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The Clear Vision DR 2000 product 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, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

The Clear Vision DR2000 system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

The detector which is used proposed device is QXR9 (K073056) and QXR16 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 510(k).

The provided 510(k) summary for the Clear Vision DR 2000 does not contain information about explicit acceptance criteria for diagnostic performance, nor does it detail a specific study proving the device meets such criteria in terms of clinical accuracy or reader performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety, and electromagnetic compatibility (EMC) testing. The "performance data" mentioned refers to these engineering and safety tests rather than clinical performance for diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The submission focuses on demonstrating technical compliance and substantial equivalence to predicate devices, not on quantitative diagnostic performance metrics.

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

Not applicable. There is no mention of a clinical "test set" for diagnostic performance evaluation. The "testing" referred to in the document pertains to electrical safety, mechanical, and EMC tests.

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

Not applicable. No ground truth establishment for diagnostic performance is described.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic performance test set or adjudication method is described.

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

Not applicable. The Clear Vision DR 2000 is a digital radiography X-ray system, not an AI-powered diagnostic tool. Therefore, an MRMC study assessing AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Clear Vision DR 2000 is a hardware system for image acquisition, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

Not applicable. No diagnostic performance evaluation requiring ground truth is described.

8. The Sample Size for the Training Set

Not applicable. The Clear Vision DR 2000 is a medical imaging acquisition device; it does not inherently involve a "training set" in the context of machine learning or AI algorithms for diagnostic purposes.

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

Not applicable. As no training set is mentioned in the context of diagnostic algorithms, the establishment of ground truth for such a set is not relevant.

Summary of the Study Discussed in the 510(k) Submission:

The study detailed in this 510(k) submission is a series of engineering and safety tests to ensure the Clear Vision DR 2000 system meets relevant industry standards and is substantially equivalent to predicate devices. These tests include:

• Electrical, mechanical, environmental safety and performance testing according to standards EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32.
• EMC testing in accordance with standard EN/IEC 60601-1-2(2007).

The acceptance criteria for these tests would be compliance with the specific requirements outlined in each of those EN/IEC standards. The reported device performance is that "All test results were satisfactory," indicating that the device met the specified engineering and safety criteria for each standard.

The focus of this 510(k) is to demonstrate that the device is safe and effective for its intended use as a digital radiography X-ray system, primarily by showing that its technical characteristics and safety features align with established standards and legally marketed predicate devices, rather than through a clinical study of diagnostic accuracy. The use of pre-cleared detectors (QXR9 and QXR16) also supports the claim of substantial equivalence.

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