(13 days)
The FLAATZ 750 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, angiographic, and mammographic applications).
The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment. The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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 functions for image data capture and correction of defects on the image data.
The provided text describes a 510(k) submission for a new device, the FLAATZ 750, which is a radiographic image acquisition device. However, the document is a regulatory submission summary and an FDA letter, not a detailed study report. Therefore, it does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantifiable manner in this document. The document says, "The FLAATZ 750 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device." This implies the acceptance criteria were met by demonstrating substantial equivalence, but the specific metrics are not detailed here.
- Reported Device Performance: The document only states that the device "has shown good performance, substantially equivalent to the predicate device" (Saturn 9000, K063710). No specific performance metrics (e.g., DQE, MTF, SNR, contrast detectability) are provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and substantial equivalence to predicate. | "Good performance, substantially equivalent to the predicate device [Saturn 9000 (K063710)]" and "met applicable ElectroMagnetic Compatibility (EMC) requirements." |
Missing Information (2-9):
The provided 510(k) summary and FDA letter do not contain the following information:
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The focus is on demonstrating "substantial equivalence" of the device (FLAATZ 750) to a predicate device, not on human reader performance with or without AI assistance. This is a hardware device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a digital radiography detector, not an algorithm.
- The type of ground truth used: Not applicable in the context of diagnostic accuracy studies for AI. For a hardware device, "ground truth" often refers to quantitative imaging performance metrics compared against industry standards or predicate device specifications.
- The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable. This is a hardware device, not a machine learning model.
Summary of available information:
- Device Name: FLAATZ 750
- Intended Use: Generating radiographic images of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
- Predicate Device: Saturn 9000 (New Medical Co., LTD., 510(k) No.: K063710)
- Study described: A functional and safety testing to demonstrate substantial equivalence to the predicate device, following FDA guidance for solid-state X-ray imaging devices, and meeting EMC requirements.
- Conclusion: The FLAATZ 750 is substantially equivalent to the Predicate Device in design and performance.
- Date Prepared: December 5, 2007 (FDA response AUG 23 2013, correcting a previous letter from Jan 23, 2008).
To obtain the detailed information requested (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.), one would need to review the full 510(k) submission, specifically the sections pertaining to "Performance Data" or "Clinical Data" which are not included in this summary.
§ 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.