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Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.

The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.

Here's a breakdown of the acceptance criteria and study as described in the provided documents for the Xplorer 1000 Digital X-ray Imager:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Xplorer 1000 was to demonstrate equivalence to its predicate devices: the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840). This equivalence was assessed in terms of intended use and radiographic performance.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

Here's a detailed breakdown of the studies conducted:

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

• Non-clinical testing (Spatial Resolution): Not explicitly stated, but "line pair resolution targets and radiological phantoms" were used. These are typically standardized, manufactured objects rather than patient data.
• Clinical testing (Image Quality): 20 human subjects were x-rayed.
• Data Provenance: Not explicitly stated, but likely prospective given the clinical testing involved x-raying subjects "both conventionally and with the Xplorer 1000." The country of origin is not mentioned.

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

• Non-clinical testing: Not explicitly stated, but for qualitative imaging of bone detail, "radiologists" were involved. The number is not specified, nor are their specific qualifications beyond being radiologists.
• Clinical testing: 3 radiologists. Their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication method for the test set:

• Clinical testing: "The results were examined by a panel of 3 radiologists and found equivalent to film." This suggests a consensus-based approach, but the specific adjudication method (e.g., unanimous agreement required, majority vote) is not detailed. It does not appear to be a 2+1 or 3+1 method.

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:

• No, an MRMC comparative effectiveness study was not explicitly done in the way typically understood for AI-assisted reading. The study aimed to show equivalence between a digital imager and film, not to demonstrate human reader improvement with AI assistance. The device is a digital X-ray imager, not an AI diagnostic tool.

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

• Yes, in a sense, the device's inherent "performance" (e.g., spatial resolution) was evaluated independently of human interpretation. The spatial resolution reported (127 microns) is a standalone measurement of the device's capability. However, this is not a standalone AI algorithm performance as the device itself is an imager, not an AI for diagnosis.

7. The type of ground truth used:

• Non-clinical testing (Spatial Resolution): Standardized resolution targets and phantoms.
• Clinical testing (Image Quality): The "ground truth" was essentially the subjective evaluation of image quality and anatomical detail (bone detail, trabeculae) by a panel of radiologists, comparing the Xplorer 1000 images to images obtained using conventional film. This is expert consensus on image quality rather than a definitive medical diagnosis or pathology.

8. The sample size for the training set:

• Not applicable. The Xplorer 1000 is an optical-based digital X-ray imager, not a machine learning or AI device that requires a "training set." It converts X-ray energy to visible light and captures it with a CCD camera.

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

• Not applicable, as there is no training set for this type of device.

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