(290 days)
The NewTom VGi evo is a cone beam computed tomographic x-ray imaging system that acquires of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views (tomographic sections, pan and ceph projections) displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
The medical electrical equipment NewTom VGi evo is an X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display. It is manufactured by QR s.r.l. and the applicable product code is OAS, Regulation 21CFR 892.1750 Computed tomography x-ray system, Class II.
NewTom VGi evo acquires a sequence of X-ray images rotating around the patient's head and then uses these images to reconstruct a three-dimensional matrix of the volume examined and produce two-dimensional views of this volume. These views can be used to reconstruct additional two-dimensional images, on which distances and angles can be measured, and threedimensional images. Each image produced can then by printed or exported onto optical media. The NewTom VGi evo hardware system is composed of the scanner unit, the control box and the external workstation, which enables the user to acquire data easily with the aid of the specific software. The software requires Windows 7 64bit operating system.
The provided text is a 510(k) Summary for the NewTom VGi evo device, seeking substantial equivalence to its predicate device, NewTom VGi (K130442). It does not contain information about acceptance criteria and a detailed study proving the device meets those criteria in the context of specific clinical performance metrics.
Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics of the new device with the predicate device and citing compliance with various medical device standards (e.g., IEC 60601-1, IEC 62366, IEC 62304).
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with/without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states the following related to performance and testing:
- Performance Data (Section VII):
- "Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the hardware and software modifications."
- The device "was designed, tested and found to be compliant with standards IEC 60601-1 (Ed. 3, 2005), IEC 60601-1-2 (Ed. 3, 2007), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-1-6 (Ed, 3, 2010), IEC 62366 (Ed. 1, 2015), IEC 60601-2-63 (Ed. 1, 2012), IEC 60825-1 (Ed. 2, 2007) and IEC 62304 (Ed. 1, 2006)."
- "A risk analysis was performed to analyze the hazards associated with the changes."
- "Non clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
- "The clinical considerations on the images in terms of quality and effectiveness sustained the diagnostic reliability and usefulness of images produced by the NewTom VGi evo applications." (This is a general statement, not a specific study description).
- "In addition to the 2-D performance data recommended by the Solid State X-ray Imaging guidance, 3-D lab performance data (including 3-D MTF and NPS) was provided to evaluate the cone-beam CT mode of operation." (This indicates lab-based image quality metrics were assessed, but no specific study details are given).
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence based on technical specifications and adherence to standards, rather than detailing a clinical performance study with acceptance criteria and ground truth validation that you've requested.
§ 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.