(15 days)
The FLAATZ 500 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammography applications).
The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The FLAATZ 500 system Includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains for image data capture and correction of defects on the image data.
Here's a breakdown of the acceptance criteria and study information for the FLAATZ 500, based on the provided text:
Acceptance Criteria and Device Performance:
The provided 510(k) summary for the FLAATZ 500 states that the device has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises" and has shown good performance, substantially equivalent to the predicate device.
However, specific numerical acceptance criteria (e.g., minimum MTF, DQE values, contrast resolution) and corresponding reported device performance metrics are not explicitly provided in the text. The summary relies on the general statement of "good performance" and "substantially equivalent" to the predicate without detailing the quantitative measures.
Study Information:
Since specific performance metrics are not listed, many of the requested details about the study (sample size, ground truth, experts, etc.) are not available in the provided 510(k) summary. The document focuses on declaring substantial equivalence to a predicate device based on general performance.
Here's what can be inferred or is explicitly stated:
| Feature | Information from Document |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Not explicitly listed as quantitative values. The overarching criterion appears to be "substantially equivalent to the predicate device" and meeting the "FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises." |
| Reported Device Performance: "Has shown good performance, substantially equivalent to the predicate device." No specific numerical values (e.g., DQE, MTF, resolution) are provided in the summary. | |
| 2. Sample size used for the test set and data provenance | Not specified. The document does not describe a specific clinical test set or its sample size. The equivalence claim is based on general performance evaluation rather than a detailed comparative study with a human-read test set. |
| 3. Number of experts and their qualifications for ground truth | Not applicable/Not specified. Since no specific clinical test set for human review against a ground truth is mentioned, the number and qualifications of experts are not provided. The evaluation appears to be technical performance-based, or against a predicate's known technical performance. |
| 4. Adjudication method for the test set | Not applicable/Not specified. No such method is mentioned as a specific clinical test set is not detailed. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The FLAATZ 500 is an image acquisition device, not an AI-powered diagnostic aid. The "AI" in the prompt relates to AI-powered algorithms, which this device is not. It's a digital X-ray detector system. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Yes (implicitly, for its function as an imaging device). The FLAATZ 500 is a radiographic image acquisition device. Its performance is inherent in its ability to capture images. The "algorithm" in this context refers to the device's internal image processing and API for data capture/correction, which operates standalone to produce the image data. Its performance is evaluated independently of human interpretation in terms of technical specifications. |
| 7. Type of ground truth used | Not explicitly stated for a clinical ground truth. Given the nature of a digital X-ray detector, the ground truth for its performance would typically involve physical phantoms for evaluating technical image quality parameters (e.g., spatial resolution, contrast-to-noise ratio, detective quantum efficiency) rather than a clinical ground truth like pathology or outcomes data. The document states it was evaluated as per FDA's guidance, which would involve these types of technical performance assessments. |
| 8. Sample size for the training set | Not applicable/Not specified. This device is an image acquisition hardware component, not an AI model that requires a training set of images. |
| 9. How the ground truth for the training set was established | Not applicable. As the device is not an AI model requiring a training set, this question is not relevant. |
Summary and Caveats:
The 510(k) summary for the FLAATZ 500, K091747, is typical for an image acquisition device seeking substantial equivalence to a predicate. It emphasizes meeting FDA guidance for such devices and demonstrating "good performance" that is "substantially equivalent" to an already cleared device (FLAATZ 750, K080064). It does not contain the detailed clinical study information often associated with AI/CADe devices, which require extensive reader studies and ground truth establishment against clinical outcomes or expert consensus. The evaluation is focused on the technical performance of the imaging hardware itself.
§ 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.