Search Results

The XR-01 Portable X-Ray System is intended to be used by trained dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.

XR-01, a portable X-ray system is mainly designed for dental diagnosis via X-ray exposure with intraoral image receptors, supplied with 25.2 V DC rechargeable Li-ion polymer battery. The portable X-ray system consist of an x-ray generator with an x-ray tube, device controller, beam limiting device, AC-DC power supply, charging unit and optional back scatter shield.

The provided text contains information about the XR-01 Portable X-ray System and its substantial equivalence to predicate devices, focusing on regulatory compliance, electrical safety, battery safety, and general performance. However, it does not include the detailed results of a study demonstrating the device meets specific acceptance criteria related to its image quality or diagnostic performance. The document primarily discusses its compliance with safety and performance standards for an x-ray system, rather than a clinical study evaluating its diagnostic accuracy.

Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and MRMC studies cannot be extracted from the provided text.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions compliance with general safety and performance standards rather than specific diagnostic acceptance criteria. The "Performance Testing" section states: "Performance test validate that accuracy, reproducibility, deviation and linearity of technical factors such as tube voltage, tube current and exposure time is meet the criteria. Safety tests in terms of HVL, leakage, x-ray field size meet Federal standard requirements."

The "criteria" are referred to as "Federal standard requirements" and "safety and performance standards", but the specific numerical acceptance values for accuracy, reproducibility, deviation, linearity, HVL, leakage, and x-ray field size are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text describes general "Performance Testing" but does not detail the nature of the test set, its size, or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no mention of a clinical study involving experts establishing ground truth for a diagnostic performance evaluation.

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

This information is not provided.

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

An MRMC study is not mentioned in the provided document. The device is a portable X-ray system, not an AI-powered diagnostic tool. The submission is for a traditional 510(k) for an extraoral X-ray source.

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

This is not applicable as the device is an X-ray system, not an algorithm, and the document focuses on its technical performance and safety for generating images.

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

This information is not provided. The "Performance Testing" section refers to technical measurements against defined standards for X-ray devices (e.g., accuracy of kVp, mA, exposure time, HVL, leakage) rather than a ground truth for diagnostic accuracy derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided. There is no mention of a training set for an algorithm in this submission.

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

This information is not provided. There is no mention of a training set or ground truth establishment for a training set in this submission.

Ask a specific question about this device

REXTAR LCD is a portable X-ray systems to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.

The REXTAR LCD consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The REXTAR LCD is an extraoral source x-ray system with a DC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source a, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

The provided text describes a 510(k) submission (K122016) for the REXTAR LCD, a portable X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader agreement.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth establishment is not available in the provided document. The document primarily highlights compliance with performance standards and a comparison of technical specifications with predicate devices.

However, based on the information provided, here's what can be inferred and what is explicitly stated:

Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a table of explicit "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, or diagnostic accuracy) or "reported device performance" against such criteria. Instead, it demonstrates compliance with recognized electrical and safety standards and compares technical specifications to predicate devices to establish substantial equivalence.

Study and Data Information:

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

   • Not provided. The document does not describe a clinical study with a test set of images or patients for performance evaluation. The submission relies on technical comparisons and compliance with standards.

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

   • Not applicable/Not provided. No clinical test set or ground truth establishment by experts is described for performance evaluation.

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

   • Not applicable/Not provided. No clinical test set involving expert adjudication is described.

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. This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • No. This is a hardware device for image acquisition, not an algorithm.

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

   • Not applicable/Not provided. The substantial equivalence claim is based on comparison of technical specifications and compliance with safety and electrical standards, not on clinical ground truth.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set.

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

   • Not applicable/Not provided.

Summary of what the document explicitly states regarding compliance/testing:

• Compliance with performance standards: "All components to which the standard applies are certified to conform to diagnostic equipment standards, 21 CFR 1020.30 and 1020.31." (Section 8)
• The device "will comply with applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32." (Section 11)
• "EMC testing was conducted by (EMC Compliance Co., Ltd. in accordance with Standard EN/IEC 60601-1-2). All test results were satisfactory." (Section 11)

The "study" in this context is the comparison to predicate devices and the demonstration of compliance with various electrical, safety, and diagnostic equipment standards, rather than a clinical performance study. The "acceptance criteria" are implied by the requirements of these standards and the characteristics of the predicate devices.

Ask a specific question about this device