(298 days)
The Galaxy 900 is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Galaxy 900 is not intended for mammography.
The Galaxy 1600 Digital CCD X-Ray Detector 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. The Galaxy 1600 is not intended for mammography.
The Digital Radiography System, Galaxy is an optical based digital x-ray imager. This device should be integrated with an operating PC. The visible light is deflected by a mirror to a high-resolution CCD camera that produces a digital image. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic. The BLADE software acquires X-ray image and viewing the image. Get image from detector, process it to ease the diagnostic, save it in database and manage it.
The provided text is a 510(k) summary for the Medien International Co., Ltd. Digital Radiography System, Galaxy 900 and Galaxy 1600. It details the device's classification, features, and intended use, along with comparisons to predicate devices and declarations of safety and effectiveness. However, it does not contain the specific information required to answer all the questions about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment.
Here's a breakdown of what can be extracted and what information is missing based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list specific acceptance criteria in a quantitative table or directly report performance metrics against such criteria. It states that:
- "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed."
- "EMC testing was conducted in accordance with standard IEC 60601-1-2(2001)."
- "Biocompatibility testing was conducted in accordance with Standard ISO 10993-1."
- "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' was performed."
- "All test results were satisfactory."
The "Product features" section for each device (Galaxy 900 and Galaxy 1600) lists technical specifications, which implicitly serve as performance requirements. Assuming "satisfactory" means these specifications were met, the table can be constructed using these features:
| Acceptance Criteria / Specification | Galaxy 900 Reported Performance | Galaxy 1600 Reported Performance |
|---|---|---|
| Imaging Area | 17" x 17" | 17" x 17" |
| Digitization | 16-bit | 16-bit |
| Operating System | MS Windows XP | MS Windows XP |
| DICOM Compliance | DICOM3.0 | DICOM3.0 |
| Image Format (Pixels) | 3,056 x 3,056 | 4,096 x 4,096 |
| High Resolution Image (lp/mm) | 3.5 lp/mm | 4.6 lp/mm |
| Safety Standards | IEC 60601-1 (Satisfactory) | IEC 60601-1 (Satisfactory) |
| EMC Standards | IEC 60601-1-2 (2001) (Satisfactory) | IEC 60601-1-2 (2001) (Satisfactory) |
| Biocompatibility Standards | ISO 10993-1 (Satisfactory) | ISO 10993-1 (Satisfactory) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "Non-clinical & Clinical considerations" as being performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for test sets.
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
The document makes no mention of an MRMC study or any AI assistance for human readers. This device is a Digital Radiography System, a hardware component for acquiring images, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance testing. The device itself is a digital radiography system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used or how it was established for any clinical or non-clinical considerations.
8. The sample size for the training set
The document does not mention a training set, as the device is a hardware imaging system, not a machine learning algorithm that typically requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned for this hardware 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.