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The Heart5R-110. Heart3R-110 are Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

The system is subject to the following limitations of use when stand-mounted:

• The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. -The device may be used for imaging of the chest when used without a grid.

This device is not intended for mammography.

The Portable X-ray machine directly provides rays for diagnostic operation, which is composed of the following parts: power supply circuit, inverter, high-voltage tank ball tube, filament circuit, control circuit, high-voltage cabinet body, user interface and collimator.

This document is a 510(k) summary for a portable X-ray machine. It demonstrates substantial equivalence to a predicate device rather than providing acceptance criteria and a study proving the device meets those criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

However, I can provide the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device to meet. Instead, it compares the specifications of the subject device to a predicate device to establish substantial equivalence.

Comparison of Subject Device (Heart5R-110, Heart3R-110) vs. Predicate Device (SR-8230/SR-8230S):

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used for clinical evaluation. The evaluation was based on non-clinical (bench) testing and comparison to an existing predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no clinical studies with a test set requiring expert ground truth were conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies with a test set requiring adjudication were conducted.

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 image analysis software. The summary explicitly states: "The software is Moderate level of concern, it is original software, and it is not a software for image analysis."

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

Not applicable, as this is a hardware device (X-ray machine) and its software is not for image analysis.

7. The Type of Ground Truth Used:

Not applicable for clinical ground truth. The "ground truth" for this submission focuses on compliance with established engineering and safety standards, and ensuring physical and functional equivalence to the predicate device through non-clinical testing.

8. The Sample Size for the Training Set:

Not applicable, as this device does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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