(30 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 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 1717TC 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.
The Aquarius 8600 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector.
The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TC and 1417TC medical devices.
The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document
Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document.
The provided text describes a 510(k) submission for the Aquarius 8600, a digital flat panel X-ray detector. However, it does not include information about a study that proves a device meets acceptance criteria related to AI/Machine Learning device performance, as there is no AI component mentioned in this submission. The submission is for a radiographic imaging system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (DQE, MTF, NPS), safety testing, and software lifecycle documentation.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC study, standalone performance against ground truth, training set details) are not applicable to this specific submission, as they relate to the validation of an AI/ML algorithm rather than a traditional medical imaging hardware component.
I will fill in the relevant information that is present in the document and explicitly state where information is not applicable or not provided.
Acceptance Criteria and Device Performance (Aquarius 8600)
The acceptance criteria here are implicitly defined by demonstrating "substantial equivalence" to a predicate device (IDC X3C Digital Radiographic Detector) through comparable performance metrics and safety standards. The study primarily relies on non-clinical (bench) testing.
1. Table of Acceptance Criteria (based on predicate equivalence) and Reported Device Performance
| Characteristic / Acceptance Criteria (vs. Predicate) | Predicate Value (X3C) | Aquarius 8600 (1717TC & 1417TC) Performance |
|---|---|---|
| Detective Quantum Efficiency (DQE) | ||
| DQE (0) | 0.641 | 0.684 |
| Acceptance Comment: | Similar performance at all spatial frequencies, with proposed device having slightly better DQE(0). | |
| Modulation Transfer Function (MTF) | ||
| MTF at 1 lp/mm | 0.385 | 0.517 |
| MTF at 2 lp/mm | 0.134 | 0.230 |
| MTF at 3 lp/mm | 0.075 | 0.123 |
| MTF at 3.5 lp/mm | 0.063 | 0.063 |
| Acceptance Comment: | Same or better resolution performance at all spatial frequencies. | |
| Noise Power Spectrum (NPS) | ||
| NPS at 0 lp/mm | 2.21 | 8.01 |
| NPS at 1 lp/mm | 0.98 | 3.30 |
| NPS at 2 lp/mm | 0.82 | 1.27 |
| NPS at 3 lp/mm | 0.82 | 0.64 |
| NPS at 3.5 lp/mm | 0.81 | 0.58 |
| Acceptance Comment: | Similar noise performance profile at spatial frequencies, but specific values differ. | |
| Environmental, Electrical, Mechanical Safety | IEC 60601-1 ed. 3.0 | Passed IEC 60601-1 ed. 3.0 |
| EMC Testing | IEC 60601-1-2:2007 | Passed IEC 60601-1-2:2007 |
| Software Lifecycle | IEC 62304 ed. 1.1:2015 | Documented as per IEC 62304 ed. 1.1:2015 |
| Image Quality (Subjective Review) | Baseline with X3C | Diagnostically similar, slightly superior, using phantoms |
Note: The increase in NPS values for the Aquarius 8600 at lower spatial frequencies compared to the X3C detector is noted in the table but the document states they have "a similar noise performance profile". This suggests that while raw values may differ, the overall expected noise characteristics for diagnostic purposes were deemed acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Test Set: Non-clinical (phantom) images were used. The document does not specify an exact number of phantom images or specific test scenarios beyond mentioning "Laboratory images using phantoms were acquired."
- Data Provenance: The testing was conducted by Imaging Dynamics Company, Ltd. (IDC) (Canada). The nature of the non-clinical testing (phantoms) means there's no patient data provenance to specify. The study is a pre-market submission for substantial equivalence, relying on bench tests, rather than a clinical trial with retrospective/prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert.
- Qualifications: A "Radiological Technologist certified in the United States of America and Canada." (Note: This is a technologist, not a radiologist, and their role was to review images for diagnostic similarity, not to establish a clinical "ground truth" from patient data.)
4. Adjudication method for the test set:
- Adjudication Method: None explicitly mentioned or applicable beyond the single radiologic technologist's review of phantom images. This was not a multi-reader clinical study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "No clinical testing was performed for this special 510(k) submission." The evaluation was primarily based on non-clinical performance parameters (DQE, MTF, NPS) and a subjective review of phantom images by one technologist.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study with human-in-the-loop AI assistance was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a digital X-ray detector, which is hardware, not an AI algorithm. Its "performance" is measured by physics-based parameters (DQE, MTF, NPS) derived from phantom images, not by an algorithm's diagnostic output against a clinical ground truth.
7. The type of ground truth used:
- Type of Ground Truth: For the quantitative performance metrics (DQE, MTF, NPS), the "ground truth" is established by the standardized measurement methodologies described in relevant international standards and best practices for X-ray detector characterization. For the qualitative image review, the "ground truth" was a subjective assessment by a certified technologist comparing images from the new device to the predicate using phantoms. No clinical "ground truth" (e.g., pathology, clinical outcomes) from patient data was used.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a hardware device; there is no AI/ML algorithm that requires a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.