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510(k) Data Aggregation
(176 days)
The IMAGEWORKS PANOURA dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
The IMAGEWORKS PANOURA is dental panoramic and cephalometric device and intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The IMAGEWORKS PANOURA is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the IMAGEWORKS PANOURA irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding reported performance for the new device (IMAGEWORKS PANOURA) in relation to its functionalities. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is largely implied by the statement that the characteristics (except 3D imaging) are identical to PANOURA 18S, and the 3D imaging is similar to ORTHOPANTOMOGRAPH.
The closest we get to "acceptance criteria" are the characteristics presented in the comparison table (Table 6-1) and the mention of conformity to recognized standards.
Implicit Acceptance Criteria (based on predicate device characteristics and standards conformity):
| Feature/Criterion | IMAGEWORKS PANOURA Performance (Implied) |
|---|---|
| Intended Use | Dental radiographic examinations of teeth, jaw, and TMJ areas, producing conventional 2D X-ray images and X-ray projection images for 3D reconstruction. Operated by dentists/qualified professionals. (Matches predicate devices, specifically similar to ORTHOPANTOMOGRAPH for 3D). |
| Equipment Type | Digital panoramic x-ray equipment (Matches predicate devices). |
| Mode of Operation | Continuous operation with intermittent load (Matches predicate devices). |
| X-ray Tube Focal Point | 0.5 mm x 0.5 mm (Matches predicate devices). |
| X-ray Tube Cooling | Oil cooling (Matches predicate devices). |
| Nominal Max. Electric Power | 0.82kW (82kV, 10mA) (Matches PANOURA 18S, but lower than ORTHOPANTOMOGRAPH's 1.44kW, 90kV, 16mA. This difference is not presented as a failure of acceptance criteria, implying it's within acceptable dental radiography ranges). |
| Tube Voltage | 58 - 82kV (Matches PANOURA 18S, narrower range than ORTHOPANTOMOGRAPH's 57 - 90kV). |
| Tube Current | 2.0 - 10mA (Matches PANOURA 18S, narrower range than ORTHOPANTOMOGRAPH's 4 - 16mA). |
| Radiation Time (Panoramic) | Adult (8, 14, 16s), Child (6.4, 11.2, 12.8s), TMJ (8s) (Matches PANOURA 18S, some differences from ORTHOPANTOMOGRAPH's 16.4s, 14.4s, 10.6s respectively). |
| Radiation Time (Cephalo/Carpus) | 8-10s (Matches PANOURA 18S, some differences from ORTHOPANTOMOGRAPH's 10-20s). |
| Radiation Time (3D) | 11.5s x 2 (3D oral), 11.5s (3D dent) (Different from ORTHOPANTOMOGRAPH's ranges for different FOVs and resolutions, but not presented as a failure). |
| Total Filtration | 2.5mmAl equivalent or over (Matches PANOURA 18S, slightly lower than ORTHOPANTOMOGRAPH's 3.2mm Al equivalent or over. This is likely acceptable given the context and regulatory limits). |
| Leakage Dose | 1.0 mGy/h or less (Matches predicate devices). |
| Image Magnification (Panoramic) | 1.2 to 1.29 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.3). |
| Image Magnification (TMJ) | 1.2 to 1.29 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.23). |
| Image Magnification (Cephalo) | 1.1 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.14). |
| Image Magnification (3D) | 1.0 (Matches ORTHOPANTOMOGRAPH). |
| EMC Classification | Class A (Matches PANOURA 18S, but differs from ORTHOPANTOMOGRAPH's Class B. This difference is accepted, implying compliance with Class A standards is sufficient). |
| Panoramic Image Pixel Size | 100 x 100 µm (Matches predicate devices). |
| Cephalometric Image Pixel Size | 100 x 100 µm (Matches predicate devices). |
| 3D Image Pixel Size | 100 x 100 µm (Differs from ORTHOPANTOMOGRAPH's 200 µm. This is an improvement and is presented as acceptable). |
| Software Validation | Validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Conformance asserted). |
| Safety Standards | Complies with IEC 60825-1 (laser safety for IMAGEWORKS PANOURA, by referencing predicate's report), IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 (EMC, Electric safety, X-ray radiation safety). (Conformance asserted). |
| Risk Assessment | Evaluated in accordance with ISO14971:2007, deemed satisfactory. (Conformance asserted). |
Summary of the "Study" (Demonstration of Substantial Equivalence):
The submission does not detail a traditional "study" in the sense of a clinical trial or a performance benchmark against specific, pre-defined quantitative metrics for the new features like 3D imaging. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.
The "study" comprises the following:
- Comparison to Predicate Devices: The primary method is a detailed comparison of the IMAGEWORKS PANOURA's characteristics (both 2D and 3D) to two predicate devices:
- PANOURA 18S (K111231): The new device is stated to be a modification of this predicate, with identical characteristics except for the addition of 3D imaging.
- ORTHOPANTOMOGRAPH OP300 (K093683): The 3D imaging functionality of the new device is explicitly compared to this predicate, cited as having similar intended use, operational characteristics, ionizing radiation, cephalometric radiograms, panoramic images, and 3D imaging.
- Bench Testing:
- Laser Safety: Bench tests for laser safety were performed to ensure conformity with IEC 60825-1. For the IMAGEWORKS PANOURA, the test report from the identical laser system of the PANOURA 18S (K111231) was used.
- Software Validation: The software was validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- EMC, Electrical Safety, X-ray Radiation Safety: Conformance with IEC60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 was confirmed through bench testing.
- Risk Analysis: The device underwent risk evaluation in accordance with ISO14971:2007, and the risk management was deemed satisfactory.
The conclusion is that these tests and analyses demonstrated that the IMAGEWORKS PANOURA did not raise any new safety or effectiveness concerns compared to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no mention of a "test set" of clinical images or patient data used for evaluating diagnostic performance in a quantitative manner. The device is an X-ray imaging system, and the evaluation focuses on its technical specifications, safety, and operational equivalence.
- Data Provenance: Not applicable. The evaluation is based on device specifications, engineering tests, and comparison to existing, legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: Not applicable. No "ground truth" for diagnostic performance on a test set is established or reported for this submission. The assessment is of the physical device and its technical compliance.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no test set or expert evaluation of diagnostic performance requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and safety, not on the diagnostic accuracy of human readers using the device's images, nor on the improvement with AI assistance (as this is an imaging device, not an AI diagnostic tool).
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Not applicable. This document describes an X-ray imaging device, not a standalone algorithm. Its performance is inherent in its hardware, software, and physical characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for diagnostic performance. For the device itself, the "ground truth" for proving safety and effectiveness are established engineering standards, regulatory guidelines (e.g., IEC standards, ISO 14971), and the technical specifications and clinical performance records of the predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI algorithm requiring a training set of images. The "software validation" mentioned refers to the development and testing of the device's control and image processing software, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm. The software validation would have involved established software development and testing methodologies, comparing output to expected logic and specifications.
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(72 days)
The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.
The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The PANOURA 18S is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the PANOURA 18S irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.
The Panoura 18S is an extraoral x-ray system, which is a medical device and not an AI/ML algorithm. The provided documentation does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH K093683) by comparing technical, operational, and intended use characteristics, and compliance with recognized consensus or voluntary standards for medical electrical equipment and radiation protection.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and performance studies. The provided text describes a traditional medical device submission, not an AI/ML-driven one.
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