(25 days)
The Care View 1800Le detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
The CareView 1800Le detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode via connecting the power box). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The software that supports the functions of the digital detector CareView 1800Le is unchanged from the predicate. Generally, CareView 1800Le is the same as the cleared product, CareView 1800L except the pixel size. The pixel size of CareView 1800Le is 140 μm, while the CareView 1800L is 154 μm.
The provided text describes a 510(k) summary for the CareView 1800Le X-ray Flat Panel Detectors. This document explicitly states that the device is "substantially equivalent" to a predicate device (CareView 1800L). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require a full safety and effectiveness evaluation as would be needed for a PMA.
Therefore, the study performed to "prove the device meets the acceptance criteria" is a non-clinical study to demonstrate substantial equivalence to a predicate device. There are no acceptance criteria in the sense of specific clinical performance metrics (e.g., sensitivity, specificity for disease detection) because this is a 510(k) for an X-ray detector, not a diagnostic AI algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance
The acceptance criteria are implicitly that the proposed device (CareView 1800Le) performs comparably to the predicate device (CareView 1800L) across key technical specifications, and that any differences do not raise new questions of safety or effectiveness. The reported device performance is a direct comparison of technical specifications.
| Item | Acceptance Criteria (Implicitly, comparable to Predicate) | Reported Device Performance (CareView 1800Le) | Predicate Device Performance (CareView 1800L) |
|---|---|---|---|
| Intended Use | Same as predicate | Digital imaging solution for general radiographic diagnosis of human anatomy; replace film/screen systems; not for mammography. | Digital imaging solution for general radiographic diagnosis of human anatomy; replace film/screen systems; not for mammography. |
| Classification Name | Same as predicate | Stationary X-ray system | Stationary X-ray system |
| Product Code | Same as predicate | MQB | MQB |
| Regulation Number | Same as predicate | 892.1680 | 892.1680 |
| X-ray Absorber | Same as predicate | CsI Scintillator | CsI Scintillator |
| Installation Type | Same as predicate | Wired, Cassette | Wired, Cassette |
| Readout Mechanism | Same as predicate | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | Comparable to predicate | 3072 × 3072 pixels | 2816 × 2816 pixels |
| Pixel Pitch | Different from predicate, but must not raise new safety/effectiveness questions | 140μm | 154μm |
| Effective Imaging Area | Comparable to predicate | 430 mm × 430 mm | 434 mm × 434 mm |
| Grayscale | Same as predicate | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | Equal or better than predicate | 3.57 line pair/mm | 3.3 line pair/mm |
| MTF (@ 1lp/mm) | Comparable to predicate | ≥63% | ~70% |
| MTF (@ 2lp/mm) | Comparable to predicate | ≥35% | ~40% |
| MTF (@ 3lp/mm) | Comparable to predicate | ≥17% | ~22% |
| MTF (@ 3.5lp/mm) | New for proposed device, but demonstrates performance | ≥10% | N/A (predicate only up to 3lp/mm reported) |
| DQE (@RQA5, 30μGy, 0lp/mm) | Comparable to predicate | ≥62% | ~65% |
| DQE (@RQA5, 30μGy, 1lp/mm) | New for proposed device, but demonstrates performance | ≥45% | N/A (predicate only up to 3lp/mm reported) |
| DQE (@RQA5, 30μGy, 3lp/mm) | Comparable to predicate | ≥17% | ~20% |
| DQE (@RQA5, 30μGy, 3.5lp/mm) | New for proposed device, but demonstrates performance | ≥10% | N/A (predicate only up to 3lp/mm reported) |
| Rated Power Supply | Same as predicate | DC +24 V, Max.1 A; Powered by power box using interface cable | DC +24 V, Max.1 A; Powered by power box using interface cable |
| Communications | Same as predicate | Gigabit Ethernet | Gigabit Ethernet |
| Imaging Plate | Same as predicate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Same as predicate | Air cooling | Air cooling |
| Dimensions | Same as predicate | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15 mm |
| Operation/Storage Conditions | Same as predicate | Specified temperature, humidity, atmospheric pressure ranges | Specified temperature, humidity, atmospheric pressure ranges |
| Electrical Safety & EMC | Must meet standards | Testing according to IEC/ES 60601-1 and IEC/EN 60601-1-2 performed with satisfactory results. | Implied similar for predicate device as per regulatory requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing rather than a study with a test set of patient cases. The testing focused on technical specifications (e.g., spatial resolution, MTF, DQE). The sample size for these technical measurements is not specified in the summary, but it would typically involve multiple measurements of the device itself under controlled conditions according to relevant standards. There is no information on data provenance relating to patient data as it's not a clinical study in that sense.
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. This is not an AI diagnostic device that requires expert-established ground truth on medical images. The measurements of performance metrics like MTF and DQE are objective physical measurements of the detector's imaging capabilities, established through standard metrology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a clinical study involving human readers or interpretation of results that would require an adjudication method.
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
No. This is not an AI device that assists human readers. It is an X-ray flat panel detector.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The "standalone" performance here refers to the physical and technical performance of the X-ray detector itself. The summary outlines the technical specifications (e.g., pixel pitch, spatial resolution, MTF, DQE) that characterize the device's standalone imaging capabilities. This is the primary subject of the "Nonclinical and clinical considerations" section, which compares these specifications to the predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of clinical ground truth for disease. The "ground truth" here is the actual physical performance of the device as measured against established engineering and physics standards for X-ray detectors (e.g., line pair patterns for spatial resolution, standardized test objects for MTF/DQE).
8. The sample size for the training set
Not applicable. This device does not employ a machine learning algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.