(69 days)
The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.
The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopic system through a dynamic digital flat panel, to digitalize, archive and review images and to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices which uses a device.
This 510(k) submission for the DRF 4343, an Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on shared indications for use and technological characteristics.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- No specific acceptance criteria or reported device performance metrics are provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly to already approved devices, its performance is acceptable.
2. Sample size used for the test set and the data provenance:
- Not applicable. The document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an operator console and imaging workstation for X-ray systems, not an AI algorithm performing diagnostic tasks. Its function is to capture, digitalize, archive, and review images, which implicitly involves human interaction.
7. The type of ground truth used:
- Not applicable. As there is no performance study or ground truth establishment described.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI model or a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set described.
Summary of available information related to the device and its approval:
- Device Name: DRF 4343
- Common Name: Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems
- Indication for Use: "The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use."
- Predicate Devices: Nical NDR+/DIVA-D (K053029), Siemens AXIOM Luminos dRF (K062623), Shimadzu DAR7000 RADspeed SAFIRE (K050925).
- Rationale for Substantial Equivalence: The DRF 4343 has the same indication for use and similar technological characteristics as the predicate devices, with minor differences not raising new questions regarding safety or effectiveness.
In conclusion, this 510(k) submission establishes substantial equivalence through comparison to existing predicate devices rather than through a dedicated performance study with acceptance criteria and a test set. Therefore, the specific details requested regarding acceptance criteria and study data are not present in the provided document.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.