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This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

This is a complete portable battery operated digital x-ray system with the indications for use stated above. It consists of the battery operator described in K182207 paired with the wireless battery operated digital x-ray acquisition components described in K191451. This is therefore a new combination of all previously cleared components. The digital x-ray receptor system uses a wireless panel and a Dell laptop computer fitted with a 300Mbps Mini Wireless N USB Adapter. The generator can be hand held (within the limitations of the indications), tripod mounted, or mobile stand mounted. Two models are proposed: IMPACT and X-RANGER. The two models differ in their targeted markets and in the type of computer supplied. The IMPACT uses a DELL PRECISION 3550 Laptop whereas the X-RANGER uses a DELL LATITUDE 7424 RUGGED LAPTOP. The IMPACT is aimed at the commercial market whereas the X-RANGER is aimed at the military market. The software is unmodified from that employed in our reference device (K191451) and it remains at a moderate level of concern. The image receptor (cleared under K191451) is wireless and measures 14x17 inches.

The provided text describes a 510(k) premarket notification for the MinXray IMPACT and X-Ranger portable X-ray systems, establishing substantial equivalence to a predicate device (TR90BH K182207) and referencing an imaging system (CMDR 2CW K191451).

However, the document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence based on the device's intended use, technological characteristics, and compliance with various safety and performance standards for medical electrical equipment.

The relevant information regarding performance is limited to:

• Panel Performance: Panel MTF ~63% (@ 1lp/mm) and Panel DQE ~62% (@ 0lp/mm), which are properties of the digital image capture panel (from reference device K191451), not acceptance criteria for the overall X-ray system.
• Safety and Effectiveness: Stated that "The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation." This is a general statement, not a specific performance metric against acceptance criteria.

Therefore, many parts of your request for acceptance criteria and a study proving their fulfillment cannot be answered from the provided text.

Here's an attempt to answer the questions based on the available information, noting where data is missing:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document primarily describes non-clinical bench testing and compliance with standards. It does not refer to a test set in the context of image data for diagnostic performance evaluation.
• No information on data provenance (country of origin, retrospective/prospective) is provided, as no such image-based test set is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No image-based test set with ground truth established by experts is mentioned. The software for image acquisition is described as "unmodified" and "remains at a moderate level of concern." "Overall operation" was verified by "reviewing test images," but the reviewers' qualifications are not stated.

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

• Not applicable. No image-based test set requiring an adjudication method 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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or mentioned. The device is purely an X-ray system, 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 an X-ray imaging device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No diagnostic ground truth was established as part of this submission, which focused on the safety and performance of the X-ray system itself.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned as this is a hardware device submission.

9. How the ground truth for the training set was established

• Not applicable.

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