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Pro Vecta 3D Prime and ProVecta 3D Prime Ceph are computed tomography x-ray units intended to generate 3D, panoramic and cephalometric (ProVecta 3D Prime Ceph Model) X-ray images in dental radiography for adult and pediatric patients. They provide diagnostic details of the maxillofacial areas for a dental treatment. The devices are operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The X-rays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard. The ProVecta 3D Prime model does not have the CEPH function.

This premarket notification is because of the biological evaluation of medical devices documentation according to EN ISO 10993-1:2020. The revision of the document is the inclusion of the Comfort Bite Foam for the bite block with direct patient contact. The relevant documents regarding biological safety were included and evaluated in this biological evaluation. Furthermore, the Biological Evaluation has been updated to the latest Version of the standard. The name, application and biocompatibility-relevant materials of the product have not changed since the last version. In addition to the current bite block (REF: 2210200100), two new, more comfortable variants were developed:

• standard bite block: an optimized version of the existing bite block
• comfort bite block: an extension of the existing bite block

The image management software was recently updated in K213326.

This document describes a 510(k) premarket notification for the "ProVecta 3D Prime and ProVecta 3D Prime Ceph" devices. The submission primarily addresses a change in the bite-block material and an updated biological evaluation, not a new or significantly altered imaging algorithm. Therefore, the information requested for acceptance criteria and a study proving device performance (especially related to AI or standalone algorithm performance) is not fully present in the provided text.

Based on the provided text, here's a breakdown of the available information:

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

The document focuses on demonstrating substantial equivalence to a predicate device (ProVecta 3D Prime Ceph, K193139) because of a change in bite-block material and an updated biological evaluation. There are no explicit "acceptance criteria" for imaging performance described in the text, nor are there reported device performance metrics in terms of clinical accuracy or diagnostic efficacy for the imaging capability itself.

The only "performance testing" mentioned relates to the new bite foam:

2. Sample size used for the test set and the data provenance

For the new bite foam testing, specific sample sizes for cytotoxicity testing are not provided in the text. There's no information on a "test set" for imaging performance, as the submission does not involve an evaluation of a new imaging algorithm.

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

Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation.

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 was done. This submission is for an X-ray unit, not an AI-assisted diagnostic device. The imaging software (VisionX 3.0) is referenced as an updated component, but the submission itself is not about the performance of the software.

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

No standalone algorithm performance study was done. This submission is for an X-ray unit, not a standalone algorithm.

7. The type of ground truth used

For the biological evaluation, the ground truth was established by laboratory testing for cytotoxicity based on EN ISO 10993-1, -5, -12 standards. No clinical ground truth (pathology, outcomes data, or expert consensus) for diagnostic accuracy is mentioned as this is not the focus of this 510(k).

8. The sample size for the training set

Not applicable. There is no mention of a training set as this submission is not about an AI algorithm.

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

Not applicable. There is no mention of a training set.

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The ScanX Swift 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift View 2.0 is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.

The ScanX Swift 2.0 and ScanX Swift View 2.0 are dental devices that scan photostimulable phosphor storage plates that have been exposed in place of dental X- Ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out all cleared plates of the sizes 0, 1, 2, 3, and 4. The phosphor plates are made of rigid photostimulable material. Intraoral phosphor plate x-ray (also known as phosphor storage plate or PSP x-ray) eliminates the need for traditional film processing for dental radiography. Phosphor storage plates can convert existing film based imaging systems to a digital format that can be integrated into a computer or network system. The intraoral Plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with a 639nm Laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of x-ray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via an Ethernet link to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he has to use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection cover and starts the read out process. After the read out process the picture is transmitted to the connected PC, the picture can be viewed and the IP is erased and ready to use for the next acquisition. The main difference between the two models is on the ScanX Swift View 2.0 the display is larger, has touch capability, and can show a preview of the scan image. The device firmware is based on the predicate firmware and is of a moderate level of concern.

The provided text is a 510(k) summary for a medical device (ScanX Swift 2.0, ScanX Swift View 2.0), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria for a specific clinical endpoint or a study proving a device meets such criteria.

Instead, it discusses the technological characteristics, safety, and performance of the device in comparison to a predicate device based on non-clinical testing and engineering principles. The document explicitly states:

• "Summary of clinical performance testing: Not required to establish substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

However, I can extract information related to non-clinical performance testing and technical characteristics, which are used to establish substantial equivalence.

Here's an analysis based on the available information:

Key Takeaways from the Document:

• Device Type: Phosphor Storage Plate (PSP) scanner for dental X-ray images.
• Purpose: Scan exposed PSPs, process digital images, and display/store them.
• Approval Basis: Substantial equivalence to a predicate device (ScanX Edge K202633).
• No Clinical Study: Clinical performance testing was explicitly stated as "Not required to establish substantial equivalence." This means the FDA cleared the device based on non-clinical data and comparison to a legally marketed predicate.

Information Related to Device Performance and Equivalence (Non-Clinical):

The document compares the subject devices (ScanX Swift 2.0, ScanX Swift View 2.0) to the predicate device (ScanX Edge) based on various technical specifications and non-clinical performance metrics.

1. Table of "Acceptance Criteria" (Technical Specification Comparison) and Reported Device Performance (as listed for the subject devices):

Since no acceptance criteria are explicitly stated as pass/fail for a clinical endpoint, I will present the comparative technical specifications as the basis for demonstrating equivalence and "performance" in this context. The "acceptance criteria" here are effectively the predicate device's performance, and the subject device's performance is compared against it for substantial equivalence.

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

• Not explicitly stated for performance testing. The document refers to non-clinical performance testing (MTF, DQE, noise power spectrum) in accordance with IEC 6220-1:2003, which would involve imaging phantoms or test objects.
• Data Provenance: Not specified, but given the manufacturer is German (DURR DENTAL SE), the non-clinical testing likely occurred in a controlled lab environment, presumably in Germany or where their R&D facilities are located. These tests are inherently "prospective" in the sense that they are conducted to characterize the specific device.

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

• Not applicable. The submission states no clinical performance testing was required. For non-clinical tests like MTF/DQE, ground truth is established by the design of the test phantom and the known physical properties being measured.

4. Adjudication method for the test set (for clinical studies):

• Not applicable. No clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "Summary of clinical performance testing: Not required to establish substantial equivalence." Therefore, no MRMC study was performed.

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

• The device itself is a standalone imaging acquisition and processing system. The performance metrics (MTF, DQE) are inherently standalone measurements of the device's image quality output.
• The ScanX Swift View 2.0 model has a "Stand-Alone-Mode" where it can operate without a connection to a computer, generate image data, and store it on a USB stick. This is a functional feature, not a separate performance study.

7. The type of ground truth used:

• For the non-clinical image quality performance metrics (MTF, DQE, noise power spectrum), the ground truth is established by physical standards and phantoms as defined by the IEC 6220-1:2003 standard. These involve known patterns and controlled radiation exposures to objectively measure the imaging system's capabilities.

8. The sample size for the training set:

• Not applicable. As this is a 510(k) for a hardware device (PSP scanner) and not an AI/ML algorithm requiring a training set in the typical sense, there is no mention of a "training set" for image processing algorithms. The image processing algorithms used within the device are stated to be "the same as cleared in K192743 for the imaging software VisionX," implying they are established and validated algorithms, not newly trained ones for this specific device.

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

• Not applicable, as there is no training set discussed for this device submission.

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