(122 days)
The Flat Panel Digital X-ray Detector 17HK700G-W 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.
The 17HK700G-W is the solid state x-ray imager, which can generate radiographic images of any part of the body. These devices intercept x-ray photons and the scintillator (CsI:TI) emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images are displayed on monitors. The digital value can be communicated to the operator console via wiring connection.
The 17HK700G-W consists of the following components: Flat Panel Detector, Control Box, Calibration Software and power cord and cables. The 17HK700G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
The provided text describes a 510(k) premarket notification for a Flat Panel Digital X-ray Detector (17HK700G-W) and its substantial equivalence to a predicate device (S4343-W of GC85A). However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Specifically, the document primarily focuses on demonstrating substantial equivalence to an existing predicate device rather than outright proving performance against specific acceptance criteria for a novel AI/Algorithm-driven diagnostic device.
Here's what can be extracted and what information is missing:
Missing Information (Crucial for a typical AI/Algorithm device study):
- A formal table of acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device's intended use.
- Detailed results of a clinical study demonstrating the device's diagnostic performance against these acceptance criteria. The document states "Clinical data has been provided... but provided further evidence in addition to the laboratory performance data to show that the device works as intended," which suggests a supportive rather than a primary diagnostic efficacy study.
- Sample size used for a test set in a diagnostic performance study.
- Provenance of clinical data (country, retrospective/prospective).
- Number of experts, their qualifications, and adjudication methods for establishing ground truth for a diagnostic test set.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, the effect size.
- Information on a standalone (algorithm only) performance study against diagnostic ground truth.
- The type of ground truth used for diagnostic performance (e.g., pathology, outcomes data).
- Sample size for the training set and how its ground truth was established.
Information Extracted from the Document (related to device performance and testing, but not a full diagnostic study):
1. Table of Acceptance Criteria (as reported or inferred from performance tests):
The document presents technical performance characteristics and non-clinical test summaries rather than diagnostic acceptance criteria. The device is a digital X-ray detector, and its performance is compared to a predicate device based on imaging quality metrics.
| Criteria Category | Specific Metric | Predicate Device Performance | Proposed Device Performance | Acceptance Criteria (Implicit for Substantial Equivalence) |
|---|---|---|---|---|
| Technical Performance | High Contrast Limiting Resolution (LP/mm) | 3.57 | 3.6 | Comparable to predicate (demonstrated as similar or better) |
| DQE @0.1lp/mm | Typ. 73% | Typ. 72% | Comparable to predicate (demonstrated as similar or better) | |
| MTF @0.5lp/mm | Typ. 84% | Typ. 89% | Comparable to predicate (demonstrated as similar or better) | |
| Resolution | 3.57lp | 3.6lp | Comparable to predicate (demonstrated as similar or better) | |
| Safety & Compatibility | Electrical Safety Standard (AAMI ES60601-1) | N/A | Compliant | Compliance Required (Demonstrated) |
| Electromagnetic Compatibility (IEC 60601-1-2) | N/A | Compliant | Compliance Required (Demonstrated) | |
| Software Validation | Software Level of Concern: MODERATE | N/A | Validated | Compliance with FDA guidance (Demonstrated) |
| Imaging Performance | According to IEC 62220-1 (Detective Quantum Efficiency - DQE) | N/A | Conducted | Conducted and results support substantial equivalence |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated for a diagnostic efficacy test. The "clinical data" mentioned is described as "further evidence" rather than a primary diagnostic study with a defined test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable/mentioned in the context of a diagnostic performance study. The ground truth for this device's validation primarily relies on physics-based imaging performance metrics and engineering standards adherence, as well as comparison to a predicate device.
4. Adjudication Method:
- Not applicable/mentioned for a diagnostic performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not performed based on the provided text. This is a detector, not an AI-driven image interpretation algorithm that assists human readers.
6. Standalone Performance (Algorithm Only):
- Not applicable in the typical sense of an AI algorithm. The device itself (the detector) is the "standalone" component being evaluated for its image acquisition performance, which is measured through metrics like DQE, MTF, and resolution.
7. Type of Ground Truth Used:
- For the non-clinical performance tests, the "ground truth" refers to established physical standards and measurement techniques for X-ray detector performance (e.g., IEC 62220-1 for DQE).
- For the "clinical data" mentioned, the specific type of ground truth is not detailed, but it's presented as supportive evidence for the device working as intended, not as a primary diagnostic accuracy study against a clinical ground truth (like pathology or clinical outcomes).
8. Sample Size for the Training Set:
- Not applicable/mentioned. This document is about a hardware device (X-ray detector), not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable.
Summary based on the document:
This 510(k) submission for the LG 17HK700G-W Flat Panel Digital X-ray Detector is primarily focused on demonstrating substantial equivalence to an existing predicate device (Samsung S4343-W). The "acceptance criteria" can be inferred as successfully demonstrating that the new device's technical specifications and safety/performance (via non-clinical tests and supportive clinical data) are comparable to or better than the predicate, and that it meets general regulatory standards for X-ray equipment. The document does not describe a clinical diagnostic performance study with specific diagnostic outcomes or reader studies often seen for AI/Algorithm-based devices.
§ 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.