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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 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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