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This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.

The MinXray HF1202 consists of an X-ray generator (tubehead/control), continuously adjustable light beam collimator, mounting trunnion, exposure cord with 2-stage exposure switch, and AC power cord. If a stand is purchased with the HF1202, such as the MinXray XGS series of gas spring portable mobile stands, instructions for assembly of the stand and the attachment of the HF1202 are included with the stand. This is a high-frequency generator of updated design. The unit has a serial port and a Bluetooth port for communication of technique factors to a PC. The PC cannot initiate an exposure. When used, the PC must employ FDA cleared software and digital receptor panels. Known compatible with Toshiba FDX4343RP and FDX4343RPW digital x-ray panels. The FDX4343RP was cleared in K130883 (and K131211) and the FDX4343RPW was cleared in K143257.

The provided text describes a 510(k) premarket notification for the MinXray HF1202H PowerPlus™ Portable X-ray Equipment, seeking substantial equivalence to a predicate device. This document does not describe a study that uses AI or machine learning, nor does it provide acceptance criteria and performance data in the typical sense for such devices (e.g., sensitivity, specificity, AUC).

Instead, this document describes a traditional medical device (an X-ray machine) and its comparison to a legally marketed predicate device. The core of the equivalence claim is based on bench testing and compliance with recognized standards, rather than performance metrics on a clinical image test set adjudicated by experts.

Therefore, for your requested information:

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

The "acceptance criteria" here are compliance with various IEC standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is the conclusion of compliance with these standards and the comparison of specifications presented in the table on pages 3-4.

2. Sample size used for the test set and the data provenance

Not applicable. The "test set" was not a collection of clinical images or patient data but rather the physical device tested against engineering standards and specifications. The document mentions "test images" were reviewed for overall operation, but no specific sample size of these images or their provenance is provided, as they were not used to establish clinical performance metrics.

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

Not applicable. Ground truth, in the context of clinical performance evaluation by experts, was not established for this type of device submission. The evaluation was primarily based on engineering compliance and functional specifications.

4. Adjudication method for the test set

Not applicable, as there was no expert adjudication of a test set of clinical cases.

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 portable X-ray machine, not an AI or CAD system. No MRMC study was conducted.

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

Not applicable. This is not an AI/algorithm-based device.

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

The "ground truth" for this submission refers to the established engineering standards, regulatory requirements, and the specifications of the predicate device. It's based on technical compliance and functional equivalence rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning system, so there is no training set in the conventional sense.

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

Not applicable, as there is no training set.

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