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The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

The Philips DuraDiagnost Digital Diagnostic Radiographic System (DuraDiagnost) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The Philips DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.

Here's a breakdown of the acceptance criteria and the study information for the Philips DuraDiagnost, based on the provided 510(k) summary:

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 setting specific performance acceptance criteria for the new device as would be found in a clinical trial protocol. Instead, the "acceptance criteria" here relate to the device meeting recognized standards and exhibiting technical characteristics similar to its predicates.

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

• Test Set Sample Size: Not applicable. This 510(k) relies on non-clinical performance testing and comparison to predicate devices, not a clinical test set of patient images.
• Data Provenance: The data provenance is primarily from bench testing, engineering verification, and validation activities against recognized standards and guidance documents. This is not patient-level data. The manufacturer is Philips Healthcare (Suzhou) Co., Ltd in China.

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

• Number of Experts: Not applicable. Since there was no clinical test set of patient images, no experts were used to establish ground truth in this context. The "ground truth" for this submission is related to engineering specifications and compliance with regulatory standards.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set of patient images requiring adjudication was used.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical study was not warranted to support this 510(k) submission, since substantial equivalence to the currently marketed and predicate devices was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; and Safety and effectiveness."
• Effect Size: Not applicable, as no MRMC study was performed.

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

• This device is a hardware digital radiographic system with integral software for image acquisition, processing, storage, and viewing. It is not an AI algorithm in the context of standalone performance. Therefore, a "standalone algorithm only" performance study is not applicable. The performance evaluation focuses on the entire system's compliance with standards and equivalence to predicate systems.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on:
  • Engineering Specifications and Design Features: Comparing the technical characteristics of the DuraDiagnost to those of the predicate devices.
  • International and FDA-recognized Consensus Standards: Compliance with electrical safety, EMC, radiation protection, software lifecycle, risk management, and usability standards (e.g., IEC 60601 series, IEC 62304, ISO 14971).
  • FDA Guidance Documents: Adherence to specific guidance for solid-state X-ray imaging, software, wireless technology, and pediatric information.
  • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (GE Brivo XR385, Philips BuckyVision, Swissray ddRVersa™ Motion) serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission is for a conventional digital radiographic system and does not involve an AI algorithm with a training set of images. The "training" for such a system would involve engineering design and software development, not machine learning from a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no AI algorithm training set involved.

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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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The ddrCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. {Not for mammography}

This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.

Here's an analysis of the acceptance criteria and study information for the ddRCruze™ device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) summary does not delineate specific, quantifiable acceptance criteria in the traditional sense, such as specific sensitivity or specificity targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technical characteristics and intended use. The device's performance is reported by stating its characteristics alongside those of the predicate devices.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Study Information

Based on the provided 510(k) summary, the following information can be extracted regarding the studies conducted:

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

   • Not Applicable. The submission explicitly states "Description of clinical tests: Not applicable." This indicates that no new clinical test set with patient data was used to demonstrate the device's performance. The basis for clearance is substantial equivalence to previously cleared devices.

2. 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. As no clinical test set was used, no ground truth needed to be established by experts for this specific device clearance.

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

   • Not Applicable. No clinical test set was used.

4. 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 study was not conducted as this is a traditional X-ray system, not an AI-assisted diagnostic tool. The submission is for a mobile digital X-ray system comprising hardware (mobile unit, digital panel) and software, all of which had prior clearances or are components of previously cleared systems.

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

   • No. This device is an imaging system, not a standalone AI algorithm. It requires a human operator and interpretation.

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

   • Not Applicable. No new ground truth was established for this device's clearance. The clearance relies on the established safety and effectiveness of its predicate components and the equivalence of its technical characteristics.

7. The sample size for the training set:

   • Not Applicable. This submission is for a conventional medical imaging device (X-ray system), not an AI algorithm that requires a training set. The "software" mentioned (PrestoDR Portable) was used unmodified and had prior clearance.

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

   • Not Applicable. No training set was used for this device's clearance.

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