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SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.

SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.

SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software.

SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files.

SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.

SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.

SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,

The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.

SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

The provided text describes the 510(k) premarket notification for "SOTA Cloud Imaging," a dental imaging software. The document asserts the device's substantial equivalence to a predicate device, "XV Web." However, it does not contain details about acceptance criteria, a specific study design to prove device performance against those criteria, or quantitative results from such a study.

The document states:

• "SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate." (Section I)
• "SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission." (Section J)
• "Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate." (Section J)

These statements indicate that testing was performed, but they do not provide the specific details requested in your prompt. The document focuses on demonstrating substantial equivalence based on similar intended use and technical characteristics to a predicate device, rather than proving performance against quantitative acceptance criteria in a clinical study. This is typical for a 510(k) submission for this class of device, which often relies on bench testing and comparison to predicates rather than large-scale clinical trials.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document refers to "Test information" being in "Software Documentation included with this submission," which is not part of this extract.

Here's a summary based on what is available:

Absence of Detailed Performance Study Information

The provided 510(k) summary for "SOTA Cloud Imaging" asserts substantial equivalence to a predicate device, "XV Web," based on intended use, indications for use, and technological characteristics. While it mentions "extensive non-clinical (bench) performance testing and validation and verification," and "performance testing to compare SOTA Cloud Imaging to the XV Web predicate," it does not include specific acceptance criteria, quantitative performance metrics, or the details of any human reader study or standalone algorithm performance study. The focus is on functionality comparison rather than a formal clinical performance study with defined endpoints and ground truth.

1. Table of acceptance criteria and reported device performance

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be non-clinical/bench testing and "predicate testing" rather than a clinical study on patient data from a specific geography.

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

• Not applicable/Not specified. The document does not describe a clinical ground truth establishment process for a test set. This device is described as imaging software where "Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed." This implies human interpretation remains central.

4. Adjudication method for the test set

• Not applicable/Not specified.

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 comparative effectiveness study is described or implied. The software is a "Medical Image Management and Processing System" that displays and allows manipulation of images, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

• Not applicable. The device is a "software-only dental image device" intended to be used by "dental professionals" for "diagnostic and non-diagnostic purposes." Its function is to acquire, display, process, and manage images, not to provide standalone diagnostic output. Thus, a standalone performance evaluation in the context of diagnostic accuracy is not relevant to its stated function.

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

• Not applicable/Not specified. The document does not describe a process for establishing ground truth for diagnostic accuracy, as the device itself does not perform diagnosis.

8. The sample size for the training set

• Not applicable/Not specified. The document does not describe an AI/ML model for which a training set would be required. The software appears to be rule-based or feature-based image processing and management, not an AI/ML diagnostic algorithm.

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

• Not applicable/Not specified (as no AI/ML training set is mentioned).

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Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient.

Clio Prime and Clio Pedo are USB-driven digital sensors designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation. Clio Pedo is a smaller version of Clio Prime and is for pediatric use. The Clio Prime and Clio Pedo design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Clio Prime or Clio Pedo is positioned in the patient's mouth in the same manner as intra-oral film is positioned. Each of Clio Prime and Clio Pedo has a CMOS x-ray imager that creates a digital imaqe from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Clio Prime or Clio Pedo through the standard USB port. Image analysis software is not part of the submission. For Clio Prime or Clio Pedo to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Clio Prime and Clio Pedo devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria. The key performance metric explicitly compared is the Modulation Transfer Function (MTF).

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

• Test Set Sample Size: Not explicitly stated as a number of distinct cases or patients. The clinical study involved providing "clinical images," but the quantity is not specified.
• Data Provenance: Not explicitly stated. The document refers to a "clinical study performance testing," but does not mention the country of origin, nor whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document only states that "Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs." It does not mention who evaluated the clinical images for ground truth.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance:

• MRMC Study: No MRMC study was described. The device is a digital intraoral x-ray sensor, not an AI-assisted diagnostic tool. Its performance was compared against predicate sensors.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• A standalone performance characterization of the sensor itself was conducted through bench testing, specifically the MTF comparison. However, the device is explicitly intended to be used by trained healthcare professionals, and "Image analysis software is not part of the submission." Therefore, a standalone "algorithm only" performance (in the context of automated diagnosis) is not applicable or described for this device. The closest is the physical sensor performance.

7. The Type of Ground Truth Used:

• The document implies a combination of:
  • "Clinical images" from a clinical study, suggesting a comparison of image quality or diagnostic utility against a clinical gold standard (though not explicitly defined).
  • Bench testing data (e.g., MTF), which relies on standardized physical measurements and engineering specifications as ground truth.
  • Comparison to predicate devices: The primary method for establishing "substantial equivalence" is direct comparison of parameters and performance with an already cleared device.

8. The Sample Size for the Training Set:

• Not applicable/Not provided. The document describes a medical device (digital x-ray sensor), not a machine learning or AI model that requires a distinct training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not provided, as there is no mention of a training set for a machine learning model.

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