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The MasteRad MX30 is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list: Varex PaxScan 2530Wv4, Varex PaxScan 4336Wv4, Varex PaxScan 4343R, Varex PaxScan 4343RC, Varex XRpad 4343F, Varex XRpad 3025, Varex XRpad 4336, Toshiba* FDXA4343R. As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377.

The MasteRad MX30 is an X-ray system, and the provided text describes its substantial equivalence to a predicate device (K143257). The acceptance criteria and supporting studies are based on demonstrating that the new device, particularly a new digital X-ray receptor panel, maintains diagnostic quality and safety.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly tied to demonstrating that the new Toshiba FDXA4343R digital panel (and the overall MasteRad MX30 system) performs at least as well as, or equivalently to, the predicate device and the previously cleared Toshiba FDX4343R panel. The primary performance criterion is diagnostic quality of images.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document does not specify a numerical sample size for the clinical images beyond stating "Clinical images were acquired from the new Toshiba panel." It implies a sufficient number were obtained for review, but no specific count is given.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the images were "acquired from the new Toshiba panel" for the purpose of this submission, which suggests a prospective acquisition for evaluation, specifically for a new panel not previously cleared by the FDA.

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

• Number of Experts: One expert.
• Qualifications: "A board certified radiologist." No specific years of experience are mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/None explicitly stated as an adjudication method. The evaluation was performed by a single board-certified radiologist who "reviewed" the images and "found them to be of excellent diagnostic quality." There is no mention of multiple reviewers or a consensus process.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
• AI Improvement Effect Size: Not applicable. This submission is for an X-ray system and its digital detector, not an AI-powered diagnostic tool for interpretation.

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

• Standalone Performance: Not applicable. This device is an X-ray acquisition system, not a standalone algorithm. The "performance" described relates to the imaging capabilities of the hardware component (the digital detector) rather than an interpretive algorithm.

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

• Ground Truth Type: Expert opinion/evaluation. The ground truth for image quality was established by a single board-certified radiologist's assessment of "diagnostic quality." This is based on the expert's interpretation of whether the images are suitable for clinical diagnosis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. The document describes the validation of a hardware system and its updated software, not a machine learning model that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there was no training set for a machine learning model.

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