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INFINITT ULite, PACS is a software device that receives medical images and data from various images. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary inage interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

The INFINITT ULIte™ system is PACS software capable of viewing and handling DICOM 3.1 medical images. The System allows displaying studies that are not in the same place where the system is placed. With its Web features, it is possible to review, modify, and approve studies located in a server.

ULite is a device that displays medical images (including mammograms) and data from various imaging sources. In the Web environments, it is not needed to download any components, for example Active X, flash, flex, sliver lite, and the user can use this viewer in the browser. Typical users of this system are professionals of clinic (e.g. physicians, radiologists, nurses, medical technicians, and assistants).

INFINITT ULite (subject device) is based upon the INFINITT G3 PACS (predicate device). The features and functions of ULite have a sub-set of the features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

INFINITT ULite Viewer: INFINITT ULIte is a medical image viewing application. It communicates with the INFINITT ULite Server to view the medical images. It supports various functions such as Windowing, Zoom, Pan, measurement, Cine play, and Report viewing.

INFINITT ULite Server: INFINITT ULite Server only supports Microsoft Windows family. INFINITT ULite Server has been built by using Microsoft Visual C++ 2010, MFC library and .net framework.

ULite software provides both 32-bit and 64-bit editions. When running on x64 editions of Microsoft Windows, the native x64-bit application of ULite must be provided for largememory support. The 32-bit application of ULite can be running on both 32bit and 64bit windows, while the maximum memory capacity might be different. Except the maximum memory support, the 32-bit edition and 64-bit edition must be virtually same in terms of functionalities.

The provided text is a 510(k) summary for the INFINITT ULite PACS software. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving that the device meets specific performance criteria.

The "Testing" section on page 4 briefly states: "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that INFINITT ULite™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy."

This statement is high-level and generic. It does not provide the specific details requested in the prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for a test set.
• Details about ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details about the training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory submission for substantial equivalence rather than detailed performance study results.

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Xelis Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software.

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Cardiac™ is a software device intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities.

Xelis Cardiac™ is a software device that consists of INFINITT Server (Database), and the software application which supports the DICOM standard with such functions as advanced DICOM viewing.

The subject device allows users to take advantage of the images from various modalities in order to view data and images and the web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic software configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

Xelis Cardiac™ supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

Xelis Cardiac™ does not perform computer aided diagnosis and does not include anv automated or semi-automated processes for the detection of nodules or other diseases and is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software.

The provided document describes XELIS Cardiac™, a software device for viewing and manipulating medical images. Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." And "If the device is installed by INFINITT CO., LTD, integration and installations verification tests are conducted against acceptance criteria prior to release to the client."

However, the specific "predetermined acceptance criteria" themselves (e.g., performance metrics, thresholds) are not detailed in the provided text. The document broadly states that the device "passed all in-house testing criteria" and "demonstrated that the predetermined acceptance criteria were met."

Therefore, a table of specific acceptance criteria and reported performance cannot be provided from this text. The study primarily focuses on demonstrating functional equivalence and safety (non-inferiority) to predicate devices rather than specific quantitative performance metrics.

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

The document does not explicitly state the sample size used for any specific test set related to image data or patient cases. It mentions "The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria."

The data provenance (e.g., country of origin, retrospective or prospective) for any image data used in testing is not specified.

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

The document states that the software "does not provide diagnostic assistance to the physician. Any diagnostic determination or treatment is solely made by a physician and not the software." It also mentions "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

However, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set (e.g., for diagnostic accuracy or image interpretation performance). The study appears to be primarily focused on the functional performance and reliability of the software as an image viewing and manipulation tool, rather than its diagnostic accuracy comparative to human experts.

4. Adjudication Method for the Test Set

Since no specific test set involving human interpretation or ground truth establishment based on expert consensus is described, there is no information provided on any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in the provided text. The document explicitly states that the software "does not perform computer aided diagnosis and does not include any automated or semi-automated processes for the detection of nodules or other diseases" and "does not provide any diagnostic assistance to the physician." Therefore, a study comparing human readers with and without AI assistance is not relevant to this device's intended use.

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

A standalone performance study of the algorithm without human-in-the-loop performance, in the context of diagnostic performance, was not conducted or reported. The device's primary function is as a PACS system for image viewing and manipulation, where the "human-in-the-loop" (the physician) is always the ultimate interpreter. The non-clinical testing focused on system functional performance and validation.

7. Type of Ground Truth Used

The document does not describe the use of any ground truth (e.g., expert consensus, pathology, outcomes data) in the context of evaluating diagnostic accuracy or similar performance metrics. The testing focused on validating the software's functional capabilities (input, output, actions) against internal criteria.

8. Sample Size for the Training Set

Since the device "does not perform computer aided diagnosis" and does not employ AI/ML algorithms that would typically require a training set for diagnostic tasks, there is no information provided regarding a training set sample size.

9. How Ground Truth for the Training Set Was Established

As no training set is described for diagnostic AI/ML algorithms, there is no information provided on how ground truth would have been established for such a set.

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The Xelis Fusion™ is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists.

Images (including mammographic) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. In addition, Xelis Fusion™ can be integrated with an institutions HIS or RIS for an integrated an electronic patient record.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.

XELIS Fusion is a Picture Archive and Communications System (PACS) software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS Fusion can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting. XELIS Fusion application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990. XELIS Fusion does not include any automated or semiautomated process for the detection of nodules or other shapes.

XELIS 3D Fusion is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

The provided 510(k) summary for XELIS Fusion does not contain a detailed study proving performance against specific acceptance criteria presented in a table format. Instead, it focuses on demonstrating substantial equivalence to predicate devices and describes general nonclinical testing.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list pre-defined acceptance criteria in a table or present specific performance metrics (like accuracy, sensitivity, specificity) for the XELIS Fusion device in relation to a specific study. It broadly states: "The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS Fusion software in each operational mode and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

Therefore, a table cannot be constructed from the provided text.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions "test at the factory" and "in-house testing criteria," implying internal testing, but no details on the origin of the data used for these tests. The testing seems to be focused on validating software functions rather than clinical performance on a specific dataset.
• Retrospective/Prospective: Not specified.

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

Not applicable. The document describes functional testing of the software rather than a clinical performance study involving expert-established ground truth. The device is a PACS software for viewing and manipulating images, with diagnosis explicitly performed by radiologists, not the software.

4. Adjudication Method for the Test Set:

Not applicable, as no external test set with ground truth requiring adjudication is described.

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

No, an MRMC comparative effectiveness study is not mentioned or described. The device's indications for use explicitly state that "Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists." This implies the device is a tool for radiologists, not an AI that improves their performance.

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

No, a standalone performance study is not described. The device is a PACS software, and its primary function is display and manipulation, with diagnosis explicitly stated to be performed by human radiologists. It's not an AI algorithm designed to make diagnostic interpretations independently.

7. Type of Ground Truth Used:

Not applicable. The nonclinical testing described appears to be focused on software validation and verification against functional requirements, rather than clinical ground truth (like pathology or outcomes data) for diagnostic accuracy.

8. Sample Size for the Training Set:

Not applicable. The document describes the device as a Picture Archive and Communications System (PACS) software for viewing and manipulating images, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no mention of a training set or an AI/machine learning component.

Summary of Device and Testing:

The XELIS Fusion device is described as a Picture Archive and Communications System (PACS) software package. Its primary functions involve viewing, manipulating, storing, and communicating DICOM-compliant medical images from various modalities (CT, PET, MRI, etc.). It explicitly states that "Diagnosis or computer aided diagnosis is not performed by the software but by Radiologists." The 510(k) submission focuses on demonstrating substantial equivalence to predicate PACS devices based on technical characteristics, general function, application, and intended use, and asserts that it does not introduce new safety risks.

The "Nonclinical Testing" section refers to in-house validation and verification activities to ensure the software's functionality and adherence to predefined acceptance criteria, which were related to evaluating "all input functions, output functions, and actions performed by the XELIS Fusion software in each operational mode." This is typical software development and quality assurance testing, not a clinical performance study with a test set of medical images and clinical ground truth.

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Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.

XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.

XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.

XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

The provided text describes the XELIS 3D software, a picture archiving and communications system, and its substantial equivalence to predicate devices. However, it does not contain specific details regarding acceptance criteria and a structured study with quantifiable performance metrics. Instead, it focuses on demonstrating that XELIS 3D performs as intended and is as safe and effective as its predicate devices.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for XELIS 3D

The XELIS 3D is a software package intended for viewing and manipulating DICOM-compliant medical images. The submission for its 510(k) clearance emphasizes its substantial equivalence to predicate devices rather than presenting a comparative effectiveness study with specific quantified acceptance criteria and performance metrics against a defined ground truth.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or any task-specific performance measures. Instead, the acceptance criteria are described in more general terms related to system functionality and safety.

2. Sample Size and Data Provenance (Test Set)

The document does not provide specific details on the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The testing described is "in-house testing criteria" and "validation testing" which seem to refer to internal software quality assurance rather than a clinical performance study with a distinct test set of patient cases.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This information is not provided in the document. The text indicates that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians," implying that human experts are responsible for interpretation, but it does not specify how ground truth was established for any performance evaluation in the context of the device's 510(k) submission.

4. Adjudication Method (Test Set)

An adjudication method (e.g., 2+1, 3+1) for establishing ground truth on a test set is not mentioned in the provided text, as a specific clinical test set for performance evaluation is not detailed.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding the effect size of how much human readers might improve with or without AI assistance, as the device primarily functions as a viewing and processing tool, not an AI-assisted diagnostic aid for detection. The text explicitly states: "XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes."

6. Standalone Performance Study (Algorithm Only)

A standalone performance study of the algorithm without human-in-the-loop performance is not described. Given the device's function as an imaging workstation and its statement that "Diagnosis is not performed by the software," a standalone study for diagnostic performance would not be applicable or expected. The testing described focuses on functional verification of the software.

7. Type of Ground Truth Used

The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any performance evaluation is not specified. The regulatory submission focuses on demonstrating functional equivalence and safety rather than a diagnostic performance study against a clinical ground truth.

8. Sample Size for the Training Set

The document does not provide information on a training set size. As the XELIS 3D does not perform automated detection or analysis (i.e., it doesn't describe AI/ML functionality requiring a training set), this information would not be relevant in this particular submission.

9. How Ground Truth for Training Set Was Established

Similarly, since there's no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for a training set is not discussed.

In summary, the 510(k) submission for XELIS 3D demonstrates substantial equivalence primarily through functional verification, safety assessments, and conformance to standards (like DICOM 3.0), rather than through a clinical performance study with defined quantifiable acceptance criteria against a clinical ground truth. The device is presented as an image viewing and manipulation tool, not an automated diagnostic system, hence many of the requested elements pertaining to AI/ML performance studies are not present or applicable in this context.

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Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

Xelis DENTAL is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction). These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Xelis Dental is a PC-based application used for storing and displaying medical images. The application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems. The implementation of Xelis Dental DICOM interface has been carefully tested to assure compliance with the DICOM Conformance Statement. However, the Conformance Statement and the DICOM standard do not guarantee interoperability of INFINITT's products and products of other vendors. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.

Xelis Dental provides viewing of optimized images for 3D dental CT images. It comprises the following features.

• 3D VR, MPR, MIP, minIP .
• MPR rotating, curve, 3D zoom .
• Nerve (canal) drawing .
• Dental implant simulation and bone-density analysis .
  The subject device and the predicate devices are supplied to end users in both Windows 32 bit and 64 bit operations systems. XELIS DENTAL software can connect to other workstations, PACS server/software, and modalities, through the DICOM communication standard.

The provided text describes a 510(k) premarket notification for a medical device called XELIS DENTAL. However, it does not include information about acceptance criteria or specific studies to prove device performance against such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, general function, application, and intended use. It mentions nonclinical testing and validation but does not provide details on specific acceptance criteria or performance metrics.

Therefore, for most of your requested points, the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

• Not Available: The document states that "predetermined acceptance criteria were met" during validation testing, but it does not specify what those criteria were or provide a table of performance results against them.

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

• Not Available: The document mentions "nonclinical testing" and "validation testing" but does not describe any specific test set, its sample size, or data provenance.

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 Available: Since no specific test set or clinical study is described, there's no information on experts establishing ground truth for a test set. The device is a viewing and analysis tool, and diagnosis is performed by medical professionals, not the software.

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

• Not Applicable / Not Available: No test set or clinical study with adjudication is described.

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 Available: The document states, "Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes." This indicates that it's a visualization and analysis tool rather than an AI-driven diagnostic aid that would typically undergo MRMC studies to evaluate reader improvement.

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

• Not Applicable / Not Available: Given the device's function as a viewing and analysis tool for medical professionals, and the explicit statement that it does not perform diagnosis or automated detection, a standalone performance study in the context of an "algorithm only" is not relevant or described. The device is intended to be used by humans.

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

• Not Applicable / Not Available: As no specific performance study against a ground truth is reported, this information is not present. The device processes existing DICOM images; it does not generate diagnostic outputs requiring a ground truth for validation in the typical sense of a CAD system.

8. The sample size for the training set

• Not Applicable / Not Available: The device is described as a software application for storing, displaying, and analyzing medical images. It does not appear to be an AI/machine learning model that would require a "training set."

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

• Not Applicable / Not Available: As there's no indication of a training set, this information is not relevant or provided.

In summary: The provided document is a 510(k) summary focused on substantial equivalence demonstration for a medical image viewing and analysis software. It attests to internal nonclinical testing and validation meeting acceptance criteria, but it does not detail those criteria or the specific performance studies that would address most of your questions, which are typically relevant for AI/CAD devices or devices with specific diagnostic claims.

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XELIS™ is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

XELIS is a CT colonography dedicated workstation designed to help radiologists to examine images. XELIS receives DICOM compliant CT images from a remote PACS server. Both primary 2D and primary 3D review modes are supported to meet the various needs of users.

• Real-time and one-pass navigation based on an unfolded view to show complex inner wall of colon.
• Automatic centerline extraction combining with easy selection UI to help fast path setup.
• Tagged-stool overlay on endoluminal and band view to enable to handle CT images with minimal preparations.
• Batch capture for reconstructed images related to lesions during the exam to report and send to clinicians.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. It describes the device, its indications for use, and confirms its substantial equivalence to predicate devices based on regulatory requirements (510(k) submission).

Therefore, I cannot populate the table or answer the specific questions about a study.

The document mainly covers:

• Device Name: XELIS™
• Common Name: Picture Archiving Communications System
• Classification: Radiological image processing system (21 CFR 892.2050, Product Code LLZ)
• Predicate Devices: K041761 (RAPIDIACOLON) and K052545 (INFINITT G3 PACS)
• Device Description: A CT colonography dedicated workstation for 2D and 3D visualization of colon images, supporting real-time navigation, automatic centerline extraction, tagged-stool overlay, and batch capture.
• Indications for Use: Software-based device for display and visualization of 3D and 2D medical image data of the colon. Images are for display and diagnosis by radiologists, clinicians, and referring physicians as an adjunct to standard radiology practices. It explicitly states that analysis of images and diagnosis is not performed by the software.
• Technological Characteristics: Software device, no patient contact, does not control life-sustaining devices, human interpretation required.
• Conclusion: Determined substantially equivalent to predicate devices.

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INFINITT Cardiology PACS™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists).

INFINITT Cardiology PACS is a software device that consists of INFINITT Server (included Database), and INFINITT Cardiology PACS.

INFINITT Cardiology PACS is a web-based DICOM view station running on Windows 2000/XP. INFINITT Cardiology PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, QCA and LVA. INFINITT Cardiology PACS allows users to take full advantage of the images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

INFINITT supported modalities include: XA, Ultrasound/Echo, MRI, CT and CR/DR. In case of XA and Ultrasound, it offers numerous cardio-specific 2D analysis tools. Intuitive user interface and system architecture offer a configurable work list management and customizable display protocols.

Web based solution distributes images and relevant information to internal and external users at anytime. Remote diagnostic configuration enables fast information delivery in a low bandwidth network environment and centralized management module enables automatic update.

INFINITT Cardiology PACS supports interoperability between IHE approved workstations (Integrating the Healthcare Enterprise) with security functions.

This document is a 510(k) summary for the INFINITT Cardiology PACS™ and does not contain information regarding
acceptance criteria, device performance, or a study demonstrating that the device meets specific criteria. It primarily
focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide the requested information based solely on the provided text. The document states that the device is a software device that does not provide any diagnostic assistance to the physician. This implies that performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices, would not be applicable or evaluated in the same manner for this type of system.

The closest relevant information is the indications for use, which outlines the intended functions of the device:

• Manipulation, displaying, and distribution of medical images.
• Display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
• Assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.

For a device of this nature (a PACS for image management), acceptance criteria would typically revolve around:

• Functionality: Does it correctly display, store, and distribute images? Does it support the specified modalities and standards (DICOM)? Are the specified analysis tools (QCA, LVA) present and operational?
• Performance (technical): Speed of image retrieval, display quality, system stability, data integrity, security, and interoperability.
• Usability: User interface effectiveness for trained professionals.

Without a specific study described in the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The document concludes by stating that the 510(k) "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This typically means that the device was shown to be as safe and effective as existing legally marketed devices for its stated intended use, based on its technological characteristics and performance specifications (which are not detailed here in quantifiable terms).

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Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

INFINITT G3 PACS is a web-based 3D-enabled DICOM viewing station running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. INFINITT G3 PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, Hanging Protocol, 3D segmentation, various MPRs, fast 3D Volume Rendering, MIP, and Virtual Endoscopy.

INFINITT G3 PACS allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images. With INFINITT G3 PACS, users can have the same diagnostic environment of their own anywhere anytime because INFINITT G3 PACS is deployed through network and supports hanging protocol radically.

This 510(k) submission for the Infinitt G3 PACS does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria.

The provided document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on establishing substantial equivalence to a predicate device. It describes the device's functions and indications for use but does not include:

• A table of acceptance criteria and reported device performance.
• Details of a study conducted to demonstrate performance. This would typically involve specific metrics (sensitivity, specificity, accuracy, etc.) and the results achieved.
• Sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance data, type of ground truth, training set size, or how training ground truth was established. These are all elements of a robust performance study that are absent in this summary.

Key observations explaining the absence of this information:

• Nature of the Device: The Infinitt G3 PACS is described as a "Picture Archiving Communications System" (PACS). Its primary function is to store, display, communicate, and process medical images, not to perform automated diagnostic interpretation or provide quantitative measurements that would necessitate extensive clinical performance metrics like those for an AI diagnostic algorithm.
• Predicate Device Equivalence: The submission focuses on demonstrating "substantial equivalence" to a predicate PACS device (INTEGRADWEB MPR/MIP, K042313). For PACS systems, substantial equivalence often relies on demonstrating similar technological characteristics, functionality, and safety profiles, rather than extensive clinical performance studies comparing diagnostic accuracy.
• Human-in-the-Loop: The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This highlights that the device is an aid to human interpretation, not a standalone diagnostic tool.
• Specific Limitations on Mammography: The document includes specific limitations for mammography: "Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." These are usage constraints for a specific diagnostic application, not performance metrics.

In summary, the Infinitt G3 PACS, as described in this 510(k) summary, is a medical imaging display and management system. Its regulatory pathway for approval did not require the kind of detailed performance study and acceptance criteria typically associated with AI-powered diagnostic or screening devices.

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Reformat Gateway™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

Reformat Gateway is a software that receives original data from several devices or PACS system, which reconstructs and sends it to other system automatically. Reformat Gateway reconstructs the thin section slice data into thick section slice data automatically for a fast and routine diagnosis. Also, it generates a MPR reconstructed image automatically according to data specification and distributes original data or reconstructed data to distributed different systems.

The provided text describes the "Reformat Gateway™" software, a Picture Archiving Communications System. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance claims. Instead, it focuses on the substantial equivalence to a predicate device for 510(k) clearance.

Therefore, I cannot populate the table and answer the study-related questions as this information is not present in the provided text.

Here's an explanation of why the information is missing based on the document:

• Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often means showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• "Validation testing" mentioned, but no details: The text states, "Validation testing was provided that confirms that Reformat Gateway™ performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS)." This indicates that some testing was done, but the document does not elaborate on the specific acceptance criteria, the study design, results, or statistical analysis. This level of detail is typically found in a separate validation report, not the 510(k) summary itself.
• "Hazard analysis" mentioned: The submission contains results of a "hazard analysis," classifying potential hazards as "minor," but again, no specifics on how this analysis was conducted or what criteria were used.

Conclusion:

Based on the provided snippets, there is no detailed information about specific acceptance criteria or a study that proves the device meets those criteria in terms of clinical performance, accuracy, or efficacy. The document focuses on regulatory clearance through substantial equivalence.

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StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

STARPACS Dental™ is a new software application that has been developed to handle digital templates for dental implants, which are placed over digital dental images. The overlay of digital templates onto digital dental images is useful in planning dental implants. The software is used together with the existing STARPACS solution (one of the predicate devices K031013). In addition to imaging and workflow features, STARPACS Dental allows dental implants simulations for dental implanting with the digital template library. STARPACS Dental is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions and possibly to shorten surgery time.

The provided K051715 510(k) summary for INFINITT Co., Ltd.'s STARPACS Dental™ device does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

This 510(k) submission is primarily focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than on a clinical performance study with defined acceptance criteria.

The document states:

• "The 510(k) Pre-Market Notification for STARPACS Dental™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices."
• "STARPACS Dental™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."
• "The submission contains the results of a hazard analysis and the potential hazards have been classified as 'Minor'."

These statements indicate that the submission relies on standards compliance, hazard analysis, and comparison to predicates for safety and effectiveness, rather than a quantifiable performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the provided text.

Specifically, the following information is missing from the document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: No test set described, thus no sample size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment described.
4. Adjudication method for the test set: No adjudication method described.
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 MRMC study described. The device is for "assisting in surgical decisions" and "demonstrating treatment paths," not for improving reader performance in diagnostic tasks in a quantifiable manner against a baseline.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device description emphasizes that it "is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions" and that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," indicating it's not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth explicitly mentioned or used for device evaluation in the provided summary.
8. The sample size for the training set: No training set mentioned.
9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

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