD) are mounted. Steel and aluminum panels enclose the Control Console. At the rear of the Control Console, opposite the operator station, there is a input power connector and input circuit breaker.

The M-IIIe is equipped with accessories necessary in the performance of mammography. Bucky grid accessories, containing either conventional linear or air-interspaced High Transmission Cellular grids, and a motor system to move the grid during exposure, are provided to reduce the effects of scattered radiation on the image. Compression plates to accommodate different sized patients and different mammographic applications are supplied and are interchangeable by the operator. A magnification table is provided, which provides a means to obtain geometrically enlarged views of suspicious areas of the breast. Footswitches are provided that operate (1) the C-arm vertical position function, to place the breast platform appropriately to the patient's height, and (2) the compression function, allowing the operator to use both hands to position the patient while applying and releasing breast compression position the patient while applying and releasing breast compression.

The M-IIIe is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA. Use of the M-IIIe with the StereoLoc does not alter the operation of the M-IIIe.

AI/ML Overview

Here's an analysis of the provided text regarding the Lorad M-IIIE Mammography System's acceptance criteria and study data:

It's important to note that this document describes an X-ray mammography machine, not an AI/CAD (Computer-Aided Detection) device. Therefore, many of the typical acceptance criteria and study designs associated with AI devices (like standalone performance, multi-reader multi-case studies, and ground truth establishment by experts for AI training) are not applicable here. The "algorithms" mentioned refer to internal device control logic, not AI for diagnosis.

The acceptance criteria are primarily technical specifications and performance measurements for an imaging device, ensuring it produces high-quality images and operates safely and effectively.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (from text)	Reported Device Performance (from text)
Mechanical Specifications	C-arm Rotation: +195° to 0° to -150° with detents at 0°, ±45°, ±90°, ±135° and +180°.	The device is designed to meet these ranges and detents. (No direct measurement report provided, but implied by design specifications).
	Manual Compression: shall be limited to 65 lb. ±7 lb. maximum	Motorized compression limited to 40 lb. in either pre-compression or full-compression mode. (Manual compression value not directly tested in provided tables, but stated as a design limit).
	Motorized Compression: Pre-compression (15-30lb., user-selected); Full compression (20-40 lb., user selected)	As stated in the criterion.
	Motorized Compression: limited to 40 lb. in either mode.	As stated in the criterion.
	Compression Force Display Accuracy: ±3 lb. from 10 lb. to 35 lb. (±13.35 N from 44.5 N to 155.75 N); ±5 lb. Above 35 lb. (±22.25 N above 155.75 N)	No direct test data on force display accuracy is presented in the provided "Summary of Non-Clinical Testing" section, beyond general statements of meeting specifications.
	Compression Thickness Accuracy: ±0.5 cm. at thickness between 0.5 and 10 cm. ±0.8 cm. at thickness between 0.5 and 10 cm. (Note: Two criteria given, likely a typo in the original text, perhaps one for a specific condition)	No direct test data on thickness accuracy is presented in the provided "Summary of Non-Clinical Testing" section, beyond general statements of meeting specifications.
	System Resolution: equal to or greater than 13 Ip/mm in width; 11 Ip/mm in length (ACR/CDC protocol).	Large Focal Spot: Parallel = 15 lp/mm, Perpendicular = 12-13 lp/mm. Small Focal Spot: Parallel = 16 lp/mm, Perpendicular = 13 lp/mm. Results meet specification.
X-ray Source & Beam	Focal Spot Size (NEMA method): Large (nominal 0.3 x 0.3 mm) max 0.45 W x 0.65 L; Small (nominal 0.1 x 0.1 mm) max 0.15 W x 0.15 L	Large Focal Spot: Width=0.43, Length=0.48-0.49. Small Focal Spot: Width=0.09, Length=0.12. Results meet specification.
	Radiation Output (Mo/Mo, large FS, 28 kV): ≥ 800 mR/second for at least 3 seconds through compression paddle.	No direct test data provided in "Summary of Non-Clinical Testing" section.
	Light Field to X-ray Field Congruency: within 1% of SID (0.65 cm) at all edges (21 CFR allows 2% total misalignment for length/width).	Comply with IEC 601-1-3 pg. 51, 94 edition. (No direct measurement report provided, but implied compliance).
Image Quality	Object Phantom Test (ACR/MQSA Minimum): Fibers ≥ 4, Specks ≥ 3, Masses ≥ 3, Total Score ≥ 10.	Phantom Film 1 & 2: Fibers = 5.5, Specks = 3.5, Masses = 4, Total Score = 13. Results meet specification.
	Mean Glandular Dose Limit (ACR): 3 mGy for Screening Mammography Image.	Phantom Film 1 & 2: MGD Measured = 1.84 mGy. Results meet specification.
	Optical Density for Phantom Image: (implied from test method to be "normal clinical procedures" to yield 1.5 average OD)	Phantom Film 1: 1.39 OD. Phantom Film 2: 1.41 OD. (These are close to the target, showing consistency).
	Contrast Diff. Ratio (Avg. density - contrast disk): ACR Requirement = 0.40 approximate.	Phantom Film 1: 0.42. Phantom Film 2: 0.44.
Automatic Exposure Control (AEC)	AEC Tracking Reproducibility: Optical density of any film to be within ±0.15 of the average OD for all test images (2-8 cm BR-12 phantoms at appropriate kV).	Results meet the specification. (Specific OD values are illegible in the provided table, but the conclusion is stated clearly).
Accuracy/Reproducibility	Reproducibility: 0.05 coefficient of variation for 10 consecutive exposures (21 CFR); Internal specification 0.04.	"See section 7.3.5.15." (Implied compliance, not explicit test data in the AEC section itself).
	Linearity: 0.10 for adjacent mAs selections (21 CFR); Internal specification 0.09.	No direct test data provided.
	Accuracy: kVp - actual value not differ by more than 1 kV; mAs: ±5% from indicated; Post-mAs: ±5% from actual.	No direct test data provided.
Stereotactic Localization	Specified Accuracy: ±1 mm for X, Y, Z localization.	StereoLoc II - DSM Equipped (512 mode): Cumulative Error = 0.6 mm. StereoLoc II - DSM Equipped (1024 mode): Cumulative Error = 0.6 mm. StereoLoc II - Film Equipped: Cumulative Error = 0.68 mm. All results meet specification.

Study Details:

Sample size used for the test set and the data provenance:
- Focal Spot Measurement: 2 tests for large focal spot, 2 tests for small focal spot. (Presumably internal lab data, USA, prospective for this device).
- Line Pair Evaluation: 2 tests for large focal spot, 2 tests for small focal spot. (Presumably internal lab data, USA, prospective for this device).
- Object Phantom Tests: 2 phantom films were used. (Presumably internal lab data, USA, prospective for this device).
- AEC Tracking: Tests performed using breast equivalent phantom materials from 2 to 8 cm. (Number of exposures not specified, but implied to be sufficient for evaluating consistency across the range. Presumably internal lab data, USA, prospective).
- Stereotactic Localization: Tests performed with a single simulated lesion (1mm diameter) positioned at a known 3D point (X=10mm, Y=20mm, Z=30mm) for 3 different configurations (DSM 512 mode, DSM 1024 mode, Film). The number of repetitions for each configuration is not explicitly stated but implies single assessments for each, measuring the "localized" vs "set" position. (Presumably internal lab data, USA, prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Object Phantom Tests: "three readers for each of two phantom films readers" were used to score the images. Their qualifications are not explicitly stated, but it's implied they are qualified to interpret mammography phantom images according to ACR procedures (likely radiologists or medical physicists specializing in mammography QA).
- Other tests: For technical measurements like focal spot size, line pair resolution, AEC optical density, and stereotactic localization accuracy, the "ground truth" is based on precise physical measurements using calibrated equipment (e.g., star patterns, line pair phantoms, known phantom thicknesses, known target positions). Human experts were not needed to establish this type of ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Object Phantom Tests: "The phantom images were scored according to standard ACR procedure, using three readers for each of two phantom films readers. The results are averaged summarized below." This implies a form of consensus or averaging, not a specific adjudication method like 2+1.
- Other tests: Not applicable as ground truth is a physical measurement.
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 document describes a mammography X-ray machine, not an AI/CAD device. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was performed or applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware mammography machine. Standalone performance for an AI algorithm is not applicable here. The "software feature algorithms" mentioned are for internal device control (e.g., Auto-Filter, Auto-Time, Auto-kV) and not for diagnostic image analysis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Physical Measurements: For most tests (focal spot, line pair, AEC tracking, stereotactic accuracy), the "ground truth" is derived from objective physical measurements using phantoms or calibrated instruments, compared against established technical standards (NEMA, ACR, IEC, 21 CFR).
- Phantom Scoring by Multiple Readers: For the object phantom tests, the "ground truth" for the phantom image quality score is an average score from three readers, indicating agreement against standardized phantom criteria (ACR/MQSA).
The sample size for the training set:
- Not applicable. This document is about a hardware device approval, not an AI model. There is no "training set" in the context of machine learning. The device's internal control algorithms are designed and programmed, not trained on data in a ML sense.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.

Summary

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K973651

Section Seven - 510(k) Summary

DEC 2 3 1997

7.1 Submitter

Lorad Division of Trex Medical Corporation 36 Apple Ridge Road Danbury, Connecticut 06810

Contact: P.G. Juhas

203-790-1188

7.2 Device Identification

M-IIIE Mammography System Mammographic X-ray System 21 CFR 892.1710

Legally Marketed Device to Which Substantial Equivalance is Claimed: Lorad M-III Mammographic X-ray System and Lorad M-IV Mammographic X-ray System.

7.3 Device Description

7.3.1 Intended Use

7.3.2 Design

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M-IIISpecification	Change	M-IlleResult
CRT Display and custom keypadsfor user interface	LCD panel display and standardQWERTY keyboard for userinterface	User interface duplicates theLorad M-IV
Separate unit suspended on anattached shelf flashesidentification data onto the film	Film flasher unit built into frameand covers of the mammographyunit.	Film flashing function nowintegrated into the unit package
Automatic Exposure Modes:• Auto-Time• Auto-kV	Automatic Exposure Modes:• Auto-Time• Auto-kV• Auto-Filter	Automatic exposure modesinclude the filter selection (Mo orRh) capability employed in the M-IV
X-ray Tube: .1/.3 mm focal spots;16° target angle.	X-ray Tube: .1/.3 mm focal spots10° target angle small focal spot,16 degree target angle large focalspot.	Increases small focal spot tubecurrent capability from 20 mA to28 mA.
Automatic Exposure Detector:• Single cell	Automatic Exposure Detector:• Averaged over threeseparate cells	Greater area of tissue sampledfor controlling exposure density.
Only Compression Thicknessindicated	Compression Thickness andcompression force indicated withdigital display.	Meets MQSA/ACR requirements
Light Field Mirror in x-ray pathduring exposure	Light Field mirror removed from x-ray path during exposure	Removes source of artifacts andeliminates effects on beamcharacteristics

7.3.3 Construction

The C-arm is attached by a locking pivot mechanism to the Control Console. The pivot allows the C-arm to be manually rotated about its central axis. The

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pivot mechanism is attached to the control console via a vertically moving prot meonlaniem is attached the of movement in the vertical direction, driven by ournage. "This camage is crew mounted to the base of the Control Console. an AS motor and a of the C-arm is locked by an electromagnetic brake attached r ne proting action of the mactuated condition, prevents rotation. The to the vertion sumaged to release the C-arm for movement. The Control Console is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. At the top of the Control Console, an operator station, consisting of a keyboard, a panel of individual pushbuttons and a Liquid Crystal Display (LCD) are mounted. Steel and aluminum panels enclose the Control Console. At the rear of the Control Console, opposite the operator station, there is a input power connector and input circuit breaker.

7.3.4 Compatible Equipment

The M-IIIe is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA. Use of the M-IIIe with the StereoLoc does not alter the operation of the M-IIIe..

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7.3.5 Physical and Functional Specifications

7.3.5.1 Electrical Input

Mains Voltage:	200/208/220/230/240 VAC nominal, ±10%, 50/60 Hz
Mains Impedance:	Maximum line impedance not to exceed 0.25 ohms
Maximum Power Consumption:	4.4 KVA for 5 seconds duration
Standby Power:	0.50 KVA nominal
Maximum Line Current:	25 amps for 5 seconds
Circuit Breaker Rating:	15A, time delay curve to allow for inrush currents(200% overload for 7 seconds)
Duty Cycle:	Full load 5 seconds on, 30 seconds off (1:7)

7.3.5.2 Dimensions

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Height:	77 inches (196 cm.)
Width:	60.25 inches (64.7 cm.)
Depth:	25.5 inches (153 cm.)
Weight:	700 lb. (317.5 kg) approximate

7.3.5.3 Operating Environment

Temperature Range:	10° C. to 40° С.
Relative Humidity Range:	30% to 75% non-condensing
ESD Susceptibility:	Level of 3 kV for contact discharge to conductive accessible parts that are not grounded. A level of 8 kV for air discharge to all accessible parts. Test Methods IEC 801-2, Test Level: IEC 601-1-2
EMI Susceptibility:	The system shall be immune from levels of 1 v/m for the frequency range of 26 mHz to 1 gHz (IEC 801-3)
EMI Generation Limits:	System shall comply with the requirements of CISPR 11 for conducted and radiated emission
Input Line Protection:	Surge, fast transient/burst, lightning, IEC 801-4, IEC 801-5

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7.3.5.4 Storage Environment

Temperature Range:

	-25° C. to +60° C.
Humidity:	0 to 95% RH (non-condensing) - not packaged for outdoor storage.

7.3.5.5 Mechanical Specifications

C-arm Rotation:	+195° to 0° to -150° with detents at 0°, ±45°, ±90°,±135° and +180°.
Rotation Lock:	Electromagnetic
Vertical Travel:	28 to 56 inches (71-142 cm) from surface of Bucky tofloor at 0°
Alignment of Focal Spot, Compression Device and Image Receptor:	The focal spot of the x-ray tube shall be located suchthat the ray falling on the edge of the image receptorclosest to the chest wall is perpendicular to the imagereceptor. The system shall allow the plane formed bythe focal spot and the chest wall of the device shallbe perpendicular to that ray, and motion of thecompression device shall provide essentially parallelcompression of the breast with respect to the plane ofthe image receptor. The compression paddle and x-ray tube shall be adjustable, chest wall to nipple, toprovide for this alignment requirement.
Source to Image Distance

65 cm (measured from nominal position of film in Bucky to the large focal spot.

Compression

A. Force

a. Manual Compression: shall be limited to 65 lb. ±7 lb. maximum
b. Motorized Compression:

shall function in two user selectable operating modes (1) Pre-compression: provides compression in a range of 15-30lb., user-selected (2) Full compression: provides compression in a range of 20-40 lb., user selected

Note: motorized compression must be limited to 40 lb. in either mode.

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C-arm pushbuttons or 2 position footswitch B. Control: C. Compression Release: Motorized, initiated by pushbutton controls on C-arm and on operator panel. Automatic release enabled by software to release at end of exposure, unless inhibited by presence of localization paddle. Automatic release shall move the compression device D. Release Distance: a distance of 15 cm., although in mag mode, this distance may be less. After compression applied, backdrive of device shall E. Backdrive: not exceed 1.5 mm in either motorized or manual modes between -90°, 0°, and +90° C-arm positions, and no greater than 3 mm in any C-arm position outside that range. In the event of a power failure, there will be means for F. Failure Mode: release of compression Vertical C-arm drive and C-arm rotation will be G. Movement Interlock: disabled if there is approximately 10 lb. or more of compression force. H. Compression Force Display: Located on upper cover of compression device in combination with compression thickness and AEC detector position. I. Compression Force Display Accuracy: ±3 lb. from 10 lb. to 35 lb. (±13.35 N from 44.5 N to 155.75 N): ±5 lb. Above 35 lb. (±22.25 N above 155.75 N); J. Compression Thickness Measurement and Display: Thickness shall be measured between 0 and 15 cm above the image receptor and displayed. The display shall be compensated for the type of image receptor installed. Display will be in 0.1 cm increments on compression device cover and on user interface screen.
- K. Compression Thickness Accuracy:

±0.5 cm. at thickness between 0.5 and 10 cm. ±0.8 cm. at thickness between 0.5 and 10 cm.

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L. Compression Paddles: the compression paddles will be transparent and marked with the location of the AEC sensor positions. The composition shall be either polycarbonate or PETq. The sensor position marking shall not be detectable on film when imaged with 1 cm of acrylic attenuator at 22 kVp to an optical density of 1.2 OD. The paddle attenuation shall be less than 15% (reduction OF mR/mAs) AT 25 kVp. The paddles will be designed to provide a parallel plane to the image receptor under 40 lb. Of compression force. The paddles will be adjustable to provide the focal spot, compression device and image receptor alignment requirement expressed previously.
the magnification table will be constructed as a tower Magnification to provide rigidity. Alternatively, it will be a platform suspended from hangers on the C-arm.
1.8x for objects 22.5 mm above the magnification A. Magnification Factor: stand breast support surface (the breast support surface will be at approximately 1.7x)
B. Material of Breast Support

Transparent polycarbonate or carbon fiber composite. Surface:

C. Size of Breast Support Surface:
15 cm wide x 12 cm deep for table construction, or 18x24 cm for alternate construction.

7.3.5.6 Image Receptor Support Device

It will contain sensors for accessory detection. It will also provide space for the existing 3 cell AEC detector moveable to 7 positions at 1.7 cm. increments. The image receptor support device shall limit the x-ray transmission to no more than 0.1 mR for the maximum technique exposure to comply with 21 CFR, section 1020.31 and shall meet the 1 uGy per exposure as defined by IEC 601-1-3. Section 29.207.2.

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7.3.5.7 X-ray Source Insert Specifications

Varian model B113/B115 X-rav Tube: Toshiba model E7290AX Large 0.3 mm, Small 0.1 mm, nominal NEMA/IEC; Focal Spot Size: the focal spot will be measured at a reference angle defined at 6° from the perpendicular, or chestwall, ray. The tube will be tilted 6° with a target angle of 16° to result in a total target angle to image plane angle of 22°. This reference angle is then the actual central ray of the x-ray tube. This must provide a system resolution of equal to or greater than 13 Ip/mm in the width dimension and 11 Ip/mm in the length dimension as measured per the ACR/CDC protocol. Tube Voltage: 22 kVp to 39 kVp maximum

Tube Current:	Large Focus - 80 mA between 22 and 28 kVp
	Small Focus - 28 mA between 25 and 28 kVp
	Operating speed of 3400 rpm (standard speed)

Thermal Characteristics:

A. Anode Heat Storage : 210 kJ (300 kHU)
B. Maximum Anode Heat Dissipation Rate:

525 W (740 HU/s)

C. Housing Heat Storage Capacity:
610 kJ (860 kHU) min.
D. Maximum Housing Heat Dissipation Rate:
72 W (6 kHU/min) without air-circulator, 300 W (25 kHU/min) with air cooling
50/60 Hz., 3000/3600 rpm Anode Rotation:
Anode Angle: The x-ray tube will have a bi-anqle anode with the large focal spot on a 10° angle. The tube will be tilted at a 6° angle to provide a 22° anode to film plane angle for the large and 16° anode to film plane angle for the small. This provides film of 24x30 cm for the large and 18x24 cm. for the small (magnification).

. '

Anode Material: Molybdenum

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X-ray window:

Beryllium, 0.8 mm thickness maximum

X-ray Tube Housing and Tube Head Cover

Continuous Heat Dissipation: 300 watts

Maximum Temperature of the Tube Housing Surface: 55° C.

Maximum Temperature of the Tube Head Cover Surface:41° C.

Over Temperature Internally provided in series with stator common Protection Sensor:

Safety Class: IEC 601-2-28

7.3.5.9 X-ray Beam Filtration

Inherent Filtration:	0.0 mm Al equivalent
Added Filtration:	30 microns Molybdenum foil, or25 microns Rhodium foil
Beam Quality:	At a given kilovoltage, the measured HVL for Mo/Mooperation with the compression paddle in the x-raybeam will be equal to or greater than the value ofkVp/100+0.03 in units of mm of aluminum but lessthan the value of kVp/100+0.12 in units of mm ofaluminum. For Mo/Rh, min>kVp/100+0.03,Max<kVp/100+0.19
Radiation Output:	The radiation output through the compression paddleat the entrance surface of the breast (4.5 cm abovethe breast support, 4 cm from the chest wall) for theMo/Mo target/filter, large focal spot combinationoperating at 28 kV shall be equal to or greater than800 mR/second for at least 3 seconds

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7.3.5.10 X-ray Collimation:

The system shall detect the attached image receptor and automatically adjust the field size to limit the beam to 18x24 or 23x30 for large spot only. An aperture detect system will be used to insure that the correct aperture is used with the selected Image Receptor. Additional collimation will be provided by fixed apertures.

7.3.5.11 Light Field Indication

Light Field to X-ray Field Congruency:

Must be within 1% of the SID (0.65 cm) at all edges of the defined x-ray field. (21 CFR states that the light field to x-ray field misalignment be no greater than 2% of the SID for either the length or width which means our design criteria is 1% for each edge, or a total of 2% for length or width edges) Comply with IEC 601-1-3 pg. 51, 94 edition.

The lamp will be activated for a period of 30 seconds Light Field Lamp: by switches located in the C-arm, whenever the compression down motor is activated. The lamp will be extinquished whenever the x-ray exposure is initiated. A shatter shield will be provided.

Light Field Illuminance:

The light localizer shall have a minimum illuminance of 160 lux and meet all of the requirements of 21 CFR, subchapter J, section 1020.31. The voltage at the lamp will be the least amount to assure 160 lux at low line conditions and there will be a surgistor in series with the lamp. These two elements will extend the life of the lamp considerable. The lamp will be surrounded by a shatter shield. The lamp will be adjustable to provide alignment of the light field to xrav field.

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7.3.5.12 High Voltage Generator

Output Rating:	2.4 kilowatt (70 mA at 34 kV) isowatt
Ripple:	Typically no greater than 2% with a maximum of 4%at lower output loads (less than 2.4 kW) and at lowline voltages.
Topology:	Pulse width modulated high frequency, active servocontrolled.
Duty Cycle:	5 seconds on, 30 seconds off (1:7)Note: this specification is for the thermal conditionsof the high voltage generator. The actual operatingduty cycle will be determined by calculation of the x-ray tube loading characteristics. This will permitexposures for stereotactic procedures to be made inas short of a time cycle as permitted by the tubeloading. Thermal equilibrium testing will be done attechnique factors of 200 mAs, 28 kV, at a rate of 1exposure every 90 seconds.

7.3.5.13 kV/mA Range

kV	Large	Small
22-24	80	24
25-28	80	28
29-34	70	24
35	60	20

Note: this is the minimum profile.

7.3.5.14 mAs Range

The M-IIIe will employ an integrating mAs timer for use as the manual timing as well as the back up timer. There will be an additional hardware safety timer employed to limit the maximum exposure time to 6 seconds.

Manual mAs Range:

3.0 through 400 mAs in 55 increments as follows: 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, 26.0, 28.0, 30.0, 32.5, 35.0, 37.5, 40.0, 42.5, 45.0, 47.5, 50.0, 55.0, 60.0, 65.0, 70.0, 75.0, 80.0, 85.0, 90.0, 95.0, 100.0, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 220, 240, 260, 280, 300, 325, 350, 375, 400 mAs.

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7.3.5.15 Accuracy, Reproducibility and Linearity

Reproducibility:	0.05 coefficient of variation for 10 consecutiveexposures (21 CFR) Internal specification 0.04.
Linearity:	(radiation output versus selected mAs) 0.10 foradjacent mAs selections per the following (X1-X2)=toor less than 0.10(X1+X2) where X1 and X2 areaverage mR/mAs values for consecutive exposures(21CFR) Internal specification 0.09
Accuracy:	kVp - the actual value will not differ by more than 1 kVfrom the indicated value. The difference between 2actual kV stations will be in compliance with thedifference of the indicated values.mAs: ±5% from indicatedPost-mAs: ±5% from actual

7.3.5.16 Image Receptors

The image receptor support device will be designed to accept the four standard image receptors, and the optional receptors listed below, which will be inserted from the front of the C-arm.

Standard items include:

A. 18x24 cm cassette holder
B. 24x30 cm cassette holder
C. 18x24 cm Bucky with linear lead strip grid
D. 24x30 cm Bucky with linear lead strip grid

Optional Items include:

A. HTC Bucky with air-interspaced cross-grid
B. StereoLoc II (film or DSM capable)
C. Digital Spot Mammography
D. Magnification Table

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7.3.5.17 Automatic Exposure Control (AEC)

AEC Detector

The active sensing area will be 3 square centimeters, derived from three 1 cm square sensors.

AEC Detector Positioning

The detector will be able to be positioned in 7 locations, centered laterally in the image receptor support device. Position #1 will be located 1 cm from the chest wall, with positions 3, 5, and 7 in 3.4 cm. increments from position #1.

The AEC position indicators will be 7 LEDs which indicate the detented positions. The position indicators will be located on the upper compression device cover.

AEC kVp and Thickness Tracking

The AEC system shall have compensation for kVp between 22 kVp and 35 kVp, as well as compensation for breast thickness tracking including different breast compositions. Tracking will include film reciprocity failure compensation. The optical density shall be within 0.15 O.D. from the mean Optical Density value at any point within the clinically defined range of kVps for breast thicknesses between 2 cm and 6 cm of breast tissue equivalent material.

Reproducibility

See section 7.3.5.15.

Exposure Termination

The system shall determine if the exposure will reach "Back-up Time" and if so, will terminate the x-ray exposure within one of the following limits.

A. 50 milliseconds

B. 4 mAs

C. with an entrance exposure to the ACR Accreditation Phantom of less than 50 mR.

Indication will be made to the operator, and a manual reset will be required to continue the exam.

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Density Range

There will be 11 density adjustment steps between -5 and +5 with a difference of approximately 10% in mAs from adjacent steps.

Post-mAs Display

There will be a display of the post-exposure mAs. The accuracy of the mAs displayed will be within 5% of the actual mAs. The display will hold until the initiation of the next exposure.

Modes of Operation

A. Manual: In this mode, the kV and mAs are both selectable.

B. Auto-Time: In this mode, the kV is the only factor selectable. The exposure is then terminated at a mAs value as determined by the AEC system microprocessor to yield an optical density to which the unit has been calibrated. A post-mAs readout indicates the mAs value at the end of the exposure and remains displayed until the initiation of the next exposure. This mode is valid for use with either the molybdenum or rhodium filter selected. The exposure may be modified up to ±50% by incrementing the DENSITY function. If determination is made that the exposure will exceed the Back-up Time, the exposure will be terminated in less than one of following limits: (a) 50 ms. (b) 4 mAs, or (c) with an entrance exposure to the ACR accreditation phantom of less than 50 mR, and indicate the termination to the operator.

C. Auto-kV: When this mode and the moly filter are selected, the kV will default to 25 kV as determined during default settings upon installation. The unit will be set to default to 25 kV at the factory. If the Rhodium filter is selected, the kV will be limited to 28-32 kV. The kV will default to 28 kV and the mA will be set to 70 mA. Normally there is no requirement to make any selection of technique in this mode. Upon exposure initiation, the AEC signal is sampled and the kV is modulated upward to a maximum of 28 kV if the moly filter is selected, or 32 kV if the Rhodium filter is selected, if determined necessary to provide an exposure within selected window of approximately 80 mAs. 120 mAs. or 160 mAs. as selected by the user. After the kV is modulated (approximately 50 msec into the exposure) the Auto-Time function completes the exposure. The post-kV and post-mAs are then displayed.

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O. Auto- Filter: This mode provides fully automatic operation of all technique factors. The kV will initially default to 25 kV. The available range for the Auto-Filter mode is 25-32 kV. The exposure is initiated and sampled to determine if the kV needs to be modulated upward to provide an exposure within the 160 mAs window. When determined by the auto-filter algorithm, the exposure will be momentarily interrupted and the rhodium filter will be switched in. After the kV or kV/filter has been selected, the Auto-Time function completes the exposure. The final kV, post-mAs and filter will be indicated after the completion of the exposure. The mA is set to 70 mA for this mode.

・・・

7.4 Summary of Non-Clinical Testing

7.4.1 Overview of Performance Evaluations

To assess and provide measurement data on the mammographic imaging performance of the M-Ille unit, a series of bench tests was developed and performed. The bench tests used the geometry and components of the M-Ille system to (1) obtain system resolution measurements, (2) to provide images of standard mammographic quality assurance phantoms, (3) to evaluate tracking performance of the Automatic Exposure Control system, and (4) to evaluate performance in stereotactic localization. The tests and the results are summarized in this section.

7.4.2 System Resolution Tests

7.4.2.1 Focal Spot Measurement

A. Measurement Method: 1 degree Star Pattern 25 kVp 8 mAs large/2 mAs small Kodak Min R E Screen and Film 90 second developing -- Kodak chemistry
B. Pass Criteria (NEMA method):

Large Focal Spot (nominal 0.3 x 0.3 mm) maximum dimensions = 0.45 W x 0.65 L Small Focal Spot (nominal 0.1 x 0.1 mm) maximum dimensions = 0.15 W x 0.15 L

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C. Results:

Large Focal Spot:
	Test 1	Test 2
Width=	0.43	0.43
Length=	0.48	0.49
Small Focal Spot:
	Test 1	Test 2
Width=	0.09	0.09
Length=	0.12	0.12

7.4.2.2 Line Pair Evaluation
- A. Measurement Method

Nuclear Associates 5-20 lp/mm Line Pair Phantom (catalog number 07-555-EY) positioned 4.5 cm. above the top surface of a Lorad moving linear grid bucky device. 23 kVp Large FS/25 kVp Small FS 8 mAs large FS/2 mAs small FS Kodak Min R E Screen and Film 90 second developing -- Kodak chemistry

B. Pass Criteria (ACR):
Parallel - 13 lp/mm Perpendicular - 11 lp/mm
C. Results
Large Focal Spot:

	Film 1	Film 2
Parallel =	15 lp/mm	15 lp/mm
Perpendicular=	12 lp/mm	13 lp/mm
Small Focal Spot:
	Film 3	Film 4
Parallel =	16 lp/mm	16 lp/mm
Perpendicular=	13 lp/mm	13 lp/mm

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7.4.3 Object Phantom Tests

Tests were performed using a standard anthropomorphic breast phantom. The RMI-156 phantom, which is recognized by the American College of Radiologists, as well as the requlations implementing the Mammography Quality Standards Act, and used in the certification process for mammography units, was used.

The phantom was imaged following normal clinical procedures to yield a film with an average optical density of 1.5. To provide a true indication of imaging performance, the mean glandular dose for the phantom images was evaluated, to ensure that the imaging performance was obtained at an absorbed dose level within the range acceptable for mammography.

The phantom images were scored according to standard ACR procedure, using three readers for each of two phantom films readers. The results are averaged summarized below.

Object Group	ACR/MQSAMinimum	Phantom Film 1	Phantom Film 2
Fibers	4	5.5	5.5
Specks	3	3.5	3.5
Masses	3	4	4
Score	10	13	13

Mean Glandular Dose Limit forScreening Mammography Image(ACR)	MGD Measured forPhantom Film 1	MGD Measuredfor Phantom Film 2
3 mGy	1.84 mGy	1.84 mGy

Parameter	Phantom Film 1	Phantom Film 2
Optical Density	1.39	1.41
Contrast Diff. Ratio (Avg.density - contrast disk)*	0.42	0.44

ACR Requirement = 0.40 approximate

7.4.4 AEC tracking

A. Test Method

Obtain automatically timed exposures usinq breast equivalent phantom materials from 2 to 8 cm at appropriate kV settings. Evaluate consistency of the resulting exposures in terms of optical density.

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B. Test Materials

2-8 cm of BR-12 (45:55) breast equivalent phantom material. Kodak Min R E film in Min R 2 cassette Film Processing - Kodak chemistry, 90 second cycle.

C. Pass Criteria

Optical density of any film to be within ±0.15 of the average OD for all the test images

D. Results

	A Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comm	Average Optical Density Minimum Optical Density Maximum Optical Density
1 077l	1 4 7	1.36

The results for Automatic Exposure Control Tracking meet the specification.

7.4.5 Stereotactic evaluation

To evaluate the M-IIIE in terms of performing as a host mammography unit for an add-on stereotactic localization device, a prototype M-IIIE was fitted with a Lorad StereoLoc II device. The StereoLoc II device was tested first using a Lorad DSM digital imaging system as the imaging medium and targetting system, and then reconfigured to use film for imaging and targetting, and the performance tests repeated. The tests results supported compatibility with stereotactic procedures suing the StereoLoc II device with either film or DSM digital imaqing.

7.4.5.1 Needle Positioning and Targetting Test

In this test, the positioning controls of the StereoLoc II device are calibrated and used to position a simulated lesion 1mm in diameter to a known 3-dimensional position (X=10mm, Y= 20mm and Z=30mm). Stereotactic images are then obtained and the simulated lesion is localized using the StereoLoc system controls. The localized X, Y and Z values are compared to the originally set X, Y and Z positions as an evaluation of accuracy of localization. This test confirms that the system is capable of providing accurate readings with the geometry of the M-III E host mammography unit.

{18}------------------------------------------------

A. StereoTactic Localization Results with StereoLoc II - DSM Equipped (512 mode)

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Cumulative Error = sqr(Xerr2+Yerr2+Zerr2)=0.6 Specified Accuracy ±1 mm Results meet specification.

B. StereoTactic Localization Results with StereoLoc II - DSM Equipped (1024 mode)

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Cumulative Error = sqr(Xerr2+Yerr2+Zerr2)=0.6 Specified Accuracy ±1 mm Results meet specification.

C. StereoTactic Localization Results with StereoLoc II- Film Equipped -

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Cumulative Error = sgr(Xerr +Yerr +Zerr2)= 0.68

Specified Accuracy ±1 mm

Results meet specification.

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.

DEC 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philip Juhas Regulatory Affairs Director LORAD® Corporation 36 Apple Ridge Road Danbury, CT 06810

Re: K973631

LORAD Model M-III (Mammographic X-Ray) Dated: December 8, 1997 Received: December 11, 1997 Regulatory Class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Juhas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above 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 vitro 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.T. Thiau 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

11973631 510(k) Number (if known): __ Device Name: LORAD M-111 ELITE M-1118

Indications For Use:

Screening and diagnostic mammography, including
magnification studies, special views, spot compression
views, as well as images used by a physician in
preparing for a biopsy.

Signature

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

Lamil C. klam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use_V (Per 21 CFR 801 109)

ાન

Gver-The-Counter Use

(Optional Format 1-2-96)

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.