(14 days)
The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.
The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:
- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .
Optional components: - . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone
The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds
In response to your request, here's an analysis of the provided text regarding the de Gotzen "synchro" Intraoral Dental X-Ray System, focusing on acceptance criteria and the study proving its compliance:
The provided text is a 510(k) summary statement for a dental X-ray system. Such submissions generally focus on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a novel clinical study with explicit acceptance criteria for performance derived from a completely new device.
Therefore, the "acceptance criteria" here are implicitly based on meeting or demonstrating comparable performance to the predicate devices in key technical specifications and safety parameters, as mandated by regulatory guidelines for substantial equivalence. The "study" proving this is the comparison of technological characteristics outlined in the document.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary focused on substantial equivalence, the "acceptance criteria" are the specifications of the predicate devices. The device "meets" these by demonstrating similar or equivalent specifications, indicating it is as safe and effective.
| Specification | Predicate Device Performance (Acceptance Criteria) | de Gotzen synchro Performance (Reported) |
|---|---|---|
| Line Requirements | Varied (e.g., 110V-120V 50Hz- | |
| 60Hz to 220V/230V/240V, 6A) | ||
| across different predicates | 220V/230V/240V, 8A | |
| 110V - 120V 5.5A | ||
| 50hZ - 60hZ | ||
| Generator Type | AC (consistent across all predicates) | AC |
| Tube Voltage | 65 kV or 70 kV (across various predicates) | 70 kV |
| Tube Current | 7 mA, 8 mA, or 10 mA (across various predicates) | 8 mA |
| Exposure Time Selection | Varied (e.g., 0.03 - 3.0 Sec to 0.08 - 3.2 Sec, various step counts) | 0.08 - 3.2 Sec. 17 Steps |
| Focal Spot | Varied (e.g., 0.6mm, 0.7mm, 0.8mm, 0.7 X 0.7 mm, 0.8 X 0.8mm) | 0.7 X 0.7 mm |
| Focal Length | 8in/12in (consistent across all predicates) | 8in/12in |
| Total Filtration in X-ray tube unit | >2 mm Al, >2.5 mm Al, >2.1 mm Al (across various predicates) | >2.0 mm Al |
| Leakage Radiation | 28 mR/hr at 1m from focal spot (for Dent-x Image x-70 Plus). Other predicates state "Compatible with Film and Digital" or "Unknown" | Less than 2.5 mGy/h (which is significantly lower than 28 mR/hr reported by a predicate, demonstrating superior safety). Compatible with Film and Digital. |
| Compatibility with Film and Digital | Yes (consistent across all predicates) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not describe a test set in the traditional sense of a clinical or image-based study. The "test set" is conceptualized as the technical specifications of the de Gotzen synchro device itself, which are compared against the specifications of five predicate devices. There is no mention of a patient or image sample size.
- Data Provenance: The data provenance is from the manufacturer's specifications and testing of the de Gotzen synchro device and the published or known specifications of the predicate devices. The document does not specify a country of origin for the data (beyond Italy for the manufacturer). It is retrospective in the sense that it relies on existing specifications of marketed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This substantial equivalence submission does not involve a direct assessment of image ground truth by experts in a clinical study. The "ground truth" for this type of submission is the engineering and performance specifications of the devices themselves, as measured and reported by their respective manufacturers and reviewed by regulatory bodies (FDA). No external experts (e.g., radiologists) are mentioned in establishing this "ground truth."
4. Adjudication Method for the Test Set
Since there is no clinical test set requiring expert interpretation or labeling, there is no adjudication method described. The comparison is based on direct specification matching and assessment of equivalence by the submitter and FDA reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document is a 510(k) submission for substantial equivalence based on technical specifications, not a clinical trial evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply to this submission.
7. The Type of Ground Truth Used
The "ground truth" used is the technical and performance specifications of the de Gotzen synchro Intraoral Dental X-Ray System, as measured by the manufacturer, and compared against the established technical and performance specifications of the predicate devices, as accepted by the FDA when those devices were cleared. This is essentially an engineering and regulatory "ground truth."
8. The Sample Size for the Training Set
This document does not describe a training set because it is not an AI/machine learning device. The "training" for such a device would be the engineering design, development, and testing processes conducted by the manufacturer to meet specific design requirements, which are then summarized in the technical specifications.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of AI/machine learning, this question does not apply. The "ground truth" in the design and manufacturing process would be established through engineering standards, regulatory requirements, and internal quality control measurements to ensure the device performs according to its intended specifications.
§ 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.