The Breast-Med Tissue Marker is a sterile, nonpyrogenic, single use tissue marker consisting of a polymeric tube filled with a dessicated solution of sodium chloride with trace amounts of gadolinium chelate that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and Magnetic Resonance Imaging (MRI). The tissue marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Breast-Med Tissue Marker. This is a medical device, and the document focuses on demonstrating its substantial equivalence to previously approved predicate devices. It does not present a study with detailed acceptance criteria and performance data in the typical sense of an AI/algorithm-based diagnostic device.

Instead, the "performance testing" described refers to bench testing to verify physical properties and radiographic visibility, rather than a clinical study evaluating diagnostic accuracy against a ground truth.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the way you might expect for an AI system. However, I can extract information related to the device's characteristics and the type of performance testing mentioned.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing but does not provide specific acceptance criteria or quantitative performance metrics in a table. It only states that bench testing was performed to "verify that the subject device has equivalent radiographic visualization to the predicates." The actual results of this verification are not detailed.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent radiographic visualization (X-ray, mammography)	Verified to have equivalent radiographic visualization to predicates
Equivalent radiographic visualization (Ultrasound)	Verified to have equivalent radiographic visualization to predicates
Equivalent radiographic visualization (MRI)	Verified to have equivalent radiographic visualization to predicates
Safety based on specific ASTM standards (F2182, F2052, F2213, F2119)	Testing performed utilizing these standards (implies compliance)
Substantial equivalence to predicate devices	Concluded to be substantially equivalent

2. Sample Size Used for the Test Set and Data Provenance:

The document refers to "bench testing" using "tissue and phantom models." It does not specify a sample size for these models or their provenance (country of origin, retrospective/prospective). This type of testing typically uses a controlled set of physical models rather than clinical patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable or provided. Bench testing of physical markers for radiographic visibility would not typically involve human experts establishing a diagnostic "ground truth" in the way an AI diagnostic system would. The "ground truth" here would be the physical presence and visibility of the marker itself, assessed objectively.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. As there's no diagnostic "ground truth" established by experts to be adjudicated, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document describes a physical medical device (a tissue marker), not an AI algorithm designed to interpret medical images. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance assessment was not done. This is a physical tissue marker, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the physical presence and visibility of the tissue marker in various imaging modalities, assessed objectively through bench testing. It's not a clinical ground truth like pathology, expert consensus, or outcomes data, as this device itself is a marker, not a diagnostic tool that interprets data.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" for this type of physical medical device. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set or associated ground truth for this physical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2015

Breast-Med Incorporated Dr. Michael Nelson President 1745 Bridgewater Road Golden Valley, MN 55422

Re: K133697

Trade/Device Name: Breast-Med Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: April 6, 2015 Received: April 8, 2015

Dear Dr. Nelson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K133697

Device Name Breast-Med Tissue Marker

Indications for Use (Describe)

The Breast-Med Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY - K133697

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Breast-Med Tissue Marker is provided below.

Submitted by:	Breast-Med, Inc.
Contact Person:	Michael Nelson, M.D.PresidentBreast-Med, Inc.1745 Bridgewater RoadGolden Valley, MN 55422Tel: 763-522-2121Email: mtnelson@comcast.net
Date of Summary:	April 10, 2015
Device Trade Name:	Breast-Med Tissue Marker
510(k) Number:	K133697
Product Code:	NEU
Common or Usual Name:	Tissue Marker
Classification Name:	Implantable clip (21 CFR 878.4300)
Predicate Device(s):	BiomarC Tissue Marker, K032347KDM-Mark1 Tissue Marker, K093473
Device Description:	The Breast-Med Tissue Marker is a sterile, nonpyrogenic, singleuse tissue marker consisting of a polymeric tube filled with adessicated solution of sodium chloride with trace amounts ofgadolinium chelate that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and MagneticResonance Imaging (MRI). The tissue marker is placed intosoft tissue during open, percutaneous, or endoscopicprocedures to radiographically mark a surgical location.
Indication for Use:	The Breast-Med Tissue Marker is indicated for use toradiographically mark soft tissue during a surgical procedure orfor future surgical procedures.

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TechnologicalCharacteristics:	The technological characteristics of the Breast-Med TissueMarker are substantially equivalent to those of the predicates interms of the following:Intended use Indications for use Target population Fundamental scientific technology Patient-contacting materials Method of delivery
Performance TestingSummary:	Bench testing was performed to verify that the subject devicehas equivalent radiographic visualization to the predicates understandard radiographs, ultrasound, and MRI in both tissue andphantom models.Safety testing of the device was performed utilizing the followingstandards: ASTM F2182, ASTM F2052, ASTM F2213 andASTMF2119.
Conclusion:	The Breast-Med Tissue Marker is substantially equivalent to thenamed predicates based on technological comparison,indications for use, and laboratory and other safety testing. It isconcluded that there are no new questions of safety andeffectiveness.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.