(29 days)
The GMR40 Digital X-ray Imaging System is intended for use with portable radiographic applications wherever conventional screen-film systems or computed radiography (CR) may be used. This device is not intended for mammographic applications.
GMR40 DR Upgrade System (GMR40) integrates a traditional analog portable X-ray system with the speed and image quality benefits of digital capture technology to produce high quality images. The GMR40 can transition a portable system like GE AMX 4 / 4+ into a portable DR solution, improving the workflow of any cassette-based exam. This is a retrofit system consisting of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB (Control Interface Box), Workstation and Main cable. This retrofit system is designed to generate a digital image while using the current analogue Xray system by upgrading only the part of an analogue cassette film to the digital panel (detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the GMR40 device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed study report. Therefore, much of the information typically found in an independent study (like specific sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC studies) is either not present or is inferred based on the comparison to the predicate device. The document explicitly states that the image quality of the GMR40 is considered the same as the predicate (GR40CW) because the key image acquisition components and software are identical.
Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the traditional sense of numerical thresholds for a new clinical study. Instead, the "acceptance criteria" for this 510(k) revolve around demonstrating that the GMR40 system, despite modifications as a retrofit kit, maintains the same performance as its predicate device (GR40CW) while meeting relevant safety and regulatory standards.
The primary performance metric is the assertion of identical image quality and functional equivalence for its intended use.
Here's a table based on the provided comparison:
| Acceptance Criteria (Inferred from Equivalence Claim) | Reported Device Performance (GMR40) |
|---|---|
| Image Quality: Identical to predicate device (GR40CW) | "Image quality of the GMR40 is the same in comparison to the predicate device GR40CW (K153401) since the major image acquisition components such as the detector panel and the imaging software are identical to GR40CW." |
| Detector Type: Csl | Csl |
| Detector Area: 14" x 17" (345mm x 425mm) | 14" x 17" (345mm x 425mm) |
| Pixel Pitch: 140 µm | 140 µm |
| High Contrast Limiting Resolution: 3.5 lp/mm | 3.5 lp/mm |
| CIB Max. Signal Input Voltage: 400V DC/AC | 400V DC/AC |
| Software Functionality: As designed, no new safety concerns | "The performance of the S-Station (Operational Software) and the power management system software have been validated as well and do not raise any new safety or effectiveness concerns." |
| Power Management System: Intelligent charging, reconditioning, state of charge monitoring, DC power control, EN 60601 certified. | The hybrid controller is a medical grade system with these features, designed, manufactured, and certified to EN 60601. |
| Battery Functionality: Withstand overcharge, overdischarge, vibration, shock. | Sealed lead acid batteries, UL recognized, designed to withstand these conditions. |
| Wireless Functionality: Tested and verified | "Wireless function was tested and verified following the FDA Guidance for Radio frequency Wireless Technology in Medical Devices." |
| Compliance with Standards: ES 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485, 21 CFR Subchapter J 1020.30 and 1020.31. | All test results were compliant with the standards. |
Study Information
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Size: Not explicitly stated as a separate "test set" for a clinical study. The device was "installed and tested on GE AMX 4 & 4+ models." This suggests testing on physical units. No information on the number of images or patients.
- Data Provenance: Not specified. The verification and validation activities were internal to NeuroLogica Corporation. It's implied to be laboratory/engineering testing rather than clinical data from a specific country or patient population.
- Retrospective or Prospective: Primarily engineering verification and validation. Not a clinical retrospective or prospective study as typically understood for clinical efficacy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Given the nature of the submission (substantial equivalence based on physical and software component identity), expert evaluation of ground truth for a clinical dataset would not be the primary focus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not mentioned. This type of clinical adjudication is not relevant to the engineering and comparative performance testing described.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an X-ray imaging system retrofit kit, not an AI-powered diagnostic tool for interpretation assistance. The focus is on the hardware's image acquisition and processing capabilities.
- Effect Size: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The core components (detector panel and imaging software) are stated to be "identical to the predicate device GR40CW." Nonclinical testing data for these components (MTF, DQE) was provided in conformance to FDA guidance. While not a "standalone algorithm" in the AI sense, the imaging performance itself (what the device produces) is evaluated independently of human interpretation in terms of technical metrics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the technical performance aspects (MTF, DQE), the "ground truth" would be the physical measurements and established scientific standards for X-ray imaging device performance. For functional aspects (battery life, connectivity), the ground truth is the expected operational specifications. There is no mention of clinical ground truth (like pathology or outcomes) for a test set, as this is a device modification submission, not a demonstration of a new diagnostic capability.
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The sample size for the training set:
- Training Set Size: Not applicable. This is a hardware/software system retrofit, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for the software would be its development and testing against specifications, not data-driven machine learning.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of machine learning. The software (S-Station and power management) was "validated" against its design specifications and intended functionality.
§ 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.