The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for 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.

Device Description

The Lorad I-650 mammography system is based on Lorad's currently marketed D-550 (K934870) and Elite (K973631) Dedicated Mammographic Systems. The mechanical packaging is similar to the D-550, while the electronics are similar to the Elite. The Lorad I-650 is a standalone mammography device, mounted on a base to be permanently mounted in position. 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 Gantry. The C-arm, which contains the 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 Gantry. 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 C-arm is attached by a locking pivot mechanism to the Gantry. The pivot allows the C-arm to be manually rotated about its axis. The pivot mechanism is attached to the Gantry via a vertically moving carriage. This carriage is capable of movement in the vertical direction, driven by an AC motor and a drive screw mounted to the base of the Gantry. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage, which, in its unactuated condition, prevents rotation. The brake must be electrically actuated to release the C-arm for movement. The Gantry is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. The operator control is mounted on the side panel of the Gantry, or may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry.

AI/ML Overview

This document describes the Lorad I-650 Mammography System. Here's an analysis of the provided text for acceptance criteria and the study proving it:

Key Takeaway: This document is a 510(k) summary for a mammography system. The "acceptance criteria" are primarily regulatory and performance specifications for the device itself, rather than acceptance criteria for an AI algorithm. The "study" described is a series of bench tests to verify these specifications, not a clinical trial involving human readers or AI performance.

Acceptance Criteria and Device Performance (Table)

The document outlines numerous specifications for the Lorad I-650 Mammography System, which serve as its acceptance criteria. The "reported device performance" are the results from the non-clinical testing.

Acceptance Criteria Category	Specific Criteria / Specification	Reported Device Performance / Result
Focal Spot Measurement	Large focal spot (nominal 0.3 mm): Max dimensions = 0.45mm W x 0.65mm L	Large: 25kV (0.47mm L x 0.33mm W), 28kV (0.46mm L x 0.31mm W), 30kV (0.46mm L x 0.30mm W)
	Small focal spot (nominal 0.1 mm): Max dimensions = 0.15mm W x 0.15mm L	Small: 25kV (0.11mm L x 0.087mm W), 28kV (0.11mm L x <0.10mm W), 30kV (0.11mm L x <0.10mm W)
System Resolution (MQSA)	Lines parallel to tube axis = 13 lp/mm minimum	Large: 14 lp/mm (for 25, 28, 30 kV). Small: 19 lp/mm (25 kV); 16 lp/mm (28 kV); 15 lp/mm (30 kV)
	Lines perpendicular to tube axis = 11 lp/mm minimum	Large: 16 lp/mm (for 25, 28, 30 kV). Small: 19 lp/mm (for 25, 28, 30 kV)
ACR Object Phantom Tests (Image Quality)	Fibers: 4 minimum	Phantom Film 1 & 2: 4.5
	Specks: 3 minimum	Phantom Film 1 & 2: 3.5
	Masses: 3 minimum	Phantom Film 1 & 2: 4
	Total Score: 10 minimum	Phantom Film 1 & 2: 12
Mean Glandular Dose (MGD) (ACR)	3 mGy limit for Screening Mammography Image	Phantom Film 1: 1.48 mGy. Phantom Film 2: 1.71 mGy
Optical Density (Phantom Film)	- (Implicitly aiming for ~1.5 average OD for phantom images)	Phantom Film 1 & 2: 1.52
Contrast Diff. Ratio (ACR)	0.40 minimum (Avg. density - contrast disk)	Phantom Film 1: 0.48. Phantom Film 2: 0.50
AEC Tracking (MQSA)	Optical density of any film within 0.15 OD of the Mean optical density for 2-6 cm breast tissue equivalent material.	Large focal spot - contact- Molybdenum filter: Mean OD = 1.52 +0.11/-0.10 Large focal spot - contact - Rhodium filter: Mean OD = 1.50 +0.15/-0.13 Small focal spot - magnification - Molybdenum filter: Mean OD = 1.51 +0.10/-0.13 (All results verify within MQSA requirements for 2002)
Stereotactic Localization Accuracy	Specified Accuracy ±1 mm for X, Y, Z coordinates (for a simulated lesion at X=10mm, Y=20mm, Z=30mm)	Localized Results: X=10.1 (Error 0.1), Y=20.4 (Error 0.4), Z=30.1 (Error 0.1). Cumulative Error = 0.42 mm. Results meet specification.
Radiation Output	Mo/Mo, large focal spot, 28 kV: >= 800 mR/second for at least 3 seconds (through compression paddle at entrance surface of breast)	(No specific numerical result provided in the "Results" section, but implicitly met as part of overall performance)
Light Field to X-ray Field Congruency	Within 1% of the SID (0.65 cm) at all edges of the defined x-ray field (21 CFR 2% total)	(No specific numerical result provided in the "Results" section, but implicitly met as part of overall performance)
Light Field Illuminance	Minimum 160 lux (21 CFR, subchapter J. section 1020.31)	(No specific numerical result provided in the "Results" section, but implicitly met as part of overall performance)
Reproducibility (Exposures)	Less than 0.05 coefficient of variation for 10 consecutive exposures (as per 21 CFR, internal spec 0.04)	(No specific numerical result provided in the "Results" section, but implicitly met as part of overall performance, referenced back to this section from AEC Tracking)
Linearity (Radiation Output vs. mAs)	Less than 0.10 for adjacent mAs selections: (X1-X2) <= 0.10(X1+X2) (21CFR)	(No specific numerical result provided in the "Results" section, but implicitly met)
Accuracy (kVp)	Not differ by more than 1 kV from indicated value; difference between 2 actual kV stations in compliance with indicated values.	(No specific numerical result provided in the "Results" section, but implicitly met)
Accuracy (mAs)	±5% from indicated	(No specific numerical result provided in the "Results" section, but implicitly met)
Compression Force Display Accuracy	±3 lb. from 10 lb. to 35 lb.; ±5 lb. Above 35 lb.	(No specific numerical result provided in the "Results" section, but implicitly met)
Compression Thickness Accuracy	±0.5 cm. at thickness between 0.5 and 10 cm. ±0.8 cm. at thickness greater than 10 cm.	(No specific numerical result provided in the "Results" section, but implicitly met)
Maximum System Input Impedance	0.25 ohms	(No specific numerical result provided)
Tube Voltage Range	22 kVp to 39 kVp maximum	Listed performance implies this range is achievable.
Tube Current - Large Focus	80 mA max.	Listed kV/mA range includes 80 mA for Large Focus.
Tube Current - Small Focus	20 mA max.	Listed kV/mA range includes 20 mA for Small Focus.
Anode Rotation	3400 rpm (60Hz), 2800rpm (50Hz)	(No specific numerical result provided)
Anode Heat Storage	210 kJ (300 kHU)	(No specific numerical result provided)
Maximum Anode Heat Dissipation Rate	525 W (740 HU/s)	(No specific numerical result provided)
Housing Heat Storage Capacity	610 kJ (860 kHU) min.	(No specific numerical result provided)
Maximum Housing Heat Dissipation Rate	72 W (6 kHU/min) w/o air, 300 W (25 kHU/min) with air	(No specific numerical result provided)
X-ray Tube Housing/Head Cover Temp.	Max Surface Temp: Housing 55°C, Head Cover 41°C	(No specific numerical result provided)
Beam Quality (HVL)	Mo/Mo: kVp/100+0.03 <= HVL <= kVp/100+0.12 (mm Al) Mo/Rh: kVp/100+0.03 <= HVL <= kVp/100+0.19 (mm Al)	(No specific numerical result provided)
High Voltage Generator Ripple	Typically <= 2% (max 4% at lower output/line voltages)	(No specific numerical result provided)
Post-mAs Display Accuracy	±5% of actual mAs	(No specific numerical result provided)

Study Details (as related to the provided document)

This document describes a medical device submission (510(k)) for a mammography system. It focuses on the technical specifications and non-clinical performance validation of the X-ray machine itself, not an AI algorithm. Therefore, many of the requested points for AI studies are not applicable.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Focal Spot Measurement: Not specified in terms of "sample size" of X-ray images, but tests were done at 3 kV settings (25, 28, 30 kV). Data provenance is "bench tests" performed by the manufacturer (Lorad Division of Trex Medical Corporation, Danbury, Connecticut).
- System Resolution: Not specified in terms of "sample size," but tests were done at 3 kV settings (25, 28, 30 kV) for both focal spots. Data provenance is "bench tests."
- Object Phantom Tests: Two phantom films were generated. This refers to the number of physical phantom images evaluated. Data provenance is "bench tests."
- AEC Tracking: Exposures were obtained using breast tissue equivalent materials ranging from 2 cm to 8 cm thickness across various kV settings (e.g., 25-30kV). No specific "sample size" of exposures is given for each condition, but the results table lists 6 conditions for Mo/Mo large focal spot, 3 for Rh large focal spot, and 6 for Mo small focal spot, with multiple thicknesses evaluated for each. Data provenance is "bench tests."
- Stereotactic Localization: One simulated lesion was targeted and localized. Data provenance is "bench tests."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Object Phantom Tests: "three readers" were used to score each of the two phantom films. Their qualifications are not specified beyond being "readers."
- For other tests (Focal Spot, System Resolution, AEC Tracking, Stereotactic Localization), the "ground truth" was derived from physical measurements against known standards or specifications, not human expert interpretation of images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Object Phantom Tests: The results were "averaged" from the three readers. No formal adjudication (like 2+1 or 3+1 consensus) is described.
- Not applicable to other tests as ground truth was not based on human consensus.
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 pertains to the primary performance of a mammography X-ray system itself, not an AI or CAD system used to assist human readers. Therefore, no MRMC study or effect size related to AI assistance is present.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This document is about a hardware medical device (mammography machine), not an AI algorithm. Its performance is evaluated inherently in a "standalone" fashion as a machine, through physical measurements and phantom imaging tests. The "algorithm" here would refer to the machine's internal controls (like AEC), which were tested for their inherent accuracy and reproducibility.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Physical Measurements against Standards/Specifications:
  - Focal Spot Size: Measured physically against NEMA method criteria.
  - System Resolution: Measured from images of line pair bar patterns against MQSA minimums.
  - Object Phantom Tests: Scored visually by readers against ACR/MQSA minimums (e.g., number of discernible fibers, specks, masses). The "ground truth" is the objective presence of these elements in the phantom.
  - AEC Tracking: Measured optical density (OD) consistency against MQSA optical density variation limits using breast tissue equivalent materials.
  - Stereotactic Localization: Comparison of localized coordinates to a known, pre-set 3D position.
- Referenced Regulatory Standards: Many "acceptance criteria" are derived directly from regulatory bodies like MQSA, ACR, NEMA, IEC, and 21 CFR.
The sample size for the training set:
- Not applicable. This document describes a physical mammography system, not an AI model. There is no concept of a "training set" in this context. The device's internal parameters and controls (e.g., AEC calibration) are set during manufacturing and validated through the non-clinical tests described.
How the ground truth for the training set was established:
- Not applicable. As there is no AI training set, this question does not apply.

Summary

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3 1999 SEP

K92280

Section Seven - 510(k) Summary

7.1 Submitter

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

Contact: Philip G. Juhas

203-790-1188

7.2 Device Identification

1-650 Mammography System Mammographic X-ray System 21 CFR 892.1710

Legally Marketed Device to Which Substantial Equivalence is Claimed: Lorad D-550 Mammographic X-ray System (K934870) and Lorad Elite Mammographic X-ray System (K973631).

7.3 Device Description

7.3.1 Intended Use

The Lorad I-650 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.

7.3.2 Design

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EliteSpecification	Change	I-650Result
LCD panel display and standardQWERTY keyboard for userinterface	LCD panel display with cursorand input keys used for techniqueand function selections.	User interface duplicates theLorad Elite Functions.
Automatic Exposure Modes:• Auto-Time• Auto-kV• Auto -Filter	Automatic Exposure Modes:• Auto-Time• Auto-kV	Subset of Elite modes
X-ray Tube: .1/.3 mm focal spots10° target angle small focal spot,16 degree target angle large focalspot.	.1/.3 mAs focal spots,16° Target angle	80 mA LF, 20 mA SF
Automatic Exposure Detector:• Averaged over threeseparate cells	Automatic Exposure Detector:• Averaged over threeseparate cells	• Same
Compression Thickness andcompression force indicated withdigital display.	Compression Thickness andcompression force indicated withdigital display.	• Same.

7.3.3 Construction

The Lorad I-650 is a standalone mammography device, mounted on a base to be permanently mounted in position. 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 Gantry. An I-650 configuration tree, identifying the major components and subassemblies that comprise the I-650, is provided in Attachment B. The C-arm, which contains the 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 Gantry. 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 C-arm is attached by a locking pivot mechanism to the Gantry. The pivot allows the C-arm to be manually rotated about its axis. The pivot mechanism is attached to the Gantry via a vertically moving carriage. This carriage is capable of movement in the vertical direction, driven by an AC motor and a drive screw mounted to the base of the Gantry. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage, which, in its unactuated condition, prevents rotation. The brake must be electrically actuated to release the C-arm for movement. The Gantry is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. The operator control is mounted on the side panel of the Gantry, or

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may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry.

7.3.4 Compatible Equipment

The I-650 is equipped with accessories necessary in the performance of mammography. Bucky accessories, are provided to reduce the effects of scattered radiation on the image. Compression paddles to accommodate different sized Buckies and different mammographic applications are supplied. Thev 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.

The 1-650 is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA (K952210). Use of the 1-650 with the StereoLoc II does not alter the operation of the 1-650. The 1-650 will be configured for application in a mobile van.

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)

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Duty Cycle:

Full load 5 seconds on, 30 seconds off (1:7)

7.3.5.2 Dimensions

Height:	70 inches (178 cm.)
Width:	24 inches (60 cm.)
Depth:	39.75 inches (100 cm.)
Weight:	660 lb. (300 kg) approximate

7.3.5.3 Operating Environment

Temperature Range:	10° C. to 40° C.
Relative Humidity Range:	30% to 75% non-condensing
ESD Susceptibility:	Level of 3 kV for contact discharge to conductiveaccessible parts that are not grounded. A level of 8kV for air discharge to all accessible parts. TestMethods IEC 801-2, Test Level: IEC 601-1-2
EMI Susceptibility:	The system shall be immune from levels of 1 v/m forthe frequency range of 26 mHz to 1 gHz (IEC 801-3)
EMI Generation Limits:	System shall comply with the requirements of CISPR11 for conducted and radiated emission
Input Line Protection:	Surge, fast transient/burst, lightning, IEC 801-4, IEC801-5

7.3.5.4 Storage Environment

Temperature Range:	-25° C. to +60° C.
Humidity:	0 to 95% RH (non-condensing) - not packaged foroutdoor 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

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Vertical Travel: 26 to 55 inches (66-140 cm) from surface of Bucky to floor at 0°

Alignment of Focal Spot, Compression Device and Image Receptor:

The focal spot of the x-ray tube shall be located such that the ray falling on the edge of the image receptor closest to the chest wall is perpendicular to the image receptor. The system shall allow the plane formed by the focal spot and the chest wall of the device shall be perpendicular to that ray, and motion of the compression device shall provide essentially parallel compression of the breast with respect to the plane of the image receptor. The compression paddle and xray tube shall be adjustable, chest wall to nipple, to provide 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:

Full compression: provides compression in a range of 20-40 lb., user selected

Note: motorized compression to be limited to 40 lb.

B. Control: C-arm pushbuttons or 2 position footswitch
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.
D. Release Distance: Automatic release shall move the compression device a distance of 15 cm.

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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: manual 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 greater than 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 PETg. 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.
Magnification is provided using either a plateform Magnification: assembly or a table assembly.
1.8x for objects 22.5 mm above the magnification A. Maqnification Factor: stand breast support surface (the breast support surface will be at approximately 1.7x)
B. Material of Breast Support Surface: Transparent polycarbonate or carbon fiber composite.
C. Size of Breast Support Surface:

15 cm wide x 12 cm deep for table construction, or 18x24 cm for the plateform construction.

7.3.5.6 Image Receptor Support Device

The IRSD contain sensors for accessory detection and houses the 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 (1 uGy) for the maximum technique exposure to comply with 21 CFR 1020.31 and IEC 601-1-3. Section 29.207.2.

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7.3.5.7 X-ray Source Insert Specifications

X-ray Tube:	Varian model M185L/B115
Focal Spot Size:	Large 0.3 mm, Small 0.1 mm, nominal NEMA/IEC.The tube will be tilted 6° with a target angle of 16° toresult in a total target angle to image plane angle of22°. This will provide a system resolution of equal toor greater than 13 lp/mm in the width dimension and11 Ip/mm in the length dimension as measured perthe ACR/Quality Control Manual protocol.
Tube Voltage:	22 kVp to 39 kVp maximum
Tube Current:	Large Focus - 80 mA max.Small Focus - 20 mA max.
Anode Rotation:	3400 rpm (standard speed)/60Hz2800rpm (standard sped)/50Hz

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.

16°

D. Maximum Housing Heat Dissipation Rate: 72 W (6 kHU/min) without air-circulator, 300 W (25 kHU/min) with air cooling
Anode Angle:

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Anode Material:

Molybdenum

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 theTube Housing Surface: 55° C.

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

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

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, or 25 microns Rhodium foil
Beam Quality: At a given kilovoltage, the measured HVL for Mo/Mo operation with the compression paddle in the x-ray beam will be equal to or greater than the value of kVp/100+0.03 in units of mm of aluminum but less than the value of kVp/100+0.12 in units of mm of aluminum. For Mo/Rh, min>kVp/100+0.03, Max<kVp/100+0.19.

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The radiation output through the compression paddle Radiation Output: at the entrance surface of the breast (4.5 cm above the breast support, 4 cm from the chest wall) for the Mo/Mo target/filter, large focal spot combination operating at 28 kV shall be equal to or greater than 800 mR/second for at least 3 seconds.

7.3.5.10 X-ray Collimation:

Collimation is provided by fixed apertures. An aperture detect system will be used to insure that the correct aperture is used with the selected Image Receptor.

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.

Light Field Lamp: The lamp will be activated for a period of 30 seconds by switches located in the C-arm, or 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 surqistor 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 xray field.

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7.3.5.12 High Voltage Generator

Output Rating:	2.24 kilowatt (70 mA at 32 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. Thermal equilibriumtesting will be done at technique factors of 200 mAs,28 kV, at a rate of 1 exposure every 90 seconds.

7.3.5.13 kV/mA Range

kV	Large	Small
22-24	80	20
25-28	80	20
29-32	70	18
33-35	60	16

7.3.5.14 mAs Range

The I-650 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

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Reproducibility:	Less than 0.05 coefficient of variation for 10consecutive exposures (21 CFR) Internalspecification 0.04.
Linearity:	(radiation output versus selected mAs) Less than 0.10for adjacent mAs selections per the following (X1-X2)=to or less than 0.10(X1+X2) where X1 and X2are average mR/mAs values for consecutiveexposures (21CFR).
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 indicated

7.3.5.16 Image Receptors

The image receptor support device will be designed to accept the three 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 holderB. 18x24 cm Bucky with linear lead strip gridC. 24x30 cm Bucky with linear lead strip grid
Optional Items include:	A. StereoLoc II with DigitizerB. Magnification platform

C. 24 x30 cm Cassette Holder

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.

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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 detected positions at 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 kV and Thickness Tracking:

The AEC system shall have compensation for kV between 22 kV and 35 kV, 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 kVs for breast thicknesses between 2 cm and 6 cm of breast tissue equivalent material. (MSQA/2002)

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.

Density Range:

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

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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 vield 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% of calculated mAs by incrementing the DENSITY function. If determination is made that the exposure will exceed the Backup 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. 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 incremented upward to a maximum of 28 kV if the Moly filter is selected, or 32 kV if the Rhodium filter is selected, to provide an exposure within the user selected window of approximately 80 mAs. 120 mAs. or 160 mAs. as selected by the user. After the kV is incremented (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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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 1-650 unit, a series of bench tests was developed and performed. The bench tests used the geometry and components of the I-650 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 Focal Spot Performance Testing

7.4.2.1 Focal Spot Measurement

A. Measurement Method:
- 0.5° and 1.5° star patterns were imaged with the center of the . star pattern located approximately 1 cm from the chest wall.
- Images were made at 25, 28, and 30kV
- Back ground optical density at 1.2 to 1.4 OD .
- Kodak MinR-2000 film and screens .
- 90 second developing Kodak chemistry .

B. Pass Criteria: (NEMA method)

. Large focal spot (nominal 0.3 mm): Maximum dimensions = 0.45mm W x 0.65mm L
. Small focal spot (nominal 0.1 mm): Maximum dimensions = 0.15mm W x 0.15mm L

c. Results:

Focal Spot	kV	Length(mm)	Width(mm)
Large	25	0.47	0.33
Large	28	0.46	0.31
Large	30	0.46	0.30
Small	25	0.11	0.087
Small	28	0.11	<0.10*
Small	30	0.11	<0.10*

*unmeasurable with star pattern

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7.4.2.2 Svstem Resolution:

A. Measurement Method:
- 5-20 lp/mm Line Pair Bar Pattern (Nuclear Associates # 07-555-. EY) positioned 4.5 cm above the breast support surface (Lorad Bucky for Large focal spot - Lorad 1.8X magnification plate for Small focal spot)
- 25, 28, and 30 kV ●
- Kodak MinR-2000 film and screens .
- 90 second processing Kodak chemistry .
B. Pass Criteria: (MQSA)
- Lines parallel to tube axis = 13 lp/mm minimum .
- Lines perpendicular to tube axis = 11 lp/mm minimum .

c. Results:

Focal spot	kV	Length(lp/mm)	Width(lp/mm)
Large	25	14	16
Large	28	14	16
Large	30	14	16
Small	25	19	19
Small	28	16	19
Small	30	15	19

7.4.3 Object Phantom Tests

Tests were performed using a standard ACR Map Phantom (RMI-156 or Nuclear Assoc. #18-220)

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.

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Object Group	ACR/MQSAMinimum	Phantom Film 1	Phantom Film 2
Fibers	4	4.5	4.5
Specks	3	3.5	3.5
Masses	3	4	4
Score	10	12	12

Mean Glandular Dose Limit forScreening Mammography Image(ACR)	MGD Measured forPhantom Film 1	MGD Measuredfor Phantom Film 2
3 mGy	1.48 mGy	1.71 mGy

Parameter	Phantom Film 1	Phantom Film 2
Optical Density	1.52	1.52
Contrast Diff. Ratio (Avg.density - contrast disk)*	0.48	0.50

ACR Requirement = 0.40 minimun

7.4.4 AEC Tracking:

A. Test Method:

Obtain automatically timed exposures using breast tissue equivalent material from 2 through 8 cm thickness at appropriate clinical kV for those thicknesses. Evaluate consistency of the resulting exposures in terms of optical density.

B. Test Materials:

2 to 6 cm of 50/50 breast tissue equivalent material .
. Kodak MinR-2000 film and screens
. Film processing - 90 seconds - Kodak Chemistry

C. Pass Criteria (MQSA)

The optical density of any film is to be within 0.15 OD of the Mean optical density. (MQSA - Oct. 28, 2002)

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D. Results:

	_arge focal spot - contact- Molybdenum filter

kV	2 cm	4 cm	6cm
25	1.63	1.60	n/a
26	1.5	1.52	1.52
27	1.51	1.50	1.45
28	1.47	1.42	1.59
29	1.59	1.59	1.53
30	1.50	1.51	1.41

Results: Mean OD = 1.52 +0.11/-0.10

Large focal spot - contact - Rhodium filter

kV	2 cm	4 cm	6 cm
28	1.43	1.37	1.48
29	1.65	1.49	1.41
30	1.61	1.58	1.49

Results: Mean OD = 1.50 +0.15/-0.13

Small focal spot - magnification - Molybdenum filter

kV	2 cm	3 cm	4 cm
25	1.61	1.51	1.49
26	1.51	1.54	1.47
27	1.51	1.51	1.44
28	1.47	1.48	1.38
29	1.56	1.57	1.60
30	1.50	1.45	1.56

+0.10/-0.13 Results: Mean OD = 1.51

The results verify that the AEC tracking is within the MQSA requirements for 2002.

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7.4.5 Stereotactic evaluation

To evaluate the 1-650 in terms of performing as a host mammography unit for an add-on stereotactic localization device, a prototype 1-650 was fitted with a Lorad StereoLoc II device. The tests results supported compatibility with stereotactic procedures suing the StereoLoc II device with the film based Digitizer System.

7.4.5.1 Needle Positioning and Targeting 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 II 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 1-650 host mammography unit.

Stereotactic Localization Results with StereoLoc II - Film Equipped

Set Position	Localized Results	Error
X=10	X=10.1	0.1
Y=20	Y=20.4	0.4
Z=30	Z=30.1	0.1

Cumulative Error = sar(Xerr2+Yerr2+Zerr2)=0.42 Specified Accuracy ±1 mm. Results meet specification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/19/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

SEP 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lorad Division of Trex Medical Corporation C/O Phillip G. Juhas, Ph.D. Director of Regulatory Affairs 36 Apple Ridge Road Danbury, CT 06810

Dear Dr. Juhas:

Re: K992280 Lorad 1-650 Dated: August 23, 1999 Received: August 26, 1999 Regulatory Class: II (two) Product Code: 90 IZH 21 CFR 892.1710

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAST Daniel S. Ochiel, M.D.

CAPT Daniel G. Schultz, M.D. Acting 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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Image /page/20/Picture/0 description: The image shows the logo for TREX Medical Corporation. The word "TREX" is in large, bold, black letters, with the "X" slightly overlapping the "E". To the right of "TREX" is the text "Medical Corporation" in a smaller, thinner font.

Page 1 of 1

510(k) Number (if known): K992280

Device Name: LORAD 1-650 Mammography System

Intended Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

David a. Segner

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

Prescription Use
21 CFR 801.109

Over-the-Counter 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.