(70 days)
The Flat Panel Digital X-ray Detector 14HQ701G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp high-definition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray generator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection.
The provided text describes a 510(k) premarket notification for a Flat Panel Digital X-ray Detector (14HQ701G-B) and its substantial equivalence to a predicate device (14HK701G-W). However, the document does not contain the specific details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.
The document discusses:
- Non-Clinical Test Summary: This section lists compliance with electrical safety, EMC, software validation, biocompatibility, performance tests (including IEC 62220-1 for DQE), and cybersecurity.
- Clinical Test Summary: It states, "Clinical data has been provided according to FDA guidance document 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.' The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended."
This phrasing indicates that clinical data was submitted to support the device's functionality, but the core of the substantial equivalence claim relies on non-clinical performance and technological characteristics, not a detailed clinical study with specific acceptance criteria that would typically be associated with AI/CAD devices. The device described is a digital X-ray detector, which is hardware, not an AI or CAD system. Thus, many of the requested points regarding AI/CAD studies (e.g., human readers, effect size of AI assistance, training set details) are not applicable to the information provided.
Therefore,Based on the provided text, the device is a Flat Panel Digital X-ray Detector, not an AI-powered diagnostic tool. As such, many of the requested details regarding acceptance criteria for AI performance and associated studies (e.g., human reader improvement, training sets, ground truth establishment methods typical for AI) are not present in this 510(k) summary.
The document mainly focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance, electrical safety, EMC, software validation, and biocompatibility, as well as general clinical data to show it works as intended.
Here's an attempt to answer the questions based only on the information provided, indicating where information is not available or not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from predicate comparison) | Reported Device Performance (14HQ701G-B) |
|---|---|---|
| Technological Characteristics | ||
| Scintillator | CsI | CsI |
| Imaging Area | 13.7 x 16.8 inches (Predicate) | 14 x 17 inches |
| Pixel Matrix | 2,500 x 3,052 pixels | 2,500 x 3,052 pixels |
| Pixel Pitch | 140 um | 140 um |
| High Contrast Limiting Resolution (LP/mm) | 3.6 lp/mm | 3.6 lp/mm |
| Communication | Wired/Wireless | Wired/Wireless |
| DQE @0.1lp/mm | Typ. 72% (Predicate) | Typ. 66% |
| MTF @0.5lp/mm | Typ. 89% (Predicate) | Typ. 84% |
| Resolution | 3.6lp | 3.6lp |
| Anatomical Sites | General | General |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) |
| Semi Dynamic mode | O (Yes) | O (Yes) |
| Wireless Standard | 802.11 a/b/g/n/ac compliance; 2.4/5 GHz; 20/40/80 MHz B/W; 2x2 MIMO | 802.11 a/b/g/n/ac compliance; 2.4/5 GHz; 20/40/80 MHz B/W; 2x2 MIMO |
| Rating | 24V --- 2.1A | 24V --- 2.1A |
| Non-Clinical Performance | ||
| Electrical Safety | Compliance with ES60601-1 | Complied |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complied |
| Software Validation | Designed/developed per software development process; verified/validated (MODERATE level of concern) | Verified and Validated |
| Biocompatibility | Compliance with ISO 10993-1 and series | Complied |
| Imaging Performance | Compliance with IEC 62220-1 (DQE) | Complied |
| Cybersecurity | Compliance with FDA guidances | Complied |
Note on Differences: The document explicitly states: "There is minor difference in the 'Imaging Area', 'DQE', and 'MTF'. The minor differences between the subject and predicate device do not affect a decision of substantial equivalence."
2. Sample size used for the test set and the data provenance
The document mentions "clinical data has been provided," but it does not specify the sample size for this clinical data or its provenance (e.g., country of origin, retrospective/prospective). It also states this data "was not necessary to establish substantial equivalence" for the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The document does not describe a ground truth establishment process involving experts in detail, nor does it specify the number or qualifications of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No adjudication method is 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
Not applicable. The device is a digital X-ray detector, not an AI or CAD system designed to assist human readers. Therefore, an MRMC study comparing human readers with/without AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a hardware component (X-ray detector), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in detail for clinical data. For the "Imaging performance test," compliance with IEC 62220-1 (determination of DQE) implies a technical, quantitative assessment rather than a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. The device is a hardware X-ray detector, not a machine learning model that requires a training set of images.
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.