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

· Vascular, cardiovascular and neurovascular imaging applications, 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 electrophysiology (EP).

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

Additionally:

· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.

• · Allura Xper FD10 is compatible with specified magnetic navigation systems.
  · Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Allura Xper FD series and Allura Xper OR Table series with ClarityIQ technology

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 122 patients (80 for AlluraClarity system, 42 for Allura Xper system) were evaluable for radiation dose analysis out of 127 randomized patients.
• Data Provenance: Prospective, controlled, randomized single-center study conducted at University Hospital Gent, Belgium.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set beyond the general context of the "interventional cardiologist assisted by a physicist." This study primarily focuses on quantifying dose reduction and procedural performance, which are objective measurements rather than subjective interpretations by multiple experts. The "ground truth" here is the objective measurement of radiation dose (DAP, CAK) and procedural metrics like fluoroscopy time and image count.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Since the primary endpoints are objective measurements (radiation dose, fluoroscopy time, etc.), a formal adjudication process (like 2+1 or 3+1) for subjective interpretations would not be applicable or necessary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the device's technical performance in terms of dose reduction and procedural metrics, not on human reader performance with or without AI assistance.

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

The study assesses the performance of the "AlluraClarity system with ClarityIQ technology" which utilizes advanced XRES4 noise reduction algorithms. While it is implied the algorithm is functioning "standalone" from a human interpretational perspective, the study is comparing this system (used by interventional cardiologists) against an older system. The direct performance of only the algorithm's output quality (e.g., image clarity metrics) without human interaction is not explicitly detailed as a primary outcome. However, the study aims to show that the dose reduction achieved by the algorithm does not negatively impact procedural performance, indirectly addressing the algorithm's effectiveness in a clinical workflow context.

7. Type of Ground Truth Used

The ground truth used consists of objective physiological measurements and procedural metrics:

• Radiation dose measurements: Cumulative Dose Area Product (DAP) fluoro, DAP exposure, DAP total (sum of DAP fluoro and DAP exposure), and Cumulative Air Kerma (CAK) values. These were collected from Radiation Dose Structured Reports and/or Allura Reports.
• Procedural metrics: Procedure time, fluoroscopy time, number of acquired exposure images, and number of acquired exposure runs.

8. Sample Size for the Training Set

The document does not specify a separate training set for the ClarityIQ technology. The study described is a clinical study to validate the dose reduction claim, not a study for training the algorithm itself. The ClarityIQ technology with its XRES4 noise reduction algorithms was previously cleared (K130638), implying its development and potential training were done prior to this specific study.

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

Since no training set is explicitly mentioned or detailed in this document, the method for establishing its ground truth is not provided. The "ground truth" in this context refers to the basis for the clinical claim being made using the already developed ClarityIQ technology.

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

· Vascular, cardiovascular and neurovascular imaging applications, 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 electrophysiology (EP).

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

Additionally:

· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.

· Allura Xper FD10 is compatible with specified magnetic navigation systems.

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

The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-rav images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.

This document describes the Allura Xper FD series and Allura Xper OR Table series by Philips Medical Systems Nederland B.V., specifically focusing on the new marketing claim related to the ClarityIQ technology for neuroendovascular procedures.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The core claim pertains to radiation dose reduction while maintaining procedural performance. Therefore, the "acceptance criteria" can be inferred from the stated marketing claim and the study's primary and secondary endpoints.

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

• Sample Size for Test Set:
  • Total eligible patients for analysis: 614
  • Allura Xper (without ClarityIQ) group: 302 patients
  • AlluraClarity (with ClarityIQ) group: 312 patients
• Data Provenance: Single center retrospective historically controlled cohort study from Karolinska Hospital - Solna, Sweden (outside the United States).

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

The study described is a retrospective historically controlled cohort study involving patient radiation dose and procedural metrics. The "ground truth" here is objective physiological and procedural data (radiation dose measurements, fluoroscopy time, number of DSA images, etc.) recorded during actual clinical procedures, rather than expert interpretation of images for diagnosis or outcomes.

• Number of Experts: Not applicable in the context of establishing a "ground truth" for image interpretation. The study collected quantitative procedural data.
• Qualifications of Experts: The study was conducted by an "interventional radiologist assisted by a physicist as necessary," but this refers to the appropriate settings for each clinical task, not for establishing a ground truth for the study's endpoints. The data itself (DAP, CAK, times, image counts) serves as the ground truth, presumably recorded by the angiography system and validated by standard hospital protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" consists of objectively measured and recorded clinical metadata (radiation dose, procedure times, image counts), not subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. This study is an evaluation of the device's technical performance (dose reduction, procedural metrics), not an assessment of human reader performance or the impact of AI assistance on human readers.

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

• Standalone Study: Yes, in effect. The study directly measures the performance of the "AlluraClarity system with ClarityIQ technology" (an algorithm/system without human-in-the-loop performance measurement) compared to the "Allura Xper system" (without ClarityIQ). The "procedural performance" metrics (fluoroscopy time, number of DSA images) assess the impact of the technology on the procedure, not the human operator's diagnostic or interventional performance. The primary endpoints (radiation dose) are purely system performance metrics.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth consists of objective clinical (procedural) data for radiation dose metrics (DAP fluoroscopy, DAP exposure, DAP total, Cumulative Air Kerma) and procedural timing/imaging metrics (procedure time, fluoroscopy time, number of acquired exposure images, number of acquired exposure runs). This data was recorded during actual neuroendovascular procedures.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information on the training set for the ClarityIQ technology. The ClarityIQ technology itself was cleared in K130638, suggesting its development and training (if applicable, for its noise reduction algorithms) happened prior to this specific 510(k) submission, which is about a new marketing claim for the already cleared technology within the Allura Xper system.

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

• How Ground Truth for Training Set was Established: Not specified in this document. As mentioned above, this 510(k) is for a new marketing claim for an already cleared technology (ClarityIQ). Information on the training of the ClarityIQ algorithms (if they are AI/ML based) would likely be in the K130638 filing.

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The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: Vascular, cardiovascular 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, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper 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 family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2.1. The Allura Xper FD R8.2.1 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table, the Allura Xper FD R8.2.1 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2.1 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.

The provided text describes a 510(k) premarket notification for the Philips Allura Xper FD series and Allura Xper OR Table series (Allura Xper FD R8.2.1), an angiographic X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study, especially in an AI context.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, experts, MRMC studies, standalone performance, ground truth types for AI models) are not explicitly provided in the document because it's a premarket notification for an imaging device, not an AI/CADe system.

However, I can extract the information that is present concerning performance, testing, and general equivalency.

Here's a breakdown based on the categories you requested, highlighting what is and isn't available in the provided text:

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

The document does not provide a formal table of acceptance criteria with corresponding performance metrics for the device. Instead, it states that the device:

• "Complies with the aforementioned international and FDA-recognized consensus standards and/or FDA guidance documents"
• "Meets the acceptance criteria and is adequate for its intended use."

The performance described is primarily related to image quality demonstrating adequacy for neuroradiological procedures.

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: Not specified. The document only mentions "Sample clinical images" were included.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of experts: One.
• Qualifications of experts: A "board certified radiologist." Specific experience (e.g., 10 years) is not mentioned.
• Role of expert: The radiologist provided a signed statement stating the images were of adequate quality.

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

Not applicable/specified. The review was by a single board-certified radiologist, not an adjudication process among multiple readers to establish a formal ground truth requiring an adjudication method.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described that would involve human readers improving with or without AI assistance. This device is an X-ray system, not primarily an AI diagnostic tool.

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

This refers to AI algorithm performance. Since no AI algorithm component is described for decision-making or diagnosis, a standalone algorithm performance study was not conducted or reported.

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

The "ground truth" concerning image quality was established by the subjective evaluation and statement of a single board-certified radiologist regarding the adequacy of the images for neuroradiological procedures. This is a form of expert opinion/evaluation, not a formal ground truth like pathology or outcomes data, which would typically be used for diagnostic accuracy studies.

8. The sample size for the training set

No training set is mentioned in the context of an AI/ML algorithm. The device is a hardware/software X-ray system.

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

Not applicable, as no described training set for an AI/ML algorithm is present in the document.

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The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: Vascular, cardiovascular 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 electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room. Allura Xper FD10 is compatible with specified magnetic navigation systems. Combined with a qualified, compatible OR table, the Allura Xper 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 family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2. The Allura Xper FD R8.2 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table. the Allura Xper FD R8.2 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Allura Xper FD series and Allura Xper OR Table series:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in the same way a de novo or PMA would. Therefore, explicit, quantifiable acceptance criteria with corresponding performance metrics are not detailed in this submission.

Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and guidance documents. The reported device performance is that it "Meets the acceptance criteria and is adequate for its intended use."

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

The document explicitly states: "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence."

Instead, "Sample clinical images that demonstrate diagnostic quality of the images are provided." This implies a limited, illustrative set of images rather than a formally sized test set for a performance study.

Therefore, for the device, there is no formally defined "test set" with a specified sample size or data provenance in the context of a clinical performance study. The data provenance for the "sample clinical images" is not specified (e.g., country of origin, retrospective/prospective).

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

Since no formal clinical study with a dedicated test set and ground truth establishment was conducted for this 510(k) submission, this information is not applicable or provided.

4. Adjudication Method for the Test Set

As no formal test set and clinical study were conducted for this submission, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance

The document states that "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence." Furthermore, the device is an X-ray system with enhanced noise reduction (ClarityIQ technology), not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study measuring reader improvement. Therefore, no MRMC comparative effectiveness study was done regarding human reader improvement with AI assistance.

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

The device itself is an angiographic X-ray system that produces images. The ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms" to improve image quality. While these are algorithms, the performance assessment described is in the context of the device producing diagnostically acceptable images, not a standalone diagnostic algorithm being evaluated for its own performance metrics (e.g., sensitivity, specificity). The focus is on the image quality produced by the system.

7. The Type of Ground Truth Used

Given that no formal clinical studies were performed for substantial equivalence and "sample clinical images" were provided to demonstrate "diagnostic quality," the concept of a formal "ground truth" as established in clinical trials is not directly applicable or described. The qualitative assessment of "diagnostic quality" would implicitly rely on expert interpretation, but the process is not detailed.

8. The Sample Size for the Training Set

The document mentions that the ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms." While algorithms often involve training data, the submission does not provide any information about the sample size used for the training set of these algorithms.

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

Similar to the above, since details about the training set are not provided, information on how its ground truth was established is not available in this document.

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The Allura Xper FD X-ray imaging systems are indicated for use on human patients to perform:

• Vascular, cardiovascular 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 electrophysiology (EP).
• Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. .

Combined with a qualified, compatible Operating Room (OR) table, the Allura Xper FD OR Table X-ray imaging systems can be used for imaging in the hybrid OR within the application domains neuro, vascular, non-vascular and cardiac. The OR table can also be used stand-alone for surgical use in the OR.

The proposed Allura Xper FD X-ray imaging systems with the SSD spacer removed are identical to the currently marketed and predicate Allura Xper FD X-ray imaging systems with the source-skin distance spacer (SSD spacer) mounted onto the X-ray tube housing, except that the SSD spacer is removed. Removal of the SSD spacer allows the execution of electrophysiology (EP) surgical procedures that require mounting of a special frame of currently marketed mapping systems (such as BioSense Webster's CARTO frame or Location Pad, etc.) underneath the patient table. With the BioSense Webster's CARTO frame mounted underneath the patient table, the SSD spacer mounted onto the X-ray tube housing of the currently marketed and predicate Allura Xper FD X-ray imaging systems interferes with the C-arc rotations during EP procedures, thus necessitating the removal of the SSD spacer. By construction, the source-skin distance cannot become smaller than 30 cm when the SSD spacer is removed. This minimum SSD complies with the international product safety standards IEC 60601-2-43 and IEC 60601-2-54 and with the minimum distance of 20 cm as required per 21 CFR, Part 1020.32(g) for certain specific surgical procedures.

This document is a 510(k) summary for a modification to an existing X-ray system, specifically the Allura Xper FD X-ray imaging systems with the SSD spacer removed. The core of the submission is to demonstrate that the modified device is substantially equivalent to its predicate device (the same system with the SSD spacer mounted). Therefore, the acceptance criteria and supporting "study" are primarily focused on proving this substantial equivalence, rather than establishing de novo performance benchmarks as a new device would.

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not involve a traditional "test set" with patient data in the way an AI algorithm submission would. Instead, the "test" is a technical comparison/analysis.

• Sample Size for Test Set: Not applicable in the context of imaging data. The evaluation is based on the system's design and mechanical/electrical components.
• Data Provenance: Not applicable. The "data" used for evaluation is primarily engineering specifications, design documentation, and regulatory standards. The submission highlights that the predicate devices are manufactured by Philips Medical Systems Nederland B.V. (The Netherlands).

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

Not applicable for this type of submission. This is not a study requiring expert clinical assessment of images or outcomes to establish ground truth. The "ground truth" here is compliance with engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous clinical data requiring adjudication. The evaluation relies on direct comparison of technical specifications and regulatory compliance.

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 comparative effectiveness study was done. This device is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers. The change is a physical modification (removal of an SSD spacer).

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

Not applicable. This is not a standalone algorithm. It is a modification to a physical medical imaging device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Engineering Specifications and Design Intent: The manufacturer's assurance that the removal of the SSD spacer does not alter the performance of the core X-ray components (tube, collimator, detector, hardware, software).
• Regulatory Standards: Compliance with international (IEC 60601-2-43, IEC 60601-2-54) and US federal (21 CFR, Part 1020.32(g)) minimum source-skin distance requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not involve a training set.

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

Not applicable, as there is no training set.

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The Allura Xper FD10 is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.

The Allura Xper FD10 is a stationary angiographic X-ray imaging system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or a ceiling suspended G-arm frontal stand.

This document is a 510(k) premarket notification for the Philips Allura Xper FD10, an angiographic X-ray system. It establishes substantial equivalence to a predicate device and does not contain acceptance criteria or a study proving the device meets them. It's a regulatory submission, not a performance study report.

Therefore, I cannot provide the requested information from the provided text, as the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number of experts, adjudication methods, or ground truth for test sets.
• Information about MRMC effectiveness studies or standalone algorithm performance.
• Details about training set size or how its ground truth was established.

This document focuses on regulatory compliance and substantial equivalence, not on the detailed performance validation of an AI/ML device.

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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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