The Siemens Magnetom CP Angio Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.

Device Description

The CP Peripheral Angio Array Coil is a receiver only coil for the Magnetom Symphony system.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (CP Peripheral Angio Array Coil for the Magnetom Symphony). It focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance acceptance criteria for a novel AI or diagnostic algorithm and then proving the device meets them through a dedicated study.

Therefore, many of the requested elements (acceptance criteria table, detailed study design for performance, sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not present in the provided document.

Here's an analysis of what is available and what isn't:

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

Not present in this format. The document describes a general approach to demonstrating "substantial equivalence" based on safety and effectiveness.
Implied Acceptance Criteria (based on predicate device): The closest the document comes to acceptance criteria are the safety and performance parameters that are stated to be "unaffected by the modifications" and measured to be "equivalent to the currently available Siemens coils." These are:
- Maximum Static Field Strength
- Rate of Change in Magnetic Field
- RF Power deposition
- Acoustic Noise Levels
- Specification Volume
- Signal to Noise (SNR)
- Image Uniformity
- Geometric distortion
- High contrast spatial resolution
- Slice profile, thickness and gap
Reported Device Performance:
- "The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils." (No specific numerical values are given, only a statement of equivalence).
- For the other listed parameters (Static Field Strength, Rate of Change, RF Power, Acoustic Noise, Specification Volume, Geometric distortion, High contrast spatial resolution, Slice profile, thickness and gap), the document states they are "unaffected by the modifications," implying they remain within acceptable limits as established for the predicate device.

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

Not explicitly stated in the provided text. The document mentions "Laboratory and clinical testing were performed," but no details on sample size, data provenance, or study design (retrospective/prospective) are provided for these tests.

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 applicable/Not present. This device is an imaging coil, not an interpretive AI algorithm. The "ground truth" concept as typically applied to AI performance studies (e.g., medical diagnosis) does not directly apply here. Instead, performance is assessed against physical and imaging quality metrics. There is no mention of human experts establishing a diagnostic ground truth for comparison.

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

Not applicable/Not present. As above, this is not a diagnostic device with an AI component requiring expert adjudication for ground truth.

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 is not a study of AI-assisted human reading. It is a study to demonstrate substantial equivalence of an MRI coil's physical and technical performance.

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

Yes, in spirit, but not for an "algorithm." The "standalone" performance assessment here refers to the engineering and imaging quality tests of the coil itself (SNR, Image Uniformity, etc.) performed in a laboratory or clinical setting (without human diagnostic interpretation being the primary endpoint). The statement "The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils" indicates this standalone testing.

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

Engineering/Physics-based measurement standards. For parameters like SNR, Image Uniformity, Static Field Strength, etc., the "ground truth" would be derived from established physical measurement techniques and engineering specifications, often compared against performance benchmarks of the predicate device or industry standards. It's not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable/Not present. This device is an imaging coil; there is no "training set" in the context of machine learning or AI algorithms.

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

Not applicable/Not present. As above, no training set or associated ground truth establishment is described for this type of device.

In summary:

The provided document is a 510(k) summary for an MRI coil, focused on demonstrating substantial equivalence to a predicate device. It highlights that the new coil maintains the safety and effectiveness characteristics of the predicate, as evidenced by laboratory and clinical testing on physical and imaging parameters (like SNR and image uniformity). It does not contain the kind of detailed performance study information typically associated with AI-driven diagnostic devices, such as specific acceptance criteria for a diagnostic task, sample sizes for AI model validation, expert ground truth establishment, or human-reader studies.

Summary

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FEB 4 2000

Appendix 11: PMN Truthful and Accurate Statement

510 (k) Summary

K994315

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.

I. General Information.

Establishment:

Siemens Medical Systems, Inc. • Address: 186 Wood Avenue South Iselin, N.J. 08830
2240869 Registration Number:
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841
Date of Summary Preparation: 12/21/99

Device Name:

CP Peripheral Angio Array Coil for the Magnetom Symphony • Trade Name:

Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000
· Classification: Class II

· Performance Standards: None established under Section 514 of the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

• Device Description:

The CP Peripheral Angio Array Coil is a receiver only coil for the Magnetom Symphony system.

• Intended Use

• Technological Characteristics

The magnet. RF system, and gradient system, of the MAGNETOM Symphony configured with the new CP Angio Array Coil is substantially equivalent to the standard MAGNETOM Symphony system with the currently marketed family of coils (which were described in K971684).

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony system with the new CP peripheral Angio Array Coil is substantially equivalent to standard operation of the commercially available MAGNETOM Symphony system. The following safety parameter with action levels:

Maximum Static Field Strength -
Rate of Change in Magnetic Field -
RF Power deposition -
Acoustic Noise Levels -

and performance levels:

-Specification Volume
Signal to Noise -
-Image Uniformity
Geometric distortion -
High contrast spatial resolution -
-Slice profile, thickness and gap

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. The new CP peripheral Angio Array Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent to the currently available Siemens coils.

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• Substantial Equivalence:

Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

CP Peripheral Angio Array Coil/ MAGNETOM Symphony System Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Yieh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.

K994315

If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".

Sinceraty you

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) に 99 イヨノ5

Device Name: CP Peripheral Angio Array Coil for the MAGNETOM SYMPHONY

Indications for Use:

The Siemens Magnetom CP Peripheral Angio Array Coil is primarily indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images of vascular structures and soft tissue of the abdomen, pelvis and lower limbs. The design of this coil facilitates imaging larger peripheral vascular areas.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use >

Over-The-Counter Use

Verrill G. Hynson

(Division Sign-Off) Division of Reproductive, Abdominat, ENT, and Radiological Devices 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.