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The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform:

• Vascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis,

· Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiclogy (EP).

· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures,

Combined with a qualified, compatible OR table, the Allura Xper FD OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

The Allura Xper FD OR Table series is a modular X-ray systems series, based on a set of components that can be combined into different single and biglane configurations to provide specialized anglography. It is identical to the Allura Xper FD systems series, to which a qualified, compatible OR table component is added.

These Allura Xper FD OR Table series X-ray systems are Angiographic X-ray Systems consisting of 1 or more of the following components: X-ray generator, X-ray tubelhousing assembly, beam limiting device, image receptor. X-ray control, frontal/lateral stand, patient support and a monitor ceiling suspension.

The provided text describes a 510(k) submission for the Philips Allura Xper FD OR Table series, an angiographic X-ray system. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of algorithm performance or clinical effectiveness beyond general safety and equivalence to predicate devices.

The document focuses on non-clinical verification and validation testing to ensure the system functions according to specifications and risk management requirements, aligning with various IEC and ISO standards. It explicitly states: "No clinical performance test was required to show safety and effectiveness of the Allura Xper FD OR Table series in the intended clinical environment." This means there is no study described here that would provide the kind of performance metrics you've requested (e.g., accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

Therefore, I cannot provide the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/algorithm-based device, as this document is for an X-ray system hardware and software system and not an AI-powered diagnostic algorithm.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing:

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

• Acceptance Criteria (Inferred from standards compliance and substantial equivalence claim):
  • Compliance with IEC 60601-1 (general safety), IEC 60601-1-1 (medical electrical systems safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), IEC 60601-1-4 (programmable electronic systems), IEC 60601-2-7 (high voltage generators safety), IEC 60601-2-28 (X-ray source assemblies safety), IEC 60601-2-32 (associated equipment safety), IEC 60601-2-43 (interventional procedures X-ray safety).
  • Compliance with IEC 62304 (medical device software life cycle processes).
  • Compliance with IEC 62366 (usability engineering).
  • Compliance with ISO 14971 (risk management).
  • Functional verification and validation for intended use relative to internal specifications.
  • Substantial equivalence in safety and effectiveness to predicate devices (Philips Integris Allura series, Philips Allura Xper FD10, Philips Allura Xper FD20, Siemens Axiom Artis, Siemens Artis Zee family, Siemens Artis Zee / Zeego family).
• Reported Device Performance: The document states, "Results of the conducted tests conclude that the Allura Xper OR Table series is substantial equivalent to its predicate device." No specific performance metrics (e.g., image quality measurements, diagnostic accuracy) are provided in this summary.

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

• Not applicable for a clinical performance study. The document states, "No clinical performance test was required." The "test set" for the non-clinical verification and validation would refer to technical test cases and scenarios, not 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)

• Not applicable. No clinical ground truth was established as no clinical performance study was conducted or required.

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

• Not applicable. No clinical test set requiring adjudication was used.

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, an MRMC comparative effectiveness study was not done. The device itself is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers in interpreting images.

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

• Not applicable. The device is an integral X-ray system, not a standalone algorithm.

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

• Not applicable. No clinical ground truth was established or used for the purpose of a performance study. For non-clinical tests, ground truth would be based on engineering specifications and expected physical outputs.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory approval for an X-ray system, not an AI algorithm trained on a dataset.

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

• Not applicable. No AI algorithm training set is referenced.

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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Non-invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Non-invasive Blood Pressure Monitoring: The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.

End-tidal CO2: The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:

• The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
• The Q-CPR option is not for use when CPR is contraindicated.

The name of this device is the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. The modification is a change that provides network connectivity via the Philips IntelliVue Network.

The provided text describes a 510(k) summary for the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and study particulars.

The document states that "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." This indicates that the device met the acceptance criteria based on its equivalence to a predicate device, but the specific numerical acceptance criteria and performance data are not provided.

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

1. Table of acceptance criteria and the reported device performance

Explanation: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence," and that "The results demonstrate that web software interface functionality meets all reliability requirements and performance claims." However, the exact numerical acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) and the corresponding reported performance values for these criteria are not provided in the given text. The focus of this 510(k) is on the network connectivity modification and its substantial equivalence to the predicate, rather than detailed performance metrics for the core defibrillator functionalities.

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

• Sample Size for Test Set: Not specified
• Data Provenance: The document mentions "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." This suggests internal testing by Philips Medical Systems, but no details about the origin of patients data (if any was used for performance validation), country of origin, or whether it was retrospective or prospective are provided. The testing appears to focus on the technical functionality of the network modification and its impact on the device as a whole, rather than clinical performance on a patient dataset.

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

• Not Applicable / Not Specified. The document describes engineering and system-level verification and validation for a network connectivity update and overall device functionality, not a study evaluating diagnostic accuracy against a ground truth established by medical experts.

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

• Not Applicable / Not Specified. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for diagnostic or interpretative tasks. This document describes technical device testing.

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, an MRMC comparative effectiveness study was not done. The device described is a monitor/defibrillator with networking software; it is not an AI-assisted diagnostic tool that would typically involve human readers evaluating results.

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

• Not Applicable. This device is a monitor/defibrillator that interacts directly with patients and is operated by medical personnel. The "performance" described relates to its overall functionality, reliability, and connectivity, not a standalone diagnostic algorithm.

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

• Based on predicate device specifications and engineering requirements. The "ground truth" for the tests described appears to be the established specifications and expected behavior based on the predicate device and design documents for the new network functionality. There is no mention of clinical ground truth (like pathology, expert consensus, or outcomes data) being used for this 510(k) submission, as the focus is on substantial equivalence of technical features and safety.

8. The sample size for the training set

• Not Applicable. The device described is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense of AI/ML development.

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

• Not Applicable. As no training set is mentioned or implied for an AI/ML model, the establishment of its ground truth is not relevant to this submission.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alparming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50. are additionally intended for use in transport situations within healthcare facilities.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release E.01 software for the IntelliVue patient monitor devices.

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors, Release E.01, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the device's functions. Instead, it makes a general statement about meeting predetermined specifications.

It's important to note that for a medical device such as a patient monitor, "specifications cleared for the predicate device" would typically encompass a wide range of performance parameters for each physiological measurement (e.g., ECG accuracy, NIBP accuracy, SpO2 accuracy, arrhythmia detection performance). However, these specific numerical criteria are not detailed in this summary.

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

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states:

• "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate."
• "Testing involved system level tests, performance tests, and safety testing from hazard analysis."

Without further details, we cannot infer the nature or origin of the test data.

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

The 510(k) summary does not provide information on the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a patient monitor, ground truth for physiological parameters would likely come from validated reference devices or established clinical methods, rather than expert interpretation of raw data.

4. Adjudication Method for the Test Set

The 510(k) summary does not specify any adjudication method for a test set. This type of method (e.g., 2+1, 3+1 consensus) is typically used for subjective assessment tasks, such as image interpretation, which are not directly applicable to the functional testing of a patient monitor.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not discussed or indicated in the provided 510(k) summary. MRMC studies are primarily relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess changes in diagnostic performance. This device is a patient monitor, not an AI-assisted diagnostic imaging tool in that context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing described is inherently standalone for the monitoring functionalities. A patient monitor's algorithms continuously process physiological signals without direct human intervention in the data processing itself. The summary implies "system level tests, performance tests, and safety testing," which would evaluate the device's algorithms and hardware independently of a human operator, while acknowledging that a human uses the displayed information.

7. The Type of Ground Truth Used

While not explicitly stated for each parameter, the ground truth for a patient monitor's performance tests would typically involve:

• Reference Devices: Using highly accurate and calibrated reference devices for each physiological parameter (e.g., an invasive blood pressure catheter for NIBP accuracy, a calibrated ECG simulator for arrhythmia detection, a gas analyzer for capnography).
• Clinical Measurements: Comparing monitor readings to gold-standard clinical measurements performed by trained professionals.
• Simulated Data: For certain performance aspects like arrhythmia detection, using validated physiological waveforms that contain known arrhythmias.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set or its sample size. This is because the device, the Philips IntelliVue Patient Monitor, is a traditional physiological monitoring device, not an AI/machine learning device that requires a distinct "training set" to develop its algorithms. Its algorithms are based on established physiological principles and signal processing techniques.

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

As no training set is mentioned or implied for this type of device, the concept of establishing ground truth for a training set is not applicable here. The algorithms for a patient monitor are developed based on scientific and medical principles, and then validated (tested) against known reference standards.

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Indicated for use by health care professionals whenever there is a need for monitoring, recording and alarming of multiple physiological parameters of patients. Intended for monitoring, of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors.

The provided text is a 510(k) summary for the Philips IntelliVue Patient Monitors, specifically for the introduction of Release D.04 software, which includes the calculation of Pulse Pressure Variation.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generally refers to "system level tests, performance tests, and safety testing."

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

The document does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The evaluation appears to be based on engineering-level testing against predetermined specifications rather than clinical expert review.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The testing seems to be based on pass/fail criteria against specifications.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The device is a patient monitor with software for physiological parameter calculation (Pulse Pressure Variation), not an imaging or diagnostic device typically evaluated with MRMC studies involving human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance evaluation was done in the sense that the device's performance (specifically the Release D.04 software including Pulse Pressure Variation calculation) was tested against "specifications cleared for the predicate device." However, the term "standalone" usually implies an AI algorithm's performance independent of human input, and this document describes the overall system's performance. The "algorithm" itself (Pulse Pressure Variation calculation) was implicitly evaluated as part of the overall performance tests.

7. Type of Ground Truth Used

The ground truth for the performance evaluation appears to be based on:

• Specifications: "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies engineering and technical specifications for accuracy and functionality.
• Predicate Device Performance: The primary method of demonstrating substantial equivalence relies on showing the device performs similarly to or within the established range of the predicate device.

8. Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning model in the modern sense that typically requires a separate training set. The "software" likely refers to deterministic algorithms and calculations.

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

Since there is no mention of a training set, the establishment of ground truth for it is not applicable.

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Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as orthopaedic surgeons, physicians and radiologists in planning and evaluating orthopaedic procedures using medical images.

The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.

The Philips Orthopaedic Applications software runs on "off the shelt" standard PC components using a Microsoft Operating System. It can be used as stand-alone SW applications or as a Plug-in on advanced image processing workstations or review workstations (PACS).

These applications provide digital alternatives for the tools medical specialists are used to work with when using conventional images printed on film: callipers, pencil, transparent sheets, scissors and tape. The software tools transform these conventional tools for working with digital images on a computer display.

The provided text is a 510(k) summary for the Philips Orthopaedic Applications, which is a software suite. This document focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested details about a study evaluating the device's performance against acceptance criteria are not present in the provided text. The document primarily focuses on the device's description, intended use, and substantial equivalence to existing devices. It does not contain information about clinical trials, performance metrics, ground truth establishment, or sample sizes related to a performance study.

Based on the provided text, here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance is based on demonstrating substantial equivalence to predicate devices in terms of functionality and safety.
• Reported Device Performance: Not reported in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity). The document states that the device "does not introduce new indications for use, nor does the use of the device result in any new potential hazard."

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

• Not provided. The document does not describe a test set or any performance study 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)

• Not provided. Ground truth establishment for a performance study is not discussed.

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

• Not provided. Adjudication methods are not discussed as no 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

• Not provided. The document does not mention an MRMC study or any AI assistance, as the device is a set of software tools for viewing, manipulating, and measuring medical images, and planning procedures. It's not described as an AI-driven diagnostic aid.

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

• Not fully applicable in the context of this document. The device is described as software applications to assist medical professionals, implying a human-in-the-loop interaction rather than a standalone algorithmic diagnosis. No standalone performance study is detailed.

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

• Not provided. As no performance study is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

• Not provided. Training data for algorithms is not discussed. This product is described as software tools, not a machine learning model that requires a training set in the typical sense.

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

• Not provided. Ground truth establishment for a training set is not discussed.

Summary of what the document focuses on instead:

The Philips Orthopaedic Applications 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices (Agfa IMPAX® OT3000 Orthopedic Workstation and Sectra Orthopedic Package). This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The core argument for substantial equivalence is based on:

• Device Description: The software runs on standard PC components and can be standalone or a plug-in.
• Intended Use: To assist medical professionals in planning and evaluating orthopedic procedures using medical images through viewing, manipulation, calibration, measurement (length, angle, area), template overlay, and simulation.
• Safety and Effectiveness: Complies with ACR/NEMA DICOM standard, and importantly, "does not introduce new indications for use, nor does the use of the device result in any new potential hazard."

Essentially, the "study that proves the device meets the acceptance criteria" in this context is the submission and FDA's review of the 510(k), where the acceptance criteria are alignment with the predicate devices and the proof is the demonstrated lack of new safety/effectiveness concerns or new indications for use compared to those predicates. No specific performance metrics or clinical study results are detailed in this summary.

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PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).

The provided document is a 510(k) summary for the Philips PANORAMA 1.0T Magnetic Resonance Diagnostic Device. It claims substantial equivalence to a predicate device (INTERA ACHIEVA, K031815) and does not contain detailed performance studies with acceptance criteria as one would expect for a novel AI device.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's a breakdown of the available information and why other fields cannot be completed:

• Acceptance Criteria and Reported Device Performance: This device is a Magnetic Resonance Diagnostic Device (MRDD). For such devices, acceptance criteria are typically related to fundamental imaging performance aspects like signal-to-noise ratio (SNR), spatial resolution, image uniformity, geometric accuracy, and safety parameters (e.g., specific absorption rate (SAR), magnetic field homogeneity). However, the document does not provide specific quantitative acceptance criteria or reported device performance metrics for the PANORAMA 1.0T. It simply states that the new device "provides the same functionalities as its predicate device" and "has the same safety and effectiveness as its predicate device."

• Study Details: Since this is a submission for a substantially equivalent device, clinical performance studies in the way you'd describe for a novel AI device (e.g., test set, expert readers, ground truth) are typically not presented in this summary document. The substantial equivalence argument relies on the inherent similarity of the new device to the predicate rather than new performance data.

Therefore, the table below will largely reflect what is not present or not applicable based on the provided text, along with a note that this is a predicate-based submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not provided. The submission is based on substantial equivalence to a predicate device, not a new clinical performance study.
• Data Provenance: Not applicable/Not provided.

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 new clinical performance study with expert ground truth was conducted or reported in this summary.

4. Adjudication method 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:

• No. This is a conventional MRI device, not an AI-assisted diagnostic tool.

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

• No. This is a conventional MRI device.

7. The type of ground truth used:

• Not applicable/Not provided. The submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable/Not provided. This is a conventional MRI device, not an AI model requiring a training set in the typical sense.

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

• Not applicable/Not provided.

Summary of the Study (as described in the document for the 510(k) submission):

The "study" or justification for the PANORAMA 1.0T's market clearance is a demonstration of substantial equivalence to an existing legally marketed device, the Philips INTERA ACHIEVA (K031815).

• Study Design: This is not a clinical trial or performance study in the traditional sense for a novel device. Instead, it's a regulatory comparison.
• Purpose: To demonstrate that the PANORAMA 1.0T, a Magnetic Resonance Diagnostic Device, is as safe and effective as its predicate device.
• Methodology: The submission highlights that the PANORAMA 1.0T "provides the same functionalities as its predicate device" and "has the same safety and effectiveness." It is a magnetic resonance diagnostic device with a vertical field, similar to its predicate which used a cylindrical field (the document states it's based on the "same platform" as the cylindrical INTERA ACHIEVA). The primary justification is the inherent similarity in design, intended use, and fundamental operating principles.
• Results: The FDA reviewed the 510(k) submission and determined that the device is "substantially equivalent" for the stated indications for use, thereby permitting its marketing. This implies that the FDA accepted the manufacturer's assertion that the performance characteristics, safety, and effectiveness would be comparable to the predicate device, without requiring new, specific quantitative performance data to be included in this summary.

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The Allura Xper FD20 is intended for:

• · Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, " e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolyses.
• · Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP),
• Non-vascular interventions such as drainages, biopsies and . vertebroplasties procedures.

The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascular, neurovascular and cardiovascular procedures, as well as non-vascular procedures.

The provided text is a 510(k) summary for the Philips Allura Xper FD20, an X-ray system. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/algorithm performance.

Therefore, I cannot fulfill your request as the required information is not present in the provided document.

The document primarily focuses on:

• Device Identification: Company name, device name (Allura Xper FD20), classification names.
• Predicate Device: Philips Integris Allura (K002016).
• Device Description: Stationary fluoroscopic angiographic X-ray system for vascular, neurovascular, cardiovascular, and non-vascular procedures.
• Intended Use: Specific applications like angiography, PTCA, stent placements, embolizations, thrombolysis, pacemaker implantations, and non-vascular interventions.
• Safety and Effectiveness: Compliance with regulatory standards (e.g., 21CFR, UL 2601-1, DICOM).
• Conclusion: The device is substantially equivalent to the predicate and introduces no new hazards or indications.

This is a typical 510(k) submission for an imaging hardware device, not an AI or algorithm-based software device, and therefore does not include the types of performance metrics and study details you've requested.

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The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.

This document (K031333) is a 510(k) summary for the Philips Integris Allura Flat Detector release 1.2 system. It states the device's intended use and declares substantial equivalence to predicate devices. However, this document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader comparative effectiveness studies.

The information provided focuses on regulatory aspects, such as:

• Company Information: Philips Medical Systems North America Company
• Device Name: Philips Integris Allura Flat Detector release 1.2 system
• Classification Name: Angiographic x-ray system, Solid x-ray Imager
• Predicate Devices: Philips Integris Allura Flat Detector release 1.0 system (K022899) and GE Innova 4100 system.
• Device Description: Angiographic x-ray system with a solid-state flat dynamic x-ray detector (amorphous silicon with a cesium iodide scintillator) for cardiovascular and vascular diagnostic and interventional procedures.
• Indications for Use: Cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
• General Safety and Effectiveness: Compliance with 21CFR, Subchapter J - Radiological Health, parts 1020.30, 32 and 1040.10, UL 2601-1, and ACR/NEMA DICOM standard.
• Conclusion: Substantially equivalent in safety and effectiveness to predicate devices.

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria and study details. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

To answer your questions, I would need a different type of document, such as a clinical study report, a detailed design validation report, or the relevant sections of the predicate device's 510(k) submission if the performance claims are based on that.

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The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil.

The provided text describes a 510(k) submission for a medical device, the "Transmit/Receive Quadrature Body Coil 3.0T." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the typical sense of algorithm-based or diagnostic efficacy studies.

Therefore, many of the typical acceptance criteria and study details you'd expect for an AI or diagnostic imaging device are not applicable to this submission. The "acceptance criteria" here are primarily regulatory: demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's how to address your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "study" proving the device meets these (mostly implicit) acceptance criteria is the substantial equivalence comparison presented in the 510(k) submission itself.

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

• Not Applicable. This is a hardware component submission based on substantial equivalence. There is no test set of patient data or images mentioned for performance evaluation in the context of diagnostic accuracy, as would be expected for an AI or diagnostic tool. The comparison is against an existing hardware component.

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

• Not Applicable. See point 2. There's no clinical "ground truth" establishment in this type of submission.

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

• Not Applicable. See point 2.

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 a hardware component (MRI coil), not an AI device. No MRMC study was conducted or mentioned.

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

• No. This is a hardware component (MRI coil), not an algorithm.

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

• Not Applicable (in the clinical diagnostic sense). The "ground truth" for this submission is regulatory: the proven safety and effectiveness of the predicate device (the Quadrature Body Coil used with the INTERA 1.5T system), to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI or algorithm-driven device.

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process.

In summary:

This 510(k) submission for the Transmit/Receive Quadrature Body Coil 3.0T is a technical submission focused on demonstrating that a new hardware component built for an existing MR system is substantially equivalent to a previously cleared hardware component for a different MR system from the same manufacturer. The "study" here is the engineering and regulatory comparison of design, materials, and intended use, rather than a clinical performance study involving patient data.

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