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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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CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.

CLIO/CLIOSOFT is a system for general dental diagnostic imaging. CLIO is an intraoral x-ray sensor and CLIOSOFT is a software program. CLIO has size 1 and size 2 sensors. CLIO sensor connects to the PCcompatible computer via an USB port. CLIOSOFT controls capture, display, treatment, review, store, print, and distribute digital x-ray images from CLIO sensors. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from an intraoral dental camera such as the Claris i310 series. CLIO/CLIOSOFT runs on standard PC-compatible computers.

CLIO connects to the computer via USB port.

When properly installed in your computer, CLIOSOFT lets you:

• . Control the direct capture of digital x-ray images from the intraoral sensor CLIO.
• . View and capture live image from intraoral cameras via USB 2.0 or video capture card.
• . Import images from various sources such as radiographic devices, flatbed scanner, digital camera, and generic image devices.
• . Export, e-mail, and print images.
• . Process digital images with several tools to enhance their diagnostic value.
• . Create a database of patients and store images in patient folders.

The provided text describes CLIO/CLIOSOFT, a dental imaging system, and its substantial equivalence to predicate devices, but does not contain information about explicit acceptance criteria or a study designed to prove the device meets those criteria, as typically found in a clinical performance study for a novel device.

The submission is a 510(k) for a device that is seen as substantially equivalent to existing, legally marketed devices. The "study" referenced implicitly in the document is a comparison to predicate devices and adherence to relevant safety and performance standards.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance

There are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a clinical performance study (e.g., sensitivity, specificity, accuracy). The submission focuses on demonstrating substantial equivalence based on technical characteristics and adherence to safety and EMC standards.

Description of the "Study" (Implicitly, the Basis for Substantial Equivalence)

The "study" in this context is not a clinical trial with performance endpoints but rather a demonstration of technical equivalence and compliance with regulatory standards.

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

   • Test Set: Not applicable in the context of a clinical performance study with "test sets" for diagnostic accuracy. The assessment relies on the inherent design, specifications, and compliance with standards.
   • Data Provenance: The 'data' underpinning the claims of safety and effectiveness comes from technical testing reports (IEC 60601-1, EN 60601-1-2) and the product specifications themselves compared against predicate devices. No information on geographical origin is given for these technical tests. They are not "retrospective" or "prospective" in the sense of a patient data study.

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

   • Not applicable. There is no "ground truth" establishment by medical experts mentioned for a diagnostic performance test set. The validation is based on engineering and regulatory compliance.

3. Adjudication method for the test set:

   • Not applicable. No diagnostic ground truth was established necessitating adjudication.

4. 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 device is a dental image management system and sensor, not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

   • Not applicable. This device is an imaging acquisition and management system, not a standalone diagnostic algorithm.

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

   • Not applicable for clinical performance. The "ground truth" for the claims made relates to adherence to specified engineering standards (e.g., electrical safety, EMC) and technical specifications (e.g., dynamic range, sensor size) being equivalent to an already cleared device.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary:

The K110886 submission for CLIO/CLIOSOFT is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices, primarily based on technical specifications, indications for use, and adherence to recognized safety and EMC standards. It does not involve a clinical performance study with patient data, diagnostic accuracies, or expert-established ground truths. The "study" mentioned within the document implicitly refers to the technical testing and comparisons outlined to support the substantial equivalence claim.

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Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece. The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient. The handpiece connects to the computer via USB 2.0 port. A cradle is provided to allow for on-off functions. Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.

The provided text describes a 510(k) summary for the Claris i310D Intra Oral Camera System and Accessories. The submission claims substantial equivalence to a predicate device (Claris i310, 510k# K032341) rather than presenting a performance study with specific acceptance criteria as would be typical for new, non-substantially equivalent devices or AI/ML-based devices.

Therefore, many of the requested details are not applicable as the submission relies on demonstrating similarity to an already approved device.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of a de novo clinical study with quantitative metrics is not explicitly present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The "performance" aspect is framed as a comparison of technological characteristics.

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) submission seeking substantial equivalence based on technological characteristics, not a clinical performance study with a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this type of submission.
3. Adjudication method for the test set: Not applicable.
4. 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: Not applicable. This device is an intraoral camera, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical camera device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the technological characteristics and safety profile of the predicate device.
7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) summary for a medical device (intraoral camera) seeking market clearance through the substantial equivalence pathway. It does not present a de novo performance study with acceptance criteria, test sets, or ground truth establishment in the way typically associated with AI/ML or novel diagnostic devices. Instead, the "study" is a comparison of the device's technical specifications and intended use against a legally marketed predicate device to demonstrate that it is "as safe and effective."

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Claris i310 intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Claris i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.

The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient.

The handpiece connects to a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.

Claris i310 is also available in a wireless option.

It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.

Images may be stored using third party software vendors.

Claris i310 includes also an optional footswitch.

The provided text describes a 510(k) summary for the Claris i310 Intra Oral Camera System and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a rigorous study on the device's performance.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not available. No specific test set or study validating performance is described.
• Data Provenance: Not available.

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

• Number of Experts: Not applicable, as no specific performance test set with ground truth is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as no specific performance test set 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:

• MRMC Study: No, an MRMC study was not done or described. This device is an intra-oral camera, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.

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

• Standalone Performance: No, a standalone algorithm performance study was not done or described. The device is purely an imaging tool, not a diagnostic algorithm.

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

• Type of Ground Truth: Not applicable, as no specific performance test with ground truth is described.

8. The sample size for the training set:

• Sample Size: Not applicable. This device is a hardware imaging system, not an AI model requiring a training set.

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

• Ground Truth Establishment: Not applicable.

Summary of Device and 510(k) Claims:

The Claris i310 Intra Oral Camera System and Accessories is an imaging device intended to provide dentists and patients with a view of the mouth before and after dental procedures to assist in describing procedures and showing results.

The 510(k) submission (K032341) claims substantial equivalence to the predicate device "DIGITAL DOC from Digital Doc. Inc." (510k # K981663). The basis for this claim is a comparison of technological characteristics, finding them "Identical" or "Similar" across various categories, including:

• Indications for use: Identical
• Target population: Identical
• Design: Similar
• Materials: Similar
• Performance: Similar (stated as "high definition imaging (494 lines/inch)")
• Biocompatibility: Similar
• Mechanical safety: Similar
• Chemical safety: Similar
• Anatomical sites: Identical
• Human factors: Similar
• Energy used and/or delivered: Similar
• Compatibility with environment and other devices: Similar
• Where used: Identical
• Standards met: Similar
• Electrical safety: Similar
• Thermal safety: Similar
• Radiation safety: Similar

The document does not provide a detailed "study that proves the device meets the acceptance criteria" in terms of specific performance metrics because the 510(k) pathway for this type of device relies on demonstrating equivalence to a legally marketed predicate, rather than novel performance claims requiring extensive new clinical or performance studies. The "study" here is essentially the comparison of technological characteristics to the predicate device, showing that it performs similarly and is thus safe and effective for its stated intended use.

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