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SDX-4343CS Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.

SDX-4343CS digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343CS is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343CS, digital flat panel X-ray detector.

The provided text is a 510(k) Special Submission for a Digital Flat Panel X-Ray Detector (SDX-4343CS). This submission focuses on establishing substantial equivalence to a predicate device and includes information on the device's description, intended use, and safety/performance testing.

However, the document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, particularly in the context of advanced AI/CAD system testing. The text describes a standard medical device submission process for an imaging hardware component, not an AI-powered diagnostic tool.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set information (which are common for AI/CAD device submissions), are not present in this document.

The document mainly focuses on proving the safety and effectiveness of the hardware and its substantial equivalence to a previously cleared predicate device based on electrical, mechanical, environmental safety, and EMC testing.

Based on the provided information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly present in the provided text. The document states that "Electrical, mechanical, environmental safety and performance testing according to standard ENVIEC 60601-1 was performed, and EMC testing was conducted in accordance with standard ENVIEC 60601-1-2(2001). All test results were satisfactory." This indicates that the device met the requirements of these general safety and performance standards for X-ray equipment, but specific numerical acceptance criteria (e.g., MTF, DQE, SNR, etc., which are common for imaging detectors) and their corresponding measured performance are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not mentioned. This submission is for an X-ray detector hardware, not an AI algorithm that processes images. Therefore, 'test sets' in the context of diagnostic performance on patient data are not relevant here. The testing mentioned (EN/IEC standards) would involve engineering and performance tests on the device itself, not a clinical study on patient images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable/Not mentioned. As this is for hardware performance, the concept of "ground truth" established by clinical experts on patient images is not relevant to this submission summary.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/CAD device. Therefore, no MRMC study of human readers with/without AI assistance was performed or reported here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/CAD device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not mentioned. For the hardware performance tests (EN/IEC standards), ground truth would refer to quantifiable physical measurements and adherence to specified tolerances, not clinical diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This is not an AI/CAD device; thus, there is no "training set" of data for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not mentioned.

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SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.

The provided document is a 510(k) summary for the SDX-4343GV Digital Flat Panel X-Ray Detector. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria related to device performance (e.g., sensitivity, specificity, or accuracy metrics) or a study that specifically proves the device meets such criteria.

The document primarily focuses on regulatory compliance, outlining:

• Company and device information.
• Comparison with a predicate device (LLX240AB01).
• Statement of compliance with electrical, mechanical, environmental, and EMC safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 61000-3-2, EN/IEC 61000-3-3).
• Conclusions regarding safety, effectiveness, and substantial equivalence.

Therefore, I cannot populate the requested table and answer the study-specific questions as the necessary information is not present in the provided text. The document confirms that "All test results were satisfactory" for safety and performance testing according to the listed standards, but it does not detail specific performance metrics, acceptance criteria, or the methodology of a clinical or performance study that would demonstrate such.

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SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.

The SDX-4336CP is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4336CP is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.

SDX-4336CP 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 is a 510(k) summary for a Digital Flat Panel X-Ray Detector (SDX-4336CP). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria, device performance results, details of a study (test set size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for the training set).

The document states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." but does not elaborate on the specific acceptance criteria or the reported performance data from these tests. These tests are general safety and EMC standards, not specific clinical performance studies that would typically assess diagnostic accuracy.

Therefore, I cannot populate the table and answer the study-related questions based on the provided text. The submission focuses on device description, intended use, and substantial equivalence, not a detailed clinical performance study with the requested metrics.

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LLX240AB0! digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

LLX240AB01 is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. LLX240AB01 is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW. LLX240AB01 is a 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 be utilized for digitalizing x-ray images by converting X-ray photons into visible light and then to electronic image data that a computer can read and display for diagnostic purposes.

I am sorry, but I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a 510(k) submission summary for a Digital Flat Panel X-Ray Detector, and it focuses on general information about the device, its classification, and its substantial equivalence to a predicate device.

The provided text does not contain any information regarding:

• Specific acceptance criteria for device performance (e.g., sensitivity, specificity, image quality metrics).
• Details of a study proving the device meets acceptance criteria.
• Sample sizes for test sets, data provenance, or ground truth establishment.
• Information on expert readers, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance.
• Training set information.

The document primarily states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." This is a general statement about regulatory compliance and safety testing, not specific clinical performance criteria or a comparative study against such criteria.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone (algorithm only) performance study.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. 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.

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