(73 days)
The DDR Digital X-Ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The DDR MAK-800 is the digital panel available alone for upgrading current systems. The DDR MAK-1000 FS is a complete system with a straight tube stand/detector combination. The DDR MAK-1100FA is a complete system with a "C-arm" shaped tube stand/detector combination which permits lateral positioning. These systems have been designed as a direct digital imaging system for use in hospital emergency rooms, imaging centers and all general radiology applications. The C-arm design maintains constant alignment between the x-ray tube and image receptor, regardless of C-arm tilt positions or image receptor angle. Its extraordinary flexibility makes the system ideal for all patients in standing, sitting or laying position, including those who are disabled or physically restricted. The DDR MAK-1100 digital flat panel detector provides advanced technology to capture radiographic images in a digital format almost instantly. The nearly 17 x 17 inch imaging area allows for the capture of chest and abdominal images without having to rotate the detector unit.
The provided text describes a 510(k) submission for a new X-ray system (DDR MAK-800, MAK-1000 FS, and MAK-1100 FA) that combines two previously cleared devices. The submission asserts "substantial equivalence" to predicate devices, focusing on the system's technical specifications and intended use rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a clinical or analytical performance study.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not explicitly addressed or applicable in the provided document, as the FDA cleared the device based on substantial equivalence, which primarily relies on technical comparison to predicate devices, and bench, user, and standards testing.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as quantitative thresholds for performance metrics. Instead, the acceptance criterion for the submission appears to be demonstrating substantial equivalence to predicate devices in terms of technical characteristics and safety/effectiveness. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate devices.
| Characteristic | Predicate Devices (K042876 & K062335) | DDR MAK-800/1000 FS/1100 FA (This Submission) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit | SAME | Same intended use as predicate devices | General purpose diagnostic X-ray unit for skull, spine, chest, abdomen, extremities, and other body parts; adult and pediatric. |
| Image Acquisition | Digital (CANON CXDI-50G, K031447) OR Film | Digital (DRTech Portable Digital Radiographic Detector, K080064) | Digital acquisition equivalent to or better than predicate | Digital acquisition using DRTech Portable Digital Radiographic Detector K080064. |
| Digital Panel Size | Up to 14" x 17" active area (for digital predicate) | 17" x 17" or 14" x 17" | Panel size comparable or larger than predicate | Larger option (17"x17") available, allowing capture of chest and abdominal images without rotating. |
| Digital Resolution | 160 x 160 microns pixel pitch, with approximately 6 million pixels (for digital predicate) | 139 x 139 OR 160 x 160 micron pixel pitch, either 6.8 or 7.8 million pixels. | Resolution comparable or better than predicate | Improved resolution (139x139 micron pixel pitch) and higher pixel count (6.8 or 7.8 million pixels) available. |
| Safety & Effectiveness | As safe and effective as other marketed devices | As safe and effective as predicate devices (based on bench, user, and standards testing) | Demonstrates equivalent safety and effectiveness to predicate | Bench, user, and standards testing indicates the new device is as safe and effective as predicate devices. |
| Technological Differences | None or minor, not raising new safety/effectiveness questions | Few technological differences, no new indications for use | No significant technological differences that raise new safety/effectiveness questions | System combines two cleared devices (K062335 and K080064), resulting in functionally identical performance to K042876. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a performance study with a defined sample size for image analysis or clinical outcomes. The evaluation was based on bench, user, and standards testing, which typically involves testing the physical device, its components, and its adherence to relevant technical standards (e.g., electrical safety, radiation output). Details on the number of units tested, the specific tests performed, or the number of "users" in user testing are not provided.
The data provenance is not specified in terms of country of origin or retrospective/prospective nature, as it's not a clinical study yielding patient data. It's focused on engineering and regulatory compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The evaluation was not based on expert-adjudicated ground truth image sets for diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and not provided, as there was no test set requiring expert adjudication for ground truth.
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
An MRMC comparative effectiveness study was not done. This device is a general-purpose diagnostic X-ray unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an X-ray imaging system, not an AI algorithm. Its performance is tied to image acquisition, not interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic algorithm evaluation is not applicable here. The ground truth for this submission was the demonstration of the device's technical specifications, safety, and effectiveness through engineering tests and comparison to already-cleared predicate devices and applicable industry standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a hardware system, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set.
Summary of the Study and Conclusion:
The "study" in this context refers to the comprehensive evaluation performed by Medicatech USA to demonstrate substantial equivalence for the 510(k) submission. This evaluation included:
- Bench Testing: Engineering tests to verify technical specifications, safety, and performance of the hardware components.
- User Testing: Likely to ensure the system's usability and interface design met expectations for operators.
- Standards Testing: Verification that the device complies with relevant medical device standards (e.g., electrical safety, radiation emission).
- Comparison to Predicate Devices: A detailed comparison of the new device's technical characteristics (intended use, user interface, maximum output, image acquisition method, digital panel size, digital resolution, method of control, collimator) against two existing legally marketed devices (SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 and a version of the DRtech Digital Panel, K080064, which combined functionally result in a device equivalent to Sedecal URS LP X-Ray Units with Digital Detector, K.042876).
The conclusion of this "study" was that the DDR MAK-800/1000 FS/1100 FA Radiographic Systems with Digital Detectors are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent. The FDA concurred with this assessment.
§ 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.