(14 days)
The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console. All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit. These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.
The provided document describes the Analogic Corporation's SyneRad IMPACT 60, SyneRad IMPACT 72, and Analogic AMS1600 Computed Tomography X-ray systems. It is a 510(k) submission, meaning the company is seeking to demonstrate substantial equivalence to previously cleared devices, rather than conducting new clinical trials for effectiveness. Therefore, the information typically associated with acceptance criteria being met by a study might not be present in the same format as for novel devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity for a diagnostic task). Instead, it relies on demonstrating comparable technological characteristics and performance (measured on phantoms) to predicate devices.
The key performance comparison is presented in the "Key Parameters Comparison Chart":
| Characteristic | Anexa IMPACT72 | Anexa IMPACT 60 | G. E. Healthcare LightSpeed 6.0 (LightSpeed Pro16) | G. E. Healthcare LightSpeed 5.0 (LightSpeed 16) | Toshiba AQUILION 16 CFX |
|---|---|---|---|---|---|
| High Contrast Spatial Res. | |||||
| 0% MTF, lp/cm | 17.25 lp/cm | 17.25 lp/cm | 15.4 lp/cm | 15.4 lp/cm | 18 lp/cm |
| 50% MTF, lp/cm | 8+ lp/cm | 8+ lp/cm | 8.5 lp/cm | 8.5 lp/cm | 9.4 lp/cm |
| Low-contrast res., mm @ % @ 4 rads | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.30%, 8" CATPHAN | 5 mm @ 0.3% @ 21.8 mGy (per MHRA) |
| Weighted CTDI shown on console | Yes | Yes | Yes | Yes | Yes |
| Dose Length Product shown on console | Yes | Yes | Yes | Yes | Yes |
| Geometric Efficiency displayed | Yes | Yes | Yes | Yes | Yes |
Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new devices perform as well as or better than the predicate devices in the listed image quality parameters, and share similar functional characteristics and intended uses.
Reported Device Performance: As seen in the table, the SyneRad systems show comparable or slightly better high-contrast spatial resolution (e.g., 0% MTF of 17.25 lp/cm vs. 15.4 lp/cm for GE, 50% MTF of 8+ lp/cm vs. 8.5 lp/cm for GE) and identical low-contrast resolution (5 mm @ 0.30%) to the predicate devices. Other features like displaying CTDI and DLP are also matched.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices."
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The testing was conducted on phantoms, which are inanimate objects designed to simulate human tissue for specific measurements. The specific number of times each phantom was scanned or the variety of phantoms used is not detailed.
- Data Provenance: The data appears to be prospective bench testing conducted internally by Analogic Corporation on their new devices in comparison to characteristics of predicate devices. There is no mention of country of origin for patient data as no patient data was used for performance comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth for phantom-based image quality measurements is typically established by physical measurements and the inherent design parameters of the phantoms themselves, not by human expert interpretation in the same way as clinical diagnostic studies.
4. Adjudication Method for the Test Set
Not applicable. As no human expert interpretation or clinical decision-making was involved in establishing the "ground truth" for the phantom testing, no adjudication was necessary.
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. This is a 510(k) submission for a new CT scanner system, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The performance evaluation was essentially "standalone" in that it focused on the device's technical specifications and image quality capabilities (phantom-based measurements) without involving human interpretation or clinical outcomes. The "algorithm" here is the CT reconstruction and imaging process itself.
7. The type of ground truth used
The ground truth for the core image quality metrics (High Contrast Spatial Resolution, Low-Contrast Resolution) was established through phantom measurements. These phantoms (e.g., "CATPHAN") have known physical properties and are used in a standardized way to objectively quantify imaging performance.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set of data. The "training" for the device, if one could apply the term, would be its engineering design, calibration, and manufacturing processes.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this traditional medical imaging device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.