Search Results

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

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.

Ask a specific question about this device

I-View Gold sensors are digital dental intraoral sensors intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

The subject I-View Gold and Imagen Gold sensors are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port: and (2) an Image Management Software package.

The subject comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm² and two brand names.

Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.

This document describes the marketing clearance for the I-View Gold and Imagen Gold Dental Sensors (K200625). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (EzSensor Classic, K153060), rather than providing detailed acceptance criteria and a standalone study proving the device meets those specific acceptance criteria for performance metrics like diagnostic accuracy.

The FDA's 510(k) clearance process primarily evaluates whether a new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It does not typically require the applicant to establish novel performance acceptance criteria or conduct a de novo clinical study to prove those criteria are met, especially for devices with well-understood technology and established clinical pathways like dental X-ray sensors.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy for a specific clinical task) is not found in this 510(k) summary. The document focuses on demonstrating that the new device functions similarly and is as safe and effective as the predicate based on bench testing (SSIX Report, electrical safety, EMC, software documentation) and comparison of technical specifications.

Here's a breakdown of what can be extracted about "acceptance" and "testing" from the provided document, framed within the substantial equivalence argument, and what information is not available:

Information Available/Inferred from the Document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied for Substantial Equivalence): The implicit "acceptance criterion" is that the technological characteristics and performance are comparable to the predicate device (EzSensor Classic, K153060) to ensure equivalent safety and effectiveness.
   • Reported Device Performance (Comparative Metrics): The table Compares technological characteristics. The "performance" here refers to measured physical and technical parameters, not diagnostic accuracy. The reported values for the subject device are expected to be sufficiently similar to the predicate to establish equivalence.

   Characteristic	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Subject Device)	Predicate Device Performance
   Common Name	Intraoral Digital X-Ray Sensor	Intraoral Digital X-Ray Sensor	Intraoral Digital X-Ray Sensor
   Indications for Use	Same as predicate	Same as predicate	Same as subject
   Intended Use	Same as predicate	Same as predicate	Same as subject
   Principles of operation	Same as predicate ('X-ray radiation => scintillator => fiber optic => CMOS => electronics => PC')	Same as predicate	Same as subject
   Sensor Thickness (mm)	4.8 mm	4.8	4.8
   USB Module	Integrated USB 2.0 module	Integrated USB 2.0 module	Integrated USB 2.0 module
   Pixel Pitch (Full/Binning mode)	14.8 / 29.6	14.8 / 29.6	14.8 / 29.6
   DQE (6lp/mm, Full/Binning mode)	0.38 / 0.34	0.38 / 0.34	0.38 / 0.34
   MTF (3lp/mm, Full/Binning mode)	0.642 / 0.630	0.642 / 0.630	0.642 / 0.630
   Typical dose range (Incisor & Canine)	300 ~ 500	300 ~ 500	300 ~ 500
   Typical dose range (Molar)	400 ~ 600	400 ~ 600	400 ~ 600
   Standards of Conformity	Compliance with relevant IEC/ISO standards	Listed standards achieved	Listed standards achieved
   Biocompatibility	Not warranted (no patient contact)	Not warranted (no patient contact), single-use protective barrier used	Not warranted (no patient contact), single-use protective barrier used
   Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2	Conforms to standards	Conforms to standards

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable/Not specified for a clinical performance test. The "test set" here refers to the physical units subjected to bench testing (e.g., for electrical safety, EMC, SSIX report). The sample size for these engineering tests is not provided in this summary.
   • Data Provenance: The tests are "Non-Clinical Performance Data." There is no mention of patient data (images) or their provenance (country of origin, retrospective/prospective) because a clinical study was not presented for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical test set with ground truth established by experts is described, as this is a substantial equivalence submission relying on bench testing and comparison to a predicate, not a de novo clinical performance study for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a digital X-ray sensor, not an AI-powered diagnostic aid. Therefore, no MRMC study or assessment of AI assistance to human readers was performed or presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a hardware sensor with image acquisition and management software, not an algorithm for autonomous diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests would be defined by engineering specifications and reference standards (e.g., a calibrated measurement for DQE, MTF).

8. The sample size for the training set:

   • Not applicable. This is a hardware device with associated image processing firmware/software, not a machine learning model that requires a training set in the AI sense.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

Summary of what's provided related to "proving" performance:

The document states "Bench tests were performed and the SSIX Report is shown in this submission. Additional certificates for the device are also within this submission." These tests (e.g., DQE, MTF, electrical safety, EMC) provide objective measurements of the device's physical and technical performance parameters, which are then compared to the predicate device to argue for substantial equivalence. The "proof" here is that these technical specifications are essentially identical to those of the cleared predicate device, and the device conforms to relevant safety and performance standards (IEC, ISO).

In a 510(k), especially for a device like this, the "acceptance criteria" for clearance are primarily:

• Same intended use as the predicate.
• Same technological characteristics as the predicate OR different technological characteristics that do not raise new questions of safety and effectiveness.
• Performance data (bench testing) demonstrating that the device is as safe and effective as the predicate.

This submission explicitly concludes: "The subject and the predicate device have the same intended use and the same technological features. I View Gold and Imagen Gold Sensors and share the same principles of operation, sensor technology, use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate." The "study" proving this is the collection of non-clinical bench tests and the detailed comparative analysis of technical specifications presented in the submission.

Ask a specific question about this device