The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.

First, the kit is intended to improve the "fine adjustment" control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for "fine adjustment" force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. "Fine adjustment" control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure.

The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design.

The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.

Device Description

The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:

1. Compression Control Module
  The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.
1. Paddle Leveling Spacers
  The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Digitec Two Stage Compression Kit, based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by addressing specific improvements in functionality. While explicit pass/fail acceptance criteria (e.g., "must achieve X% improvement") are not detailed as they might be for a performance-based device, the document does describe the intended improvements and implies functionality relative to the predicate device's design.

Note: The 510(k) submission largely focuses on the description of the improvements and the intent to improve performance, rather than providing quantitative performance data from a specific study with defined acceptance thresholds. The "reported device performance" in this context refers to the described capabilities and intended improvements.

Acceptance Criteria (Implied)	Reported Device Performance
Improve "fine adjustment" compression control	The Compression Control Module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force. The kit modifies the control sequence to achieve smoother fine adjustment control, which is required to slowly and incrementally add the last bit of compression.
Reposition compression paddle to be flat and parallel	The Paddle Leveling Spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky. The kit removes the 1.2-degree tilt of the original GE Senographe 600T series design, which elevated the chestwall edge of the compression paddle off of the breast support plate.
Not change basic operation of compression system	The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast.
Not change compression release features or safety	The kit does not change the compression release features in any way. The kit does not change the safety or compression release features in any way.
Compatibility with GE Senographe 600T series X-Ray Mammography	The kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems.

Study Information

The provided text does not describe a specific clinical study with a test set, ground truth, or statistical analysis to prove these acceptance criteria. Instead, the submission focuses on design modifications and intended improvements based on an understanding of the predicate device's functionality.

It appears to be a 510(k) submission for an accessory where the changes are considered minor enough not to require extensive clinical performance data for substantial equivalence. The "study" here is more of a description of the engineering modification and its intended effect.

Here's an attempt to answer the questions based on the absence of such information in the provided text:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. No clinical test set seems to be described.
- Data Provenance: Not applicable, as no external data or test set is referenced.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. No ground truth establishment is described.
- Qualifications of Experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no test set requiring adjudication is described.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not described. This device is a mechanical/electrical accessory, not an AI or imaging interpretation device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone study was not described. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as no ground truth is established for performance testing. The "ground truth" for the claims is the engineering design and its intended physical impact on the mammography system's operation.
The sample size for the training set:
- Sample Size: Not applicable, as this is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.

Summary

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DEC 21 1996

K993681

510 (K) SUMMARY

Name:	Digitec Medical Service Corporation
Address:	465 Maltbie Street, Suite 407,Lawrenceville, GA. 30045
Phone:	770-995-0050
Fax:	770-995-8553
Contact person:	James McGinty
Date of preparation:	October 29, 1999
Name of Device:	Digitec Two Stage Compression Kit
Trade:	Digitec Two Stage Compression Kit
Common:	Accessory to Mammography Compression Device
Classification name:	Accessory to Mammographic X-Ray SystemPer 21 CFR SEC 892.1710

Legally marketed device to which we are claiming equivalence:

The device to which substantial equivalence is being claimed is the GE Senographe 600T and 600Ts. X-ray mammography systems. The 510(k)document control number for this comparison device is K881882.

Description of Device

The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:

1. Compression Control Module
  The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.

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1. Paddle Leveling Spacers
  The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.

Intended Use of The Digitec Two Stage Compression Kit

The kit is intended to improve the performance of the compression system of the GE Senographe 600T series x-ray mammography systems. It is designed to position the compression paddles flat and parallel with the bucky surface and to give the technologist a smoother method for applying "fine adjustment" compression force.

It is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. The kit does not change the compression release features in any way.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 1999

James J. McGinty Digitec Medical Service Corporation 465 Maltbie Street, Suite 407 Lawrenceville, GA 30045

Re:

K993681 Digitec Two Stage Compression Kit Dated: October 29, 1999 Received: November 1, 1999 Regulatory class: II\ 21 CFR 892.1710/Procode: 90 IZH

Dear Mr. McGinty:

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). Vou 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 (Special Controls) or dass 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 requlation (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 vour 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 yours,

APT 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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STATEMENT OF INDICATIONS OF USE

The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.

David A. Sezman

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

Prescription Use
(Per 21 CFR 801.109)

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.