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Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (Multiplanar reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.

Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles.

These are the operating principles:

• On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard. -
• On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface. -
• -On Mixed Reality qlasses the interaction is performed with a dedicated pointing device.

The subject device provides or integrates the following frequently used functions:

• -Select medical images and other healthcare data to be displayed
• -Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views)
• Change view layout (e.g. maximize / minimize views, close / open / reorder views) -
• Manipulate views (e.g. scroll, zoom, pan, change windowing) -
• Perform measurements (e.g. distance or angle measurements) -
• -Place annotations at points of interests

The provided document is a 510(k) summary for the "Viewer" device from Brainlab AG. It describes the device, its intended use, and its comparison to a predicate device and a reference device to demonstrate substantial equivalence. However, it does not contain the detailed information required to fill out the table of acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth establishment, or multi-reader multi-case studies for AI components.

The document primarily focuses on verifying the software's functionality, user interface, DICOM compatibility, and integration, rather than clinical performance metrics of an AI algorithm. The device is a "Picture Archiving And Communications System" (PACS) that displays medical images and other healthcare data and is not intended for primary image diagnosis. This indicates that the regulatory requirements for performance metrics such as sensitivity and specificity, which are common for AI algorithms involved in diagnosis, would not apply to this specific device.

Therefore, most of the information requested in your prompt cannot be extracted from this document because the device described is not an AI diagnostic algorithm, and the provided text focuses on software functionality verification rather than clinical performance studies.

Here's what can be extracted and what cannot:

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

Missing Information/Not Applicable: The document does not provide acceptance criteria or performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) because the device is explicitly stated as not intended for primary image diagnosis.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The verification tests mention "companywide test data" and "various platforms and combination with other products" but do not provide specific numbers of cases or images.
• Data Provenance: Not specified. The document mentions "companywide test data" but does not detail the country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. Since the device is not for primary diagnosis and the tests focus on software functionality, there is no mention of experts establishing ground truth for diagnostic purposes. The "ground truth" for the software functionality tests would be the expected behavior of the software.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified. The testing methods described are interactive testing, automated/semi-automated tests, and usability tests. There is no mention of an adjudication method typical for diagnostic performance studies.

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

• Not applicable. The document does not describe an AI algorithm intended to assist human readers in diagnosis. It's a DICOM viewer. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

• Not applicable. This device is a viewer, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, expert consensus) does not apply here as the device is not for primary diagnosis. For its stated functions, the "ground truth" would be the expected, correct functioning of the software features (e.g., correct display of DICOM data, accurate measurements of distance/angle).

8. The sample size for the training set

• Not applicable/Not specified. The device is a viewer, not an AI model that undergoes a "training" phase with a dataset.

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

• Not applicable. (See point 8).

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The Image Fusion Element is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets.

The Image Fusion Element can be used in clinical workflows that benefit from the co-registration of image data. For example, this applies to navigation systems or medical data information terminals for image processing or image guided surgery in general as well as for treatment planning software for radiosurgery and radiotherapy. The device itself does not have specific clinical indications.

The Image Fusion Element is intended to co-register volumetric medical image data (e.g. MR, CT). It allows rigid image registration to adjust different spatial position and orientation of two data sets. It also offers deformable registration to compensate image distortion or spatial deviation between image acquisitions.

The Image Fusion Element gives the possibility to show basic planning content (e.g. objects, points, trajectories) defined from one dataset on another dataset and to display datasets of corresponding anatomic planes simultaneously. Further it could process co-registered data to highlight differences between distinct scanning sequences or to assess the response to a treatment.

The provided document is a 510(k) premarket notification for Brainlab AG's "Image Fusion" device. It outlines the device's intended use, technological characteristics, and a summary of safety and effectiveness, primarily through demonstrating substantial equivalence to predicate devices.

However, this document does not contain the detailed study information typically found in a clinical performance study report that would prove the device meets specific acceptance criteria using a test set, ground truth, and statistical analysis as requested in your prompt. The document outlines a verification and validation (V&V) process, but it does not specify quantitative acceptance criteria or report the results of a controlled study against a predefined ground truth in the manner you've described.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device's features and functionality to existing legally marketed predicate devices (Mirada XD, K101228, and iPlan, K113732). The "Changes to Predicate Device" section and the "Technological Characteristics" table highlight this comparison.
• Verification and Validation Summary: Stating that verification and validation were performed according to internal plans and processes, including usability testing, to ensure design specifications are met and the device can be used safely. There are no specific performance metrics or statistical results presented.

Therefore, I cannot provide the information requested in your numbered list for this specific device from the provided text, as the necessary details regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a clinical performance study are not present.

The document's statement: "Functionality and features considered as substantially equivalent have been verified and validated. The system Image Fusion with its set of functionalities is substantially equivalent to its predicate devices," serves as the core of its argument for market clearance rather than presenting a detailed clinical study demonstrating quantitative performance against specific acceptance criteria.

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Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

This document outlines the substantial equivalence of the "Elements™" dental impression material to a predicate device, "Take 1 (K091613)", based on non-clinical performance testing. It does not describe a study involving an AI-powered medical device or human readers. Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.

The provided text focuses on the following:

• Device: Elements™ (dental impression material)
• Predicate Device: Take 1 (K091613)
• Purpose: To demonstrate substantial equivalence for FDA 510(k) clearance.
• Study Type: Non-clinical performance testing based on ISO 4823-2000.
• Key Finding: "No clinical testing was performed."

Since the request is about an "AI device" and "how much human readers improve with AI vs without AI assistance," the provided document is irrelevant to answering those specific questions. The document details the physical properties and a comparison of a traditional dental material, not an AI or software as a medical device.

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The Elements Obturation Unit is intended to be used in Dentistry to:

1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
2. For tissue cauterization and coagulation, and
3. To backfill and downpack gutta percha during Endodontic root canal treatment.
4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.

The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.

The provided text is a 510(k) Summary for the "Elements Obturation Unit," a dental device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory submission for premarket notification, focusing on demonstrating that the device is "substantially equivalent" to already legally marketed devices. This regulatory pathway typically relies on comparing the new device's technological characteristics and intended use to a predicate device, rather than requiring formal clinical trials or new performance studies to demonstrate safety and effectiveness from scratch.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text does not contain this information.

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The Elements Diagnostic Unit is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The device is a battery-operated, endodontic diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

The provided text does not contain information about specific acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or detailed study methodologies. The document is a 510(k) summary for the "Elements Diagnostic Unit," primarily focusing on establishing substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The text describes the device's intended use and functionality, and states that it is substantially equivalent to a previously marketed device. There is no information about how this equivalence was demonstrated through specific performance testing or clinical studies with detailed acceptance criteria.

Information NOT Found in the Document:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance results.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

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