(135 days)
Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR is used to acquire/Process/Display/Store/Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screener CR system is used.
Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.
The Wireless/ Wired X-Ray Flat Panel Detectors are designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water. This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (CsI). The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.
Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR", runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:
- User Login
- Display Connectivity status of hardware devices like detector
- Patient entry (Manual, Emergency and Worklist)
- Exam entry
- Image processing
- Search patient Data
- Print DICOM Image
- Exit
This document describes the 510(k) clearance for Allengers Wireless/Wired X-Ray Flat Panel Detectors (K243734). The core of the submission revolves around demonstrating substantial equivalence to a predicate device (K223009) and several reference devices (K201528, K210988, K220510). The key modification in the subject device compared to the predicate is an increased scintillator thickness from 400µm to 600µm, which consequently impacts the Modulating Transfer Function (MTF) and Detective Quantum Efficiency (DQE) of the device.
Based on the provided text, the 510(k) relies on non-clinical performance data (bench testing and adherence to voluntary standards) to demonstrate substantial equivalence, rather than extensive clinical studies involving human subjects or AI-assisted human reading.
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 defined by the comparison to the predicate device's performance, particularly for image quality metrics (MTF and DQE). The goal is to demonstrate that despite changes, the device maintains diagnostic image quality and does not raise new safety or effectiveness concerns.
| Metric (Units) | Acceptance Criteria (Implicit - Maintain Diagnostic Image Quality | Reported Device Performance (Subject Device) | Comments/Relation to Predicate |
|---|---|---|---|
| DQE @ 0.5 lp/mm (Max.) | $\ge$ Predicate: 0.78 (for Glass) / 0.79 (for Non-Glass) | 0.85 (for G4343RC, G4343RWC, G4336RWC - Glass) | |
| 0.79 (for T4336RWC - Non-Glass) | Meets/Exceeds predicate values. Improves for Glass substrate models. Matches for Non-Glass substrate model. | ||
| DQE @ 1 lp/mm (Max.) | $\ge$ Predicate: 0.55 (for Glass) / 0.58 (for Non-Glass) | 0.69 (for G4343RWC, G4336RWC, G4343RC - Glass) | |
| 0.58 (for T4336RWC - Non-Glass) | Meets/Exceeds predicate values. Improves for Glass substrate models. Matches for Non-Glass substrate model. | ||
| DQE @ 2 lp/mm (Max.) | $\ge$ Predicate: 0.47 (for Glass) / 0.49 (for Non-Glass) | 0.54 (for G4343RC, G4343RWC, G4336RWC - Glass) | |
| 0.49 (for T4336RWC - Non-Glass) | Meets/Exceeds predicate values. Improves for Glass substrate models. Matches for Non-Glass substrate model. | ||
| MTF @ 0.5 lp/mm (Max.) | $\sim$ Predicate: 0.90 (for Glass) / 0.85 (for Non-Glass) | 0.95 (for G4343RC, G4343RWC, G4336RWC - Glass) | |
| 0.90 (for T4336RWC - Non-Glass) | Meets/Exceeds predicate values. Improves for Glass substrate models. Improves for Non-Glass substrate model. | ||
| MTF @ 1 lp/mm (Max.) | $\sim$ Predicate: 0.76 (for Glass) / 0.69 (for Non-Glass) | 0.70 (for G4343RWC, G4336RWC, G4343RC - Glass) | |
| 0.69 (for T4336RWC - Non-Glass) | Slightly lower for Glass substrate models (0.70 vs 0.76). Matches for Non-Glass substrate model. The submission claims this does not lead to "clinically significant degradation of details or edges." | ||
| MTF @ 2 lp/mm (Max.) | $\sim$ Predicate: 0.47 (for Glass) / 0.42 (for Non-Glass) | 0.41 (for G4343RC, G4343RWC, G4336RWC - Glass) | |
| 0.42 (for T4336RWC - Non-Glass) | Slightly lower for Glass substrate models (0.41 vs 0.47). Matches for Non-Glass substrate model. The submission claims this does not lead to "clinically significant degradation of details or edges." | ||
| Thickness of Scintillator | Not an acceptance criterion in itself, but a design change. | 600 µm | Increased from predicate (400 µm). |
| Sensitivity (Typ.) | $\sim$ Predicate: 574 LSB/uGy | 715 LSB/uGy | Increased from predicate. |
| Max. Resolution | 3.57 lp/mm (Matches predicate) | 3.57 lp/mm | Matches predicate. |
| General Safety and Effectiveness | No new safety and effectiveness issues raised compared to predicate. | Verified by adherence to voluntary standards and risk analysis. | Claimed to be met. The increased scintillator thickness is "deemed acceptable" and experimental results confirm "superior noise performance and smoother image quality compared to the 400μm CsI, without clinically significant degradation of details or edges." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the submission relies on "Non-clinical Performance Data" and "Bench testing". There is no mention of a clinical test set involving human subjects or patient imaging data with a specified sample size. The data provenance would be laboratory bench testing results. The country of origin of the data is not explicitly stated beyond the company being in India, but it's performance data, not patient data. The testing is described as functional testing to evaluate the impact of different scintillator thicknesses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the clearance is based on non-clinical, bench testing data (physical performance characteristics like MTF and DQE) rather than clinical image interpretation or diagnostic performance that would require human expert ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a human-read test set or ground truth adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not mention an MRMC study or any study involving human readers, with or without AI assistance. The device is an X-ray detector, not an AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
Not applicable in the context of an AI algorithm, as this device is an X-ray detector and associated acquisition software. However, the "standalone" performance of the detector itself (MTF, DQE, sensitivity) was assessed through bench testing and measurements, which can be considered its "standalone" performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims (MTF, DQE, sensitivity) is based on physical phantom measurements and engineering specifications obtained through controlled bench testing following recognized industry standards (e.g., IEC 62220-1-1). It is not based on expert consensus, pathology, or outcomes data from patient studies.
8. The Sample Size for the Training Set
Not applicable. This submission is for an X-ray flat panel detector, not an AI/ML model that would require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As stated above, this device does not involve an AI/ML model with a training set.
§ 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.