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The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.

The JADE Mobile X-Ray, is a mobile x-ray device that comes in two models: JADE-32 (3.2kw max. output and JADE-40 (4kw max. output). JADE is a non-motorized mobile diagnostic xray device that can facilitate X-ray examinations, in situations where it is not possible or feasible to transport the patient to a ward with fixed equipment. The unit is stable and precise when using the optional Mobile or Portable Stand. The electric tube unit and wheel locks. column rotation, and a simple user interface to provide for added operator convenience and rapid patient positioning. X-Ray technique presets can be saved. The JADE Mobile X-Ray device can be used with a film screen cassette or a flat panel detector which are supplied by the user and are not part of the JADE Mobile X-Ray, device. The software used with the JADE Mobile system is new and is not based on the predicate device.

The JADE device consists of:

• . High-Frequency X-ray Generator
• Collimator with 30 seconds LED lamp timer
• User Programmable APR
• . Exposure Hand Switch
• . Software(SDK, HT Frame and Membrane Console Firmware)

The provided text describes the JADE Mobile X-Ray device and its substantial equivalence to a predicate device (AMADEO M-DR Mini, AMADEO M-AX Mini). However, it does not contain information about specific acceptance criteria related to a device's performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study designed to prove the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics of the JADE Mobile X-Ray to those of the predicate device and by listing compliance with various safety and EMC standards. It explicitly states:

• "Clinical testing is not necessary for the JADE Mobile system in order to demonstrate substantial equivalence to the predicate device."
• "Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This indicates that the "acceptance criteria" referred to are likely related to engineering specifications, safety standards compliance, and functional validation of the device's components and software, rather than performance metrics derived from a clinical or diagnostic accuracy study.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets performance-based acceptance criteria (like sensitivity/specificity), as such a study is explicitly stated as not necessary and not included in this 510(k) summary.

Here's what can be extracted based on the provided text regarding the non-clinical testing and general acceptance:

1. A table of acceptance criteria and the reported device performance:
   As mentioned, no performance-based acceptance criteria (like sensitivity, specificity, or accuracy for image interpretation) are stated in the document. The "acceptance criteria" refer to compliance with various international standards and functional validation of the device's components. Since these are pass/fail assessments against engineering and safety standards, a quantitative "reported device performance" in the context of clinical metrics is not applicable here.

   Acceptance Criterion Type	Reported Device Performance
   Safety Standards (e.g., IEC/EN 60601 series)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
   EMC Standards (e.g., EN60601-1-2)	Passed all predetermined testing criteria; complies with applicable regulatory requirements and design standards.
   Functional Validation (input/output, actions)	Validation testing indicated that predetermined acceptance criteria were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable (N/A). The document refers to non-clinical testing of the device hardware and software against engineering and safety standards, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy, which was explicitly stated as not necessary for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A.

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:
   N/A. This is a primary X-ray device, not an AI-assisted diagnostic tool for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   N/A.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   N/A. For engineering and safety tests, the "ground truth" would be the specifications and requirements of the applicable standards.

8. The sample size for the training set:
   N/A. The "software" components mentioned (JADE_HTC, JADE_MCC, CPC_SDK) appear to be firmware and control software for the X-ray generator, not an AI or machine learning model that would require a "training set" of data in the typical sense.

9. How the ground truth for the training set was established:
   N/A.

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