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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:

1. User Login
2. Display Connectivity status of hardware devices like detector
3. Patient entry (Manual, Emergency and Worklist)
4. Exam entry
5. Image processing
6. Search patient Data
7. Print DICOM Image
8. 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.

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.

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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/screen or CR system is used

Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.

Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is 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 nongrid 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 (Csl) or gadolinium oxy sulfide (GOS).

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 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:

• 1. User Login
• 2. Display Connectivity status of hardware devices like detector
• 3. Patient entry (Manual, Emergency and Worklist)
• 4. Exam entry
• 5. Image processing
• 6. Search patient Data
• 7. Print DICOM Image
• 8. Exit

The provided text outlines the performance data for the "Wireless/Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR." However, it does not specifically present a table of acceptance criteria and reported device performance in a quantitative manner (e.g., sensitivity, specificity, accuracy). Instead, it primarily focuses on compliance with recognized standards and guidance documents, emphasizing non-clinical tests.

Here's an analysis of the information provided, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria (e.g., specific metrics like DQE values, spatial resolution, or SNR targets) with corresponding reported device performance values. Instead, it states that the device "confirms to the voluntary standards" and that "the image quality evaluation confirmed that the image quality of the Wireless/ Wired X-Ray Flat Panel Detectors is substantially equivalent to that of the predicate device."

The acceptance criteria are implicitly tied to the successful demonstration of compliance with a long list of international and FDA-recognized consensus standards and guidance documents. The reported performance is that the device "Met all requirements" for each of these standards.

Implicit Acceptance Criteria and Reported Performance (based on document content):

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 primarily describes non-clinical performance data (bench testing). There is no mention of a specific "test set" with a sample size of patient data. The provenance of testing (e.g., country of origin, retrospective/prospective) for these non-clinical tests is not detailed, beyond being conducted by Allengers Medical Systems Limited and likely by accredited testing labs for compliance with international standards.

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)

This information is not applicable or not provided since no clinical study with a "test set" requiring expert ground truth establishment for diagnostic performance is described. The evaluation focuses on engineering and regulatory compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or not provided as there was no clinical test set requiring expert 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 MRMC comparative effectiveness study was done or reported. The document explicitly states: "Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies." Furthermore, this device is an X-ray flat panel detector and associated acquisition software, not an AI-powered diagnostic algorithm designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the context of an X-ray detector. The device itself is a component for acquiring images. Its "standalone performance" is assessed through engineering metrics and compliance with imaging standards (e.g., DQE, MTF, noise characteristics), which are part of the non-clinical testing. It's not an "algorithm" in the sense of a standalone diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is typically defined by the technical specifications of the standards and test methodologies themselves. For example:

• For IEC 62220-1-1 (DQE), the ground truth is the physical properties of the detector under specific X-ray conditions, measured according to the standard's protocol.
• For biocompatibility (ISO 10993), the ground truth is the absence of adverse biological reactions as determined by standardized in vitro and in vivo tests.
• For safety (IEC 60601-1), the ground truth is meeting the safety limits and design requirements outlined in the standard.

There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) as no clinical studies were performed.

8. The sample size for the training set

Not applicable. This device is a hardware component (X-ray detector) and its associated acquisition software. It is not described as involving a machine learning algorithm that requires a "training set" of data for diagnostic purposes. The software mentioned ([AWS] Synergy DR FDX/ Synergy DR) is for image acquisition, processing, display, and storage, not for AI-driven detection or diagnosis.

9. How the ground truth for the training set was established

Not applicable for the reasons stated in point 8.

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