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The DMX is a radiographic system used in hospitals, clinics, and medical practices. The DMX enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The DMX is not meant for mammography. The DMX can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The DMX is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes

The DMX System is a permanently-installed diagnostic x-ray system for general purpose radiographic imaging for use in hospitals, clinics, and medical practices. It is intended to produce diagnostic x-ray images of human anatomy.

The DMX System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. The resultant images are evaluated by a radiologist within the diagnostic process prior to the development of a treatment plan. It is not intended for fluoroscopy, angiography, or mammography.

The DMX System typically includes a tube support, x-ray tube, radiographic table, radiographic wall stand, and collimator. Systems that include the overhead tube crane provide autotracking of the tube crane based on the position of the radiographic table or wall stand.

The provided text describes a medical device, the DMX radiographic system, and outlines its substantial equivalence to a predicate device, the OTC12D Auto. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm's performance. The document is a 510(k) summary for an X-ray system, focusing on its safety, effectiveness, and substantial equivalence to an existing device for general radiographic imaging.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving an AI device meets them. The document primarily discusses the physical components and regulatory compliance of a conventional X-ray system.

To answer your request, here's what could be inferred if this were an AI device undergoing a performance study:

1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not contain any acceptance criteria or reported device performance for an AI/ML algorithm. The tables in the document compare components and general functionality of the DMX system to its predicate, not performance metrics like sensitivity or specificity for diagnosis.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document does not describe a test set or data provenance for an AI/ML algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document does not describe the establishment of a ground truth for an AI/ML algorithm.

4. Adjudication Method for the Test Set:
Not applicable. The document does not describe a test set or adjudication method for an AI/ML algorithm.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The document does not mention an MRMC study or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. The document does not mention a standalone performance study for an AI/ML algorithm.

7. Type of Ground Truth Used:
Not applicable. The document does not describe the type of ground truth for an AI/ML algorithm.

8. Sample Size for the Training Set:
Not applicable. The document does not describe a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. The document does not describe how ground truth was established for a training set for an AI/ML algorithm.

In summary, the provided FDA 510(k) summary for the DMX X-ray system focuses on the substantial equivalence of its hardware and general functionality to a predicate device. It does not contain any information related to the performance evaluation or clinical studies of an AI/ML device.

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