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The AlluraClarity Xper FD Series X-ray System is 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 AlluraClarity Xper FD Series X-ray System is compatible with a hybrid Operating -Room.
• FD10 is compatible with specified magnetic navigation systems.

The AlluraClarity Xper FD Series X-Ray System (AlluraClarity system) 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 AlluraClarity system can also be used for imaging in the Hybrid OR. The AlluraClarity system is provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.

This device is an X-ray system, and the provided documentation focuses on its software validation and clinical performance based on questionnaires and dose reports, rather than a typical AI/ML-driven diagnostic device with specific performance metrics like sensitivity and specificity. Therefore, the questions related to ground truth, expert adjudication, MRMC studies, and separate training/test sets are not directly applicable in the conventional sense for this type of submission.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to "clinically acceptable" performance and successful utilization of the system for its indicated uses, as determined by physicians. There are no quantitative performance metrics such as sensitivity, specificity, or AUC provided in the document for the device's diagnostic capabilities, as the focus is on radiation dose reduction and image processing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of images or cases. The clinical performance data is based on "retrospective collected and analyzed clinical data," specifically "DICOM structured dose reports and customer satisfaction questionnaires." The number of questionnaires or dose reports reviewed is not provided.
• Data Provenance: Retrospective clinical data. The country of origin is not specified, but the manufacturer is Philips Medical Systems Netherlands B.V., so the data could originate from various international sites where Philips systems are used.

3. Number of Experts and Qualifications for Ground Truth

This question is not directly applicable in the context of this submission. The "ground truth" here is the physician's subjective assessment of the system's clinical acceptability and utility, rather than external verification of a disease state.

• Number of "Experts": Not specified. The document mentions "all physicians indicated...", implying multiple physicians participated in the questionnaires, but an exact number is not given.
• Qualifications of "Experts": The "experts" are the physicians who utilized the AlluraClarity System during clinical procedures and completed the satisfaction questionnaires. Their specific qualifications (e.g., area of specialty, years of experience) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There was no formal adjudication process for a "test set" in the sense of verifying diagnostic accuracy or discrepancies between readers. The assessment was based on individual physician feedback via questionnaires.

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

No. This document does not describe an MRMC comparative effectiveness study, nor does it quantify the improvement of human readers with or without AI assistance. The study focuses on the overall perceived clinical performance of the system as a whole, including its new image processing algorithms.

6. Standalone (Algorithm Only) Performance Study

No. The clinical performance data describes the performance of the integrated AlluraClarity Xper FD Series X-ray System, which includes the new image processing software (XRES4/ClarityIQ technology), not the algorithm in isolation.

7. Type of Ground Truth Used

The "ground truth" for the clinical performance assessment was expert consensus in the form of physician feedback/satisfaction questionnaires. This feedback directly addressed the "clinical acceptability" and "successful utilization" of the device for its indicated uses. While DICOM structured dose reports were also analyzed, they primarily provide objective data on dose, not clinical decision-making ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an X-ray system with a new image processing algorithm, not a machine learning model that relies on a distinct "training set" in the conventional sense of supervised learning for classification or detection. The algorithms themselves would have been developed and tuned using various image data, but this is not characterized as a "training set" in the context of a clinical validation study's sample size.

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

Not applicable, as there is no mention of a distinct "training set" for the purpose of a clinical validation study with established ground truth. The XRES4 algorithms are described as "noise reduction algorithms," implying their development would involve signal processing and image quality metrics, rather than labeled clinical outcomes or pathology for training a diagnostic AI model.

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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 CX50 2.0 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.

CX50 2.0 is a modification of the CX50 (1.0) compact diagnostic ultrasound system cleared for Philips Ultrasound in K081802. The 2.0 modification adds 4 additional transducers for use with the CX50 system; these transducers and software changes in release 2.0 enable expanded intended uses for the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound system cleared in K030455), to which CX50 2.0 is substantially equivalent.

Here’s an analysis of the provided text regarding the Philips CX50 2.0 Diagnostic Ultrasound System, focusing on acceptance criteria and supporting studies.

Important Note: This document describes a 510(k) premarket notification. For ultrasound systems, particularly for updates adding new transducers or expanding indications, the primary "study" proving acceptance criteria is often demonstrating Substantial Equivalence (SE) to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, without raising new questions of safety or effectiveness. Direct performance metrics like sensitivity, specificity, accuracy, or reader study results, which are common for AI-based or novel diagnostic devices, are usually not extensively detailed in such 510(k) summaries unless a significant new technology or clinical claim (beyond equivalence) is being made.

Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• Same gray-scale and Doppler capabilities.
• Essentially same technologies for imaging, Doppler, and signal processing. | CX50 2.0 & Predicate: Both have the same gray-scale and Doppler capabilities. Both use essentially the same technologies for imaging, Doppler functions, and signal processing. |
  | Safety:
• Acoustic output levels below FDA limits.
• Manufactured under equivalent quality systems.
• Materials with equivalent biosafety and found safe.
• Designed and manufactured to same electrical and physical safety standards. | CX50 2.0 & Predicate:
• Both have acoustic output levels below Track 3 FDA limits.
• Both are manufactured under equivalent quality systems.
• Both are manufactured of materials with equivalent biosafety, found safe.
• Both are designed and manufactured to the same electrical and physical safety standards. |
  | Effectiveness: The device performs as effectively as the predicate for its stated indications. | CX50 2.0 & Predicate: Demonstrated substantial equivalence to the Philips iU22 diagnostic ultrasound system (K030455) and the CX50 (1.0 release) (K081802). The new transducers integrate capabilities already cleared on other Philips systems, or are minor modifications of previously cleared transducers. The "Integrated Ultrasound" capability facilitates workflow, which is not a direct diagnostic performance claim but an operational improvement. The FDA's clearance (K091804) indicates acceptance of this demonstrated equivalence. |

Study Details Proving Acceptance Criteria

Given this is a 510(k) for a modification to an existing ultrasound system, the "study" is primarily an equivalence demonstration rather than a traditional performance study with a test set, ground truth, etc., as one would expect for a novel diagnostic algorithm.

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

• The document does not describe a specific "test set" of patient data for evaluating diagnostic performance in the way a clinical trial might.
• The "test" for this 510(k) is the comparison of the CX50 2.0's design, technology, and indications for use against the cleared predicate devices (Philips iU22 and CX50 1.0). This is inherent in the 510(k) process for demonstrating substantial equivalence.
• Data Provenance: Not applicable in the sense of patient data. The provenance for the comparison comes from the design specifications, technical documentation, and safety testing (e.g., acoustic output, biosafety, electrical/physical safety) of both the new device and the predicate(s). This is retrospective, drawing on existing clearances and design files.

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

• Not applicable. Ground truth in this context refers to the established safety and effectiveness of the predicate devices, as determined by prior FDA clearances and accepted industry standards. There isn't a "ground truth" established by a panel of experts for a novel diagnostic performance claim within this 510(k) summary. The "ground truth" is the regulatory standard for safety and effectiveness that the predicate device already met.

4. Adjudication Method for the Test Set:

• Not applicable. As there is no specific "test set" of patient cases requiring ground truth, there is no adjudication method described. The FDA reviewer performs the "adjudication" by reviewing the submission and determining if substantial equivalence is met.

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

• No, an MRMC comparative effectiveness study was not done (or at least, not mentioned in this summary). This type of study is usually conducted when a device introduces a new diagnostic capability or significantly alters the interpretation of images, requiring a comparison of human reader performance with and without the device. The CX50 2.0 is an expansion of an existing ultrasound platform, demonstrating equivalence to an already cleared device.

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

• No, a standalone performance study was not done. This device is a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It does not include an "algorithm only" component that would be evaluated in a standalone manner.

7. Type of Ground Truth Used:

• Regulatory Standard of Substantial Equivalence: The "ground truth" is effectively the established safety and effectiveness profile of the predicate devices (Philips iU22 diagnostic ultrasound system K030455 and the CX50 1.0 system K081802). The submission asserts that all new features and indications of CX50 2.0 fall within, or are substantially equivalent to, these previously cleared devices. This includes adherence to FDA guidance, acoustic output limits, biosafety, and electrical/physical safety standards.

8. Sample Size for the Training Set:

• Not applicable. The CX50 2.0 is an ultrasound imaging system, not an AI/ML algorithm that develops its diagnostic capabilities from a "training set" of data. Its performance is based on established ultrasound physics, transducer design, and signal processing.

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

• Not applicable. As there is no "training set" for this type of device, no ground truth was established for it.

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