The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.

Device Description

The Machnet Bilateral Open Breast Coil is designed as a bilateral open breast coil which allows clinical imaging combined with very precise multiple localizations of breast lesions and subsequently small interventional breast procedures. Features: Dual channel phased array configuration. Allows bilateral and unilateral imaging of the breast and surrounding tissues. Minimal variation of contrast across images. The design allows adequate reception of signals from chest wall and axilla Ergonomic design minimizes motion artifacts. Open coil design allows virtually all sizes of breasts to be imaged. Breast support and positioning devices allow controlled positioning. High sensitivity allows thin slices. Interventional MRI possible with optional device (MICS-MIA). Accurate (2 to 3 mm) multiple computer-assisted localizations of breast lesions (with MICS-MIAS). Compatibility: GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them in the way a typical AI/ML medical device submission would. This document is a 510(k) summary for a medical device (a breast coil for MRI) from 2002, which predates the widespread use of AI/ML in medical devices and the specific reporting requirements for such devices.

Instead, the document details the device's substantial equivalence to a predicate device based on design, function, and intended use. The "Testing information and Conclusion" section broadly states that "Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics, sample sizes, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML device study design from the provided text.

Based on the document, here's what can be extracted, acknowledging the absence of AI/ML specific information:

Acceptance Criteria and Device Performance (Not applicable for AI/ML criteria):

Acceptance Criteria (Not explicitly stated for AI/ML)	Reported Device Performance (General)
Substantial Equivalence to Predicate Device	"In all material respects, the 'Machnet Bilateral Open Breast Coil' (Catalog # MICS-GSXX) is substantially equivalent to MRI Devices Model OBC-149 (K003340)."
Satisfy design intent	"Test results support the conclusion that actual device performance satisfies the design intent."
Produce diagnostic images	"Produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician."
Features/Capabilities	Dual channel phased array, bilateral/unilateral imaging, minimal contrast variation, adequate signal reception (chest wall/axilla), ergonomic, open coil, breast support, high sensitivity (thin slices), interventional MRI possible (with optional device), accurate multiple computer-assisted localizations (with MICS-MIAS).
Compatibility	GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.

Specific Questions (Answers based on the provided text, indicating "Not Applicable" or "Not Provided" for AI/ML specific criteria):

A table of acceptance criteria and the reported device performance: See table above. It is important to note these are functional and equivalence criteria, not performance metrics for an AI/ML diagnostic output.
Sample size used for the test set and the data provenance: Not provided. The text mentions "Testing was performed according to internal company procedures," but gives no details on the sample size or provenance of data used in those tests. This would typically involve physical testing of the coil, not a dataset in the AI/ML sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like an MRI coil, "ground truth" would relate to its physical properties (e.g., signal-to-noise ratio, image uniformity) rather than diagnostic interpretations of images requiring expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for diagnostic agreement on image interpretation, which is not described for the testing of this MRI coil.
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: Not applicable. This document is for a non-AI medical device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a non-AI medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, and likely not applicable in the AI/ML sense. The "ground truth" for a physical device would relate to engineering specifications and performance measurements.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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FEB 01 2002

EXHIBIT 2

MACHNET BV PO BOX 85444 NL-3508 AK UTRECHT THE NETHERLANDS

AMERSFOORTSEWEG 24 A

NL-3951 LB MAARN PHONE +31(0)343 444 355 FAX +31(0)343 444 934 Contact: Abe van der Werf, President November 28, 2001

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: "Machnet Bilateral Open Breast Coil" (Catalog # MICS-GSXX) (Classification Name: 90 MOS, COIL, MAGNETIC RESONANCE, SPECIALTY Common/Usual Name: Breast Coil Array Assembly
1. Equivalent legally marketed device: This device is similar in design and identical in function to the MRI Devices Corp. Model OBC-149 Breast Array Coil K003340
1. Indications for Use (intended use):. The Machnet Bilateral Open Breast Coil, Catalog Number MICS-GSXX, is for use in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician
1. Description of the device: The Machnet Bilateral Open Breast Coil is designed as a bilateral open breast coil which allows clinical imaging combined with very precise multiple localizations of breast lesions and subsequently small interventional breast procedures. Features: Dual channel phased array configuration. Allows bilateral and unilateral imaging of the breast and surrounding tissues. Minimal variation of contrast across images. The design allows adequate reception of signals from chest wall and axilla Ergonomic design minimizes motion artifacts. Open coil design allows virtually all sizes of breasts to be imaged. Breast support and positioning devices allow controlled positioning. High sensitivity allows thin slices. Interventional MRI possible with optional device (MICS-MIA). Accurate (2 to 3 mm) multiple computer-assisted localizations of breast lesions (with MICS-MIAS). Compatibility: GE Signa® (3X-LX) 1.5T, 1.0T, 0.5T MR scanners.

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MR proton imaging of female breast and surrounding tissues. Accurate Interventional MRI possible with optional device (MICS-MIA/S).

Photo of Machnet Product

Photo of predicate device

Image /page/1/Figure/4 description: The image shows a black and white drawing of a mask. The mask has a stylized design with eye holes and a mouth area. The mask appears to be a Guy Fawkes mask, which is often associated with the Anonymous movement. The mask is set against a black background.

1. Safety and Effectiveness, comparison to predicate device:

Comparison Areas	MRI Devices Corp. ModelOBC-149 Breast Array CoilK003340	"Machnet Bilateral OpenBreast Coil" (Catalog #MICS-GSXX)
Indications for use	In conjunction with a MagneticResonance Scanner to producediagnostic images of the breastand axillary tissues that can beinterpreted by a trained physician	SAME
Use with MRI Model	GE Signa	SAME
Description	See photo above	See photo above
Function	Receive only	SAME

1. Testing information and Conclusion
  In all material respects, the "Machnet Bilateral Open Breast Coil" (Catalog # MICS-GSXX) is substantially equivalent to MRI Devices Model OBC-149 (K003340). Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is facing left and is enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 1 2002

Machnet BV % Mr. Daniel Kamm. P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K013985 Trade/Device Name: Machnet Bilateral Open Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 28, 2001 Received: December 3, 2001

Dear Mr. Kamm:

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 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 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 one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

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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j) Indications for Use

510(k) Number__ Ko 1 3985

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V OR

Over the Counter Use (Per 21 CFR 801.109)

Nancy C. Broadon
Division Sign-Off

510k) N

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.