CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 by TREX MEDICAL CORP.

The Bennett Contour 2000 Mammographic System, Model CTR-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The CTR-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Contour 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Contour 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.

AI/ML Overview

The provided text describes a 510(k) submission for the "Bennett Contour 2000 Mammography System, Model CTR-2000." This document asserts substantial equivalence to predicate devices and focuses on the system's technical specifications and safety rather than a clinical performance study with specific acceptance criteria and reported device performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as structured in the prompt because the available text does not contain details about a clinical performance study with specific acceptance criteria, test sets, ground truth establishment, or expert evaluations.

The document is a 510(k) summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices based on design, intended use, operation, and safety testing (e.g., conformance to requirements, hazard analysis). It does not present data from a clinical trial or a standalone algorithm performance study.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "The safety functions of the Contour 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Contour 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations." However, it does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) or reported performance metrics from a clinical study. The focus is on technical and safety conformance, not diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No clinical test set or data provenance is mentioned. The testing described is related to the device's technical and safety functions, likely using engineered test cases or simulated conditions, not patient data in a clinical study context.

3. 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)

Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No clinical test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. The device described is a mammography imaging system (hardware), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Cannot be provided. The device is a mammography imaging system (hardware), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. No clinical ground truth is mentioned. The "ground truth" for this device's evaluation would relate to its technical specifications and safety performance (e.g., x-ray output accuracy, mechanical stability), not diagnostic outcomes.

8. The sample size for the training set

Cannot be provided. This is a hardware device, not a machine learning model, so there is no "training set" in the AI sense.

9. How the ground truth for the training set was established

Cannot be provided. Not applicable as this is a hardware device.

Summary of Device and its Evaluation (Based on provided text):

The "Bennett Contour 2000 Mammography System, Model CTR-2000" is a dedicated mammographic imaging system used as an x-ray source for mammographic examinations. Its 510(k) clearance (K984091) was based on demonstrating substantial equivalence to legally marketed predicate devices, including the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, and Planmed Sophie Classic mammographic imaging systems.

The evaluation process described in the 510(k) summary focused on:

Comparison of basic features, operation, and functionality to predicate devices.
Rigorous testing and analysis of safety functions to conform to requirements and ensure identified hazardous conditions would not occur under simulated conditions.
Fulfilling design requirements to provide safe and effective mammographic examinations.

Key takeaway: This document pertains to the clearance of a medical imaging hardware device, not a diagnostic AI algorithm. Therefore, the assessment criteria and study design are fundamentally different from what would be expected for an AI-based diagnostic tool.

Summary

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

K 5784091

FEB 5 1999

SECTION 2 SUMMARY AND CERTIFICATION

510(k) SUMMARY

Submitted by:	Trex Medical Corporation, Bennett Division
Address:	445 Oak Street, Copiague, NY 11726
Phone:	(516) 691-6100, (516) 691-6103 (fax)
Contact:	Lim Cheung
Device Name:	Bennett Contour 2000 Mammography System, Model CTR-2000
Equivalent Device:	Bennett Contour Mammography System, Model M-CTR (#K925725),LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, andPlanmed Sophie Classic
Date:	November 13, 1998

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 as promulgated in 59 FR 64287-01 for §807.92.

Description of the Device: The Bennett Contour 2000 Mammographic System, Model CTR-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The CTR-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Contour 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Contour 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.

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

Same Intended Use: The Bennett Contour 2000 Mammography System (Model CTR-2000), 2. like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha IQ, GE Senographe 800T, and Planmed Sophie Classic mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
The Bennett Contour 2000 Mammography System is substantially equivalent to currently marketed devices in terms of basic features, operation, and functionality. The safety functions of the Contour 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions. The Contour 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 5 1999

Walter F. Schneider President Trex Medical Corporation Bennett Division 445 Oak Street Copiague, NY 11726

Re:

K984091 Bennett Contour 2000 Mammography System Model CTR-2000 Dated: November 13, 1998 Received: November 16, 1998 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. Schneider:

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). 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 compilance 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 vitro 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.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

.
Capt. Daniel G. Schultz, 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

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

Page / ol /

510(k) Number (il known):_

Midel CTR-2000 Device Name: Contaur 2000 Mammography System

Indications I-or Use:

system, Model CTR-2000, is The Contour 2000 Mammography used for dedicated a ographic examination mami

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

0:4

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-95)

David A. Seymore

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