(182 days)
LTX240AA01-A Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems to in all general purpose diagnostic procedures. Not to be used for mammography.
LTX240AA01-A is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. LTX240AA01-A is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic
The provided text does not contain any information about a study that proves the device meets specific acceptance criteria.
The document is a 510(k) summary for a Digital Flat Panel X-Ray Detector (LTX240AA01-A). It primarily focuses on:
- Device identification and description.
- Comparison to a predicate device (Canon CXDI-50G).
- Safety, EMC, and performance testing against standards (EN/IEC 60601-1 and EN/IEC 60801-1-2(2001)). It states all test results were satisfactory but doesn't mention specific acceptance criteria or the results themselves.
- Indications for Use.
- A conclusion of substantial equivalence to the predicate device.
It lacks details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document indicates that electrical, mechanical, environmental safety, and performance testing was "performed" and "All test results were satisfactory," but it does not detail what these tests were, what the acceptance criteria for those tests were, or what the specific satisfactory results implied in terms of performance metrics.
Therefore, I cannot fulfill your request for a table of acceptance criteria and the study details because that information is not present in the provided text.
§ 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.