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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.

Device Description

This portable X-ray system (Model: INNOVISION-P5) consists of an LCD display with up and down soft keys for controlling the kV settings. It includes a line-powered X-ray generator (transformer), an X-ray tube assembly, a collimator, a support stand, imaging processing software, and a digital flat-panel detector. The INNOVISION-P5 is a battery-operated, portable X-ray system designed for use with a flat-panel detector.

The major components of the X-ray main unit include handle, enclosure, main control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), system control software running on the system control board, imaging processing software, and detector. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software displays the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator, and monitor the working status of the device, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with portable or fixing sites.

This INNOVISION-P5 is not intended for mammography.

The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. Under certain exposure conditions, the inverter generator irradiates X-rays and the X-rays penetrate the patient's body. The Software (Elui-P) and portable x-ray unit communicate via Bluetooth to send/receive data to operate the product. The X-ray information is turned into electrical signals by a detector. The electrical signals are magnified and converted into digital signals to create image data. The image is sent to the image processing software (Elui-P) via Wifi. This portable X-ray System is designed for handheld or stand-mounted imaging. Model INNOVISION-P5 can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 6kgs to ensure the mechanical stability and effectiveness of the device.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the INNOVISION-P5 Mobile X-Ray System details the device's technical specifications and a comparison to a predicate device. However, it does not provide specific acceptance criteria or a detailed study that proves the device meets such criteria in a quantitative manner, nor does it include information about sample sizes for test/training sets, expert qualifications, or adjudication methods for quantitative performance metrics. The document primarily focuses on demonstrating substantial equivalence through technical comparisons and compliance with recognized safety and performance standards.

The information closest to "acceptance criteria" and "device performance" is presented in a qualitative statement about clinical image evaluation.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, or specific image quality metrics) in a table format. The "reported device performance" related to image quality is a qualitative statement.

Criterion Type	Acceptance Criteria (as implied/stated)	Reported Device Performance (as stated)
Diagnostic Image Quality	Meets diagnostic radiography standards by producing high-resolution and detailed images.	"This device meets the diagnostic radiography standards by producing high-resolution and detailed images. Furthermore, it has been evaluated that this device effectively supports diagnostic purposes and delivers reliable performance in clinical applications."
Safety and Essential Performance	Conformance to various IEC standards (see below).	Verified through non-clinical testing against listed IEC and FDA guidance standards.
Substantial Equivalence	Same indications for use, similar performance, equivalent safety and effectiveness as the predicate device.	Concluded that the device is substantially equivalent to the predicate (K210479).

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

Sample Size for Test Set: Not specified. The document mentions "X-ray images acquired using the subject device were evaluated," but no number of images or cases is provided.
Data Provenance: Not specified. The country of origin of the data (patients, images) or whether the study was retrospective or prospective is not mentioned.

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

Number of Experts: The document states "evaluated for image quality by a clinical expert." This implies one clinical expert.
Qualifications of Experts: The expert is described as a "clinical expert" and "qualified expert." Further specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given that only "a clinical expert" is mentioned, it's highly probable that no formal adjudication method was used (e.g., 2+1 or 3+1 consensus). The evaluation appears to be a single expert's assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. The document does not describe a multi-reader multi-case study, nor any comparative effectiveness study involving human readers with and without AI assistance. The device is a mobile X-ray system, not an AI-powered diagnostic tool, so such a study would not typically be required for this type of submission.
Effect Size of Human Readers Improvement with AI: Not applicable, as no such study was performed or needed for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: Not applicable/Not explicitly separate. The device itself is an X-ray imaging system. Its fundamental "performance" is the generation of diagnostic images. The software (Elui-P) mentioned is for image processing, acquisition, transmission, and display, as well as parameter control for the X-ray unit. While the software underwent Verification and Validation, its "performance" is integrated into the overall device's ability to produce diagnostically acceptable images. There is no mention of a separate "algorithm-only" diagnostic performance study in the way one might evaluate an AI detection algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the image quality evaluation appears to be expert consensus on diagnostic adequacy. The expert determined if the images met "diagnostic radiography standards" and "effectively support diagnostic purposes." There is no mention of pathology, long-term outcomes data, or other objective measures for establishing ground truth regarding specific findings or diseases.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. The document describes an X-ray imaging system, not a device incorporating a machine learning or AI algorithm that would require a "training set" in the conventional sense for diagnostic performance.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. See reason above.

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