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This digital radiographic system 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, chest, abdomen, extremittes, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Excludes fluoroscopy, angiography, and mammography.

This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and ceiling suspension. The digital panel is the Pixium 3543pR (K090625) and the digital subsystem is the SmartRad, CMT Medical Technologies, K003438.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek WL Series Digital Diagnostic Digital X-Ray Systems (K091752):

It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data for new acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics tested against pre-defined acceptance criteria is not explicitly present in this type of document.

The "acceptance criteria" in this context are primarily tied to demonstrating the Viztek WL Series is as "safe and effective" and "substantially equivalent" to its predicate devices (K082604, K090625, and K003438). This usually involves showing that performance characteristics (like pixel size, software, safety standards) are comparable, and there are no new risks or concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate device. The "reported device performance" is essentially that it meets or is comparable to these characteristics.

Summary of "Acceptance": The device's performance is deemed "as safe and effective" and "substantially equivalent" to the predicate devices due to having "few technological differences" and "no new indications for use." The primary "acceptance" relies on meeting the same regulatory standards and having comparable technical specifications.

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

The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices," and "After analyzing bench and external laboratory testing to applicable standards..."

• Sample Size for Test Set: Not specified. The document does not detail specific sample sizes for any testing (e.g., number of images, number of patients).
• Data Provenance: The testing is referred to as "bench and external laboratory testing." The country of origin for this data is not specified, nor is whether it was retrospective or prospective. It's typical for bench testing to not involve patient data in the same way clinical trials do.

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

Not applicable/Not specified. This type of 510(k) summary for an X-ray system, especially one establishing substantial equivalence based on technical specifications and safety standards, does not typically involve expert review for "ground truth" derived from patient images in the way AI/CAD devices do. The "ground truth" here is compliance with technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As no expert review for "ground truth" is mentioned, no adjudication method would be detailed.

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

No. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. This document is for a digital X-ray system, not an AI or CAD system designed to aid human readers. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

Not applicable/Not specified. This is a digital X-ray system, not an AI algorithm. Its performance is measured by its ability to acquire diagnostic images according to established standards and technical specifications, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Bench and external laboratory testing to applicable standards: This implies objective measurements of physical characteristics, adherence to electrical safety standards (IEC-60601), and performance standards (21 CFR 1020.30).
• Comparison of technical specifications: Matching or demonstrating acceptable differences in parameters like pixel size and other hardware components against the predicate device.

It does not rely on expert consensus, pathology, or outcomes data, as it's not evaluating diagnostic accuracy of a finding but rather the system's ability to produce images safely and effectively.

8. Sample Size for the Training Set

Not applicable/Not specified. This document does not describe the development of an AI algorithm with a training set. The software component mentioned (SmartRad) is an existing, previously cleared device (K003438), which would have had its own validation.

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

Not applicable/Not specified. As there is no AI algorithm being developed by Viztek for this submission that would require a dedicated training set, this information is not available in the document.

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