Search Results
Found 5 results
510(k) Data Aggregation
(190 days)
Exam Vue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. Exam Vue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
ExamVue DR is not indicated for use in mammography.
The Exam Vue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3tt party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
The provided text is a 510(k) premarket notification for the ExamVue DR device. It describes the device's indications for use, comparison to a predicate device, and general statements about safety and performance testing. However, it does not contain specific acceptance criteria, detailed results of a study proving the device meets those criteria, or the other requested information regarding sample sizes, expert qualifications, or ground truth establishment.
The section titled "7. Safety, EMC and Performance Data" states:
"Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. We have also provided performance and clinical testing using example X-ray detectors, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices""
This indicates that performance and clinical testing were conducted, but the details of these tests, including the acceptance criteria and results, are not provided in this document.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Ask a specific question about this device
(605 days)
The Clear Vision DR7000F 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 DR7000F 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 DR7000F 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 LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).
The provided 510(k) summary for the Clear Vision DR7000F does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm-only performance.
The document describes a digital radiography X-ray system, which is a hardware device, not an AI or algorithm-based diagnostic tool. The submission focuses on demonstrating substantial equivalence to predicate hardware devices and compliance with electrical, mechanical, environmental safety, and performance standards for X-ray systems.
Therefore, most of the requested information regarding AI/algorithm performance, ground truth establishment, expert review, and training/test set sizes is not applicable to this document.
Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing / not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical, Mechanical, Environmental Safety & Performance: Compliant with EN/IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32. | All test results were satisfactory. |
| EMC: Compliant with EN/IEC 60601-1-2(2007). | Testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory. |
| X-ray Detector Performance: Not explicitly stated as a separate criterion, but performance and clinical testing were provided as recommended by FDA guidance for Solid State X-ray Imaging Devices. | Performance and clinical testing for the X-ray detectors were provided. (The document indicates the detectors LTX240AA01-A and LLX240AB01 were previously cleared by FDA 510(k), implying their performance was acceptable.) |
| Substantial Equivalence: To predicate devices CDX-DR80D (Choongwae Medical Corp.) and LTX240AA01-A, LLX240AB01 (Samsung Mobile Display Co. Ltd.). | The conclusion states the device is substantially equivalent to the predicate devices, implying it meets the necessary performance and safety profiles. |
Regarding specific questions related to AI/Algorithm performance:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This device is an X-ray imaging system, not an AI algorithm. The "clinical testing" mentioned for the X-ray detectors likely refers to performance evaluation under clinical conditions, not an algorithm's diagnostic accuracy on a test set of images.
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)
- Not applicable / Not provided. No specific "ground truth" establishment for an algorithm's performance is mentioned. Evaluation of an X-ray system focuses on image quality, radiation dose, safety, and functionality, which are assessed against technical specifications and clinical utility, rather than diagnostic "ground truth" for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / 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
- Not applicable / Not provided. This submission is for a medical imaging device, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For an X-ray device, "ground truth" generally relates to physical measurements (e.g., spatial resolution, contrast-to-noise ratio, MTF, DQE) and clinical image quality (diagnostic acceptability) rather than a pathology reference for an AI diagnosis.
8. The sample size for the training set
- Not applicable / Not provided. No AI training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No AI training is mentioned.
Summary regarding the device:
The Clear Vision DR7000F is a digital radiography X-ray system. The study proving it meets acceptance criteria primarily involves engineering and performance testing against established international standards (EN/IEC 60601 series) for medical electrical equipment, as well as specific guidance for solid-state X-ray imaging devices. The acceptance criteria relate to electrical, mechanical, environmental safety, electromagnetic compatibility (EMC), and the technical performance and clinical utility of the X-ray detectors. The "study" mentioned is the compilation of these satisfactory test results conducted by the manufacturer, demonstrating compliance and substantial equivalence to existing cleared predicate hardware devices.
Ask a specific question about this device
(325 days)
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.
Ask a specific question about this device
(59 days)
Ask a specific question about this device
(150 days)
Ask a specific question about this device
Page 1 of 1