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510(k) Data Aggregation
(271 days)
The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.
The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures. The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).
The provided text describes a 510(k) premarket notification for a CT scanner (CTXX85 with software version 1.3). The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/ML-based device.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML performance.
The submission confirms that:
- No clinical studies were required or conducted to support the substantial equivalence claim.
- The device's enhancements are primarily related to software-based algorithms (Metal Artifact Reduction, Extended Field of View), and new accessories/functionalities, rather than a completely new AI/ML diagnostic algorithm requiring extensive clinical validation.
- Performance data was collected through non-clinical test/performance testing (bench testing, phantom tests), adhering to various international and FDA consensus standards related to CT image quality, electrical safety, EMC, and software life-cycle processes.
Without a clinical study, details like sample size for a test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics are not available in this document.
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(30 days)
The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.
The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration).
The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.
The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).
Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.
The provided text describes specific performance data for the Analogic CTXX85 CT Scanner, particularly focusing on the CT1685 model and its iterative reconstruction algorithm (LISA). However, the document does not present a formal table of acceptance criteria with corresponding reported device performance, nor does it detail a clinical study with specific metrics like sensitivity, specificity, or reader performance improvement (MRMC).
Based on the information provided, here's a breakdown of the requested elements:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of acceptance criteria with precise numerical targets. Instead, it indicates that the device's performance was evaluated against a set of standards and for image quality. The general acceptance criterion seems to be that the device "performs as intended" and its image quality is "diagnostic."
| Acceptance Criteria Category | Specific Criteria (Implicit/General) | Reported Device Performance Statement |
|---|---|---|
| Bench Testing Compliance | Fulfills requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33, and specific IEC/NEMA standards (IEC61223-2-6, IEC61223-3-5, IEC 60601-2-44, NEMA PS 3.1 - 3.20, IEC 60601-1-3, NEMA XR 25, NEMA XR 28, IEEE Std. 3333.2.1, IEC 62366, IEC 60825). | "Bench testing was performed and the new scanner model CT1685 fulfills the requirements..." and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence." |
| Image Quality | Assessment of modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body using standard phantom models. Performance of the iterative reconstruction algorithm (LISA) in reducing image noise while maintaining (or improving) spatial resolution. Images reconstructed via FBP and LISA with different strengths must be of diagnostic quality. | "Image Quality performance testing for the CT1685 was conducted on standard phantom models to assess [list of metrics]... The results of these tests demonstrate that the proposed device performs as intended." and "Sample clinical images... were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality." |
| Biocompatibility | Patient contacting accessories (patient table CT slicker cushion, head holder, wedge knee pad, table top and patient restraints) comply with AAMI/ANSI/ISO 10993-1 for Surface Contact: Skin, Duration: Limited <24hr. | "The patient contacting accessories comply with the biocompatibility standard requirements." |
| Electrical Safety & EMC | Compliance with AAMI/ANSI/ES 60601-1 and IEC 60601-1-2. | "Electrical safety testing is compliant with the following standards." |
| Software V&V | Conformance to special controls for medical devices containing software, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," for a "moderate" level of concern device. Compliance with EN IEC 62304 Medical Device Software Life-Cycle Processes. | "Software verification and validation testing were conducted and documentation was provided..." and "The CTXX85 CT Scanner complies with EN IEC 62304 Medical Device Software Life-Cycle Processes." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Sample clinical images of the brain, chest, abdomen and extremity" but does not specify a numerical sample size for this evaluation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One "board-certified radiologist" was used.
- Qualifications: "board-certified radiologist." No information on years of experience is provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that a single board-certified radiologist evaluated the images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The evaluation involved a single radiologist confirming diagnostic quality of images. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.
6. Standalone (Algorithm Only) Performance
The document states, "Image Quality performance testing for the CT1685 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body." This indicates that standalone performance testing on phantoms was done to evaluate the image quality produced by the device, including its iterative reconstruction algorithm (LISA).
7. Type of Ground Truth Used
- For the phantom studies: The ground truth was based on physical phantom characteristics and established imaging metrics (e.g., MTF, low contrast detectability, noise, CT number accuracy).
- For the clinical image evaluation: The ground truth was established by expert consensus (albeit by a single expert), specifically the assessment of "diagnostic quality" by a board-certified radiologist.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This submission appears to be related to the substantial equivalence of a new model (CT1685) within an existing product line (CTXX85) and the performance of an advanced algorithm (LISA), but it doesn't detail the development or training of such an algorithm. The current document focuses on verification and validation testing of the device itself.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
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