(198 days)
The BladeView is a full featured Radiographic Flat-Panel Digital Imaging System. It Is intended to replace conventional film screen systems. The BiadeView allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremittee. The BladeView enables a qualified operator to acquire, process, and display images. The BladeView system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or anglographic applications.
The BladeView is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The main configuration includes a portable X-ray detector, generator, workstation and various other allied parts and components necessary for radiographic studies. It is also configurable to be used in an existing conventional radiographic room (Film or CR) and only the Flat panel and workstation would be needed. The system has medications ranging from but not limited to cranial, skeletal, thoracic and lung exposures as well as examination of the extremities.
The provided 510(k) summary for the "BladeView" device does not describe specific acceptance criteria and a detailed study proving the device meets those criteria in the way typically found for AI/ML-driven devices with quantitative performance metrics.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (CPI RAD VISION K083224 and Pausch HDR Vision K081073) by comparing:
- Intended Use: Showing the BladeView's intended use is substantially similar to or a subset of the predicate devices.
- Technological Characteristics: Highlighting that the core technology (X-ray received by Flat Panel Detector, digital image conversion, processing, storage, and distribution) is the same. Differences noted are primarily about the BladeView not including fluoroscopy capabilities present in one predicate, which is justified as not affecting safety or effectiveness for its intended radiographic use.
There is no mention of a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC) to quantify the device's diagnostic accuracy or improvement over human performance. This type of detailed performance evaluation is more common for novel diagnostic algorithms or AI/ML-driven systems where performance is not inherently similar to existing devices due to a different mechanism of action or analytical principle.
Therefore, many sections of your request cannot be fulfilled from the provided document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). The "performance" assessment is qualitative, relying on comparison to predicate devices, asserting that the BladeView operates on the same technological principles for its intended use.
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. No performance study with a test set is described.
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. No performance study with ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No performance study with adjudication 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. No MRMC study is described. The device is a "Flat Panel Digital Imaging System" and is not described as having "AI assistance" in the sense of an algorithm interpreting images for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The BladeView is a digital X-ray imaging system, not presented as an "algorithm only" device. Its function is to acquire, process, and display images for a qualified operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study is described that would require ground truth.
8. The sample size for the training set:
Not applicable. The document describes a medical device (digital X-ray imager), not an AI/ML algorithm that undergoes a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. See #8.
Summary of Device Equivalence (as presented in the document):
The submission argues for substantial equivalence based on the following:
- Intended Use: The BladeView is a full-featured Radiographic Flat-Panel Digital Imaging System intended to replace conventional film screen systems. It allows qualified operators to perform digital radiographic examinations of various anatomical regions (skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle, extremities) on adult and pediatric patients. It enables image acquisition, processing, display, storage, hardcopy printing, or network transmission. It is explicitly "not intended for mammographic, fluoroscopic and or angiographic applications." This intended use is compared to the predicate devices and differences are explained as either minor phrasing adjustments, or a subset of practices (e.g., BladeView not doing fluoroscopy) which does not affect safety or effectiveness for its specific intended use.
- Technological Characteristics: Both the BladeView and the predicate devices (CPI RAD VISION K083224 and Pausch HDR Vision K081073) use X-rays received by a Flat Panel Detector to create diagnostic images. The detector converts images into a digital format for viewing, processing, local storage, archiving, printing, or sending to DICOM devices. The key difference noted with the Pausch HDR Vision is that BladeView does not perform fluoroscopy and does not use a fluoroscopy-capable Flat Panel Detector, being designed solely for radiographic images. This difference is argued to not affect safety and effectiveness for BladeView's intended purpose.
In conclusion, this 510(k) summary for the "BladeView" device demonstrates substantial equivalence through a direct comparison of intended use and technological characteristics with predicate devices, rather than through a detailed clinical performance study with quantitative acceptance criteria and metrics.
§ 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.