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1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck. spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography.

1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this SIOK submission) for a radiographic diagnosis and analysis.

The provided text is a 510(k) summary for the 1210SGA Digital Flat Panel X-ray Detector. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria related to diagnostic performance.

Therefore, the document does not contain information on the acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

The device is a digital X-ray detector, and its "performance" in this context is primarily related to electrical, mechanical, and environmental safety, as well as its ability to capture and digitalize X-ray images, similar to its predicate.

Here's a breakdown of what the document does provide, addressing the requested points where possible, and noting where information is absent:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of diagnostic performance (e.g., sensitivity, specificity). The submission relies on demonstrating substantial equivalence to a predicate device (Xmaru1210P, K101590) and compliance with relevant safety and EMC standards.
   • Reported Device Performance:
     • Electrical, mechanical, environmental safety and performance testing: According to standard EN/IEC 60601-1.
     • EMC testing: Conducted in accordance with standard EN/IEC 60601-1-2(2001).
     • Results: "All test results were satisfactory."

   Summary Table (based on available information):

   Acceptance Criteria (Implicit)	Reported Device Performance
   Compliance with Electrical, Mechanical, and Environmental Safety Standard (EN/IEC 60601-1)	Satisfactory
   Compliance with EMC Standard (EN/IEC 60601-1-2(2001))	Satisfactory
   Substantial Equivalence to Predicate Device (Rayence Co., Ltd., Xmaru1210P, 510(k) K101590)	Concluded by manufacturer and concurred by FDA for stated indications of use

2. Sample size used for the test set and the data provenance: Not applicable. This submission doesn't describe a diagnostic performance study with a test set of patient cases. The "testing" refers to technical compliance and safety testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic performance study involving expert interpretation of medical images is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No diagnostic performance study requiring adjudication is described.

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: Not applicable. This device is a digital X-ray detector, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic performance. For the technical and safety testing, the "ground truth" would be the specifications and requirements defined by the regulatory standards (e.g., voltage limits, EMI levels, mechanical stability).

8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) Special Summary for the 1210SGA Digital Flat Panel X-ray Detector details its technical characteristics and claims substantial equivalence to a predicate device based on compliance with safety and EMC standards. It does not include information about diagnostic performance studies with specific acceptance criteria, test sets, or expert evaluations as would be expected for a diagnostic AI/CAD device.

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