Search Results

Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy.

EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.

EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

• segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG))
• superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system,
• . register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures.
• The 3D segmented data set can be displayed with a color map annotation received ● from an external source.
• position visual markers on the 3D volume ●
• visualize the inside of the 3D volume (EndoView) .
• certain buttons on the user interface control EP Logix functions; ●
• visual marker positions are transmitted to EP Logix; .
• color map information is received from EP Logix. .

The provided document is a 510(k) Summary for the Philips EP navigator device. It describes the device, its intended use, indications for use, and a summary of testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "EP navigator 3 complies with standards as detailed in annex 009 of this premarket submission" and "Non-clinical verification and validation tests were performed relative to the requirement specifications and risk management results". It also states that a "Clinical evaluation was performed to show safety and effectiveness to of EP-Navigator in the intended clinical environment."

However, the document does not provide a table specifying the acceptance criteria (e.g., accuracy metrics, specific performance thresholds) nor does it report detailed device performance against those criteria. It merely states that the device "complies" and that "clinical evaluation" showed "safety and effectiveness."

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

The document makes a general statement: "Corresponding clinical evaluation report and test results are included in this submission."

However, it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data).

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

The document mentions a "Clinical evaluation" but does not specify the number of experts, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set:

No information on adjudication methods (e.g., 2+1, 3+1, none) is provided.

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

The document does not mention any MRMC study or the effect size of human readers improving with AI assistance. It focuses on the device's standalone capabilities and its intended use for navigation support.

6. Standalone (Algorithm Only) Performance:

The document states that "EP navigator image software processing algorithms are executed on a PC based hardware platform," and its functions involve "segment previously acquired DICOM 3D CT or other image data," "superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image," and "register the segmented 3D CT or other data with live fluoroscopic X-ray images."

This strongly implies that the algorithm has standalone performance for these image processing and registration tasks. However, the document does not explicitly present a dedicated standalone performance study with specific metrics, but rather refers to "non-clinical verification and validation tests performed relative to the requirement specifications."

7. Type of Ground Truth Used:

While "clinical evaluation" and "non-clinical verification and validation tests" are mentioned, the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data) for validating the device's performance is not detailed.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. Given that it is an "image software processing algorithm," it likely involves some form of training or calibration, but this is not discussed in the summary.

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

As no training set information is provided, there is no description of how ground truth for a training set was established.

In summary:

The 510(k) Summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety risks. It indicates that clinical evaluation and non-clinical verification/validation were performed, but it lacks the specific quantitative details about acceptance criteria, detailed study designs (test set size, provenance, expert involvement, adjudication), and training set information that you've requested. This level of detail is typically found in the full submission referenced by the summary, not in the summary itself.

Ask a specific question about this device

As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse. The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.

The provided text describes a 510(k) submission for the "Wireless Portable Detector FD-W17." However, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies.

The submission focuses on:

• Device Identification: Manufacturer, submitter, product names, classification.
• Compliance with Standards: Federal X-Ray performance standards (CFR 1020.30, .31), electrical safety (UL 60601-1, IEC 60601-1), radiation protection (IEC 60601-1-3), Electromagnetic Compatibility (IEC-60601-1-2), and risk management (ISO 14971).
• System Description: How the detector integrates into a larger X-ray system.
• Intended Use: Acquiring digital radiographic images for routine, intensive care, trauma, and pediatric exams, excluding fluoroscopy, angiography, and mammography.
• Equivalence Information: Demonstrating substantial equivalence to a predicate device (Pixium 4600) and other existing Philips components for the workstation and pre-processing.
• Safety Information: Mature technology, compliance with standards, wireless transmission evaluation, and risk management.
• Conclusion: Stating substantial equivalence based on similar indications for use, technological characteristics, and no new hazards.
• FDA Clearance Letter: Confirming substantial equivalence based on the provided indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

Ask a specific question about this device

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Applications:

• Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures.

The device consists mainly of two parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, mains control unit, an user interface for image/patient handling and optionally an integrated workstation).

All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

Here's an analysis of the provided text regarding the Veradius device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided 510(k) summary is for a new version of a mobile C-arm X-ray system, where the primary change is the Image Detection Subsystem (IDS), specifically replacing an Image Intensifier with a Flat Detector. The summary emphasizes substantial equivalence to a predicate device (Pulsera K061685). Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the new component (IDS) does not compromise image quality or safety and maintains the same intended use as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (substantial equivalence for a component change), the acceptance criteria are not explicitly stated in quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they relate to overall image quality and functional equivalence to the predicate device.

The new IDS detects X-rays and converts them to digital images, applying calibration to obtain required data, functionally similar to the predicate's IDS. (Page 2, Section 5) |
| No new indications for use. | "The Veradius does not introduce any new indications for use..." (Page 2, Section 7)
"Indications for Use are equal to Pulsera." (Page 3, Table 1, Row 9)
The Indications for Use statement on Page 5 is identical to the general description of the predicate's use. |
| No new potential hazards or effects on safety. | "Nor does the use of the device result in any new potential hazard." (Page 2, Section 7)
"The new technologic characteristic does not affect safety or introduce any new type of hazards." (Page 2, Section 7)
"A product risk management is executed and all risks are reduced to an acceptable level by implementation and verification of appropriate measures." (Page 3, Section 9)
The Level of Software concern is MODERATE (Page 3, Section 9). |
| Maintain substantial equivalence to predicate device. | "Philips Medical Systems Nederland BV considers the Veradius to be substantially equivalent with the predicate device." (Page 2, Section 7)
"Results of the conducted tests conclude that the Veradius is substantial equivalent to its predicate device." (Page 3, Section 8) |
| Function as intended for specified applications. | The device is intended for "radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies," across various applications (Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac). (Page 2, Section 6 and Page 5, Indications for Use)
Non-clinical and clinical tests were performed to "verify and validate the system functionality for the intended use." (Page 3, Section 8) |

Study Details from the Provided Text:

This document is a premarket notification (510(k)), not a detailed study report. As such, it provides summary statements rather than in-depth methodological details of the studies.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "comparison between images pairs taken during non-clinical performance tests." This implies a set of images was used, but the quantity is not provided.
• Data Provenance: The study is described as "non-clinical performance tests." This suggests the data was likely generated in a controlled, engineering-focused environment within Philips Medical Systems Nederland B.V. (The Netherlands, where the manufacturer is located). Given it's a "non-clinical" test, it likely involved phantoms or standardized test objects, not patient data in the clinical sense of "retrospective or prospective."

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned. This type of detail is usually found in a full study report, which is not this document. Since the evaluation was likely "non-clinical performance tests" focused on image quality comparison, it may not have required formal adjudication of clinical diagnoses.

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

• MRMC Study: No, an MRMC study was not explicitly mentioned or described. The performance evaluation focuses on "Image Quality is equal or even better" based on the "comparison between images pairs taken during non-clinical performance tests." This typically implies objective measurements or subjective comparison by engineers/specialists, not a formal MRMC study involving human readers diagnosing clinical cases with and without AI assistance (as this is an X-ray system, not an AI diagnostic tool in the modern sense).

6. If a Standalone Performance (Algorithm Only) Was Done

• Standalone Performance: The description of "non-clinical performance tests" to evaluate "Image Quality" of the new "Image Detection Subsystem (IDS)" is essentially a standalone performance evaluation of the system's image acquisition and processing capabilities. The IDS itself is an algorithm-driven component (converting X-rays to digital images and applying calibration). However, it's not "algorithm only" in the sense of a pure AI diagnostic software; it's a core hardware/software component of the imaging chain.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: Not explicitly stated. For "non-clinical performance tests" assessing "Image Quality," the ground truth likely involved:
  • Objective image quality metrics: Such as spatial resolution, contrast-to-noise ratio, modulation transfer function (MTF), dose efficiency, etc., measured using phantoms.
  • Reference images: Comparison against images produced by the predicate device under identical conditions, or against established standards for image quality.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of advanced AI models that require large training datasets. The "Veradius" is a C-arm X-ray system with a new detector, not an AI diagnostic algorithm that learns from vast image datasets to identify pathologies. The "IDS" performs image conversion and calibration, which are rule-based or empirically derived processes, not deep learning-based training.

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

• Ground Truth for Training Set: Not applicable for the same reasons as #8. The "training" of such a system would involve engineering and calibration procedures during design and manufacturing, not data-driven machine learning.

Summary Takeaway:

This 510(k) emphasizes substantial equivalence for a physical device (mobile C-arm X-ray system) with a component change (detector type). The "studies" mentioned are "non-clinical performance tests" designed to show that the new detector either maintains or improves image quality and that the overall system remains as safe and effective as its predicate. It is not an AI diagnostic device, so many of the requested details concerning AI-specific study methodologies (MRMC, large training sets, expert consensus for ground truth) are not present in this type of submission.

Ask a specific question about this device

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

The SureSigns VS2 Vital Signs monitor and the SureSigns VM1 are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility. The addition of the wireless functionality to the predicate VS3 does not change the intended use or indications for use. The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design as the predict device. The composition of the VS2 and the VM1 materials are different than the predicate device, however are made of a material previously used in other medical devices. The chemical composition of the subject devices has changed but is the same as material used in other predicate devices. The energy source of the subject device the VS2 is an external power supply, while the VM1 will use a power supply that is the same as the predicate device. The VS2 and the VM1 both can run on battery power with batteries similar to the predicate devices.

The provided 510(k) summary for the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs Monitor does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets specific acceptance criteria in the way typically expected for AI/ML device evaluations.

This document is a pre-market notification (510(k)) for physiological monitoring devices, specifically patient monitors, and their modifications. The evaluation for substantial equivalence in such devices often focuses on comparing technical characteristics and performance to legally marketed predicate devices, rather than establishing novel performance metrics against a defined ground truth using a clinical study with a specified sample size and expert review in the context of an algorithm.

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

The document states:
"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the subject devices with respect to the predicates. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM1 Patient Monitors and SureSigns VS2 Vital Signs monitor and the modification to the SureSigns VS3 Vital Signs Monitor meet all reliability requirements and performance claims and supports a determination of substantial equivalence."

This indicates that the "acceptance criteria" were essentially the specifications of the predicate device and the subject device, and the "study" was system-level, performance, and safety testing aimed at demonstrating substantial equivalence. However, specific numerical performance metrics are not provided in this summary.

Therefore, many parts of your request cannot be directly answered from the provided text.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not give a sample size of patients or data records.
• Data Provenance: Not specified. It's likely these tests were conducted internally by Philips Medical Systems (Andover, MA, United States), but the origin of any clinical data (if used) is not detailed. The distinction between retrospective or prospective data is not applicable given the type of testing described (device function/safety rather than algorithm performance on clinical data).

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

• Not applicable / Not specified. This type of information (number and qualification of experts establishing ground truth) is typically relevant for studies evaluating an AI/ML diagnostic or prognostic system against a human standard. For a patient monitor, "ground truth" would be established by reference standards or direct physical measurements, not expert consensus on interpretations of images or signals.

4. Adjudication method for the test set

• Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers when establishing ground truth. This is not typically part of the testing for a physiological monitor's basic functions.

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 / Not done. This is a physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device's evaluation.

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

• Not applicable / Not mentioned in this context. While these devices contain algorithms for processing physiological signals (e.g., arrhythmia detection, NIBP calculation), the 510(k) summary does not describe a "standalone" algorithm performance study in the way it's typically understood for AI/ML devices where the algorithm's output is compared to a ground truth independent of human interaction. The testing described focuses on the integrated device's performance.

7. The type of ground truth used

• Likely reference standards and direct physical measurements. For physiological monitors, ground truth for parameters like blood pressure, heart rate, or SpO2 would typically involve highly accurate reference devices or invasive measurements (e.g., arterial line for blood pressure) against which the monitor's readings are compared. The document does not explicitly state this but it's the standard practice for such devices.
• Not pathology, outcomes data, or expert consensus in the context of diagnostic interpretation.

8. The sample size for the training set

• Not applicable / Not specified. These devices are not described as employing machine learning models that require a "training set" in the modern sense. They rely on established signal processing algorithms. If any adaptive algorithms or calibrations exist, the "training" would be internal calibration processes rather than a distinct dataset.

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

• Not applicable. As a traditional physiological monitor, the concept of a "training set" and associated ground truth establishment for a machine learning model is not relevant to the information provided in this 510(k) summary.

Ask a specific question about this device

As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.

The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images. As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography. The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.

The provided text is a 510(k) summary for the Philips XD-S Direct Radiography Workstation/Package. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy).

The "Performance Standards" section refers to compliance with federal X-Ray performance standards, electrical safety standards, electromagnetic compatibility standards, and DICOM. These are regulatory and technical standards, not clinical performance acceptance criteria in the sense of a medical diagnostic device.

Therefore, I cannot populate the table or answer most of your specific questions related to clinical performance studies, as this information is not present in the provided document.

Here's what can be extracted based on your request, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Information Not Provided: The document does not describe a clinical performance test set, its sample size, or the provenance of any data used for such a test. The evaluation here is based on substantial equivalence and compliance with technical standards.

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

• Information Not Provided: As no clinical performance study or test set is described, there is no mention of experts or ground truth establishment in this context.

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

• Information Not Provided: No test set 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

• Information Not Provided: This device is a digital image acquisition workstation, not an AI-powered diagnostic assist tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and not mentioned.

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

• Information Not Provided: This device is a workstation for acquiring, processing, storing, and displaying images. It does not contain an autonomous algorithm whose standalone performance would typically be evaluated in this context. Its "standalone version" refers to its integration level with other X-ray system components, not an AI algorithm.

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

• Information Not Provided: No clinical performance study requiring ground truth is described.

8. The sample size for the training set

• Information Not Provided: This document does not describe a machine learning model that would require a training set.

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

• Information Not Provided: Not applicable, as no training set is described.

Summary of Device Evaluation in the 510(k) Summary:

The Philips XD-S Direct Radiography Workstation/Package obtained clearance through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices (Philips Digital Diagnost and Philips Computed Radiography). The evaluation also focused on:

• Compliance with federal X-ray performance standards and various international electrical safety and electromagnetic compatibility standards.
• Adherence to the DICOM standard for digital imaging communication.
• The use of mature technology and software deemed to have a MINOR level of concern.
• Implementation of product risk management according to ISO 14971, with all risks reduced to an acceptable level.

The 510(k) process for this type of device (a digital image acquisition workstation) at the time (2007) typically focused on safety, fundamental performance, and equivalence to existing devices, rather than detailed clinical performance metrics like sensitivity and specificity derived from a dedicated clinical study against a defined ground truth.

Ask a specific question about this device

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.

The provided text is a 510(k) summary for the Philips Medical Systems Masimo SET SpO2 module. This document focuses on establishing substantial equivalence of a new device to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device's specific clinical efficacy or accuracy.

Therefore, much of the requested information cannot be directly extracted from the provided text. The summary explicitly states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims."

This indicates that the testing performed largely confirmed the new device's ability to operate similarly to the predicate under various conditions, rather than a clinical study establishing new performance benchmarks.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific acceptance criteria or reported device performance metrics in a table format for the new device. The focus is on equivalence, not on new performance claims.

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

This information is not provided in the 510(k) summary. The summary refers to "system level tests, integration tests, environmental tests, and safety testing," which are typically laboratory or engineering tests, not clinical studies with a "test set" in the context of patient data.

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 not provided. As noted above, the "test set" likely refers to engineering testing, not a clinical dataset requiring expert ground truth.

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

This information is 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

This information is not provided. The device is an SpO2 module, which provides a physiological measurement, not an AI-powered diagnostic tool requiring human reader studies to improve interpretation. An MRMC study would not be relevant in this context.

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

The device is a pulse oximetry module, which inherently provides a standalone measurement (SpO2, pulse rate). The summary confirms its "functionality" and "performance claims," implying its ability to provide these measurements independently. However, the exact details of standalone performance metrics are not explicitly stated beyond meeting predicate specifications.

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

For a pulse oximeter, "ground truth" for accuracy is typically established through controlled desaturation studies compared against arterial blood gas measurements. The provided text does not detail the type of ground truth used for specific accuracy validation, but implies it was sufficient to demonstrate equivalence to the predicate.

8. The sample size for the training set

This information is not provided. Pulse oximeters do not typically employ a "training set" in the machine learning sense. Their algorithms are based on established physiological principles and signal processing, often calibrated and validated against clinical data, but not "trained" as an AI model would be.

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

As there is no "training set" in the AI sense for this device, how its ground truth was established is not applicable and therefore not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a detailed clinical study report on the new device's performance metrics against specific acceptance criteria.

Ask a specific question about this device

The BV Pulsera system is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients except babies, within the limits of the systems. The system is to be used in health care facilities both inside the operating room, sterile as well as non-sterile environments, with a variety of procedures.

The 3D-RX functionality on the BV Pulsera provides 3D imaging and intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high-contrast objects and anatomical structures.

The 3D application areas for the BV Pulsera are:

• Skull (Ear Nose and Throat, Maxillo Facial)
• . Cervical spine
• . Fore arm
• Elbow .
• Hand /Wrist ●
• . Knee
• Lower leg ●
• Foot / Ankle .

The 3D-RX Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operated 3D information of high contrast objects and anatomical structures.

The Philips 3D-RX Option for BV Pulsera is a mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques, which extends the functionality of the BV Pulsera Release 2.2 with 3D imaging. Using the 3D-RX Option on the BV Pulsera, an operator another a rotation run to acquire images. These images are used by an integrated 3D workstation which creates a 3D reconstruction, and which provides tools for further processing and analysis. Both hardware and software additions are added to the BV Pulsera C-Arm X-Ray System to produce the 3D-RX Option.

This submission K061685 describes the 3D-RX Option for BV Pulsera, Release 2.2, a mobile C-Arm X-Ray System with 3D imaging capabilities. The
review indicates this is a traditional 510(k), and therefore this device was found substantially equivalent to predicate devices via performance testing. However:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are provided within the document. The submission focuses on substantial equivalence to the predicate device (Siemens ArcadisOrbic 3D, K042646) based on general safety and effectiveness, and compliance with applicable standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information is provided regarding the sample size of a test set, data provenance, or study design (retrospective or prospective). The submission primarily discusses compliance with safety standards and substantial equivalence.

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): No information is provided about experts establishing ground truth, as no specific performance study with a test set is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is provided about an adjudication method for a test set, as no specific performance study is detailed.

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 or AI assistance is mentioned in the document. The device is a 3D imaging option for an X-ray system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an imaging system providing 3D reconstructions, not a standalone algorithm for diagnosis without human-in-the-loop performance. Its functionality is to provide 3D information for physicians during procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth type is mentioned, as no performance study is detailed. The assessment is based on the system's ability to create 3D reconstructions of high-contrast objects and anatomical structures, implying visual assessment by physicians would be the primary verification method in clinical use.

8. The sample size for the training set: Not applicable. The submission does not describe a machine learning or AI algorithm development that would require a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

Ask a specific question about this device

Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.

Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.

Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.

The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology,

Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.

Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components

The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for the Philips Xcelera, focusing on its general description, intended use, and substantial equivalence to predicate devices. It states that "The Philips Xcelera does not introduce new indications for use, nor does the use of the device result in any new potential hazard," and therefore no specific performance acceptance criteria or a study demonstrating adherence to those criteria are mentioned.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, data provenance, or details of expert involvement for ground truth establishment.
3. Adjudication methods.
4. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. Details on the type of ground truth used for any hypothetical studies.

The 510(k) summary confirms the device's substantial equivalence based on its features and intended use aligning with existing predicate devices (Philips Medical Systems Harmony and Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation), rather than through a detailed performance study against specific acceptance criteria.

Ask a specific question about this device

XperCT is a software option on the Allura Xper product family intended for imaging bone, soft tissue and other body structures. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.

XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images.

The provided 510(k) summary for Philips Medical Systems Nederland B.V.'s XperCT software option (K060749) does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested study design parameters.

The submission is a summary of substantial equivalence to a predicate device (DynaCT by Siemens, K042646) rather than a detailed report of a performance study with defined acceptance criteria. The basis for substantial equivalence is stated as:

• XperCT does not introduce new indications for use.
• XperCT has the same technological characteristics as the predicate device.
• XperCT does not introduce new potential hazards or safety risks.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be provided. The document does not specify any quantitative acceptance criteria or report performance metrics from a specific study (e.g., sensitivity, specificity, accuracy). Its clearance is based on substantial equivalence to a predicate device with similar technological characteristics and intended use.

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

• Cannot be provided. The document does not describe a performance study with a distinct test set.

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)

• Cannot be provided. No information on ground truth establishment for a test set is available.

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

• Cannot be provided. No information on adjudication methods for a test set is available.

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

• Cannot be provided. The document does not mention any MRMC study or evaluate the improvement of human readers with AI assistance. XperCT is described as a software option that reconstructs 3D volumes and provides CT-like images, not necessarily an AI-assisted diagnostic tool in the sense of improving human reader performance.

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

• Cannot be provided. The document describes the device's function (reconstructing 3D volumes) but does not detail a standalone performance evaluation in terms of diagnostic effectiveness. Its clearance is based on similarity to a predicate device, implying its performance is expected to be comparable without needing an explicit standalone clinical study description in this summary.

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

• Cannot be provided. No performance study details are available to infer the type of ground truth used.

8. The sample size for the training set

• Cannot be provided. The document does not describe the development or training of an AI algorithm in a way that would involve a training set. The device is a reconstruction software.

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

• Cannot be provided. As above, no training set or ground truth establishment for training is discussed.

Ask a specific question about this device

FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

FLXIS is a family of image detection components including image intensifiers, a camera, an image processing functionality and a remote control user interface, of which several an inage probeconfigured. Each configuration can be delivered with a display module.

This Philips Medical Systems 510(k) summary for the FLXIS device, primarily focuses on demonstrating substantial equivalence to a predicate device (OmniDiagnost Eleva) rather than presenting a detailed study proving performance against explicit acceptance criteria. The document does not contain the information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The summary states: "FLXIS does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems Nederland B.V. considers FLXIS to be substantially equivalent with the predicate device." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to an already cleared device, not through new performance testing against specific quantitative acceptance criteria as would be typical for a novel device or a modified device undergoing performance evaluation.

Therefore, I cannot provide the requested table or answer the specific questions about the study design because the provided document does not contain this information. The document is a 510(k) submission summary for regulatory clearance based on substantial equivalence.

Ask a specific question about this device