(25 days)
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system. The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly Constant-potential radiation system that produces, clear, sharp radiography with minimal elapsed exposure time. Includes 2 versions- integrated and remote, that are compatible to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Flow X-Ray Corporation's EnVision Intraoral Dental X-Ray Machines:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, no specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or performance metrics are stated for the EnVision Intraoral Dental X-Ray Machine. The document focuses on establishing substantial equivalence to a predicate device, not on meeting specific, quantifiable performance targets for diagnostic accuracy.
The reported device performance, therefore, is primarily in relation to its equivalence to the predicate:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K#896024, MDT/Castle Model HDX Dental X-Ray Machine) in intended use and technology. | The EnVision and HDX Dental X-Ray Machines are "virtually identical" in regard to intended use and technology. Bench testing and software validation demonstrate no differences in technological characteristics, raising no new issues of safety or effectiveness. |
| Compliance to applicable voluntary standards (IEC 60601-1, IEC 60601-2-7, ISO 14971:2000 for Risk Assessment) | The device demonstrates compliance to these standards. |
| Ability to minimize potential operator errors in selecting x-ray exposure times. | A new feature of preset anatomical manual exposure time settings was added to reduce errors in selecting proper exposure times. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document states that "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set was used to evaluate the device's diagnostic performance.
- Data Provenance: Not applicable. As no clinical tests were performed, there's no data provenance to report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Since no clinical tests were performed, no experts were used to establish ground truth for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set was used that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done? No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable," indicating no clinical studies were conducted, including MRMC studies.
- Effect Size: Not applicable. Without an MRMC study, there is no effect size to report.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done? No. This device is an X-ray machine (hardware), not an algorithm. Its performance is evaluated through bench testing and its ability to achieve substantial equivalence to a predicate device, not through an "algorithm only" study.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for diagnostic performance. The "ground truth" in this submission relates to the device meeting engineering and safety standards and replicating the functionality of a predicate device. This is primarily established through bench testing and software validation, which confirm its technical specifications and operational safety.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is an x-ray machine, not an AI or machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth for a training set.
Summary of Study Type:
The submission for the EnVision Intraoral Dental X-Ray Machines is a substantial equivalence (SE) submission. This means the primary "study" involved demonstrating that the new device is as safe and effective as a legally marketed predicate device (K#896024, MDT/Castle Model HDX Dental X-Ray Machine) that is already on the market. This demonstration was achieved through:
- Bench Testing: To confirm technical specifications and performance.
- Software Validation: To ensure the proper functioning of the machine's control software, particularly with the new preset exposure time feature.
- Compliance with Voluntary Standards: Adherence to established safety and risk management standards (IEC 60601-1, IEC 60601-2-7, ISO 14971:2000).
No clinical studies, diagnostic performance studies, or AI/ML specific evaluations (like training sets or standalone performance) were conducted or reported in this 510(k) summary.
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.