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PreXion 3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital X-ray images of the dental (oral), maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

PreXion 3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer. During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

The provided text is a 510(k) Summary for the PreXion 3D Excelsior device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI-driven diagnostic aid.

Specifically, the document discusses:

• Device Description: The PreXion 3D Excelsior is a dental cone-beam computed tomography (CT) device.
• Modifications from Predicate: The subject device adds a "CT-panoramic" mode (reconstructing panoramic images from CT raw data) and an "Airway measurement function" (calculates volume and cross-section area of airways).
• Non-Clinical Performance Data: Conformance to various harmonized standards (e.g., IEC 60601-1, ISO 14971) and specific testing for 3D imaging performance (MTF for three image orientations).
• Software Quality Activities: Compliance with software moderate level concern based on risk management and usability evaluation, including bench tests and user evaluations.
• Conclusion: The device is substantially equivalent to the predicate device.

However, the document does NOT provide the requested information regarding acceptance criteria related to AI/Machine Learning performance (e.g., sensitivity, specificity, AUC) or a clinical study proving AI-driven diagnostic aid performance. The "Airway measurement function" is described as an additional supplemental function, but no performance metrics for this automated measurement function are presented, nor is it explicitly stated to be an AI-driven diagnostic aid in the sense of pattern recognition or disease detection.

Therefore, I cannot extract the information required to formulate the table and answer the detailed questions about acceptance criteria for an AI device and the study proving it meets those criteria. The provided submission is for a medical imaging device (CT scanner) and its software, not an AI diagnostic software that requires assessment of diagnostic accuracy.

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PreXion 3D is intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillo-facial regions at the direction of healthcare professionals as diagnostic support.

The PREXION 3D consists of scanner and two software including Console software, and Viewer software used for the Image Analysis System and Data processing. A qualified computer named Console computer is distributed with the PREXION 3D.

The PREXION 3D uses the Image Analysis System and the processed data acquired by the scanner to analyze 2D and 3D images, perform image edition, such as creating cross-section views, and output results to a printer or other output device.

During scanning, X-rays are generated from the X-ray tube head mounted in the arm of the scanner and the X-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware and the Console software installed on the qualified computer. The detected X-ray absorption data is processed by the Console software and viewer software on a computer to reconstruct images. Scanning is performed using X-ray penetration signals of a patient taken from multiple directions for the diagnosis of hard tissue including bones and teeth of the jaw and mouth cavity. The PREXION 3D performs two types of scanning including CT scan generating two (2) and three (3) dimensional images and Panoramic scan generating two (2) dimensional images.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: PREXION 3D
K Number: K120948

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The provided summary does not specify a sample size for a test set in the context of clinical or image-based studies with human subjects. The testing described focuses on technical performance metrics (MTF, artifact analysis) and safety standards, likely using phantoms or laboratory setups rather than patient data for "test sets" in the diagnostic performance sense.

Data Provenance: Not applicable in the context of the described technical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the technical tests (like MTF and artifact analysis) is established by measurement against defined physical standards or comparison to a predicate device's known performance, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the tests were technical and did not involve human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on technical substantial equivalence, not comparative diagnostic effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

No, a standalone algorithm performance study was not explicitly described. The device, an X-ray system, produces images for human healthcare professionals to interpret; it is not presented as an AI-driven diagnostic algorithm. The software validation mentioned pertains to the software's functional correctness for image processing and system control.

7. The Type of Ground Truth Used

• For Laser Safety: Compliance with IEC 60825-1 (international standard).
• For Modulation-Transfer Function (Spatial Resolution): Measurements in accordance with IEC 61223-3-5 (international standard).
• For Artifact Analysis: Comparison to the predicate device (FineCube K063622). The "ground truth" here is the established and accepted performance of the predicate device.
• For Software Verification/Validation: Compliance with FDA guidance for software in medical devices.
• For EMC, Electrical Safety, X-ray Radiation Safety: Compliance with relevant IEC 60601 series standards.
• For Risk Analysis: Compliance with ISO 14971:2007.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set of data. The software validation is for the image acquisition and processing functions, which are deterministic, not for a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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