(175 days)
Xmaru1210P Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Xmaru1210P is a portable digital X-ray flat panel detector which consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. Xmaru1210P is designed specifically to be integrated with an operating PC and a Xray generator to digitalize x-ray images into DICOM compatible image files for the purpose of diagnostic analysis.
The provided text describes the Xmaru1210P Digital Flat Panel X-ray Detector and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and the study proving adherence to them, especially regarding clinical study specifics like sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document describes the device performance primarily in comparison to its predicate device, the Canon CXDI-50G, rather than against explicit, pre-defined acceptance criteria with specific thresholds. The "acceptance criteria" appear to be implicit in demonstrating performance superior or equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Xmaru1210P) |
|---|---|
| Image Quality (MTF) | Better performance than Canon CXDI-50G |
| Image Quality (DQE) | Better performance than Canon CXDI-50G |
| Resolution | Better than Canon CXDI-50G |
| Exposure Sensitivity | Higher than Canon CXDI-50G |
| Image Quality (Overall) | Better than Canon CXDI-50G |
| Safety (Electrical) | Satisfactory (according to IEC 60601-1, IEC 60601-1-1) |
| Safety (Mechanical) | Satisfactory (according to IEC 60601-1, IEC 60601-1-1) |
| Safety (Environmental) | Satisfactory (according to IEC 60601-1, IEC 60601-1-1) |
| EMC | Satisfactory (according to IEC 60601-1-2) |
Study Details
The document mentions "SSXI non-clinical report" and "SSXI Non-clinical and clinical report" as evidence of performance. However, it lacks most of the specific details requested for a clinical study.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is based in Korea (Vatech Co., Ltd.).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention the involvement of experts for establishing ground truth in a clinical study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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:
- Not specified. The device is a digital X-ray detector, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The study focuses on evaluating the imaging capabilities of the detector itself.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "non-clinical" and "clinical" reports mentioned would inherently evaluate the device's imaging performance in a standalone capacity (i.e., how well it produces images) without human interpretation as part of the primary performance metric, though human evaluation of the image quality would be implicit. No "algorithm only" performance is mentioned as this is a hardware device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of a digital X-ray detector (producing images for diagnostic analysis rather than an automated diagnosis), the "ground truth" in a clinical evaluation would likely relate to the diagnostic utility of the images produced, potentially via radiologist interpretation or comparison to other imaging modalities or clinical outcomes, but this is not detailed.
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The sample size for the training set:
- Not applicable as this is a hardware device (digital X-ray detector), not a machine learning algorithm that requires a "training set" in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary, the provided text highlights that the Xmaru1210P detector demonstrated better performance in technical specifications (MTF, DQE, resolution, exposure sensitivity) compared to its predicate device, based on non-clinical and clinical reports. However, it significantly lacks the granular details about the clinical study methodology, sample sizes, and expert involvement that would be expected for a detailed description of acceptance criteria proof.
§ 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.