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As a part of a radiographic system, the Pixium 4343RCE is intended to acquire digital radiographic images. The Pixium 4343RCE is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

The pixium 4343RCE is a Stationary x-ray system that converts x-ray patterns into electrical signals. The signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.

The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered by and connected with the x-ray system. The device is connected to the Philips Eleva Workspot to create a complete x-ray imaging chain, and it is intended to be used in Philips x-ray systems such as the DigitalDiagnost.

The provided text describes the Philips pixium 4343RCE, a stationary x-ray system. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device (Philips pixium 4343RC, K131483).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum DQE, MTF values that must be met) for the pixium 4343RCE, nor does it provide a direct side-by-side comparison of claimed performance data against such defined criteria. Instead, the acceptance criteria are implicitly stated as demonstrating similar performance to the predicate device and compliance with various standards. The "Discussion" column in the comparison table serves as the "reported device performance" against the implicitly accepted criterion of not negatively impacting safety or effectiveness compared to the predicate.

Here's a table summarizing relevant performance metrics and the discussion provided, which indicates how the device meets (or is considered to meet) implied acceptance criteria of non-inferiority or slight improvement:

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As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

The Pixium 4343RC is a Solid State X-ray Imaging Device that converts x-ray patterns into electrical signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.

The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered and connected with the x-ray system. The device is connected to the Philips XD-S Eleva Radiography Workstation to create a complete x-ray imaging chain, and it is intended to be used exclusively in the Philips Digital Diagnost x-ray system, one of the predicate devices.

Here's an analysis of the acceptance criteria and study information for the Philips Pixium 4343RC, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Philips Pixium 4343RC primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and a clinical concurrence study. It does not explicitly list "acceptance criteria" in a quantitative performance metric sense (e.g., target accuracy, sensitivity/specificity thresholds for diagnostic tasks). Instead, the acceptance criteria are implicitly that the new device performs at least as well as, or is equivalent to, the predicate devices across various technical and clinical aspects.

The table below summarizes the key technical characteristics and performances compared between the new device and its predicates, which serve as the implicit "acceptance criteria" for demonstrating equivalence.

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

The document mentions a "concurrence study" was conducted but does not specify the sample size (number of images or cases) used for the test set.

The data provenance is not explicitly stated as country of origin, nor is it explicitly labeled as retrospective or prospective. Given it's a "concurrence study" for regulatory submission, it is typically a controlled study, which could be either.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the concurrence study. It only states that the study confirmed the device "provides images of equivalent diagnostic capability to the predicate radiographic system." This implies expert assessment, but details are missing.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used in the concurrence study.

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

The document does not mention or describe an MRMC comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. The study described is a "concurrence study" focused on the diagnostic capability of the new device's images being equivalent to a predicate, not on human-AI collaboration.

6. Standalone (Algorithm Only) Performance Study

The device itself is a Solid State X-ray Imaging Device (a digital detector), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance study, often associated with AI software, is not applicable in this context. The entire device, including its hardware and integrated image processing software (XD-S Eleva Workstation), is being evaluated as a system that produces diagnostic images.

7. Type of Ground Truth Used

The document implies that the ground truth for the concurrence study was based on the diagnostic capability of images from the predicate device. The study's goal was to show that the new device "provides images of equivalent diagnostic capability to the predicate radiographic system." This means the predicate device's images (presumably deemed diagnostically acceptable by current clinical practice) served as the reference for equivalence. It does not explicitly mention pathology or outcomes data as direct ground truth for the study itself, but rather clinical equivalence.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is understandable as the Pixium 4343RC is a hardware device (X-ray imager) with associated image processing software. While the image processing software itself might have been "trained" or optimized during its development, this submission focuses on the performance of the integrated hardware and software system, comparing it to predicate devices, not detailing the training of specific algorithms within the image processor.

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

Since no training set and associated ground truth are explicitly mentioned for this device's submission, this information is not provided in the document.

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Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

This device is simply the combination of two cleared devices, the same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to existing film x-ray systems. It should be installed by a qualifics trained by a qualifics trained

The KrystalRad 660 Digital Radiographic Portable Retrofit System's acceptance criteria and study details are provided below based on the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in quantitative terms (e.g., minimum sensitivity, fidelity metrics). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The primary performance metric is the qualitative comparison of clinical images and integration testing.

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

The document states, "Clinical images were acquired and compared to our predicate images." However, it does not specify the sample size for the test set (number of images or patients).

The data provenance is not explicitly stated regarding its country of origin or whether it was retrospective or prospective. It only mentions "clinical images were acquired," which could imply prospective acquisition, but this is not confirmed.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical images. The comparison is described simply as "compared to our predicate images," suggesting an internal comparison rather than a formal expert review process for ground truth.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method for the test set. The statement "no significant differences between them" suggests a qualitative assessment without detailing a specific process like 2+1 or 3+1 consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this submission. The study focuses on demonstrating equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

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

The device is a hardware combination (digital X-ray panel and image processing software). The "performance" being evaluated is the image quality and functionality of this combined system itself. Therefore, the "standalone" performance in this context refers to the system acquiring images, which was done by collecting and comparing clinical images. It's not an "algorithm-only" performance in the sense of an AI diagnostic aid.

7. The Type of Ground Truth Used

The ground truth for the comparison was based on "our predicate images." This implies comparing images from the KrystalRad 660 system to images produced by the previously cleared predicate devices (Philips Wireless Portable Detector FD-W17 K090625 and the image processing software from K080582 DDR MAK Series or K100403 OmniVision). The "ground truth" is therefore the established image quality and clinical utility of the predicate devices.

8. The Sample Size for the Training Set

The device is a combination of two already cleared predicate devices. The "study" described is a comparison and integration test of this combination, not the development or training of a new algorithm. Therefore, there is no specific "training set" mentioned for the KrystalRad 660 as it's not a de novo AI algorithm requiring training. The image processing software itself (cleared under K080582 or K110040) would have had its own validation/training, but details are not provided here for KrystalRad 660.

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

As stated in point 8, there isn't a "training set" for the KrystalRad 660 as a new device. The ground truth for the predicate image processing software or detector would have been established during their original clearance, likely involving various methods (e.g., expert review, physical phantoms for image quality metrics), but these details are not provided in this submission for K112132. The KrystalRad 660 leverages the already established "ground truth" (i.e., safety and effectiveness) of its predicate components.

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

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

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

The submission focuses on:

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

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

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