(167 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, 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. Not intended for mammography.
The Aquarius 8600 1417WC is a digital flat panel (specifically termed solid state digital X-Ray detector), with the option for users to use the detector in either a tethered or wireless mode. 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.
This 510(k) submission describes the Aquarius 8600 1417WC, a digital flat panel X-ray detector. It is a modification of a previously cleared device (Aquarius 8600 1717TC) and integrates a 510(k)-cleared tethered/wireless flat panel detector with existing software and workstation components. The submission focuses on demonstrating substantial equivalence to the predicate device.
Here's an analysis of the provided text in the context of acceptance criteria and supporting studies:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative manner for specific diagnostic tasks. Instead, it compares the technological characteristics and performance metrics of the proposed device (Aquarius 8600 1417WC) with those of the predicate device (Aquarius 8600 1717TC), aiming to demonstrate "similar" or "better" performance, thereby supporting substantial equivalence.
| Characteristic | Acceptance Criterion (Implicitly "Similar to or Better Than Predicate") | Reported Device Performance (Aquarius 8600 1417WC) | Predicate Performance (Aquarius 8600 1717TC) |
|---|---|---|---|
| DQE (0) | ≥ Predicate DQE (0) | 0.817 | 0.684 |
| MTF (1 lp/mm) | ≥ Predicate MTF (1 lp/mm) | 0.557 | 0.517 |
| MTF (2 lp/mm) | ≥ Predicate MTF (2 lp/mm) | 0.280 | 0.230 |
| MTF (3 lp/mm) | ≥ Predicate MTF (3 lp/mm) | 0.157 | 0.123 |
| MTF (3.5 lp/mm) | ≥ Predicate MTF (3.5 lp/mm) | 0.118 | 0.088 |
| NPS Profile | "Similar noise performance profile" | Reported NPS curves (e.g., 19.15 at 0 lp/mm) | Reported NPS curves (e.g., 8.01 at 0 lp/mm) |
| Resolution | "Same or better resolution performance" (based on MTF comparison) | "Same or better resolution performance" | Referenced by MTF values |
| Image Quality (Diagnostic Similarity) | Produces images diagnostically similar to the predicate device | "produces images that are diagnostically similar" | Implicitly the images from the predicate device |
| Environmental, Electrical, Mechanical Safety | All testing passed based on IEC 60601-1 and IFC 60601-1-2 | All testing passed | Not explicitly stated, but implied as predicate is already cleared |
| Software Lifecycle/Validation | Documented lifecycle, design, requirements, verification, validation, regression testing per FDA/IEC guidance | Documentation and testing performed | Not explicitly stated, but implied as predicate is already cleared |
2. Sample size used for the test set and the data provenance:
- Sample Size for DQE, MTF, NPS: Not explicitly stated as a numerical count of images or measurements. These are physical characteristics of the detector itself, typically measured under controlled laboratory conditions, not on a "test set" of patient images in the traditional sense.
- Sample Size for Diagnostic Similarity: "Laboratory images using phantoms were acquired with the proposed Aquarius 8600 1417WC detector and compared to images acquired with the Aquarius 1717TC predicate device." The number of phantoms or images is not specified.
- Data Provenance: The DQE, MTF, and NPS measurements are laboratory-derived data. The "laboratory images using phantoms" are also laboratory-derived. There is no indication of country of origin for the data; it would likely be from the manufacturer's testing facilities. The tests are non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "A Radiological Technologist certified in the United States of America and Canada has reviewed the images (included in this submission)..." This indicates one radiological technologist was involved.
- Qualifications of Experts: "Radiological Technologist certified in the United States of America and Canada." (No mention of years of experience or specialization beyond general radiology).
4. Adjudication method for the test set:
- No formal adjudication method (e.g., 2+1, 3+1) is described for the image review to establish diagnostic similarity. It appears to be a single reviewer's assessment.
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:
- No MRMC study was done. The device is a digital X-ray detector, not an AI-assisted diagnostic tool. The comparison is between the performance of the proposed detector and a predicate detector, not between human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in spirit, for the detector's physical performance. The DQE, MTF, and NPS measurements represent the standalone performance of the detector hardware. While a human is involved in analyzing the output (e.g., in phantom image review), the core metrics (DQE, MTF, NPS) characterize the intrinsic performance of the detector itself, independent of a diagnostic interpretation by a human.
7. The type of ground truth used:
- For DQE, MTF, NPS: These are objective physical performance metrics measured under controlled laboratory conditions using established methodologies. The "ground truth" is the accurately measured physical response of the detector.
- For Diagnostic Similarity: The "ground truth" is essentially the predicate device's image quality, which is already considered diagnostically acceptable. The expert's role was to confirm that the proposed device's images (of phantoms) were "diagnostically similar" to those of the predicate device. This is a form of expert consensus/comparison against an established benchmark rather than an independent "ground truth" for disease detection.
8. The sample size for the training set:
- Not applicable. This submission is for a digital X-ray detector, which captures images. It does not describe an AI/machine learning model that would require a "training set" of images to learn from. The software (Magellan 3) processes and displays images but is not an AI algorithm in the context of typical training sets.
9. How the ground truth for the training set was established:
- Not applicable. As no training set for an AI/ML model is described, there's no mention of how ground truth for such a set would be established.
§ 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.