(219 days)
Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.
The provided documentation describes the PointNix Dental Digital X-ray Imaging Device models Point 500HD and Point 500C HD. However, it does not contain details about specific acceptance criteria or a study that evaluates the device against such criteria beyond general non-clinical safety and performance testing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document focuses on establishing substantial equivalence to a predicate device (Panoura 18S - K111231) through comparison of intended use, operating characteristics, and radiation properties, as well as reporting on non-clinical safety standards. It does not define specific acceptance criteria for image quality or diagnostic performance, nor does it present a study to demonstrate performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available as no clinical test involving a test set is discussed. The document explicitly states: "Discussion of Clinical Tests Performed: Not Required".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available as no clinical test involving a ground truth is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available as no clinical test involving adjudication is discussed.
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
This information is not available. The device described is a dental X-ray imaging system, not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. The device is an imaging hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available as no clinical test utilizing a ground truth is discussed.
8. The sample size for the training set
This information is not available. The document describes a medical device (an X-ray imaging system), not a machine learning or AI algorithm that would typically involve a training set.
9. How the ground truth for the training set was established
This information is not available, as no training set or ground truth for such a set is discussed.
Summary of what the document does provide regarding device evaluation:
The document outlines the following evaluations:
- Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by showing substantial equivalence to a legally marketed predicate device (Panoura 18S - K111231). Key comparisons include intended use, operating characteristics (tube voltage, tube current, focal spot size, scan time), and radiation.
- Non-Clinical Tests:
- Electrical, mechanical, and environmental safety and performance testing: Performed according to international standards (EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32).
- EMC testing: Conducted in accordance with EN/IEC 60601-1-2.
- Results: All test results were reported as "satisfactory."
- Clinical Tests: Explicitly stated as "Not Required."
This type of submission (510(k)) often relies on demonstrating equivalence to an existing device rather than on extensive clinical performance data against specific, pre-defined acceptance criteria, especially for established device types like X-ray systems.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.