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The VEX-S100W is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

VEX-S100W is an extraoral source dental X-ray system intended for intraoral imaging. It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The X-ray controller allows for accurate exposure control, and an adjustable mechanical arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system.

The VEX-S100W is an extraoral source dental X-ray system. The submission indicates that no clinical testing was performed or relied upon for this premarket notification. The device is claimed to be substantially equivalent to the predicate device, ESX (K092103), based on similar indications for use and technical characteristics.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" as a set of quantified performance targets for diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating compliance with international standards and similarity to a predicate device. The performance testing described is focused on verifying compliance with specifications affecting image quality and patient dose, and detecting malfunctions.

The table below presents relevant performance specifications of the proposed device as compared to the predicate device. The "Acceptance Criteria" implicitly are that the device meets these specified technical characteristics and demonstrates satisfactory performance according to the cited engineering and safety standards.

2. Round: 300 mm (Option)
3. Rectangular Cone: 200 mm (Option)
4. Rectangular Cone: 300 mm (Option) |
   | Anode Material | Tungsten | Tungsten |
   | Compatible with film and digital imaging | Yes | Yes |
   | Weight (kg) | 23.8 kg (52.5 lbs) | 18.5 kg (40.8 lbs) |
   | Compliance with Normative Standards | Satisfactory performance according to IEC61223-3-4, IEC60601-1, IEC60601-1-1, IEC60601-1-3, IEC60601-2-7, IEC60601-2-28, IEC60601-2-32, IEC 60601-1-2. | All performance tests and safety tests conducted were satisfactory. |

2. Sample Size Used for the Test Set and the Data Provenance

The submission explicitly states: "This premarket notification submission for a determination of substantial equivalence does not require nor rely on the clinical testing." Therefore, there is no clinical "test set" in the traditional sense of patient data in this submission. The "test set" refers to the device itself being tested for compliance with engineering and safety standards. No specific sample size of images or patients is mentioned as no clinical studies were performed. The testing was conducted on the VEX-S100W device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of experts establishing ground truth for a clinical test set, as no clinical testing was performed or relied upon. The ground truth for the engineering performance tests would be defined by the specified technical parameters and safety standards, the evaluation of which would be conducted by qualified engineers or technicians in a testing laboratory.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication of findings was used.

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 MRMC study or any clinical study involving human readers or AI assistance was performed. This device is an X-ray generator, not an image analysis or AI diagnostic tool.

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

Not applicable, as this device is a physical X-ray system, not an algorithm.

7. The type of ground truth used

For the engineering and safety performance tests, the "ground truth" would be the technical specifications and regulatory requirements outlined in standards like IEC61223-3-4, IEC60601-1, etc. Compliance with these established standards and specifications serves as the basis for satisfactory performance.

8. The sample size for the training set

Not applicable. As no clinical testing was performed and the device is an X-ray generator, there is no "training set" of data in the context of machine learning or AI.

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

Not applicable, as there was no training set.

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