(61 days)
PreXion3D Explorer is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
PreXion3D Explorer 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 Explorer 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.
X-ray image data is acquired while the rotation around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, CT-Panoramic scan) and Cephalometric Scan.
This document is a 510(k) premarket notification for the PreXion3D Explorer, a Computed Tomography X-Ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device (PreXion3D Excelsior) rather than providing detailed clinical efficacy study results for an AI-powered device. Therefore, much of the requested information regarding acceptance criteria for AI performance and detailed study methodologies (like MRMC studies, ground truth establishment for AI, sample sizes for training/test sets for AI models, etc.) is not present in this document, as the device is not described as having an AI component in the manner of a diagnostic AI algorithm.
However, I can extract the acceptance criteria and performance data for the device itself based on the provided tables and text, treating "performance" as the device's physical capabilities and measured output rather than AI diagnostic performance.
Here's the closest interpretation of your request based on the provided document:
Device Name: PreXion3D Explorer
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the PreXion3D Explorer (Subject Device) to its predicate device (PreXion3D Excelsior) to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly meeting or improving upon the predicate's performance and complying with relevant standards. The "reported device performance" is the measured characteristics of the PreXion3D Explorer.
| Acceptance Criteria (Implicit - based on Predicate and Standards) | Reported Device Performance (PreXion3D Explorer) | Comparison / Notes |
|---|---|---|
| Indications for Use: | ||
| - Produce 2D (panoramic, cephalometric) & 3D images of dental, oral, maxillofacial, ENT, neck regions for diagnosis in adult & pediatric patients. Cephalometric includes hand/wrist for growth/maturity assessment. | - Identical, with minor wording differences that "do not raise any additional questions of safety or efficacy." | Same |
| Target Population: Children aged 6+ to elderly | Children aged 6+ to elderly | Same |
| Anatomical Site: Dental, oral, maxillofacial, ENT, neck region | The dental, oral, maxillofacial, ENT, neck region | Same |
| Users: Health care professionals | Health care professionals | Same |
| Technological Characteristics: | ||
| - Patient Contact Material Biocompatibility: Safe for intended use (Polycarbonate, Silicone, PVC for predicate) | CHIN REST: polycarbonate, HEAD SUPPORT: carbon, HANDLE GRIP: silicone rubber | "Biocompatibility test results support that the material is safe for the intended use." (Implies acceptance criteria met) |
| - Sterility: Non-sterile | Non-sterile | Same |
| - X-ray Tube Voltage: Comparable/Safe (60-110KV for predicate) | 90-110KV | "Applied current is reduced so that the dose level is equivalent." (Implies meeting dose safety criteria despite higher minimum voltage) |
| - Pulse Exposure Function: Yes | Yes | Same |
| - X-ray Tube Current: Comparable/Safe (1-6mA for predicate) | 1-3mA | "Applied current is reduced so that the dose level is equivalent." (Implies acceptance criteria for dose met) |
| - Focal Spot Size: Consistent (0.3mm x 0.3mm for predicate) | 0.3mm x 0.3mm | Same |
| - Detector: FPD (TFT) | FPD (TFT) | Same |
| - Pixel Size: Comparable or improved | 248 μm x248μm (With binning), 124 μm x124μm (Without binning) for CT, CT-Panoramic, Ceph | Predicate has 125 μm x125μm, 125μm x250μm (CT), 125 μm x 125μm (Panoramic), 140 μm x 140μm (Ceph). The different binning options suggest flexibility. |
| - Pixel Number: Comparable or improved | 1024x1280 (With binning), 2560x2048 (Without binning) | "FPD has been changed and gets bigger. The performance gets better." (Implies acceptance criteria met or exceeded) |
| - Size of Area Receiving X-ray: Comparable or improved | 253.95mm x 317.44mm (CT, CT-Panoramic, Ceph) | Predicate has 160mm x 128mm (CT), 160mm x 12.5mm (Panoramic), 295.68 x 245.56mm (Ceph). "FPD gets bigger so that it can scan larger object." (Implies acceptance criteria met or exceeded) |
| - Number of Bits: Comparable (16 bits for CT/Panoramic, 14 bits for Ceph in predicate) | 16bits (CT, CT-Panorama, Ceph) | Improved for Ceph (16 bits vs 14 bits in predicate) |
| - SID/SOD (Scanner Geometry): Comparable | 700mm/ 420mm (CT, CT-Panoramic, Ceph) | Predicate has 700mm/ 470mm (CT, Panoramic), 1735mm / 1500mm (Ceph). "Radius of rotation gets smaller so that they are substantially equivalent." (Implies acceptance criteria for image quality/dose met despite change) |
| - Dimensions & Weight: Practical and safe | (WHD) 880 mm x 1237 mm x 2268 mm, 165 kg | "Cephalo is integrated, thus, it gets lighter." (Refers to weight comparison with predicate's separate ceph unit, implying improvement or equivalence on design) |
| - Imaging Mode: CT Scan, Panoramic Scan, Cephalometric Radiography | CT scan, CT-Panoramic scan, Cephalometric radiography | Equivalent |
| - Scan Time (Panoramic): Comparable (18s for predicate) | 8-16sec | "Irradiance level is equivalent." (Implies shorter scan time does not compromise safety/efficacy) |
| - Scan Time (Cephalometric): Comparable (0.1s for predicate) | 0.5-0.8 sec | "Improved" (Implies faster scan time) |
| - Scan Time (CT): Comparable (5.2-25.6s for predicate) | 10-20sec | "Similar" |
| - FOV (Voxel Size): Comparable or improved | Diameter 150mm x H156mm, 150mm x H78mm, 50mm x H50mm (all 0.100 - 0.200mm) etc. | Predicate has 100mm x H81mm, 100mm x H50mm, 50mm x H50mm (all 0.100 - 0.200mm). "FPD gets bigger so that it can scan larger object." (Implies acceptance criteria met/exceeded for imaging area) |
| - Volume Size: Comparable | 500x500x500, 750x750x780 | Predicate has 512x512x512, 512x512x950, 1024x1024x816, 1024x1024x1515. "Volume Size is smaller; thus, the file size gets smaller." (Implies efficiency while maintaining equivalence, within acceptance range) |
| - Dose Level (CTDIw): Comparable or improved | Standard (110KV, 2mA, 10s): 1.7mGy (15cm), 0.5mGy (5cm) etc. | "Dose Level is similar and improved." (Detailed comparison shows various modes for both, all within acceptable safety limits, often lower for the subject device.) |
| - Spatial Resolution (MTF): Comparable or improved | Standard mode: 50%MTF: 0.95LP/mm, 20%MTF: 2.0LP/mm etc. | "Spatial Resolution is similar and improved." (Predicate has 50%MTF: 1.2LP/mm, 20%MTF: 2.3LP/mm. The subject device has slightly lower LP/mm than the predicate, but it is stated as "similar and improved," indicating it meets the relevant performance thresholds. This might reflect different measurement methodologies or acceptable variations). |
| - Viewer Software (Image Analysis System Software): Compare features | Display High-resolution 2D and 3D Images, Image Processing (Airway measurement), Image Operation | Same function |
| - Console Software System Settings: Compare features | Output Function, CT Scan (include CT-Panoramic mode) | Same function |
| Compliance with Standards: | ||
| - Electrical Safety: ANSI/AAMI ES60601-1, IEC 60601-1-3, IEC 60601-1-6 | Complies | Same (Listed as tested and passed) |
| - Electromagnetic Compatibility: IEC 60601-1-2 | Complies | Same (Listed as tested and passed) |
| - Usability Safety: IEC 60601-1-6, IEC 62366-1 | Complies | Same (Listed as tested and passed) |
| - Software Lifecycle: IEC 62304 | Complies | Same (Listed as tested and passed) |
| - Dental Extra-Oral X-ray Equipment Essential Performance: IEC 60601-2-63 | Complies | Same (Listed as tested and passed) |
| - Imaging Performance Acceptance Tests: IEC 61223-3-4, IEC 61223-3-5 | Complies | Same (Listed as tested and passed) |
| - Laser Safety: IEC 60825-1 | Complies | Same (Listed as tested and passed) |
| - Risk Management: ISO 14971 | Complies | Same (Listed as tested and passed) |
| - DICOM: NEMA PS 3.1 - 3.20 | Complies | Same (Listed as tested and passed) |
| - Biocompatibility: ISO 10993-1, -5, -10 | Complies | Same (Listed as tested and passed) |
| - Storage and Transport: ISO 4180 | Complies | (Listed as tested and passed) |
Study Proving Device Meets Acceptance Criteria:
The key study mentioned is "Non-Clinical Performance Data."
- Study Type: Non-clinical bench testing, electrical safety testing, software validation, biocompatibility testing, and compliance with various international and national standards. This is a device validation study, not a clinical study on diagnostic accuracy or AI performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of patient cases or images for testing the device's performance. The testing refers to engineering tests performed on the device and its components, often using phantoms or controlled environments, not clinical image sets as one would use for an AI diagnostic algorithm.
- Data Provenance: Not applicable in the context of clinical images for an AI study. The "data" here refers to measurements from bench tests performed by PreXion Corporation. The company is based in Tokyo, Japan. The testing is reported as a "non-clinical" effort, not involving human subjects or clinical data in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an imaging system itself, not an AI diagnostic algorithm that requires expert-established ground truth on clinical images for its performance evaluation. The "ground truth" for this submission are the technical specifications, measured physical parameters, and compliance with safety and performance standards.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication process for image interpretation (as would be typical for an AI diagnostic device) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This means no study was performed to assess human reader performance with or without the device, as is common for AI diagnostic devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is the imaging equipment itself, not a separate diagnostic algorithm. Its "performance" refers to its ability to acquire images meeting technical specifications and safety standards, not a diagnostic output from an algorithm.
7. The Type of Ground Truth Used:
- The ground truth for this submission is based on engineering specifications, physical measurements (e.g., dose, spatial resolution on phantoms), and compliance with established national and international standards for medical electrical equipment, radiation safety, and imaging performance (e.g., IEC 60601 series, ISO 10993). It is not based on expert consensus, pathology, or outcomes data from human subjects.
8. The Sample Size for the Training Set:
- Not applicable. This document describes the clearance of an imaging device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as #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.