The MR-guided procedure package is an optional hardware and software package for the Magnetom Open. The package contains a new scan room console (/footswitch), new imaging coil, in-bore light, chair, new software and optimized sequences.

AI/ML Overview

This looks like a 510(k) summary for a medical device submitted to the FDA, which is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This type of submission often focuses on establishing "substantial equivalence" rather than presenting a detailed clinical study for novel performance claims as you might find for a PMA or de novo submission.

Given this context, many of your requested fields related to a clinical study proving the device meets acceptance criteria may not be directly applicable or explicitly stated in this type of summary. The document focuses on demonstrating that the new "MR Guided Procedures Package" for the MAGNETOM OPEN system is substantially equivalent to the existing MAGNETOM OPEN system, and that its technological characteristics and safety/effectiveness concerns are similar.

Here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations inherent in a 510(k) summary:

Acceptance Criteria and Study for K955389 - MAGNETOM OPEN MR GUIDED PROCEDURES PACKAGE

Based on the provided 510(k) summary, the "acceptance criteria" are primarily framed around demonstrating substantial equivalence to the predicate device (the standard MAGNETOM OPEN system) and showing that the modifications do not introduce new safety or effectiveness concerns. The "study" mentioned refers to testing performed to support this claim of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Technological Characteristics:	The magnet, RF system, and gradient system of the MAGNETOM OPEN configured with the MR Guided Procedures Package is substantially equivalent to the standard MAGNETOM OPEN system.
General Safety and Effectiveness Concerns (Operation):	Operation of the MAGNETOM OPEN system with the new MR Guided Procedures Package is substantially equivalent to standard operation of the MAGNETOM OPEN system.
Safety Parameter Action Levels (Unaffected): - Static field strength- RF exposure	These specified safety parameter action levels (from FDA guidance) are unaffected by the modifications.
Performance Levels (Unaffected): - Signal-to-noise- High contrast spatial resolution- Slice thickness- Image uniformity- Geometric distortion	These specified performance levels (from FDA guidance) are unaffected by the modifications. Note: Additional SNR and image uniformity measurements were performed for a new imaging coil, implying similar performance to the predicate or within acceptable ranges. This implies successful demonstration of these characteristics.
Re-evaluated Safety Documentation:	Warnings, contraindications, precautions, and safety instructions were reevaluated and revised/expanded (e.g., emergency shutdown procedures) to address increased in-room physician/technologist presence. This implies the device, with updated labeling, meets safety standards for its new use.
No New Questions of Safety and Effectiveness:	Laboratory and clinical testing were performed to support substantial equivalence and to show that technological differences do not raise any new questions pertaining to safety and effectiveness.

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

Sample Size: The document does not specify a sample size for any test set (e.g., number of patients, number of images, or number of tests conducted). It vaguely mentions "laboratory and clinical testing."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not mention any experts used to establish ground truth or their qualifications. The focus is on demonstrating equivalence based on engineering and performance parameters, not on diagnostic accuracy assessed by experts.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method.

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

No, an MRMC comparative effectiveness study is not mentioned or described. The document focuses on demonstrating substantial equivalence, not comparative effectiveness with or without AI assistance (as this device is not an AI algorithm itself, but an MR-guided procedures package).

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

This question is not applicable as the device (MR Guided Procedures Package) is an assistive technology for procedures, not a standalone algorithm/AI for diagnostic interpretation. Its performance is inherently tied to human use in interventional procedures.

7. The Type of Ground Truth Used:

The document does not explicitly state "ground truth" as it would be understood in a diagnostic accuracy study (e.g., pathology, outcomes). Instead, the "truth" or reference standard for comparison appears to be the performance specifications and safety profiles of the predicate device (the standard MAGNETOM OPEN system) and FDA guidance documents for MR diagnostic devices. The testing likely involved physical measurements and observations verifying that the new package performs within expected ranges and does not negatively impact the established parameters.

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. This is expected as the submission describes a hardware and software package for MR-guided procedures, not a machine learning model that would typically have a "training set."

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

This question is not applicable as no "training set" or explicit "ground truth" for a training set (in the context of machine learning) is mentioned or relevant to this 510(k) submission.

Summary

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K955389

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The 10 1896

Appendix 9:

510(k) Summary

11/22/95 510(k) Premarket Notification MAGNETOM OPEN MR GUIDED PROCEDURES PACKAGE

Appendix 9 Page 1

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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.

I. General Information.

Establishment:
• Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
• Registration Number:	2240869
• Contact Person:	Cathy Anne PintoSr. Technical Specialist, Regulatory Affairs(908) 321-4887(908) 321-4841
• Date of Summary Preparation:	November 22, 1995
Device Name:
• Trade Name:	MR Guide Procedures Package/MAGNETOM OPEN
• Classification Name:	Magnetic Resonance DiagnosticDevice, CFR § 892.1000
• Classification:	Class II
• Performance Standards:	None established under Section 514 ofthe Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

• Device Description:

• Intended Use

The MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.

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Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM OPEN configured with the MR Guided Procedures Package is substantially equivalent to the standard MAGNETOM OPEN system.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM OPEN system with the new MR Guided Procedures Package is substantially equivalent to standard operation of the MAGNETOM OPEN system. The following safety parameter action levels:

static field strength,
i RF exposure,

and performance levels:

signal-to-noise,
high contrast spatial resolution,
slice thickness,
image uniformity and,
geometric distortion.

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. Additional SNR and image uniformity measurements were performed for a new imaging coil.

Even though the imaging room has always been accessible to the physician and / or technologist during the MR procedure (assuming the identified warnings and contraindications for the system were adhered to) the new configuration for the OPEN requires the user to remain within the imaging room for a higher percentage of time. Therefore, the warnings, contraindications, precautions, and safety instructions (e.g. emergency shutdown of the magnet) for the system have been reevaluated. As a result of this analysis existing warnings have been revised and additional warnings have been included.

· 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 pertainging to safety and effectiveness.

Kathleen Rutherford
Kathleen M. Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions

11/20/95
Date

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.