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510(k) Data Aggregation
(26 days)
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
The subject of this Special 510(k) submission is a change to the CXDI Control Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.
Here's a summary of the acceptance criteria and study information for the Enhanced Feature Software Pack for CXDI Series, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and device performance metrics. However, the core change in the proposed device is the "One Shot Long Length Imaging" feature, which involves automatic stitching of images from multiple detectors with manual adjustment capabilities. The performance is largely implied by the claim of substantial equivalence and successful mitigation of risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Quality / Stitching Accuracy for One Shot Long Length | The "One Shot Long Length" feature allows obtaining images across multiple detectors, automatically stitched together, with the ability to make manual adjustments after the automatic stitching. It enables capturing images up to 120cm in length in one exposure. The text implies that the performance for this feature is adequate, and substantially equivalent to the predicate device for its intended use, as no specific performance deficiencies are noted. The study would have demonstrated that the automatically stitched images are clinically acceptable and that the manual adjustment feature provides sufficient control for fine-tuning. |
| Safety and Effectiveness | The hardware within the Canon Digital Radiography CXDI Series Detectors has not been modified, and the detectors retain the same performance, biocompatibility, effectiveness, and safety as the predicate device. A FMEA methodology was used to analyze risks and hazardous impacts of the device modification, and risk control and protective measures were reviewed and implemented. "The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted." The device complies with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-32), and FCC and ICES standards for wireless detectors. This indicates that the device's performance, post-modification, continues to meet established safety and effectiveness standards, especially given that the core imaging hardware remains unchanged. |
| Maintenance of Indication for Use | The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s). This is explicitly stated, suggesting the new feature does not alter the fundamental clinical applications for which the device is intended. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a "Special 510(k) Submission" for a software change, and typically such submissions might rely on internal validation and verification testing demonstrating that the new feature does not adversely affect the already cleared device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission focuses on the technical aspects of the software modification and its substantial equivalence. Clinical studies with expert-adjudicated ground truth are not explicitly mentioned in this summary.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 or any assessment of human reader improvement with or without AI assistance. The "Enhanced Feature Software Pack" introduces an "One Shot Long Length Imaging" feature that automatically stitches images, but it's not described as an AI-driven diagnostic aid that would typically involve an MRMC study for assessing reader performance. It's more of an image acquisition and processing enhancement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not explicitly state that a standalone performance study was done for the "One Shot Long Length Imaging" algorithm. However, given that it's an automated stitching process, internal verification and validation testing would have been conducted to ensure the accuracy and quality of the stitched images generated by the algorithm. This would be a form of standalone testing, but specific metrics and methodology are not detailed here.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any testing. For an image stitching feature, ground truth would likely involve measurements of anatomical alignment and continuity as determined by expert review or comparison to reference images, but this is not explicitly stated.
8. The Sample Size for the Training Set
This information is not provided in the document. The device primarily involves an automated image stitching algorithm, rather than a machine learning model that typically requires a large training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. As mentioned above, it's unclear if a traditional "training set" with ground truth, as used for machine learning, was employed in the development of this image stitching feature.
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(35 days)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.
Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:
Acceptance Criteria and Device Performance Table:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K150816, K153119) for diagnostic radiographic exposures of various body parts in adults and pediatrics, excluding mammography. | "Equivalent" to predicate devices. |
| Configuration of Digital Panels | Battery or AC operated wireless IEEE 802.11n or Wired Ethernet. | "Same" as predicate devices. |
| Digital Panel Models and their Clearance Numbers | Utilize previously cleared FDA digital flat panel detectors (specific K numbers listed in Note 1). | "Similar functionality" to predicate devices (Note 1 states the subject device uses different flat panel detectors that are previously FDA cleared, and testing demonstrates no increased safety concern or effect on effectiveness). |
| Image Acquisition Panel Specifications | Comparable pixel resolution and size range (e.g., 3,320 x 3,408 Pixels 125 µm, 3,072 x 3,072 Pixels 139 µm, etc.). | "Similar functionality" to predicate devices (Note 1). |
| DICOM Compliance | DICOM 3 compliant. | "Same" as predicate devices. |
| WiFi Wireless (if applicable) | Functionality similar to predicate wireless detectors. | "Similar functionality" to predicate devices (specific Canon, Varex, PerkinElmer, and DRTECH wireless detectors listed). |
| Image Acquisition Software | Utilize previously cleared FDA image processing software (specific K numbers listed in Note 2). | "Similar functionality" to predicate devices (Note 2 states Prognosys uses previously cleared FDA software and does not modify it). |
| Power Source | AC Line, various voltages available. | "Same" as predicate devices. |
| X-ray Generator | Range of power ratings (e.g., 32 kW to 80 kW, 125 kV/150 kV). | "Same or similar functionality" to predicate devices (Note 3 states the subject device uses similar X-ray generators with different power ratings and that these generators have been used in previously cleared 510(k) devices). |
| X-ray Tubes | Range of kV, focal spot sizes, and heat units (e.g., Toshiba E7239FX, Varex RAD14, etc.). | "Similar functionality" to predicate devices (Note 4 states both configurations provide similar imaging resolution and these tubes have been used in previously cleared 510(k) devices). |
| Collimator | Adequate inherent filtration. | "Similar functionality" to predicate devices (Note 5 states the inherent filtration is different but does not affect safety and effectiveness). |
| Performance Standard Compliance | Compliance with FDA 21 CFR 1020.30-31 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components). | "Same" as predicate devices. |
| Electrical Safety | Compliance with IEC 60601-1. | "Same" as predicate devices. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device complies with this standard. |
| Radiation Protection | Compliance with IEC 60601-1-3. | Device complies with this standard. |
| Specific Safety/Performance for X-ray Equipment | Compliance with IEC 60601-2-54. | Device complies with this standard. |
| Usability | Compliance with IEC 60601-1-6. | Device complies with this standard. |
| Risk Management | Compliance with ISO 14971. | Device complies with this standard. |
| Cybersecurity | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" guidance for device labeling. | Cybersecurity concerns were addressed based on the US FDA Guidance document. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
- Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist.
- Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.
3. Adjudication method for the test set:
- Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.
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:
- MRMC Study: No. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
- Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.
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