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ViVIX-S wireless is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography and/or for fluoroscopy.

The ViVIX-S Wireless is a digital X-ray flat panel detector which has 35.8cm x 43cm (FXRD-1417WA, FXRD-1417WB) imaging area and communicates via not only the wireless communication feature (IEEE 802.11a/b/g/n) but also wired communication feature (Giga-bit Ethernet communication method by connecting to a tether cable) optionally. The device intercepts X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, it is converted to a digital value, and an image will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a specific table for them in the traditional sense of performance metrics with thresholds. However, it implicitly uses a "substantial equivalence" framework. The performance data presented focuses on comparing the new device, ViVIX-S Wireless, to a predicate device, ViVIX-S.

• Quantum limited performance: No significant difference reported.
• Modulation Transfer Function (MTF): No significant difference reported.
• Effects of aliasing: No significant difference reported.
• Sensitivity linearity: No significant difference reported.
• Lag (Erasure thoroughness): No significant difference reported.
• Change in detection sensitivity: No significant difference reported.
• Dose requirement and reciprocity changes: No significant difference reported.
• Stability of device characteristics with time: No significant difference reported.
• Uniformity of device characteristic: No significant difference reported.
• Noise power spectrum (NPS): No significant difference reported.
• Spatial resolution: No significant difference reported.
• Minimum dose: No significant difference reported.
• Image Acquisition time: No significant difference reported.
• Black level: No significant difference reported. |
  | Clinical equivalence | - Comparison of Clinical Images: "No significant difference between the images of the ViVIX-S Wireless and those of the predicate device." |
  | Safety and EMC (Implicit) | - Electrical safety and EMC testing: "All test results were satisfactory" according to IEC 60601-1 and IEC 60601-1-2. |

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

• Sample Size for Test Set: 30 clinical images were used for the clinical study.
• Data Provenance: Not explicitly stated, but the company is based in South Korea. The study compares the new device to a predicate device, implying these images likely originated from a clinical setting where both devices could be used, or the predicate device was the source. This would likely be retrospective as it compares existing images or recent acquisitions for the purpose of demonstrating equivalence, rather than a planned prospective study where specific patient cohorts are followed.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in either the non-clinical or clinical studies. The clinical study states a "concurrence study" was done, implying expert review, but details are absent.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The term "concurrence study" suggests some form of agreement or comparison, but the methodology for resolving discrepancies or establishing the "true" finding is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document describes a "concurrence study of 30 clinical images" to compare performance. While clinical images were used and a comparison was made, it does not explicitly describe an MRMC comparative effectiveness study with human readers improving with AI vs. without AI assistance. This device is an X-ray detector, not an AI diagnostic algorithm. The study's aim was device equivalence, not reader performance with AI. Therefore, no effect size for human reader improvement with AI is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, the "non-clinical study" can be considered a standalone performance evaluation of the device's technical specifications. It assessed intrinsic image quality metrics like DQE, MTF, NPS, spatial resolution, etc., independent of human interpretation for diagnostic tasks.

7. The Type of Ground Truth Used

• Non-clinical study: The "ground truth" for the non-clinical studies was based on objective, quantifiable physical and technical performance metrics of the X-ray detector itself (e.g., measured DQE, MTF, NPS, etc.) compared to established benchmarks or the predicate device's measured performance.
• Clinical study: For the clinical images, the "ground truth" or reference standard for comparison was the images from the predicate device. The study aimed to show "no significant difference" between images produced by the new device and the predicate device. This implies that the image quality and diagnostic information contained within the predicate device's images served as the de facto reference. The document does not mention pathology, outcomes data, or a separate expert consensus establishing specific diagnoses as ground truth for these 30 images, but rather the quality and equivalence of the images themselves.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ViVIX-S Wireless is a digital X-ray detector, a hardware device, not an AI algorithm that requires a training set of data.

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

This information is not applicable and not provided, as the device is a hardware component and not an AI algorithm requiring a training set.

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