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Your MAGNETOM MR system [Aera/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

Your MAGNETOM MR system [Aera/Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Combi Suite Neurosurgery is the marketing name for an optional package for the MAGNETOM systems Aera and Skyra that includes the modified Combi Dockable Table for use with standalone OR tables (Operation Room) in a clinical workflow. The market name, MAGNETOM Combi Suite Neurosurgery, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow. MAGNETOM Combi Suite Neurosurgery enables the user to move a patient via the Combi Dockable Table from the OR table to the MR and vice versa in order to acquire intraoperative images.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets acceptance criteria in the manner typically associated with clinical performance studies for diagnostic devices (e.g., sensitivity, specificity, accuracy).

Instead, the document details the substantial equivalence of the "MAGNETOM Combi Suite Neurosurgery" to a predicate device, focusing on hardware and software changes and conformity to safety standards for MR systems.

Here's an analysis of the provided information:

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

• The document does not explicitly present a table of acceptance criteria and reported device performance in terms of diagnostic accuracy or clinical effectiveness.
• The primary "acceptance criteria" discussed are related to:
  • Substantial Equivalence: The device is found substantially equivalent to the predicate device (K140253). This implies that its performance, as a magnetic resonance diagnostic device, is expected to be similar to the predicate under its specified Indications for Use.
  • Safety Standards: Compliance with recognized industry standards such as ISO 14971:2007 (Risk Management) and the IEC 60601-1 series (electrical and mechanical hazards).
  • Biocompatibility: The device passed tests for Cytotoxicity, Skin Irritation, and Sensitization.
  • Electrical Safety & EMC: Compliance with IEC 60601-1, and exclusion from IEC 60601-1-2:2007 requirements for components within the controlled area when not connected to the MR system.
  • Software Verification and Validation: Conducted according to FDA guidance for a "moderate" level of concern.
  • Bench and Acoustic Testing: MR Imaging, Spectroscopy, Safety, Static Magnetic Field Strength, Acoustic noise level, dB/dt, and RF Heating. (Specific performance values for these tests are not provided, only that they were conducted).

2. Sample size used for the test set and the data provenance

• Not applicable. This submission is not based on a clinical test set with patient data comparing diagnostic performance. The testing described is primarily engineering and safety validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth determination by experts for a diagnostic test set is mentioned.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a diagnostic test set is mentioned.

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. An MRMC comparative effectiveness study was not performed, as this device (MAGNETOM Combi Suite Neurosurgery) is a hardware package facilitating patient transfer for intraoperative imaging, not an AI-assisted diagnostic tool.

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

• No. This is not an algorithm-only device. It's an optional hardware package for MR systems.

7. The type of ground truth used

• Not applicable. No diagnostic "ground truth" (expert consensus, pathology, outcomes data) was used or required for this type of submission, which focuses on hardware and safety equivalence. The "ground truth" in this context would be compliance with engineering standards and successful execution of verification tests.

8. The sample size for the training set

• Not applicable. This device is a hardware/software package for an existing MR system, not a machine learning model that requires a training set of data.

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

• Not applicable. As above, no training set or associated ground truth for a machine learning model is relevant here.

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