(28 days)
The CareView 1500P 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.
CareView 1500P is a kind of portable wireless digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by backup network port) optionally.
The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.
The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
The provided text describes a 510(k) premarket notification for the CareView 1500P X-ray Flat Panel Detectors. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove meeting acceptance criteria in the context of an AI/algorithm-based device.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this document, as it pertains to an X-ray detector itself, not an AI algorithm.
However, I can extract information related to the device's technical specifications and the comparison made for substantial equivalence.
Here's a summary based on the provided text, indicating when information is not applicable (N/A) or not provided (NP):
1. Table of Acceptance Criteria and Reported Device Performance
The document directly compares the proposed device (CareView 1500P) with its predicate device (CareView 1500Cw) to demonstrate substantial equivalence, rather than listing specific "acceptance criteria" in the sense of performance thresholds for an AI/algorithm. The performance specifications are presented as direct comparisons.
| Item | Acceptance Criteria (Predicate: CareView 1500Cw) | Reported Device Performance (Proposed: CareView 1500P) |
|---|---|---|
| X-ray Absorber | Csl Scintillator | Csl Scintillator |
| Installation Type | Wireless, Portable | Wireless, Portable |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2304 x 2816 pixels | 2304 x 2816 pixels |
| Pixel Pitch | 154μm | 154μm |
| Effective Imaging Area | 355 mm × 434 mm | 355 mm × 434 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | Min. 3.3 line pair/mm | Min. 3.3 line pair/mm |
| Rated Power Supply | DC +24 V, Max.1.5 A; Powered by power box or battery pack | DC +24 V, Max. 4 A; Wired Powered by switching power supply, Wireless Powered by battery pack |
| Power Consumption | Max. 36 W | Max. 96 W |
| Communications | Gigabit Ethernet; IEEE 802.11a/b/g/n (2.4 / 5 GHz) | Wired Gigabit Ethernet; Wireless IEEE 802.11a/b/g/n (2.4 / 5 GHz) |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Dimensions | 384 mm x 460 mm x 15 mm | 470.4 mm × 510.4 mm × 18.2 mm |
| Operation Temperature | +5 ~ +35°C | +5 ~ +35°C |
| Operation Humidity | 30 ~ 75% (Non-Condensing) | 30 ~ 75% (Non-Condensing) |
| Operation Atmospheric Pressure | 70 ~ 106 kPa | 70 ~ 106 kPa |
| Storage/Transport Temperature | -20 ~ +55°C | -20 ~ +55°C |
| Storage/Transport Humidity | 10 ~ 90% (Non-Condensing) | 10 ~ 90% (Non-Condensing) |
| Storage/Transport Atmospheric Pressure | 70 ~ 106 kPa | 70 ~ 106 kPa |
| MTF (@ 1lp/mm) | ~70% | ~70% |
| MTF (@ 2lp/mm) | ~40% | ~40% |
| MTF (@ 3lp/mm) | ~22% | ~22% |
| DQE (@RQA5, 30µGy, 0lp/mm) | ~65% | ~65% |
| DQE (@RQA5, 30µGy, 3lp/mm) | ~20% | ~20% |
| Dynamic range | ~82 dB | ~80 dB |
| Mechanical Structure | 384mm x 460mm x 15mm; built-in foldable handle; carbon fiber plate front cover; multifunctional I/O port | 470.4mm x 18.2mm; integral handle; protective film on carbon fiber plate front cover; power input port and backup network port |
Study Proving Device Meets Acceptance Criteria:
The document states that Electrical safety and EMC testing according to IEC/ES 60601-1 and IEC/EN 60601-1-2 was performed, and "All test results are satisfactory."
For performance, the document relies on a comparison to the predicate device, CareView 1500Cw (K150929). It argues that the proposed device, CareView 1500P, maintains similar technological characteristics and performance (e.g., MTF, DQE, imaging specifications) to the cleared predicate, and that the differences in mechanical structure and power consumption do not raise new questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance: Not applicable (N/A) – this is a hardware device clearance, not an AI algorithm. No clinical test set data is described in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A - no test set involving expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A - no test set 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: N/A - this is a hardware device, not an AI product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A - this is a hardware device, not an AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A - no ground truth in the context of an AI algorithm is mentioned. The ground truth for the device's technical specifications would be engineering measurements and adherence to standards.
8. The sample size for the training set: N/A - no AI training set is described.
9. How the ground truth for the training set was established: N/A - no AI training set is described.
§ 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.