(214 days)
Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system 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 Tomosynthesize 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, pulmonary, intra-abdominal, intra-cranial, intra-cranial, interventional, or fluoroscopic applications. This device is not intended for imaging pediatric or neonatal patients.
Nanox.ARC is a tomographic and solid-state X-ray system (product codes IZF and MQB) intended to produce tomographic images of the human musculoskeletal system from a single tomographic sweep, as an adjunct to conventional radiography, on adult patients.
Nanox.ARC is a floor-mounted tomographic system that consists of a user control console, a multisource, tiltable arc gantry with five alternately-switched tubes, a motorized patient table, a flatpanel detector of a scintillator-photodetector type, and Protocols database and Image processing software packages.
Nanox.ARC utilizes several small-sized X-ray tubes that are independently and electronically switched, thereby dividing the overall power requirements over multiple tubes. Nanox.ARC utilizes a tilting imaging ring with five X-ray tubes, operated sequentially, one at a time, used to generate multiple low-dose X-ray projection images acquired from different angles during a single spherical (non-linear) sweep. 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 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 image reconstruction service, as well as the system's protocol database and DICOMization services, can be hosted either locally or as part of the Nanox.CLOUD, according to customer preference. The resultant images are sent using the DICOM protocol.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly list specific quantitative acceptance criteria in a table format with separate reported device performance values for each criterion. Instead, it states that "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."
The "Table 2: Non-clinical Performance Data" lists various tests performed and reports a "PASS" for each, indicating that the device met the acceptance criteria for those specific tests.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Acceptance Criterion (Implied by Test Description) | Reported Device Performance |
|---|---|
| System Electrical Qualification | PASS |
| System Performance (Motion resolution & accuracy) | PASS |
| System Longevity & Consistency | PASS |
| Tube Longevity and Reliability | PASS |
| Functional Verification | PASS |
| Motion Control stability | PASS |
| Detector and image acquisition functionality | PASS |
| Usability Summative (Safety, effectiveness, no failures) | PASS |
| Transportation safety | PASS |
| Dimensional and Mechanical Properties | PASS |
| Image Quality | PASS |
| Phantom Validation (Diagnostic quality vs. predicate) | PASS |
| Software verification and validation | PASS |
| Compliance to 21 CFR 1020.30 and 1020.31 | PASS |
| Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2) | PASS |
| Radiation Safety (IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54) | PASS |
| Biocompatibility (ISO 10993-1) | PASS |
Study Details:
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Sample size used for the test set and the data provenance:
- Clinical Sample Evaluation (for image quality): Nine (9) Digital Tomosynthesis image cases were acquired from healthy adult human subjects (patients).
- Phantom Performance Exams: Twelve (12) Digital Tomosynthesis phantom performance exams (total cases = 9 human + 12 phantom = 21 cases).
- Data Provenance: From a clinical study conducted at Shamir Medical Center in Israel. The study appears to be prospective as it states "image cases were acquired from healthy adult human subjects (patients) from a clinical study conducted at Shamir Medical Center in Israel."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One (1)
- Qualifications: An ABR-certified radiologist.
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Adjudication method for the test set:
- Adjudication Method: Not explicitly stated, but with only one radiologist reviewing, there was no multi-expert adjudication mentioned (e.g., 2+1, 3+1). If only one expert makes the determination, it's effectively "none" in terms of reaching a consensus among multiple experts.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The clinical sample evaluation involved a single ABR-certified radiologist evaluating the diagnostic quality of the Nanox.ARC images themselves, "against a reference comparison which was the standard of care radiographies." This was a direct comparison of images, not a study on human reader performance with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the described "Bench Testing" and "Non-clinical Performance Data" table largely represent standalone algorithm and system performance without human intervention in the diagnostic interpretation loop. The "Image Quality" and "Phantom Validation" tests also assessed the device's output directly. The clinical sample evaluation by the radiologist was to evaluate the diagnostic quality of the images produced by the device, effectively assessing the device's standalone output for clinical utility.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the clinical sample evaluation, the diagnostic quality of the Nanox.ARC images was evaluated by an ABR-certified radiologist "against a reference comparison which was the standard of care radiographies." This implies the "ground truth" was essentially the interpretive diagnostic quality determined by a single expert, compared to standard of care imaging. For the phantom studies, the ground truth would be based on the known physical properties and measurements within the phantoms.
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The sample size for the training set:
- Training Set Sample Size: The document does not provide any information regarding the sample size used for the training set of the Nanox.ARC system's image reconstruction or processing algorithms.
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How the ground truth for the training set was established:
- Training Set Ground Truth: The document does not provide any information on how ground truth was established for the training set.
§ 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.