(174 days)
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
The Aquarius 8600 1717TG and Aquarius 8600 1417TG are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Aquarius 8600 1417TG & 1717TG) | Predicate Device Performance (Aquarius 8600 1717TC) | Notes |
|---|---|---|---|
| Detective Quantum Efficiency (DQE) (0) | 0.446 | 0.684 | The proposed devices show slightly reduced DQE performance at all spatial frequencies compared to the predicate, with the difference increasing with spatial frequency. This is attributed to the change in scintillator. |
| Modulation Transfer Function (MTF) at 1 lp/mm | 0.596 (1417TG), 0.585 (1717TG) | 0.502 | The proposed devices show similar but slightly improved MTF response compared to the predicate device. |
| Modulation Transfer Function (MTF) at 2 lp/mm | 0.290 (1417TG), 0.283 (1717TG) | 0.230 | The proposed devices show similar but slightly improved MTF response compared to the predicate device. |
| Modulation Transfer Function (MTF) at 3 lp/mm | 0.142 (1417TG), 0.144 (1717TG) | 0.104 | The proposed devices show similar but slightly improved MTF response compared to the predicate device. |
| Modulation Transfer Function (MTF) at 3.5 lp/mm | 0.095 (1417TG), 0.103 (1717TG) | 0.083 | The proposed devices show similar but slightly improved MTF response compared to the predicate device. |
| Noise Power Spectrum (NPS) at 0 lp/mm | 8.56 | 8.10 | The proposed devices have a similar noise performance profile at spatial frequencies compared to the predicate device. |
| Noise Power Spectrum (NPS) at 1 lp/mm | 4.21 | 3.20 | The proposed devices have a similar noise performance profile at spatial frequencies compared to the predicate device. |
| Noise Power Spectrum (NPS) at 2 lp/mm | 1.43 | 1.20 | The proposed devices have a similar noise performance profile at spatial frequencies compared to the predicate device. |
| Noise Power Spectrum (NPS) at 3 lp/mm | 0.64 | 0.60 | The proposed devices have a similar noise performance profile at spatial frequencies compared to the predicate device. |
| Noise Power Spectrum (NPS) at 3.5 lp/mm | 0.52 | 0.55 | The proposed devices have a similar noise performance profile at spatial frequencies compared to the predicate device. |
| Environmental, electrical, mechanical safety | All testing passed (based on IEC 60601-1, IEC 60601-1-2) | Not explicitly compared here, but predicate likely met similar standards | Compliance with international standards for medical electrical equipment and electromagnetic compatibility. |
| Software lifecycle and validation | Documented lifecycle based on IEC 62304, full verification, validation, and regression testing performed | Not explicitly compared here, but predicate likely met similar standards | Adherence to FDA guidance for software in medical devices, indicating robust software development practices. |
| Diagnostic image quality (visual assessment) | Images diagnostically similar, and slightly superior, to the predicate device | (Reference: predicate images) | Laboratory images using phantoms were reviewed by a certified Radiological Technologist. |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of images or cases in the provided text for the DQE, MTF, NPS, or visual assessment tests. For the visual assessment, it mentions "laboratory images using phantoms were acquired." These are likely a set of standardized phantom images.
- Data Provenance: The data for DQE, MTF, and NPS are from "measured" curves, implying direct testing of the device hardware. The visual assessment used "laboratory images using phantoms." This suggests the data is prospectively generated from controlled laboratory settings, not from patient data. The country of origin for the testing is not specified, but the applicant company is located in Canada.
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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: One (a single Radiological Technologist).
- Qualifications: "A Radiological Technologist certified in the United States of America and Canada." Specific experience level (e.g., years) is not provided.
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Adjudication method for the test set:
- No adjudication method is described for the visual assessment. A single expert made the determination without mention of a consensus or tie-breaking process. For the DQE, MTF, and NPS, these are quantitative measurements that do not require expert adjudication.
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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:
- No MRMC comparative effectiveness study was done. The submission states: "No clinical testing was performed for this special 510(k) submission." The visual assessment mentioned was a comparison of phantom images by a single technologist, not a clinical study involving multiple readers assessing patient cases. Also, this device is an X-ray detector, not an AI-assisted diagnostic tool, so improvement with AI assistance is not applicable in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a digital X-ray detector, not a standalone algorithm. Its performance is measured directly through physical parameters (DQE, MTF, NPS) and its ability to produce diagnostic images.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the DQE, MTF, and NPS measurements, the "ground truth" is generally considered to be the intrinsic physical properties of the detector, measured against established standards and methodologies.
- For the visual assessment, the "ground truth" was the subjective opinion of a single certified Radiological Technologist comparing images from the proposed device to the predicate device using phantoms.
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The sample size for the training set:
- Not applicable/Not provided. This device is a hardware component (digital flat panel detector) and associated software for image acquisition and processing. It does not employ machine learning or AI models that require specific "training sets." The IDC Magellan software underwent "full system level verification, validation and regression testing" as part of its development, but this is software testing, not ML model training.
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How the ground truth for the training set was established:
- Not applicable, as there is no specific "training set" in the context of machine learning model development for this device. The software validation relies on established software engineering principles and testing against specifications inherent to its function.
§ 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.