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IB Neuro™ software allows the post-processing and display of dynamically acquired MR datasets to evaluate image intensity variations over time. IB Neuro™ v1.0 plug-in accepts data from existing MRI systems, performs quality control checks and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP) and sends the maps to a PACS for subsequent viewing. These images when interpreted by a trained physician may yield information useful in clinical applications. Our advanced technology is designed to be compliant with healthcare standards such as DICOM and is easily and rapidly integrated into existing medical image visualization applications.

IB Neuro "" OsiriX Plugin is software designed to analvze dynamically acquired datasets. Using well-established algorithms, parametric perfusion maps can be generated such as Relative Cerebral Blood Volume (rCBV), Cerebral Blood Flow (CBF), Mean Transit Time (MTT) and Time to Peak (TTP). The strength of our software is its ability to extend the productivity of any existing viewer, CAD workstation or PACS via a platform-independent base library that allows for quick and seamless integration into existing server and workstation applications. It also includes other critical features such as:

• Enables rapid creation of a complete array of critical perfusion parameter o maps of rCBV, CBF, MTT, TTP
• o Automated correction of contrast agent leakage for rCBV maps
• o Automated brain mask generation
• Ability to normalize parameters to normal appearing white matter (NAWM) o
• o Automated report generation
• View dynamic signal time course on a per-voxel basis o
• Interactive Arterial Input Function (AIF) selection o
• o Automatic export of perfusion parameter maps to DICOM images within the same study

Acceptance Criteria and Device Performance Study for IB Neuro™ v1.0

The provided document describes the 510(k) submission for IB Neuro™ v1.0. This submission primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or a table of reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). The primary performance claim is that the device "performs quality control checks and generates parametric perfusion maps" and for "image analysis and processing and generation of parametric maps to provide additional information beyond standard imaging."

Since there are no explicit acceptance criteria or quantitative performance metrics reported in the provided text, the table below reflects the general claims and the basis for the 510(k) clearance:

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

The provided document states: "Discussion of Clinical Tests Performed: N/A". This indicates that no clinical tests, and therefore no specific test set with a defined sample size, data provenance, or ground truth, were performed for this 510(k) submission. The clearance was based on demonstrating substantial equivalence to predicate devices and non-clinical software validation.

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

As no clinical tests were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

As no clinical tests were performed, there was no test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted as indicated by "Discussion of Clinical Tests Performed: N/A". Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No standalone performance study of the algorithm's diagnostic accuracy metrics was conducted for this submission, as indicated by "Discussion of Clinical Tests Performed: N/A". The focus was on the software's functional capabilities and substantial equivalence.

7. Type of Ground Truth Used

No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used for this submission, as clinical tests were not performed.

8. Sample Size for the Training Set

The document does not provide information about a training set or its sample size. This is typical for submissions based on substantial equivalence and software validation, where the focus is on the software's ability to process and generate standard outputs rather than its performance against a diagnostic gold standard learned from data. The algorithms are described as "well-established."

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

As no training set is mentioned or implied, the method for establishing ground truth for a training set is not applicable here.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
• 2. A limb protection for patient table.
• 3. Modified pulse sequences.
• 4. A new software release.

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

• Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
• Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
• Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
• Modifications to the S-scan (K063207):
  • Device that locks the patient table.
  • Limb protection for the patient table.
  • Modified pulse sequences.
  • A new software release.
• Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

• Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
• Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

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