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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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