(104 days)
This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
The digital radiography SKR 3000 performs X-ray imaging of the human body using an X-ray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.
- This device is not intended for use in mammography
- This device is also used for carrying out exposures on children.
The Console CS-7, which controls the receiving, processing, and output of image data, is required for operation. The CS-7 is a software with basic documentation level. CS-7 implements the following image processing; gradation processing, frequency processing, dynamic range compression, smoothing, rotation, reversing, zooming, and grid removal process/scattered radiation correction (Intelligent-Grid). The Intelligent-Grid is cleared in K151465.
The FPDs used in SKR 3000 can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The SKR 3000 is distributed under a commercial name AeroDR 3.
The purpose of the current premarket submission is to add pediatric use indications for the SKR 3000 imaging system.
The provided FDA 510(k) clearance letter and summary for the SKR 3000 device focuses on adding a pediatric use indication. However, it does not contain the detailed performance data, acceptance criteria, or study specifics typically found in a clinical study report. The document states that "image quality evaluation was conducted in accordance with the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'" and that "pediatric image evaluation using small-size phantoms was performed on the P-53." It also mentions that "The comparative image evaluation demonstrated that the SKR 3000 with P-53 provides substantially equivalent image performance to the comparative device, AeroDR System 2 with P-52, for pediatric use."
Based on the information provided, it's not possible to fully detail the acceptance criteria and the study that proves the device meets them according to your requested format. The document implies that the "acceptance criteria" likely revolved around demonstrating "substantially equivalent image performance" to a predicate device (AeroDR System 2 with P-52) for pediatric use, primarily through phantom studies, rather than a clinical study with human patients and detailed diagnostic performance metrics.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will provide the information that can be inferred or directly stated from the document and explicitly state when information is not available.
Disclaimer: The information below is based solely on the provided 510(k) clearance letter and summary. For a comprehensive understanding, one would typically need access to the full 510(k) submission, which includes the detailed performance data and study reports.
Acceptance Criteria and Device Performance Study for SKR 3000 (Pediatric Use Indication)
The primary objective of the study mentioned in the 510(k) summary was to demonstrate substantial equivalence for the SKR 3000 (specifically with detector P-53) for pediatric use, compared to a predicate device (AeroDR System 2 with P-52).
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (adding a pediatric indication based on substantial equivalence), the acceptance criteria are not explicitly quantifiable metrics like sensitivity/specificity for a specific condition. Instead, the focus was on demonstrating "substantially equivalent image performance" through phantom studies.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Image quality of SKR 3000 with P-53 for pediatric applications to be "substantially equivalent" to predicate device (AeroDR System 2 with P-52). | "The comparative image evaluation demonstrated that the SKR 3000 with P-53 provides substantially equivalent image performance to the comparative device, AeroDR System 2 with P-52, for pediatric use." |
| Compliance with "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" for pediatric image evaluation using small-size phantoms. | "image quality evaluation was conducted in accordance with the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'. Pediatric image evaluation using small-size phantoms was performed on the P-53." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document indicates "small-size phantoms" were used, implying a phantom study, not a human clinical trial. The number of phantom images or specific phantom configurations is not detailed.
- Data Provenance: Not specified. Given it's a phantom study, geographical origin is less relevant than for patient data. It's an internal study conducted to support the 510(k) submission. Retrospective or prospective status is not applicable as it's a phantom study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. Given this was a phantom study, ground truth would likely be based on physical measurements of the phantoms and expected image quality metrics, rather than expert interpretation of pathology or disease. If human evaluation was part of the "comparative image evaluation," the number and qualifications of evaluators are not provided.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. For a phantom study demonstrating "substantially equivalent image performance," adjudication methods like 2+1 or 3+1 (common in clinical reader studies) are generally not applicable. The comparison would likely involve quantitative metrics from the generated images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. The document states "comparative image evaluation" and "pediatric image evaluation using small-size phantoms." This strongly implies a technical performance assessment using phantoms, rather than a clinical MRMC study with human readers interpreting patient cases. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported, as AI assistance in image interpretation (e.g., CAD) is not the focus of this submission; it's about the imaging system's ability to produce quality images for diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable in the traditional sense of an AI algorithm's diagnostic performance. The device is an X-ray imaging system. The "performance" being evaluated is its ability to generate images, not to provide an automated diagnosis. The "Intelligent-Grid" feature mentioned is an image processing algorithm (scattered radiation correction), but its standalone diagnostic performance is not the subject of this specific submission; its prior clearance (K151465) is referenced.
7. The Type of Ground Truth Used
- Ground Truth Type: For the pediatric image evaluation, the ground truth was based on phantom characteristics and expected image quality metrics. This is inferred from the statement "pediatric image evaluation using small-size phantoms was performed."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The SKR 3000 is an X-ray imaging system, not an AI model that requires a "training set" in the machine learning sense for its primary function of image acquisition. While image processing algorithms (like Intelligent-Grid) integrated into the system might have been developed using training data, the submission focuses on the imaging system's performance for pediatric use.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set (in the context of an AI model's image interpretation learning) is explicitly mentioned or relevant for the scope of this 510(k) submission for an X-ray system.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.