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510(k) Data Aggregation
(55 days)
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
Acquisition of intraoral X-Ray image of the human dental arch. In particular:
• The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally.
• The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.
The StarX-1, StarX-2, StarX PRO-1 and the StarX PRO-2 are digital intraoral sensors based on CMOS technology for intraoral X-Ray image acquisition of the human dental arch. The sensors are available in two sizes; in particular:
• StarX-1 / StarX PRO-1 sensors: active area 20 x 30 mm
• StarX-2 / StarX PRO-2 sensors: active area 26 x 34 mm
The differences between the sensors are the sizes and the different kind of scintillator (Cesium lodide - Csl and Gadolinium Oxysulfide - GOS).
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 are directly connected to the acquisition PC through the USB connection. Up to three sensors can be connected to one PC at time.
The type of X-ray systems that integrate with the sensors are wall-mounted Xray intraoral generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, which will control the exposure time.
The sensor is supplied with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission.
The device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver only.
Before FONA sells this device, the team discuss the hardware and software requirements of the user to make sure that their systems are compatible with the FONA sensors.
FONA provides technical support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.
This document describes the regulatory submission for the StarX-1, StarX-2, StarX PRO-1, and StarX PRO-2 intraoral digital X-ray sensors. The submission aims to establish substantial equivalence to a predicate device (Quick Ray HD, K151926).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Acquisition of intraoral X-Ray image of the human dental arch for diagnosis of dental diseases. | Acquisition of intraoral X-Ray image of the human dental arch. |
| Sensor Technology | CMOS chip + optical fiber plate + CSi | STARX PRO: CMOS + Optical fiber plate + CSi |
| STARX: CMOS + Optical Fiber plate + GOS | ||
| Matrix Dimensions (Size 1) | Active area: 600mm² | STARX-1 and STARX PRO-1: 600mm² |
| Matrix Dimensions (Size 2) | Active area: 884mm² | STARX-2 and STARX PRO-2: 884mm² |
| Matrix Dimensions (Pixels, Size 1) | 1000 lines X 1500 columns | 1000 x 1500 (STARX-1 and STARX PRO-1) |
| Matrix Dimensions (Pixels, Size 2) | 1300 X 1700 | 1300 x 1700 (STARX-2 and STARX PRO-2) |
| Resolution | Real ≥ 20lp/mm (for CSi-based) | STARX 12lp/mm (GOS) |
| STARX PRO 20lp/mm (CSi) | ||
| Pixel Size | 20x20 µm | 20x20 µm |
| Grey Levels | 14 bits | 14 bits |
| Lifespan (CMOS) | Min. 100,000 cycles | Min. 125,000 cycles |
| Operating Temperature | 0°C to 35°C | 0°C to 35°C |
| Sensor Input Voltage/Current | 5V (via USB connection); 0.15A Max | 5V (via USB connection); 0.15A Max |
| Clinical Adequacy | Clinically acceptable image quality for diagnostic purposes. | Professional evaluation of imaging samples found to be of good quality, high resolution, clinically acceptable, and substantially equivalent to the predicate device. |
| Electrical Safety | Compliance with IEC 60601-1. | Compliance with IEC 60601-1. |
| EMC | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. |
| Usability | Compliance with IEC 60601-1-6 & IEC 62366-1. | Compliance with IEC 60601-1-6 & IEC 62366-1. |
| Performance (Imaging) | Compliance with IEC 61223-3-4 and IEC 62220-1 (DQE). | Compliance with IEC 61223-3-4 and IEC 62220-1. |
| IP Code | Compliance with IEC 60529. | Compliance with IEC 60529. |
Note on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied by the performance characteristics and regulatory compliance of the predicate device. The applicant aims to show that their device performs equivalently or better in relevant aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Sample clinical images from the FONA device were evaluated." However, it does not specify the sample size for this clinical evaluation.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is FONA S.r.l. from Italy. The study appears to be a retrospective evaluation of images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document states: "Professional evaluation of imaging samples were found to be of good quality, high resolution, clinically acceptable and substantially equivalent to the predicate device."
- Number of experts: Not specified.
- Qualifications of experts: Only referred to as "Professional." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the evaluation of clinical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The evaluation method focused on the quality and acceptability of images from the new device rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself (StarX intraoral digital X-ray sensor) is an image acquisition component, not an AI algorithm for image analysis. Therefore, a "standalone algorithm performance" study as typically understood for AI-driven diagnostic tools would not be applicable in this context. The performance evaluated here relates to the imaging capabilities (resolution, grey levels, DQE, etc.) and clinical adequacy of the acquired images.
7. The Type of Ground Truth Used
The ground truth for the clinical evaluation was based on expert consensus regarding the "good quality, high resolution, clinically acceptable" nature of the images.
8. The Sample Size for the Training Set
The document does not mention any training set or associated sample size. This device is an image acquisition sensor, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned (since this is an image acquisition device, not an AI model), this question is not applicable.
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