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MRIMath i2contour is intended for the semi-automatic labeling, visualization, and volumetric quantification of WHO grade 4 glioblastoma (GBM) from a set of standard MRI images of male or female patients 18 years of age or older who are known to have pathologically proven glioblastoma. Volumetric measurements may be compared to past measurements if available. MRIMath i2contour is not to be used for primary diagnosis and is not intended to be the sole diagnostic metric.

The MRIMath i2Contour is a web-based software platform designed for the contouring and segmentation of the T1c and FLAIR sequences of the MRIs of patients already diagnosed with GBM. It combines AI with a user interface (UI) for review, manual contouring, and approval. The software is intended to be used by trained medical professionals as an aid in the tumor contouring process. Review by a trained professional is a requirement for completion.

The AI algorithm within MRIMath i2Contour generates an initial tumor contour, which serves as a starting point for medical professionals to complete the contouring process manually. It is important to note that the software does not alter the original MRI images and is not intended for turnor detection or diagnostic purposes. MRIMath i2Contour is specifically designed to generate turnor volume contours for GBM. It is not intended for use with images of other brain tumor types.

Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text:

Device: i2Contour

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly set by comparing the device's performance to the predicate device's best mean DICE score (DSC) and demonstrating statistically significant improvement over a 50% chance of exceeding this threshold.

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I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.

For clinical use, l2C must be integrated into a radiation therapy system. I2C will interact with components of the radiation therapy center. I2C supports the acquisition of 2D, 2D stereoscopic and 3D images using 2D detectors. I2C will be used by the clinical therapist to verify by imaging that the treatment target position received from the treatment control applicative laver is 'valid', i.e. that it brings the center of the treatment target volume at the isocenter of the therapy equipment with required accuracy. If it is not, InC will propose a correction shift - or correction vector - that will be exported to the radiation therapy system.

Here's a summary of the acceptance criteria and study information for the I2C device:

1. Table of Acceptance Criteria and Reported Device Performance

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The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I₂ is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.

Esophageal probe for measuring blood flow in the descending aorta. Sterile. For single use only. Overall length 89 cm (35"). Shaft construction Spring enclosed in silicone rubber. Shaft color Clear (non-pigmented) shaft. Shaft flexibility (N) 0.095. Main shaft diameter 14 FG (~4.8 mm). Distal tip diameter 19FG (~6.3 mm). Maximum Usage time (hours) 6, 24 or 72. Main shaft wall thickness 0.03" (~0.7mm). Marks in the shaft The probe shaft has three depth markers at 35, 40 and 45 cm. Color of transducer head "clear" (non-pigmented). Color of the molded connector "white" (pigmented). Color of the shaft "clear" (non-pigmented). Connection to the monitor non-reversible connector with ROM to identify probe type. Doppler transducer / Central frequency 4MHz. Doppler transducer / Global maximum output 195 mW/cm². Doppler transducer / Mechanical index 0.039. Spring wire 0.030" (0.76 mm) diameter to BS5216 HS3, Pre-galvanized. Spring length 550mm (+/- 25 mm). Spring internal diameter 1.80/2.00 mm. Spring external diameter 3.30/3.50 mm. Spring pitch The spring has fewer turns per unit of length (it has a larger pitch than DP 240). ROM memory This ROM memory is characteristic for the particular probe. Mode of operation Esophageal probe transmits and receives 4 MHz Continuous Wave Doppler (CWD) ultrasound from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Signals are returned via the Patient Interface Cable (PIC) to CardioQ Monitor. This permits to measure blood flow velocities in the descending thoracic aorta. Compatible Monitor CardioQ monitor. Rx Status Rx. Physicians Caution included in labeling Yes.

The provided document is a 510(k) Summary for the Deltex Medical Ltd I2n Series Doppler Probe. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with specific acceptance criteria and performance data for the subject device.

Therefore, many of the requested elements regarding acceptance criteria, study design, and performance metrics are not explicitly stated within this 510(k) summary. The document focuses on comparing the design and materials of the new I2n Series probe to existing predicate devices (DP240 Hour Doppler Probe, CardioQ Probe, and Hemosonic 100 Esophageal Probe). The "study" mentioned is implicitly a comparison of physical and operational specifications to demonstrate equivalence, rather than a clinical performance study with defined acceptance criteria.

Specific answers to your questions based on the provided text:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly present acceptance criteria or reported device performance in the format of a clinical performance study with quantitative results against predefined thresholds. Instead, it provides a comparative table outlining the features of the subject device (I2n-series) against three predicate devices. The "performance" demonstrated is through feature-by-feature comparison, indicating that the new device is either identical or has minor, non-significant differences from the predicates, particularly highlighting the improved shaft flexibility.

   Implicit Comparison Table (derived from the document's comparative table):

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