(63 days)
The Venul 748V flat panel detector is provided as an imaging component to the system manufacturer. It is mainly used in long bones, spine and other inspection fields. After collecting static imaged data is output to the processing equipment.
This device is suitable for providing radiography imaging for adult via DR system. The remaining notes depend on the final DR system.
It is not intended for mammography, dental applications, neonatal and fluoroscopy.
Digital flat panel detector is a cassette-size wired X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It was developed to provide X -Ray image, which contains an active matrix of 3064×8696 with 139um pixel pitch. Detector's scintillator is CsI(Cesium iodide). The biggest feature of Venu1748V is that it supports imaging of large-scale objects, including long bones and complete spine detection.
This document is a 510(k) Pre-Market Notification from iRay Technology Taicang Ltd. to the FDA for their Digital Flat Panel Detector, model Venu1748V. It outlines the device's technical characteristics and compares them to a predicate device.
Analysis of Acceptance Criteria and Study Details:
The provided document does not describe a clinical study or a multi-reader, multi-case (MRMC) study to prove the device meets acceptance criteria. Instead, it relies on non-clinical studies (bench testing) to demonstrate substantial equivalence to a predicate device. This is a common approach for imaging components like flat panel detectors where the primary concern is the technical performance of the imaging hardware itself, rather than diagnostic accuracy involving human interpretation when coupled with a full DR system.
Therefore, many of the requested points regarding clinical study design, expert involvement, and human reader performance are not applicable to this submission.
Here's a breakdown based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate table with pass/fail thresholds. Instead, it presents a comparison of key technical specifications between the proposed device (Venu1748V) and the predicate device (VIVIX-S 1751S). The implication is that meeting or exceeding the performance of the predicate device for these parameters constitutes "acceptance."
| Item | Predicate Device: VIVIX-S 1751S | Proposed Device: Digital flat panel detector Venu1748V | Implied Acceptance (Relative to Predicate) | Reported Device Performance (Venu1748V) |
|---|---|---|---|---|
| Model Name | VIVIX-S 1751S | Venu1748V | N/A (Identification) | Venu1748V |
| 510(K) Number | K190611 | To be assigned | N/A (Identification) | To be assigned |
| Classification Name | Stationary X-Ray System | Same | Same | Same |
| Product Code | MQB | Same | Same | Same |
| Regulation Number | 21 CFR 892.1680 | Same | Same | Same |
| Panel | Radiology | Same | Same | Same |
| Classification: | II | Same | Same | II |
| X-Ray Absorber (Scintillator): | Gd2O2S:Tb (Gadolinium oxysulfide) | CsI | Different but acceptable | CsI |
| Installation Type: | Portable | Same | Same | Portable |
| Detector structure: | Amorphous silicon TFT | Same | Same | Amorphous silicon TFT |
| Dimensions: | 1357.0mm × 532.0mm × 30.0mm | 1271.4mm × 586.6mm × 20.8mm | Comparable/Improved Size | 1271.4mm × 586.6mm × 20.8mm |
| Max. Image Matrix Size: | 3072 × 9216 pixels | 3064 × 8696 pixels | Comparable | 3064 × 8696 pixels |
| Pixel Pitch: | 140μm | 139μm | Comparable/Improved Resolution | 139μm |
| Max. Effective Imaging Area (H×V): | 430.08mm × 1290.24mm | 425.8mm × 1208.7mm | Comparable | 425.8mm × 1208.7mm |
| Spatial resolution | 3.5 lp/mm | 3.4 lp/mm | Comparable | 3.4 lp/mm |
| Greyscales | 16 bit | Same | Same | 16 bit |
| Modulation Transfer Function (MTF) | 40% at 1.0 lp/mm | 56% at 1.0 lp/mm | Superior | 56% at 1.0 lp/mm |
| Detective Quantum Efficiency (DQE) | 20% at 1.0 lp/mm | 24% at 1.0 lp/mm | Superior | 24% at 1.0 lp/mm |
| Power Consumption: | Max. 72 W | Max. 50 W | Superior (Lower) | Max. 50 W |
| Communications: | Wired LAN | Same | Same | Wired LAN |
| Cooling: | Air cooling | Same | Same | Air cooling |
| Protection against Matter/Water | IPX0 | Same | Same | IPX0 |
| Operation Temperature: | 10 to 35°C | 5 to 35°C | Comparable/Improved Range | 5 to 35°C |
| Operation Humidity: | 30 to 85% (Non-Condensing) | 10 to 90% (Non-Condensing) | Comparable/Improved Range | 10 to 90% (Non-Condensing) |
| Operation Atmospheric pressure: | 70 to 106 kPa | Same | Same | 70 to 106 kPa |
| Operation Altitude: | Max. 3000 meters | Same | Same | Max. 3000 meters |
| Storage and Transportation Temperature: | -15 to 55°C | -20 °C ~ 55 °C | Comparable/Improved Range | -20 °C ~ 55 °C |
| Storage and Transportation Humidity: | 10 to 90% (Non-Condensing) | 5% ~ 95% (Non-Condensing) | Comparable/Improved Range | 5% ~ 95% (Non-Condensing) |
| Storage and Transportation Atmosphere: | 50 ~ 106 kPa | 70kPa~106kPa | Comparable | 70kPa~106kPa |
| Storage and Transportation Altitude: | Max. 3000 meters | Same | Same | Max. 3000 meters |
| Software | VXvue | iDetector | Different but acceptable | iDetector |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The "test set" here refers to the non-clinical bench testing of the detector's physical performance characteristics. These tests are typically performed on a limited number of manufactured units (e.g., a few samples per batch) to ensure they meet specifications. The document does not specify the exact number of units tested for each parameter.
- Data Provenance: The company is iRay Technology Taicang Ltd., located in Taicang, Jiangsu, CHINA. The testing was performed internally or by a contracted lab. The data is retrospective in the sense that it was collected as part of the device's development and verification, prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For non-clinical tests of a flat panel detector, "ground truth" is established by physical measurement standards and calibrated equipment, not by human expert consensus or clinical diagnosis. For example, MTF is measured using a phantom and analytical methods, not by radiologists.
4. Adjudication Method for the Test Set:
Not applicable. Since no human experts are establishing ground truth for diagnostic decisions, there's no need for adjudication.
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. The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles." This device is a hardware component (a flat panel detector), not an AI algorithm assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a hardware component. There is no "algorithm only" performance in the sense of an AI diagnostic tool. The detector captures raw image data.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests consists of:
- Physical standards/measurements: For parameters like dimensions, pixel pitch, greyscales, power consumption, temperature/humidity ranges.
- Engineering metrics: For performance characteristics like MTF, DQE, spatial resolution, signal-to-noise ratio, uniformity, defect, minimum triggering dose rate, and low contrast resolution. These are established through standardized testing procedures using phantoms and calibrated instruments.
- Compliance with standards: Electrical safety (IEC/ES 60601-1, IEC60601-2-54) and EMC testing (IEC 60601-1-2) ensure the device meets predefined safety and electromagnetic compatibility benchmarks.
- Software verification: The software "iDetector" hazards, requirements specification, and design specification were tested against the intended design specification.
8. The Sample Size for the Training Set:
Not applicable. This is a hardware device. "Training set" typically refers to data used to train AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for an AI/ML model for this hardware 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.