(36 days)
The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.
By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.
The TROPHYPAN/TROPHYPAN C System is a panoramic extra-oral dental x-ray system, already marketed in the United States. Orthoimaging and OMS Imaging software consist of patient management software for dental, orthodontic, and oral surgery practices. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device K040556:
Executive Summary:
The provided 510(k) summary for the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory (K040556) does not contain information about specific performance acceptance criteria or a dedicated study demonstrating that the device meets such criteria.
Instead, the submission hinges on substantial equivalence to a previously cleared device. The "study" mentioned is the assertion that "The modifications to the TROPHYPAN/TROPHYPAN C do not affect the materials, intended use, operating principles, or manufacture of the system as previously cleared." The core modification is the addition of software for image archiving and management, not a change to the fundamental image acquisition capabilities. Therefore, specific performance metrics and their acceptance are implicitly covered by the predicate device's clearance.
Here's a breakdown based on your requested information, acknowledging the limitations of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission relies on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- No specific test set or sample size is mentioned for this 510(k) submission. The core assertion is that the modifications to the already cleared TROPHYPAN/TROPHYPAN C system (the addition of image archiving and management software) do not alter the performance of the image acquisition.
- Data Provenance: Not applicable, as no new clinical or performance data is presented to support the modification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No new ground truth establishment was described, as the submission relies on substantial equivalence for the core device functionality.
4. Adjudication Method for the Test Set
- Not applicable. No test set or expert adjudication process is described in relation to the modifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done (or at least not described in this submission). The device is an X-ray system with archiving software; the regulatory pathway chosen (substantial equivalence for a modification) generally does not require such studies unless the modification significantly impacts diagnostic accuracy or decision-making.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is an imaging system and associated software, not primarily an "algorithm only" product in the sense of AI diagnostics without human involvement for which standalone performance would be a primary metric. Its function is to acquire and store images for human interpretation.
7. The Type of Ground Truth Used
- Not explicitly described for this submission's modifications. For the underlying TROPHYPAN/TROPHYPAN C system, the ground truth would inherently be clinical diagnostic standards and pathologies confirmed through various means in dental practice. However, this submission focuses on the software's ability to archive and manage images, rather than its diagnostic performance.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a medical device, specifically an X-ray imaging system with accessory software for image management. It is not an AI/ML algorithm that would typically have a "training set" in the modern sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" described for this type of device and submission.
§ 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.