The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.

Device Description

The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle localization procedure to target mammographically previously discovered breast abnormalities. The device provides breast stabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast.

The device is intended for appropriately trained and qualified physicians, radiologists, and radiology/medical technicians who have previously performed manual and/or stereotactic needle localizations procedures.

The TraxyLoc™-1 System stabilizes the breast in a compression unit which is attached to the mammography equipment. After obtaining two images sterentactically (horizontal and vertical images) the previously identified breast artifact is identified and located on the Overlay Grids. The view orientation and artifact location data is then entered into the Traxalign™ software and the system settings for performing a needle localization are obtained. The localization needle is southings to personally holder. The needle holder is then placed onto the guidance frame as per the software directions. The needle is inserted into the breast as per a typical manual needle localization procedure. At least one confirmatory mammography image should be taken to ensure the position of the needle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TraxyLoc™-1 System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device performs as intended.	All testing demonstrated satisfactory performance of the device.
Image quality of breast artifact.	Equivalent to current standards.
Breast stabilizer comfort.	Compresses the breast comfortably.
Breast stabilizer impact on image quality.	Does not impact image quality.
Breast stabilizer stability during procedure.	Does not uncompress during the procedure.
Software accuracy of needle placement.	+/- 1mm. Note: This accuracy is dependent upon accurate user data input, needle straightness, breast density, and user attention to needle assembly positioning. At least one and sometimes a pair of post needle localization confirmatory X-ray images are required as part of standard practice.

Study Details

The provided text describes bench testing, not a clinical study involving human subjects or experts establishing ground truth for a test set in the traditional sense of medical image analysis.

Sample size used for the test set and the data provenance: Not applicable. The text mentions "bench testing," which typically refers to laboratory testing of the device's components and functionality under controlled conditions. It does not refer to a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of "test set" data is described. The acceptance criteria focus on physical and software performance rather than diagnostic accuracy against a ground truth established by experts.
Adjudication method for the test set: Not applicable. No adjudication process is described as there isn't a test set requiring expert review.
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, an MRMC study was not done. The device is an accessory to mammography equipment for stereotactic needle localization, not an AI-powered diagnostic tool for interpreting images. The focus is on the device's mechanical and software performance in guiding needle placement, not on improving human reader performance in interpreting images.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "software accuracy of the needle placement is +/-1mm" suggests a standalone assessment of the software's geometric calculation capability. However, the note explicitly states its dependence on user input and actions, indicating it's not a fully automated, standalone device for performing the localization without human interaction. It's a guidance system.
The type of ground truth used:
- For image quality, the ground truth appears to be "current standards," which likely refers to established industry or regulatory benchmarks for mammographic image quality.
- For breast stabilizer performance (comfort, impact on image quality, stability), the ground truth would be ergonomic assessment and physical stability testing.
- For software accuracy of needle placement, the ground truth would be precise measurements in a controlled bench setting, verifying the calculated coordinates against known physical targets.
The sample size for the training set: Not applicable. The text describes bench testing for device performance, not the training of a machine learning model.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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90 JZH 892.1710

Traxyz Medical Inc. TraxyLoc™-1 System 510(k) Summary 10.0

KOSOGG 3 .

APR 8 2005

Company:

Traxyz Medical, Inc. 200 Highland Avenue Suite 301 Needham, MA 02494

Contact:

SON Medical 290 Turnpike Road, #323 Westborough, MA 01581 F. David Rothkopf

Date Prepared:

March 7, 2005

Name of Device:

Traxyz Medical Inc. TraxyLocTM-1 System

Predicate Device:

Lorad Digital Spot Mammography KS09810 Mammospot Paddle K954521

Intended Use:

ાવ

CONFIDENTIAL March 2005

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Device Description:

The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle The TraxyEoo - - ByBoraphically previously discovered breast abnormalities. The 100ailed of mainmostabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast.

Technological Characteristics:

The technological characteristics of the new device are less than those of the predicate device.

Performance Data:

Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance of the device.

The image quality of the breast artifact with the device is equivalent to current . standards.
The breast stabilizer compresses the breast comfortably, does not impact . image quality, and does not uncompress during the procedure.
The software accuracy of the needle placement is +/-1mm. Note this accuracy . is dependent upon accurate user data input, needle straightness, breast density and user attention to needle assembly positioning. At least one and sometimes a pair of post needle localization confirmatory X-ray images are required as part of standard practice.

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

Traxyz Medical, Inc. 510(k)

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

APR 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Traxyz Medical, Inc. % Mr. F. David Rothkopf President SON Medical 290 Turnpike Road, #323 WESTBOROUGH MA 01581 Re: K050663

Trade/Device Name: TrazyLocTM-1 System Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system

Regulatory Class: II Product Code: IZH Dated: March 9, 2005 Received: March 15, 2005

Dear Mr. Rothkopf:

. Dear Mr. Rothkopt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your and equivalence of your device to a legally premarket nothleation. The PDA mianing of backannal system and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dories on on the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notifications the Also, please note the regulation entired, "Theorananages on your responsibilities under the Act from the 807.97). You may obtain outcr general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko50663 510(k) Number (if known):

Device Name: TraxyLocTM-1 System

Intended Use:

(Please do not write below this line – Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Nancy Brogdon
	(Division Sign-Off)
	Division of Reproductive, Abdominal,
	and Radiological Devices
510(k) Number	K050663

Prescription Use	OR	Over-the-Counter Use
21 CFR 801.109

Traxyz Medical, Inc. 510(k)

CONFIDENTIAL March 2005

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.