(27 days)
Nanox.ARC X is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.
This device is intended to be used in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, physicists.
Digital Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in prone, supine, and lateral positions.
This device is not intended for mammographic, angiographic, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Nanox.ARC X is a stationary, floor-mounted, stand-alone digital tomosynthesis system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, from a single tomographic sweep. It serves as an adjunct to conventional radiography, for adult patients in recumbent positions. The system is intended for use in professional healthcare settings such as hospitals, clinics, and imaging centers by trained radiographers, radiologists, and physicists
The Nanox.ARC X includes a secured, dedicated off-the-shelf handheld operator console, a multisource, tiltable arc gantry with five identical tubes, a motorized patient table, and a flat panel detector of a scintillator-photodetector type. The image reconstruction service and DICOMization services can be hosted either locally or as part of the secured Nanox.CLOUD, according to customer preference. Nanox.CLOUD also hosts a protocol database service package.
The Nanox.ARC X X-ray tubes are operated sequentially, one at a time, generating multiple low-dose images acquired from different angles, during a single sweep, dividing the overall power requirements among the tubes. The sweep is performed over a motorized patient table. Patients can be placed in prone, supine, and lateral positions.
The acquired projection imaging data is anonymized and automatically reconstructed to form tomographic slices of the imaged object, with each slice parallel to the table plane. The Tomosynthesis image result reduces the effect of overlying structures and provides depth information on structures of interest. The resultant images are re-identified and sent using the DICOM protocol.
Here's an analysis of the provided FDA 510(k) clearance letter for Nanox.ARC X, focusing on the acceptance criteria and the study that proves the device meets those criteria.
Key Observation: The provided document is a 510(k) Clearance Letter. These letters primarily address the "substantial equivalence" of a new device to a predicate device, rather than providing detailed clinical efficacy trial results as would be found in a Premarket Approval (PMA) application or a de novo classification request. This type of clearance often relies heavily on non-clinical bench testing and technological comparisons to demonstrate that the new device is as safe and effective as a legally marketed predicate.
Therefore, the information regarding in-depth clinical studies (like MRMC studies, specific ground truth methods, or detailed acceptance criteria for diagnostic accuracy) is limited or absent in this document because it's not typically required for a 510(k) clearance based on substantial equivalence to an existing device with similar technological characteristics. The focus is on demonstrating that the modifications to the predicate device (Nanox.ARC) do not negatively impact its safety or effectiveness.
Acceptance Criteria and Device Performance Assessment
Based on the provided document, the "acceptance criteria" are primarily framed around demonstrating that the modified device (Nanox.ARC X) is as safe and effective as its predicate (Nanox.ARC), despite minor technological changes. The proof relies heavily on non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary focused on substantial equivalence and technological comparison, the "acceptance criteria" are inferred from the types of non-clinical tests performed to ensure the new device functions as intended and is as safe and effective as the predicate. The "reported device performance" are the general conclusions drawn from these tests.
| Acceptance Criterion (Inferred from testing performed) | Reported Device Performance |
|---|---|
| System Electrical Qualification | Functioned as intended. |
| System Performance | Functioned as intended. |
| Longevity and Consistency | Functioned as intended. |
| Tube Longevity and Reliability | Functioned as intended. |
| Functional Verification | Functioned as intended. |
| Motion Control | Functioned as intended. |
| Dimensional and Mechanical Properties | Functioned as intended. |
| Image Quality | Functioned as intended. |
| Tube Comparison CEI and Nanox Korea | Functioned as intended. |
| Human Factors Summary | Functioned as intended. |
| Phantom Validation | Functioned as intended. |
| Weight Considerations | Functioned as intended. |
| Transportation | Functioned as intended. |
| Software Verification and Validation | Functioned as intended. |
| Overall Safety and Effectiveness | Similar to predicate device. |
Note: The level of detail provided in a 510(k) letter doesn't include specific quantitative metrics for each test, only a general statement that the system "functioned as intended" and overall safety/effectiveness are similar to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of patient data. The testing described primarily involves bench testing, phantom studies, and system-level verification and validation. There is no indication of a clinical test set involving human patients as one might expect for a diagnostic accuracy study.
- Data Provenance: Not applicable in the context of clinical patient data for this 510(k) pathway, as no clinical tests were performed. The "data" comes from the results of the various non-clinical bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Since no clinical tests were performed on human patients and no diagnostic accuracy claims are being established through reader studies, there was no need for expert ground truth establishment for a clinical test set.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was explicitly NOT done. The document states: "No clinical tests were performed for the subject device." This type of study would be a clinical test.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was done.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The document does not describe a standalone diagnostic accuracy study of an AI algorithm. The device is a tomographic X-ray system, not an AI diagnostic algorithm, although it does include "image reconstruction service" and "DICOMization services." These are intrinsic functionalities of the imaging system itself, not separate AI components whose standalone diagnostic performance would be evaluated. The "Software Verification and Validation" likely covers the functional correctness of these reconstruction algorithms.
7. The Type of Ground Truth Used for the Test Set
- Type of Ground Truth: Not applicable for a clinical test set. The "ground truth" for the non-clinical tests would be the established engineering specifications, phantom measurements, and functional requirements against which the device's performance was measured (e.g., a known phantom structure for image quality, or expected electrical parameters for qualification).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This 510(k) is for a hardware device (X-ray system) with associated software for image reconstruction. It is not an AI/ML algorithm that undergoes a distinct "training" phase on a specific dataset for diagnostic interpretation. The image reconstruction algorithms are typically deterministic or based on established physics and signal processing, not on deep learning models trained on large image datasets.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of an AI/ML diagnostic algorithm for which ground truth would be established. The "ground truth" for the development of image reconstruction algorithms would be based on mathematical models, physical principles of X-ray interaction, and calibrated phantom data to optimize image quality and accuracy.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.