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Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists,

Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include CT, PET, MR, SPECT and planar NM. Supported image types include static, gated and dynamic.

The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

Mirada XD allows the user to register combinations of anatomical images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The registration operation can assist the user in assessing changes in image data, either within or between exammations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.

Mirada XD provides a number of tools such as rulers and region of interests intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up.

Mirada XD allows the user to define, import, transform, store and export regions of interest structures in DICOM RT format for use in radiation therapy planning systems.

XD is a stand-alone desktop software application with tools and features designed to display or view medical images as well as tools for performing quantitative readings of the imaging data.

The use environment for XD is in a clinical environment, typically within dedicated radiology reading rooms or areas.

The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of user-defined regions of interest.

The software system runs on a dedicated workstation and is intended for display and processing, of a Computed Tomography (CT), Magnetic Resonance (MR), Positron Emission Tomography (PET), Single-Photon Emission Computed Tomography (SPECT) or Nuclear Medicine (NM) images, including contrast enhanced and dynamic or multisequence images.

XD is not intended for specific populations; the system can be used to display data of any patient demographic chosen by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists for use in clinical workflows.

The Mirada XD is a medical imaging software application. The provided text describes the device's indications for use, comparison to a predicate device, and performance testing, but does not explicitly state specific acceptance criteria or provide a detailed study report with all the requested information.

Here's an analysis based on the available text, with indications where specific information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with corresponding performance metrics. It generally states that the device "meets the user needs and requirements" and passed various tests.

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

This information is not provided in the document. The text mentions "performance testing (Bench)" but offers no details on the number of cases, images, or patient data used, nor their origin (e.g., country, retrospective/prospective).

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

This information is not provided in the document. The text refers to "user actions" and "responsibility of the user" for clinical accuracy of segmentations, implying human interpretation, but does not detail the process of establishing ground truth for testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed. The document focuses on performance testing of the device itself and its equivalence to a predicate, rather than an AI-assisted human vs. non-AI-assisted human comparative study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document mentions "performance testing (Bench)" for features like "Thick Slab visualization" and "PET hotspot finder." It also states, "The software's functions are dependent on the user actions as well as on the available information in the provided medical image data." and "The use of the segmentation tools to achieve a satisfactory delineation of any regions of interest is a user operation and the clinical accuracy of segmentation is the responsibility of the user and not an XD function." This suggests that while underlying algorithms are tested, the overall clinical performance is not treated as standalone algorithm performance but rather as a tool for a human user. It's not explicitly stated that a standalone algorithm-only performance study was conducted in a clinical context.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for testing. Given the nature of the device (medical image management and processing system with tools for segmentation, registration, and quantification), it's likely that ground truth would involve:

• Expert Consensus/Manual Delineation: For segmentation accuracy, experts would typically manually delineate regions of interest.
• Known Physical Measurements/Phantoms: For distance and volumetric measurements.
• Reference Image Registrations: For image registration accuracy.

However, the text emphasizes the user's responsibility for clinical accuracy, making it unclear how ground truth was precisely established for the "performance and accuracy" evaluation mentioned.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes a "Medical image management and processing system" that includes segmentation, registration, and visualization tools. It does not explicitly mention "training sets" in the context of machine learning, suggesting that the primary verification and validation focus was on software functionality and accuracy rather than a machine learning model's performance based on a training set.

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

Since a training set for machine learning is not mentioned, the method for establishing its ground truth is also not provided.

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XD880A Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.

The provided document does not describe a study involving an AI/Machine Learning device or an imaging device. Instead, it is a 510(k) premarket notification for a physical medical device: the XD880A Ultrasonic Osteotomy Surgical System. This system is an ultrasonic surgical tool used for cutting and shaping bone.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/ML or imaging device is not applicable to this document.

The document focuses on demonstrating the substantial equivalence of the XD880A Ultrasonic Osteotomy Surgical System to existing legally marketed predicate devices. The performance testing described is related to the physical and functional aspects of the surgical tool, not an AI or imaging algorithm.

Here's a breakdown of the performance testing that was conducted, as described in the document:

• Electrical Safety and Electromagnetic Compatibility (EMC): The system complies with IEC 60601-1:2006 for safety and IEC 60601-1-2:2007/2010 for EMC.
• Biocompatibility: Components in contact with patients (handpiece, tips, liquid-flow sleeve/tube) were tested. Materials (Titanium Alloy TC4, Medical Silicone Rubber) met ISO and JISK requirements, and studies showed them to be biocompatible.
• Software Verification and Validation: Conducted in line with FDA guidance for "moderate level of concern" software.
• Mechanical and Acoustic Testing: Bench testing and acoustic testing performed; results "demonstrated that the subject device performs within its specifications." (Specific acceptance criteria and reported performance values are not detailed in this summary).
• Animal Study (GLP):
  • Objective: Evaluate efficiency, convenience, and safety of 15 tips during spine surgery.
  • Subjects: 10 beagles, split into two groups of 5.
  • Procedure: Spinal surgery (cutting vertebral plate) using the device at maximum power settings.
  • Evaluation Metrics:
    • Efficiency: Cutting time of bone, bleeding volume.
    • Safety: Neurophysiological parameters (SEP latent period and fluctuation, MEP) before, during, and after surgery; clinical observation (mental state, behavior) on days 1, 3, 7 post-op; CT scan on day 7; histopathology on day 8.
  • Results: All tips were efficient and safe.
    • Average cutting time: 12min 2sec (Group 1), 10min 24sec (Group 2).
    • Average bleeding volume: 31.4mL (Group 1), 28.6mL (Group 2).
    • No accidental damage to nerves, vessels, or soft tissues.
    • Normal SEP/MEP values (with explanation for minor anomalies attributed to anesthesia).
    • Normal clinical evaluation scores (with minor, resolved anomalies).
    • CT scan showed normal spine, expected absence of vertebral plate, and minor post-op edema.
    • Histopathology showed no spinal cord tissue damage, and inflammatory cells considered normal tissue reaction.

In summary, the provided text describes a submission for a physical surgical device, not an AI/ML or imaging diagnostic device. Therefore, the questions about AI/ML performance metrics, data sets, and expert evaluations are not applicable to this document.

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Allows for drainage and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.

The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only.

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no study described that demonstrates the device meets acceptance criteria. The document mainly focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Specifically, the document states:

• Description: "The XDS provides a simple to use, closed loop system for the drainage of cerebrospinal fluid (CSF) and allows for pressure monitoring. XDS consists of a disposable drainage bag attached to a drainage tubing set that incorporates a calibrated scale and a graduated drip chamber used for estimation of drainage fluids. The systems will be provided sterile and will be labeled for single use only."
• Intended Use: "The XDS allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP."
• Predicate Device: Medtronic Becker External Drainage and Monitoring System, K984053

A 510(k) summary typically includes a declaration that the device is substantially equivalent to a legally marketed predicate device. This often means that the device has similar technological characteristics and/or that differences in technological characteristics do not raise different questions of safety and effectiveness. It does not necessarily require the submission of extensive clinical performance studies comparing the new device against specific acceptance criteria in the same way a new drug or novel device might.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document is solely a regulatory filing for substantial equivalence based on a predicate device.

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