(131 days)
The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometic radiographic examinations for use in orthodontic treatment planning and evaluation.
The Progeny Vantage Panoramic X-Ray System is an extraoral radiographic imaging system for producing digital radiographs in panoramic and cephalometric views of the teeth, jaw and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation, Digital Image Receptor, Rotating C-Arm for tubehead and image receptor mounting, Overhead Arm, Elevating Column, Patient Positioning Table, Electronic Control Unit, Computer Display Workstation, 8 ft. coil cord with exposure switch, Optional cephalometric extension arm.
Here's an analysis of the acceptance criteria and the study performed for the Progeny Vantage Panoramic X-Ray System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for image quality. Instead, the acceptance is based on a determination of "at least as effective as" predicate devices by expert consensus.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image quality deemed acceptable for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | Two licensed dentists deemed image quality acceptable and effective. |
| Image quality deemed at least as effective as predicate devices (Instrumentarium OP200D and Planmeca ProMax). | Two licensed dentists concluded Progeny Vantage images were at least as effective as Instrumentarium and Planmeca images. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The clinical test involved images taken of "a skull phantom". This suggests a sample size of one skull phantom.
- Data Provenance: The images were specifically generated for the purpose of this K122643 submission through a clinical test using the Progeny Vantage device itself, as well as images from predicate devices. The text doesn't specify a country of origin beyond the device manufacturer being based in Lincolnshire, IL, USA. This appears to be a prospective test conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two licensed dentists.
- Qualifications of Experts: They are described as "licensed dentists." No further details regarding their years of experience or specialization (e.g., oral radiologist) are provided in the document.
4. Adjudication Method for the Test Set
The document states: "Both dentists deemed that the image quality was acceptable..." and "...concluded that the Progeny Vantage images were at least as effective as the Instrumentarium and Planmeca images."
This indicates an unspecified consensus or individual agreement model. There's no mention of a formal adjudication process like 2+1 or 3+1, but rather a collective conclusion from both reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- No AI assistance is mentioned in the context of this device. The device is an X-ray system, not an AI-powered diagnostic tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an X-ray imaging system. Its "performance" is the quality of the image it produces, which is then interpreted by a human (dentist). It does not have an autonomous algorithm that would perform a standalone diagnostic function.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's image quality was established through expert consensus/opinion by the two licensed dentists. They reviewed the images and made a subjective judgment on their acceptability and comparative effectiveness against predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This document describes a traditional medical device (an X-ray system), not a machine learning or artificial intelligence algorithm that would typically require a training set. The device's operation is based on established physics and engineering principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
§ 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.