(113 days)
Nanox.ARC 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, and 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, cardiac, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Nanox.ARC 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 radiologists, and physicists.
The Nanox.ARC 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 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-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 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.
The provided text is a 510(k) summary for the Nanox.ARC device. It mentions a "Clinical Sample Data evaluation" and confirms that the device can "generate diagnostic-quality images for the expanded Indications for Use," but it does not provide specific details on acceptance criteria or the study design and results as requested in the prompt.
Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes (for test/training), ground truth details, expert qualifications, or adjudication methods directly from the provided text. The document states that "The non-clinical performance testing conducted on the predicate device submitted under K222934 remain applicable to the subject device," implying that some of the detailed testing justification might reside in the predicate device's 510(k) submission (K222934).
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., sensitivity, specificity, image quality scores).
- Reported Device Performance: "Nanox.ARC System functioned as intended" and "generate diagnostic-quality images for the expanded Indications for Use. This includes the evaluation of complex and abnormalities of various sizes and shapes."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (test set): Not specified. The document mentions "clinical sample data" but not the number of cases.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified.
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
- An MRMC study is not mentioned. The device is described as an imaging system intended to produce tomographic images, with "adjunctive to conventional radiography." This phrasing suggests human interpretation of the images produced by the device, but not necessarily an AI-assisted interpretation workflow and its comparative effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies the device generates images for human interpretation ("trained radiographers, radiologists, and physicists"). A standalone algorithm performance (without human-in-the-loop) is not discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. The document uses terms like "diagnostic-quality images" and "evaluation of complex and abnormalities," which generally implies comparison against established diagnostic standards, likely expert-interpreted images or clinical findings, but the specific type of ground truth (e.g., expert consensus, pathology, follow-up) is not detailed.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
§ 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.