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ulricheasyINJECT Max 2M (XD 10140) / 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection - GE Healthcare Inc., Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., VUEWAY™ (gadopiclenol) – Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved single dose bottles and Gadavist (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection - Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol) Injection - Bracco Diagnostics, Inc., MultiHance (gadobenate dimeglumine) - Bracco Diagnostics, Inc., Clariscan™ (Gadoterate Meglumine) Injection - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection -Guerbet, LLC, Gadavist™ (gadobutrol) Injection - Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection -Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist™ (gadobutrol) Injection -Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Iniection - Fresenius Kabi AG. contrast media as supplied in approved Imaging Bulk Packages (IBPs).

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:

• Spikes,
• Easy-Click-Cassette flex
• Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:

• Saline containers.
• Single-dose contrast media bottles,
• IBP contrast media containers, and
• Cannula.

ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulricheasyINJECT Max is provided in three models:

• ulricheasyINJECT Max 2M (XD 10140),
• ulricheasylNJECT Max 3 (XD 10150), and
• ulricheasylNJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

The provided text describes a 510(k) premarket notification for the ulricheasyINJECT Max contrast media management system, which primarily references a previously cleared predicate device (K233737) for most of its acceptance criteria and supporting studies. The information available focuses on the differences between the current device and its predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in a separate column. Instead, it describes various non-clinical tests conducted for the predicate device (K233737) and states that the subject device (ulricheasyINJECT Max) supports a broader range of contrast media, with additional testing performed to address this difference.

The following table summarizes the performance characteristics and states of verification for the device and its predicate:

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify exact sample sizes for each test set. It mentions "studies" and "testing" without providing numerical details for the number of units or data points tested in non-clinical assessments.
• Data Provenance: All non-clinical testing (Software, EMC/Electrical Safety, Sterilization Validation, Shelf Life and Transport Validation, Contamination Control and Rinsing, Biocompatibility, Performance – Bench, Extractables and Simulation, Human Factors / Usability) was performed as part of K233737, indicating it was conducted for the predicate device. Additional chemical compatibility testing was conducted for the current submission (K241850) to support new contrast media. The origin of the data (e.g., country) is not specified beyond being part of ulrich GmbH & Co. KG's submission, implying internal company testing. Studies are described as "non-clinical" and "bench," which means they are not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document discusses non-clinical bench testing, not image-based diagnostic performance involving expert readers establishing ground truth. The "Human Factors / Usability" study confirms the device's safety and effectiveness for its intended users (trained healthcare professionals), but it's not about expert clinical interpretation for a diagnostic algorithm.

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

Not applicable. This type of adjudication method is used for establishing ground truth in diagnostic studies involving multiple human readers, which is not described in this document.

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. This device is a contrast media management system, not an AI-powered diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical medical device (an injector) with software controls, not an algorithm meant for standalone diagnostic performance.

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

For non-clinical testing, "ground truth" generally refers to established scientific principles, engineering specifications, recognized industry standards (e.g., ISO, IEC), and predetermined specifications for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For sterilization, it's achieving a specified Sterility Assurance Level. For performance metrics like flow rate and volume accuracy, it's meeting the ±5% specification.

8. The sample size for the training set

Not applicable. The document refers to a physical medical device and its controls, not a machine learning model that requires a training set.

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

Not applicable, as no training set for a machine learning model is mentioned.

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ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.

Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravasular administration of contrast agent.

The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.

ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol), - Bracco Diagnostics Inc, MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection - Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.

Easy-Click-Cassette - flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.

Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.

ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.

The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.

ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects underqoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).

The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:

• . Spikes,
• . Easy-Click-Cassette - flex
• . Patient Tubing

The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing), ulricheasylNJECT Max is intended to be used with the following components that are not supplied with the system:

• Saline containers,
• Single-dose contrast media bottles, and .
• . Cannula.

ulricheasylNJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.

The ulricheasyINJECT Max is provided in three models:

• . ulricheasyINJECT Max 2M (XD 10140),
• . ulricheasyINJECT Max 3 (XD 10150), and
• . ulricheasyINJECT Max 3 (XD 10180).

The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.

The ulricheasyINJECT Max system, a contrast media management system, underwent a comprehensive study to demonstrate its substantial equivalence to a predicate device, ulrichINJECT CT motion (K192872). The study focused on non-clinical testing to ensure its safety and effectiveness for its intended use in magnetic resonance (MR) applications.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it states that "Verification results indicate that the ulricheasyINJECT Max tubing system complies with the standard" or "conforms to its predetermined specifications." The "Comparison" column in the Comparative Analysis table acts as a high-level summary of performance against the predicate.

Below is a table summarizing the areas tested and the reported performance based on the provided text:

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

The document does not explicitly state the numerical sample sizes for the test sets used in the non-clinical studies (e.g., number of units tested for EMC, number of samples for chemical compatibility). It refers to the tests performed and their general outcomes.

The data provenance is from non-clinical testing performed by ulrich GmbH & Co. KG, for the purpose of a 510(k) premarket notification. This indicates the data is prospective in the context of device validation. The "country of origin of the data" is not explicitly stated but the submitter is based in Ulm, Germany.

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

This information is not applicable as the described studies are non-clinical (bench testing, software validation, biocompatibility, etc.) and do not involve human readers or refer to "ground truth" in the context of expert review of clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies described are analogous to standalone performance evaluation for the device's functional and safety aspects. The software and various physical parameters (e.g., flow rate accuracy, air detection) were tested independently of human intervention during the functional tests, demonstrating the device's inherent performance. Human Factors/Usability assessments considered human interaction but focused on the device design's safety and effectiveness, not the clinical performance of an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by recognized industry standards and predetermined specifications for device performance, safety, and material properties. Examples include:

• IEC 60601-1 for electrical safety and EMC.
• ISO 11135:2014 for sterilization.
• ISO 10993-1 for biocompatibility.
• ISO 8536-4:2010 (applicable requirements) for infusion equipment performance.
• Internal predetermined specifications for aspects like flow rate accuracy (± 5%), volume accuracy (± 5%), air detection limit (0.05 mL), and alarm limits.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a contrast media injector system, not an AI/ML algorithm that requires a separate training set. The "software verification and validation" refers to traditional software testing, not machine learning model training.

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

This information is not applicable as there is no mention of an AI/ML training set.

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FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.

The device consists of an X-ray generator, a CPU that manages the exposure time and a mechanical suspension system, for wall mounting or mobile stand.
The image detectors (a necessary component for a fully-functional diagnostic system) are not part of the current submission.
The device, unlike the previous IntraOs 70 with AC power supply of the tube, is powered at constant potential, i.e. direct current, guaranteeing excellent quality of the final image. From an application point of view, FONA XDC radiographic system is similar to the IntraOs 70; it is possible to select nine anatomical zones (two more than in IntraOs 70), two patient body sizes and three types of receptors that can be set at different sensitivities.
The basic radiographic system allows to operate at 20 cm (8") source-skin distance (SSD) with circular radiation beam. The FONA XDC primary collimator, as for the IntraOs 70, consists of a brass cylinder and the limitation of the beam on a circular surface of 6 cm in diameter from the focus for a working distance of 20 cm. It is possible to bring the working distance to 30 cm from the focus by adding a cone extension. It is also possible to reduce the exposed circular area both by working at 20 cm and at 30 cm. with the interposition of rectanqular 3x4 cm or 2x3 cm BLD adaptor, for image receptors of size 2 (adult) or size 0 (child) respectively

The provided text is a 510(k) summary for a dental X-ray device (FONA XDC) seeking substantial equivalence to a predicate device. It details the device's technical specifications and compares them to the predicate, but it does not include any information about studies proving the device meets acceptance criteria related to AI/algorithm performance.

The document explicitly states: "Based on the device nature (an x-ray generator similar to the predicate), clinical testing is not required to demonstrate substantial equivalence. Successful bench testing results should be enough proof that the FONA XDC works as intended."

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance (for an AI/algorithm-based device): Not applicable, as this is an X-ray generator, not an AI device.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence of the FONA XDC to a predicate device (IntraOs 70) and a reference device (Heliodent Plus) based on technical specifications, intended use, and adherence to performance standards for X-ray generators. The table provided in the document (pages 6-7) compares various technical characteristics like power supply, line voltage, focal spot, tube voltage, tube current, and adherence to electrical safety and radiation protection standards, which would serve as "acceptance criteria" for an X-ray generator.

Summary of Non-Clinical Testing and Conclusion:
The document mentions that "FDA consensus standards have been employed for electrical safety, electromagnetic compatibility, performance and usability. Each produced device is checked against the FDA performance standards for Ionizing radiation emitting products. The performance of the predicate device and the subject device have been validated using the same testing models." This implies that the device underwent bench testing to ensure it met these standards, and these standards serve as the acceptance criteria for the X-ray generator.

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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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The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, orthopedic, neurologic, peripheral vascular, critical care, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.

The FDR CROSS is mobile X-ray fluoroscopy equipment designed and manufactured by Fujifilm Corporation (FTYO) featuring high mobility arising from small size and light weight. The C-arm cart irradiates X-rays and detects X-rays by the flat panel sensor to perform X-ray fluoroscopy and radiography. A flat panel sensor has higher sensitivity than an image intensifier, which can result in dose reduction. The flat panel sensor is same as FDR D-EVO III Flat Panel Detector System (predicate device) cleared as radiography purpose. (K192932) The system contains the console software (DR-ID 340CL), control cabinet software (DR-ID 3000MC) and X-ray controller software (DR-ID 3000SX). The DR-ID 340CL and DR-ID 3000MC is modified to add fluoroscopic function based on the DR-ID 300CL and DR-ID 1200MC which are used in FDR D-EVO III Flat Panel Detector System cleared as radiography purpose (K192932). The software's Level of Concern is Moderate.

The provided text is a 510(k) Summary for a medical device (FDR CROSS (DR-XD 3000)), primarily focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and indicates what standards and guidance documents were followed for non-clinical performance data.

However, the document does not contain any information about an acceptance criteria table, device performance data against acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, or standalone algorithm performance.

The "SUMMARY OF STUDIES" section states: "Non-clinical Performance Data: The FDR CROSS (DR-XD 3000) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, IEC 62366-1, DICOM 3.0, IEC 60601-2-43, IEC 60601-2-54. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory."

This indicates that the performance evaluation was based on conformance to voluntary standards and internal verification and validation activities, rather than a clinical study involving human readers or AI performance metrics against a clinical ground truth. The device listed (FDR CROSS (DR-XD 3000)) appears to be an X-ray imaging system, not an AI/CADe device that would typically have the kind of acceptance criteria and performance study described in your prompt.

Therefore, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The performance evaluation focuses on conformance to general medical device standards for X-ray systems.
2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned are non-clinical (conformance to standards, software testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No human expert review to establish ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 done/Not applicable. This device is an imaging system, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The performance is assessed against engineering and regulatory standards for X-ray devices.
8. The sample size for the training set: Not applicable/Not provided. This device is an X-ray system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary for the FDR CROSS (DR-XD 3000) does not contain the type of acceptance criteria and study information (e.g., clinical performance metrics, AI-specific studies) you are asking for. The clearance for this device is based on its substantial equivalence to a predicate X-ray system, demonstrated primarily through engineering safety and performance testing against recognized standards.

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The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological surgery
• · Plastic and Reconstructive surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Wound Care
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue breakage and aspiration.
• Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
• . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
  The Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.

This looks like a 510(k) summary for an Ultrasonic Surgical Aspirator System (Model: XD880B) seeking to demonstrate substantial equivalence to a predicate device (K202299).

Here's an analysis based on your request, focusing on acceptance criteria and supporting studies. It's important to note that for a Class II device like this, the focus is often on demonstrating equivalence to an existing device rather than establishing novel clinical efficacy against specific, quantitative acceptance criteria in the same way a new drug or high-risk device might. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs at least as well as the predicate device, especially for any design changes.

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the entire device. Instead, it describes changes from the predicate and then cites testing to show these changes do not negatively impact safety or effectiveness.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to the modifications:

Note: The document states, "the test results confirm that the performance specifications meets the modification inputs." This is the general statement of "acceptance," indicating compliance with internal specifications derived from the predicate's performance.

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

The document mentions "non-clinical tests" and "bench testing." It does not specify sample sizes for these tests, nor does it provide details on data provenance like country of origin or whether a "retrospective" or "prospective" design applies to bench testing (these terms are more relevant for human data). These are laboratory-based tests.

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)

This information is typically not relevant or included for non-clinical, bench testing of an ultrasonic surgical aspirator system. The "ground truth" for such tests would be measurable physical parameters (e.g., thermal output, acoustic frequency, cutting depth/speed) against established engineering specifications or comparisons to the predicate device.

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

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading, clinical outcomes). Since the testing described is non-clinical bench testing, this concept and information are not applicable or provided.

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

An MRMC study is not mentioned as this device is not an AI-powered diagnostic imaging tool requiring human interpretation. It is a surgical tool.

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

This refers to the performance of an algorithm or AI without human involvement. The Ultrasonic Surgical Aspirator System is a physical surgical device, not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The device's performance is inherently linked to its physical operation properties.

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

For the non-clinical tests mentioned:

• Soft Tissue Protection in Bone Cutting Mode: The ground truth would likely be based on objective measurements of tissue damage or protection, adhering to predetermined safety thresholds.
• Acoustic Performance Testing for modified tips: The ground truth would be quantitative measurements of acoustic parameters (e.g., frequency spectrum, amplitude) compared to design specifications or predicate measurements.
• Cutting Efficiency and Thermal testing Report for Modified Tips: The ground truth would be objective measurements of cutting speed/volume and temperature generated during operation, compared against predicate performance or safety limits.

The "ground truth" is thus based on objective physical measurements and engineering specifications, rather than subjective human interpretation, pathology, or clinical outcomes data for these non-clinical tests.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical surgical tool and not an AI or machine learning system, there is no "training set."

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

As there is no training set for an AI/ML model, this question is not applicable.

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Agfa's DX-D Imaging Package with XD Detectors is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of the human anatomy. The DX-D Imaging Package with XD Detectors may be used wherever conventional screen-film systems may be used.

Agfa's DX-D Imaging Package with XD Detectors is not indicated for use in mammography.

The DX-D Imaging Package, previously cleared under K142184, is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiographic images of the human body. It is a combination of Agfa's NX workstation with MUSICA TM image processing and one or more flat-panel detectors of the scintillator-photodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is capable of replacing other direct radiography, including computed radiography systems with conventional or phosphorous film cassettes.

This submission is to add the XD Detectors (XD 10/10+, XD 14/14+ and XD 17/17+) Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. Agfa's XD Detectors are currently marketed by Vieworks Co. Ltd. as FXRD-4343VAW/VAW Plus. FXRD-3643VAW/VAW Plus. and FXRD-2530VAW/VAW Plus which is the predicate for this submission (K200418).

The optional image processing allows users to conveniently select image processing settings for different patient sizes and examinations. The image processing algorithms in the new device are identical to those previously cleared in the DX-D Imaging Package - DX-D 40 (K142184reference) device and other devices in Agfa's radiography portfolio today. The addition of the offline workflow is identical to the Vivix-S VW (K200418) predicate device.

Principles of operation and technological characteristics of the new, predicate and reference devices are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically similar to the predicate device (K200418) which includes the addition of an offline workflow capable of storing up to 200 images on the flat-panel detector for later viewing. It uses the same NX workstation with MUSICA™ image processing as the reference device (K142184) and the same flat panel detectors of the scintillator-photodetector type (Cesium Iodide - Csl or Gadolinium Oxysulfide - GOS) to capture and digitize the images as the predicate device (K200418). Laboratory data and image quality evaluations conducted with internal specialists confirm that performance is equivalent to the predicate. Differences in devices do not alter the intended diagnostic effect nor do they impact the safety and effectiveness of the device.

The provided text describes a 510(k) premarket notification for Agfa’s DX-D Imaging Package with XD Detectors. The submission focuses on demonstrating substantial equivalence to a predicate device (Vieworks Vivix-S VW, K200418) and a reference device (Agfa DX-D Imaging Package -DX-D 40, K142184) rather than establishing new performance criteria or conducting extensive clinical trials of the AI component.

Key takeaway: This submission primarily focuses on the physical components of the imaging system (detectors, workstation, image processing) and their equivalence to existing cleared devices. It does not contain details about specific acceptance criteria or performance metrics for an AI algorithm in the way one might expect for a novel AI-driven diagnostic device. The "AI" mentioned is related to existing "MUSICA image processing" which is identical to previously cleared versions and is referred to as "image processing algorithms", rather than a new AI model with specific diagnostic performance targets.

Therefore, many of the requested details, especially those related to AI-specific performance criteria, ground truth establishment for a test set, and multi-reader studies, are not explicitly present in the provided document. The performance data presented refers to the physical detector characteristics (Spatial Resolution, DQE, MTF).

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent:

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

The document does not define explicit "acceptance criteria" in terms of clinical performance metrics for an AI algorithm. Instead, it demonstrates performance equivalence of the new detector models to existing ones.

The "acceptance criteria" appear to be met by demonstrating that the new detectors (XD series) have comparable or superior technical performance characteristics (Spatial Resolution, DQE, MTF) to the existing reference devices, and that the image processing ("MUSICA™ image processing") is identical to previously cleared devices. The document states: "The results of these tests fell within the acceptance criteria for the DX-D Imaging Package with XD Detectors." However, the quantitative thresholds for these "acceptance criteria" are not specified beyond the presented performance values.

2. Sample size used for the test set and the data provenance:

• Test Set (for image quality evaluation): "anthropomorphic adult and pediatric phantoms".
  • Data Provenance: Not explicitly stated (likely internal laboratory data, given "internal specialists"). This was bench testing, not clinical data from patients.
• Software Test Iterations (NX 23): Two software iterations were tested.
• Performance Functionality Evaluation: Not a sample size of data, but related to the number of experts (see below).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Image Quality Evaluations: "qualified internal experts" (radiographers) evaluated the overall image quality using phantoms. The exact number of radiographers is not specified.
• Performance Functionality Evaluations: "four qualified experts". Their specific qualifications (e.g., radiologist, years of experience) are not detailed beyond "qualified experts".
• Ground Truth: For the phantom studies, the ground truth is inherently defined by the known properties of the phantoms (e.g., specific structures, resolution targets).

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

Not explicitly stated. The evaluations seem to be internal assessments for comparison rather than a formal human reader study with adjudication for a clinical diagnostic task.

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 was performed. The document explicitly states: "No clinical trials were performed in the device. No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld."
• The "image processing algorithms in the new device are identical to those previously cleared." This suggests that the "AI" (MUSICA image processing) is not a new or modified component requiring a new MRMC study to demonstrate clinical impact or improvement for human readers.

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

• Performance data (Spatial Resolution, DQE, MTF) are presented for the detectors themselves, which can be considered "standalone" technical performance metrics of the hardware.
• For the MUSICA image processing software, its "standalone" performance is implied to be equivalent to its previously cleared versions since it is "identical." No new quantitative standalone performance metrics for the algorithm itself are provided in this submission beyond this statement of identity.

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

• For the technical performance data (Spatial Resolution, DQE, MTF) related to the detectors: The ground truth is based on standard metrology and engineering principles for measuring detector performance using physical test objects (e.g., bar patterns, uniform fields) and laboratory equipment according to established standards.
• For the image quality evaluations: The ground truth was based on "anthropomorphic adult and pediatric phantoms," meaning the content and structures within the phantoms served as the reference.
• For the software testing: Ground truth for software verification and validation is against pre-defined requirements and design specifications, with "deviations or variances...documented in a defect database and addressed."

8. The sample size for the training set:

The document mentions "MUSICA™ image processing" which contains algorithms. However, this submission states these algorithms are "identical to those previously cleared" and does not describe the development or training of any new AI models. Therefore, information about a training set for a novel AI algorithm is not applicable to this 510(k) submission, as it is leveraging previously cleared technology.

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

As no new AI model training is described in this submission, information on how a training set's ground truth was established is not applicable.

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The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

The Benvenue Luna XD Ti Interbody Fusion System consists of the Luna XD Ti Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna XD Ti Interbody Fusion System are identical to the primary predicate device. The Luna XD Ti Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility.

The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window.

The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580).

The Luna XD Ti Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface.

The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.

The extract provided describes the Luna XD Ti Interbody Fusion System, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.

Based on the provided text, the device is not an AI/ML powered device. The information focuses on mechanical testing, material properties, and sterilization, comparing the device to a predicate device. Therefore, several of the requested categories related to AI/ML device performance, such as 'number of experts used to establish ground truth', 'adjudication method', 'MRMC study' and 'standalone algorithm performance' are not applicable to this submission.

Here is the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document primarily describes mechanical and material testing based on ASTM standards. It does not mention human subject studies or a "test set" in the context of clinical data for AI/ML performance. The "testing" refers to bench testing of the device and its materials.
• No information on "data provenance" (country of origin, retrospective/prospective) is provided as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a medical device (interbody fusion system) of the mechanical type, not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" as related to expert interpretation of data is not relevant here.

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

• Not Applicable. See point 3.

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. This is not an AI-assisted device.

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

• Not Applicable. This is not an algorithm.

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

• For mechanical and material performance, the "ground truth" is established by adherence to recognized ASTM and other relevant standards for material properties, mechanical integrity, and biocompatibility, as well as comparison to the performance of a legally marketed predicate device. The ultimate "ground truth" for substantial equivalence lies in demonstrating that the modified device performs similarly or better than the predicate device in relevant bench tests.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. See point 8.

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The Intelli Vue XDS Software is intended for use as an additional, independent display for viewing screens, generated by specified network-connected Philips patient monitors. The IntelliVue XDS Software alone is not intended for remotely monitoring patients without caregivers in vicinity (unattended patients).

It is indicated for local and remote operation of these Philips patient monitors. It is indicated for printing reports as generated by these Philips patient monitors. It is indicated to be used by trained healthcare professionals.

Rx Only: Caution, U.S. Federal Law restricts this device to sale by or on the order of a physician.

The IntelliVue XDS Software (867019) is a bedside information system. The IntelliVue XDS Software provides network services, printing services, patient monitor remote display services, launch pad services, input device sharing services and XDS database services.

The IntelliVue XDS Software can be connected to one or more specified Philips patient monitors and allows the remote viewing of the patient monitor generated data. Depending on the configuration, the remote operation of the network-connected patient monitor with standard off-the shelf information technology equipment input devices (touch screen, keyboard, and mouse) is also supported.

The IntelliVue XDS software does not modify or alter the Philips specified patient monitor. nor does it generate any data on its own. It is solely displaying the patient monitor generated data. It also displays the current alarm and INOP states for the patient, but does not provide an auditory alarm signal announciation function. The IntelliVue XDS Software is not a primary monitoring or alarming device.

The IntelliVue XDS Software is a software only product. It is intended to be installed on customer supplied compatible off-the shelf information technology equipment that meet the technical requirements as specified by Philips.

The provided text describes a 510(k) submission for the Philips IntelliVue XDS Software. It focuses on the substantial equivalence of the modified software (Rev. M.1) to a previously cleared version. However, it does not contain the detailed acceptance criteria and a specific study proving the device meets those criteria, as typically found in a clinical study report.

Here's an analysis based on the information provided, highlighting what is present and what is missing, and making inferences where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics. It generally states:

• "Pass/Fail criteria were based on the specifications cleared for the predicate device and all test results showed substantial equivalence."
• "The results demonstrate that the Philips IntelliVue XDS Software (SW Rev.M.1) meets all safety and reliability requirements and performance claims."

This indicates that the acceptance criteria were likely related to maintaining the functionality, safety, and reliability of the predicate device. Specific performance metrics (e.g., accuracy, latency, resolution) are not detailed.

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

The document states:

• "Testing involved software testing on integration level (functional testing and regression testing) and software testing on system level (hazard analysis testing and dedicated software performance testing)."

This refers to software engineering testing rather than a clinical study with a "test set" of patient data. Therefore, the concept of sample size for a test set of patient data and data provenance (country of origin, retrospective/prospective) is not applicable to the type of testing described. The testing focused on the software itself rather than its performance on a dataset of patient cases.

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

As the testing described is not a clinical study on patient data but rather software verification and validation, there is no mention of experts establishing ground truth for a test set in the context of medical image or signal interpretation.

4. Adjudication Method

Given the nature of the testing described (software verification and validation), an adjudication method (like 2+1 or 3+1) for a test set is not applicable.

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

An MRMC study compares human reader performance with and without AI assistance. The provided document describes software that acts as an "additional, independent display" and allows "remote operation" of patient monitors. It explicitly states:

• "The IntelliVue XDS Software alone is not intended for remotely monitoring patients without caregivers in vicinity (unattended patients)."
• "The IntelliVue XDS Software is not a primary monitoring or alarming device."

This indicates the device is an accessory display/control system, not an AI interpreting data or aiding human readers in diagnosis. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

The described device is software that displays and allows remote operation of patient monitor data. It "does not modify or alter the Philips specified patient monitor, nor does it generate any data on its own." It "solely displays the patient monitor generated data."

While software verification and validation were performed on the algorithm itself, this is not a "standalone performance study" in the sense of an AI algorithm producing diagnostic outputs without human intervention. The software's function is to mirror existing monitor data and enable control, not to independently interpret or diagnose.

7. Type of Ground Truth Used

For the software verification and validation, the "ground truth" would be the expected functional behavior and performance defined by the software's specifications and the predicate device's characteristics. It is not based on expert consensus, pathology, or outcomes data related to patient conditions.

8. Sample Size for the Training Set

The document pertains to the verification and validation of a software application for displaying and interacting with patient monitor data, not an AI/ML algorithm that is "trained" on a dataset. Therefore, there is no concept of a "training set" as understood in AI/ML, and thus no sample size for a training set is provided or applicable.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary of what is present and missing:

• Acceptance Criteria/Performance: General statements about meeting safety, reliability, and performance claims, and substantial equivalence to the predicate device. Specific quantitative criteria are not provided.
• Study Details (Test Set, Experts, Adjudication, MRMC, Standalone, Ground Truth): Not applicable or not performed in the context of a clinical study or AI performance evaluation, as the device is a display/control software, not an AI diagnostic tool.
• Training Set: Not applicable, as the device is not an AI/ML algorithm that requires training.

The provided document describes a software verification and validation process to ensure the new software version maintains the same functionality, safety, and performance as its predicate, rather than a clinical study to establish new performance claims against a defined ground truth for medical interpretation.

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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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