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The Suni3D is a computed tomography x-ray system, which is a diagnostic x-ray system intended to produce panoramic, cephalometric, and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

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I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Suni3D computed tomography x-ray system, confirming its substantial equivalence to a predicate device. It specifies the intended use and regulatory information but does not detail performance metrics, study designs, or ground truth establishment.

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The SuniRay II Digital Radiography System is used 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 Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email).

The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System.

The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment.

The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box.

The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI.

The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.

This report does not contain the information required to fulfill your request. The document is a 510(k) summary for the SuniRay II Digital Radiography System, primarily focused on demonstrating substantial equivalence to a predicate device.

Specifically, it lacks the following crucial information:

• Acceptance criteria and reported device performance
• Details about any study conducted to prove the device meets acceptance criteria. This includes:
  • Sample size used for the test set
  • Data provenance
  • Number of experts and their qualifications for ground truth establishment
  • Adjudication method
  • Information about multi-reader multi-case (MRMC) comparative effectiveness studies
  • Information about standalone performance studies
  • Type of ground truth used
  • Sample size for the training set
  • How ground truth for the training set was established

The document describes the device's function and components, its software, and its compliance with safety and electromagnetic compatibility standards (EN 60601). It also references Apteryx, Inc.'s 510(k) (K983111) for their GUI and states that Apteryx is responsible for product validation and GMP compliance. However, it does not provide details of any clinical or technical performance studies that would include acceptance criteria or specific performance metrics.

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For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system.

Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest.

The provided document is a 510(k) premarket notification for the SuniPan Imaging System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data with detailed acceptance criteria and performance metrics typically seen for novel devices or AI/ML-based systems.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against those criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Here's a breakdown of why the requested information isn't available in the provided text:

• Premarket Notification (510(k)) Context: A 510(k) submission aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance claims to the predicate. It usually doesn't require new clinical efficacy studies of the same rigor or depth as a PMA (Premarket Approval) submission, especially for established technologies like X-ray imaging.

• Device Type: The SuniPan is a digital imaging device that combines an existing X-ray unit (PC-1000, identical to a film-based unit) with an aftermarket digital sensor (Scan300fp/Retropan). The digital sensor itself was previously cleared. The focus here is on the combination being equivalent to other digital panoramic systems.

• Absence of Clinical Study Section: The document is primarily administrative and descriptive, listing device details, classification, equivalency claims, and the FDA's clearance letter. It lacks a dedicated "Clinical Study" or "Performance Data" section with detailed methodologies.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document indicates the device meets the regulatory requirements for "substantial equivalence" based on comparison to predicate devices, but it does not describe a study with explicit acceptance criteria for performance as would be expected for a novel diagnostic instrument.

However, I can extract what is available regarding "equivalency" which serves as the basis for marketing clearance:

1. Table of "Acceptance Criteria" (Implied by Substantial Equivalence) and Reported Device Performance

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

• Not explicitly stated in the document. The 510(k) process typically relies on bench testing, comparison to predicate device specifications, and sometimes limited clinical data, but the specifics are not detailed here.

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

• Not explicitly stated. Given it's a 510(k) for an established imaging technology, expert review for image quality or substantial equivalence might have been performed, but the document does not detail this.

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

• Not explicitly stated.

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 is not an AI/ML device, nor is it a multi-reader multi-case study as described in the document. The device is a standard digital X-ray imaging system.

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

• No. This is not an AI/ML diagnostic algorithm. It is a digital imaging acquisition system.

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

• Not explicitly stated. For an imaging system, "ground truth" (if established for performance testing) would typically relate to the accuracy of imaging features against known physical standards or clinical outcomes. However, the document relies on its substantial equivalence to previously cleared devices.

8. The sample size for the training set:

• Not applicable as this is not a machine learning/AI device requiring a "training set."

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

• Not applicable.

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