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The purpose of Acuity is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.

RadmediX Acuity combines components into a complete stationary x-ray system, including software, tube stands, tube heads, collimators, generators, tables, and digital radiography panels.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance:

The document describes the Acuity SDR Standard, Acuity SDR Plus, and Acuity FDR Standard as stationary x-ray systems. The core claim for substantial equivalence is that the device performs the same functions using the same technological methods as the predicate device (Visaris Vision®) to produce diagnostic x-ray images.

Study Information:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a numerical sample size of clinical cases for a formal clinical trial. Instead, the non-clinical testing involved acquiring DICOM images from "all major body structures" using one AcuitySDR system configuration.
   • Data Provenance: The document does not specify the country of origin for the image acquisition or whether it was retrospective or prospective. It was a "field tested" system, implying real-world or simulated real-world scenarios.

2. Number of Experts and Qualifications (for Ground Truth):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified, beyond the statement that images were generated for "diagnostic x-rays" and assessed as "clinically acceptable." This implies evaluation by trained personnel (e.g., radiologic technologists, radiologists), but their specific qualifications or number are not detailed.

3. Adjudication Method:

   • No formal adjudication method is described. The assessment of image quality was based on whether images were "of high quality and contrast and clinically acceptable."

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was performed or described. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical image quality assessment, not on human reader performance improvement with or without AI assistance.

5. Standalone Performance Study (Algorithm Only):

   • Yes, a standalone study (non-clinical testing) was performed. The algorithm (software) alongside the hardware components was tested to acquire and process images. The output (DICOM images) was then evaluated for inherent quality and acceptability. The assessment "all images were of high quality and contrast and clinically acceptable" refers to the output of the integrated system.

6. Type of Ground Truth Used:

   • Expert Consensus / Clinical Acceptability: The ground truth for image quality was established through subjective expert assessment of "high quality and contrast and clinically acceptable." It does not mention pathology or outcomes data.

7. Training Set Sample Size:

   • Not applicable. This device is an X-ray system, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation or diagnosis. The "software" components mentioned (AccuVueMED, AccuVue) are image acquisition and processing software, which are generally deterministic and not "trained" on data in the way a diagnostic AI would be. They are "previously cleared software supplied with the system."

8. How Ground Truth for Training Set Was Established:

   • Not applicable, as there is no specific "training set" for an AI/ML algorithm in this submission. The software components were previously cleared by the FDA, implying their performance was established through other means at the time of their original clearance (K152172 and K141440).

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The EVS 3643 Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The EVS 3643 is a wired/wireless flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 3643 differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

EVS 3643 consists of main components such as SSU. USB Switch Box, Battery Pack, Battery charger and other accessories (Tether Interface Cable, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).

EVS 3643 should be integrated with an operating PC and an X-Ray generator.

Here's a breakdown of the acceptance criteria and study information for the EVS 3643 device, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document states that the EVS 3643 is functionally identical and shares similar performance to the predicate device (EVS 4343) with minor differences in these specified metrics, which are presented as the acceptance criteria against which the new device was compared. The conclusion is that the EVS 3643 "meets the acceptance criteria and is adequate for this intended use."

Study Information

1. Sample size used for the test set and the data provenance:

   • The document mentions "Clinical images were provided," but does not explicitly state the specific sample size of images used in the clinical study.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study was conducted as a "single-blinded concurrence study," which implies it was likely a prospective collection for this specific study, but the source of the images themselves is not detailed.

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

   • The document states a "single-blinded concurrence study" was conducted. It does not specify the number of experts or their qualifications (e.g., years of experience, specific board certifications) used to establish ground truth or evaluate diagnostic capability.

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

   • The document describes a "single-blinded concurrence study." This typically implies that reader evaluations are compared to a predetermined ground truth, or to evaluations by other readers, but it doesn't specify an adjudication method like "2+1" or "3+1." The phrase "concurrence study" suggests agreement among observers or with a known reference, but the precise adjudication process is not detailed.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described.
   • The study was a "single-blinded concurrence study" to confirm "equivalent diagnostic capability to the predicate devices," not to measure human performance improvement with AI assistance. The device itself is an X-ray detector, not an AI interpretation tool.

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

   • Yes, performance metrics such as DQE, MTF, and Resolution were evaluated for the device itself (EVS 3643) and compared to the predicate device (EVS 4343) in a "comparison test." This represents standalone performance. The clinical study also implicitly assesses the standalone image quality produced by the detector.

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

   • For the clinical "concurrence study," the ground truth was based on the premise of "equivalent diagnostic capability to the predicate devices." This implies that the images produced by EVS 3643 were deemed to provide equivalent information that would lead to the same diagnosis as those from the predicate device or a recognized standard, likely established by expert review ("concurrence"). The specific method of establishing this diagnostic ground truth (e.g., expert consensus on specific findings, long-term outcomes) is not further detailed.

7. The sample size for the training set:

   • The document does not describe the use of a training set for an AI/algorithm system. The device is a digital X-ray detector, and the description focuses on its hardware and imaging characteristics, not on machine learning model development. Therefore, a training set for an AI model is not applicable here.

8. How the ground truth for the training set was established:

   • As there's no mention of a training set for an AI/algorithm, there's no information on how its ground truth was established.

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