(164 days)
Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.
The device is to be operated and used by legally qualified health care professionals.
Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.
The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.
The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity and maxillofacial area positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.
The provided document is a 510(k) summary for the Planmed Verity, a Computed Tomography X-ray System. It describes the device, its intended use, and comparisons to a predicate device, but it does not contain a table of acceptance criteria and reported device performance as requested. Therefore, I cannot generate the table or directly answer some of the specific questions about acceptance criteria in numerical detail.
However, I can extract information related to the studies performed and general conclusions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific thresholds or reported numerical device performance against those criteria. It states: "All results were equivalent or slightly better in Planmed Verity than in the predicate device." and "the imaging performance of Planmed Verity was found both substantially equivalent to the predicate device and sufficient for clinical use." Without specific metrics defined in the document, a table cannot be constructed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: "A clinical study was completed to evaluate the image quality of Planmed Verity's maxillofacial area. The images for this clinical study were selected from patients imaged as part of normal clinical routine in a university hospital in Finland."
- Sample Size: The sample size for this clinical study is not specified in the provided text.
- Data Provenance:
- Country of Origin: Finland (university hospital).
- Retrospective/Prospective: The phrasing "selected from patients imaged as part of normal clinical routine" suggests a retrospective collection of images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document describes a clinical study to evaluate "image quality" and compares the new device to a predicate device, focusing on "imaging performance." It does not mention an AI component or evaluate human reader performance with or without AI assistance. Therefore, an MRMC study comparing human readers with AI assistance was not done based on the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a CT X-ray system, not an AI algorithm. The performance evaluation would be for the imaging system itself, not a standalone algorithm. The clinical study assessed the "image quality" of the system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states the clinical study was to evaluate "image quality." It does not explicitly define the "ground truth" method used for this evaluation beyond stating that the "results show that the imaging position... gives a clinically sufficient image quality." This usually implies expert assessment/consensus of the images for diagnostic quality, but the specifics are not detailed.
8. The sample size for the training set
This information is not applicable as the document describes a CT imaging device evaluation, not a machine learning model's training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.