The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.

The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Rubicor Flexible Loop Electrosurgical Electrode. It details the device's intended use and claims substantial equivalence to predicate devices based on in-vitro testing. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study specifics.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

Acceptance Criteria	Reported Device Performance
Not specified	"Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function."

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (other than "in-vitro testing"). The document does not mention country of origin, nor whether the data was retrospective or prospective.

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)

Not specified. The document only mentions "in-vitro testing," which typically doesn't involve human experts establishing ground truth in the same way clinical imaging studies do.

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

Not applicable/Not specified as it was in-vitro testing.

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

No. This document describes an electrosurgical electrode and its safety/effectiveness for tissue sampling. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant or mentioned.

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

No. This device is a surgical instrument, not a standalone diagnostic algorithm. Its performance is tied to its physical function in tissue sampling.

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

For "in-vitro testing," ground truth would typically refer to established physical or chemical properties, measurements, or the ability to perform the intended function (e.g., cut soft tissue, collect samples for subsequent histologic examination). The document implies the ability to provide tissue samples for histologic examination, but the specific "ground truth" for the in-vitro performance itself is not detailed.

8. The sample size for the training set

Not applicable/Not specified. This is a conventional medical device, not an AI/machine learning model that would require a "training set."

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

Not applicable, as there is no "training set" for this type of device.

Summary of Study:

The document states that "Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function." This indicates a study was conducted in a laboratory setting, likely involving tests to assess the device's ability to cut soft tissue and collect samples, as per its intended use for diagnostic sampling of breast tissue. The study aimed to show substantial equivalence to predicate devices like the Rubicor EnCapsule™ Breast Biopsy Device, SenoRx Shape Select Scalpel, Wallach LOOP Electrodes, and Megadyne Electrosurgical Electrode. However, no specific details about the methods, sample sizes, or precise outcomes of this in-vitro testing are provided beyond the general statement of safety and effectiveness.

Summary

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Rubicor Flexible Loop Electrosurgical Electrode

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510(k) Notification

5 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: January 9, 2007

MAR 0 9 2007

510(k) number: _ K 070275

Applicant Information:

Rubicor Medical, Inc. 600 Chesapeake Dr. Redwood City, CA 94063

Contact Person:	Chris Daniel
Phone Number:	(650) 556-1070
Fax Number:	(650) 556-1821

Device Information:

Classification: Common Name: Trade Name: Classification Name: 878.4400)

Class II Electrosurgical Electrode Not yet determined Electrosurgical Device and accessories (21 CFR

Equivalent Device:

The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor EnCapsule™ Breast Biopsy Device (K052506), SenoRx Shape Select Scalpel (K012799), Wallach LOOP Electrodes (K020711), and Megadyne Electrosurgical Electrode (K973346).

Intended Use:

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K070275

Rubicor Flexible Loop Electrosurgical Electrode

Page 2 of 2

510(k) Notification

that the tissue margins be examined for completeness of removal using standard surgical procedures.

Test Results:

Performance

Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function.

Summary:

Based on the intended use, product, and performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the department's name, which is written in a circular arrangement around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rubicor Medical, Inc. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services 455 East Trimble Road San Jose, California 95131-1230

MAR 0 9 2007

Re: K070275

Trade/Device Name: Flexible Loop Electrosurgical Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 22, 2007 Received: February 23, 2007

Dear Mr. Christensen:

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 (PMA), 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

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Page 2 - Mr. Morten Simon Christensen

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

fol Pdo th

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 Indication for Use Statement

510(k) Number (if known):

K070275

Device Name: Flexible Loop Electrosurgical Electrode

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Genera Restorative,

and Neurological Devices

510(k) Number	12070275
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Rubicor Medical, Inc.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.