Model 415PH-64/42: Phased Array Shoulder Coil With Model 855PH: Synergy MultiConnect. Compatible with a Philips 1.5T/1.0T MRI System. Magnetic Resonance Imaging Coil.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Model 415PH-64/42: Phased Array Shoulder Coil:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel performance criteria for a new type of device. Therefore, the "acceptance criteria" are implicitly that the new device performs at least as well as, or identically to, the predicate device in terms of safety and imaging parameters. The "reported device performance" is essentially a statement of no change from the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety Parameters:
Maximum Static Magnetic Field	No change
Rate of Magnetic Field Strength Change	No change
RF Power Deposition	No change
Acoustic Noise Levels	No change
Biocompatibility	No change
Imaging Performance Parameters:
Specification Volume	No change
Signal-to-Noise Ratio (SNR)	No change
Image Uniformity	No change
Geometric Distortion	No change
Slice Thickness and Gap	No change
High Contrast Spatial Resolution	No change
Overall Safety and Effectiveness (Instructions for use, precautions, etc.)	Instructions for use included (indications, precautions, cautions, contraindications, warnings, QA testing) assure safe and effective use.

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

The provided 510(k) summary does not detail a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of submission for a coil often relies on engineering testing and comparison to predicate device specifications rather than clinical trials with patient data. The "no change" statements imply that the technical characteristics of the coil were tested and found to be consistent with or within the acceptable range of the existing Philips MRI system and its predicate coils.

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

This information is not provided in the document. As this is a submission for a medical device accessory (MRI coil) and not an AI-powered diagnostic algorithm, the concept of "ground truth" established by experts in a clinical context for a "test set" as typically understood for AI algorithms, is largely inapplicable here. The "ground truth" for the technical specifications of the coil would be established by engineering standards and measurements.

4. Adjudication Method for the Test Set

This information is not provided and is not typically relevant for a 510(k) submission of an MRI coil, which focuses on technical performance and safety rather than diagnostic accuracy requiring expert consensus.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an MRI coil, not an AI-powered diagnostic tool, therefore, the concept of "human readers improve with AI" is not applicable.

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

No, a standalone algorithm-only performance study was not done. This device is hardware (an MRI coil), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on engineering measurements and technical specifications compared against established standards for MRI system safety and imaging quality. This would involve measurements of static magnetic fields, RF power deposition, signal-to-noise ratios, image uniformity, geometric distortion, etc., rather than clinical ground truth derived from pathology or expert consensus on diagnostic images.

8. The Sample Size for the Training Set

This information is not applicable as this is a hardware device (MRI coil) and not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable for the same reasons as #8.

Summary

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JUN 1 3 2002

510(k) Summary of Safety and Effectiveness

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ប្រទេស

K02/433

Device Name	Model 415PH-64/42: Phased Array Shoulder CoilWith Model 855PH: Synergy MultiConnect
Applicability	Compatible with a Philips 1.5T/1.0T MRI System
Reason for 510(k)	Control mechanism change to an existing product
Classification Name	Magnetic Resonance Diagnostic Device
Device Classification Panel	Radiology
Device Classification Number	892.1000
Product Code	90MOS
Common Name	Magnetic Resonance Imaging Coil
Proprietary Name	Model 415PH-64/42: Phased Array Shoulder Coil
Establishment Registration Number	2183683
Address of MFG Facility	IGC-Medical Advances Inc.10437 Innovation DriveMilwaukee, WI 53226
Point of Contact	Jerry FrohlichManager, Regulatory Affairs414.258.3808 Ext. 206
Classification	Class II
Diagnostic Uses	2D, 3D imaging, proton density, T1 and T2weighted imaging. 2D, 3D time of flight, phasecontrast imaging.
Anatomic Regions	Shoulder and other related joint structures.
Performance Standards	None Established under Section 514
Voluntary Safety Standards	UL 2601-1	Medical Electrical Equipment, Part1: General Requirements for Safety
	UL 94	Tests for Flammability of PlasticMaterials
	IEC 601-1	General Safety Requirements forMedical Electrical Equipment

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Overview

The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notifications that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:

The GE 1.5T Signa MRI system operated with the Medical Advances UltraImage "Temporal Lobe Array Coil is substantially equivalent to the same system operated with the legally marketed predicate devices listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:

Safety Parameters

Maximum Static Magnetic Field:	No change
Rate of Magnetic Field Strength Change:	No change
RF Power Deposition:	No change
Acoustic Noise Levels:	No change
Biocompatibility:	No change

Imaging Performance Purameters

Specification Volume:	No change
Signal-to-Noise Ratio:	No change
Image Uniformity:	No change

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Geometric Distortion:	No change
Slice Thickness and Gap:	No change
High Contrast Spatial Resolution:	No change

General Safety and Effectiveness Concerns

The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures sufe and effective use of the device.

Substantial Equivalence Summary

The Philips 1.5T Intera MRI system operated with the Medical Advances Phased Array Shoulder Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate devices. The use of these coils does not affect the Philips Intera system safety parameter specifications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. R. Jerry Frohlich Manager, Ouality Assurance and Regulatory Affairs IGC-Medical Advances, Inc. 10437 Innovation Dr. MILWAUKEE WI 53226

Re: K021433

JUN 1 3 2002

Trade/Device Name: Model 415PH Series: Phased Array Coil with Synergy MultiConnect Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 3, 2002 Received: May 6, 2002

Dear Mr. Frohlich:

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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Page _ 1 of __________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Model 415PH Series: Medical Advances Phased Array Shoulder Coil with Synergy MultiConnect

Indications for Use:

Magnetic resonance imaging (MRI) of the shoulder.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96

David G. Tegenon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 4021433 510(k) Number _

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.