(281 days)
The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.
The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.
All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:
- a. A 14x17in (35x43cm) tethered cassette sized panel
- b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
- c. A 17x17in (43x43cm) tethered panel for fixed installations.
The provided document is a 510(k) premarket notification for a medical device called the "ClearVision ExamVue Flat Panel Detector". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving a device meets specific clinical acceptance criteria through a dedicated study.
Therefore, many of the requested elements for describing specific acceptance criteria and study details cannot be fully extracted from this document. The document presents laboratory performance data and mentions "clinical images" but does not detail a formal clinical study with specific acceptance criteria as one would find in a clinical trial.
However, based on the information provided, here's what can be inferred and stated:
Acceptance Criteria and Reported Device Performance
The document does not specify formal clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets that the device must meet for a specific diagnostic task). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through technical specifications and performance characteristics, as well as indications for use and safety. The primary "study" proving the device meets these (implied) acceptance criteria is the comparison of its technical specifications and general performance to those of the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (ClearVision ExamVue Flat Panel Detector) |
|---|---|
| Technical Equivalence to Predicate Devices: | |
| Pixel Pitch (similar to 139um-143um of predicates) | 143um (FDX3543RP, FDX4343R), 140um (FDX3543RPW) |
| Limiting Resolution (compared to predicates) | 3.7lp/mm (all models), which is superior to "Over 3lp/mm" and "3lp/mm" of predicates. |
| DQE @ 1 lp/mm (compared to predicates) | 57% (FDX3543RP), 60% (FDX3543RPW), 58% (FDX4343R), which is superior to 33% Gadox / 46% CsI and 45% Gadox / 65% CsI of predicates. (Note: The new device exclusively uses CsI, which is stated to be higher performance than Gadox). |
| MTF @ 1 lp/mm (compared to predicates) | 63% (FDX3543RP), 68% (FDX3543RPW), 65% (FDX4343R), which is comparable to or superior to 63% Gadox / 72% CsI and 57% Gadox / 59% CsI of predicates. (Again, comparing CsI to CsI performance where applicable given the new device's exclusive use of CsI). |
| Scintillator technology (same type as predicate CsI option) | Exclusively CsI |
| Digital Image Conversion (14-16 bit) | 16 bit (FDX3543RP), 14 bit (FDX3543RPW, FDX4343R) - comparable to 14 bit of predicates. |
| DICOM compatibility | Yes |
| Use of aSi TFTD technology | Yes |
| Functional Equivalence: | |
| General radiography and exclusion of mammography in Indications for Use | Indicated for general radiology, specialist radiology (podiatry, orthopedic), and mobile x-ray systems. Not indicated for mammography. (Same as predicates). |
| Integration with ExamVueDR software for image processing, presentation, and storage | Integrated with ExamVueDR software for final processing and presentation, which was previously 510(k) cleared (K142930) and used with the predicate devices. |
| Electrical Safety and EMC Standards (IEC 60601-1, IEC 60601-1-2) | Met. |
| Biocompatibility | Data provided for patient-contacting surfaces showing no known adverse reactions. |
| Image acquisition control interface (hard-wired to x-ray generator or AED, and software) | Tested as part of laboratory and clinical testing; software control interface for exposure settings previously tested with K142930. |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "Clinical images were provided" and "clinical testing of the hardware" but does not specify a separate "test set" in terms of number of cases/patients used to evaluate performance against specific diagnostic endpoints or ground truth.
- Data provenance (country of origin, retrospective/prospective) is not specified for these "clinical images". The application is from JPI Healthcare Co., LTD, based in Seoul, South Korea, so the data may originate from there, but this is not explicitly stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "clinical images" and "clinical testing" are used to show the device "works as intended" in addition to laboratory data, rather than for a formal evaluation against expert-derived ground truth for diagnostic accuracy.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as a formal adjudication process for a diagnostic performance test set is not described.
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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 MRMC comparative effectiveness study is mentioned. This device is an X-ray detector, not an AI diagnostic algorithm, so "human readers improve with AI vs without AI assistance" is not applicable in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a hardware component (Flat Panel Detector) and not an "algorithm" in the sense of an AI/CAD system. Its performance is assessed standalone through technical specifications and image quality metrics (DQE, MTF, Limiting Resolution) in a laboratory setting, and "clinical images" are used for qualitative assessment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "clinical images" mentioned, the type of ground truth is not specified. Given the context, it's likely qualitative assessment by radiologists that the images are of diagnostic quality for their intended use, rather than a comparison to a definitive clinical ground truth for specific pathologies. For the technical specifications (DQE, MTF, Limiting Resolution), these are objective measurements derived from physical phantom or test object images, not clinical ground truth.
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The sample size for the training set:
- This device is hardware; it does not have a "training set" in the context of machine learning algorithms. The associated software (ExamVueDR) processes and presents images, but details about its own training data (if any for image processing algorithms) are not provided here.
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How the ground truth for the training set was established:
- Not applicable, as this is hardware and not a machine learning algorithm.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.