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Jazz Classic is a clinical software application that captures images and data from Jazz intraoral xray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations.

It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.

Jazz Classic is a dental imaging software application that equips trained dental professionals with the tools to capture, process, organize,save, and share diagnostic images of patients. The software operates on standard PC hardware and displays images on the PC's connected display or monitor. Images can be acquired from digital dental imaging devices, including intraoral x-ray sental panoramic and cephalometric scanners, and intraoral cameras. It stores images using lossless compression, and can export them as DICOM, PNG, JPEG, or TIF files. It enables dental practitioners to visualize, and manipulate patient images to assist in case diagnosis, review, and treatment planning to further enhance the diagnostic value of images.

Jazz Classic integrates with client-server practice management software, bridging patient information from the user's existing practice management solutions to be used for scheduling, clinical note-taking, and billing.

Jazz Classic neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by the software but by dentists and other licensed dental professionals.

The provided text includes a 510(k) summary for the Jazz Classic device, a dental imaging software application. The summary outlines the device's intended use, comparison to a predicate device, and a brief description of non-clinical and clinical tests. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a quantitative manner.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (CLIO/CLIOSOFT, K110886) through technological and indications for use comparisons, and general verification and validation activities.

Here's a breakdown of the available information based on your requests:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The text mentions "verification testing confirmed that the software design requirements have been met" and that "Jazz Classic meets operational and clinical needs to acquire and evaluate dental images safely and effectively based on expert opinion," but no specific quantitative acceptance criteria or corresponding performance metrics are listed in a table format.

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

• Test Set Sample Size: The document mentions "bench testing was performed on Jazz Classic and the predicate device" using "images acquired from scientific phantom targets." It also states "Jazz Imaging also performed a clinical evaluation." However, specific sample sizes (e.g., number of images, number of patients) for either the bench testing or the clinical evaluation are not provided.
• Data Provenance: The document does not specify the country of origin for any data used. The bench testing used "scientific phantom targets," implying synthetic data. The clinical evaluation is mentioned, but whether it was retrospective or prospective is not stated.

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

• Number of Experts: For the clinical evaluation, it states "Based on expert opinion." The exact number of experts used is not specified.
• Qualifications of Experts: The qualifications of these experts are not provided. It only refers to them as "expert opinion."

4. Adjudication Method for the Test Set:

The document mentions "Based on expert opinion" for the clinical evaluation. This suggests a form of expert review, but the specific adjudication method (e.g., 2+1, 3+1, none) is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as a "software only medical device" for imaging management and processing, with diagnosis performed by dental professionals, implying it's a tool, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance:

The document states "Diagnosis is not performed by the software but by dentists and other licensed dental professionals." This indicates that the device is intended to assist human professionals and is not described as a standalone diagnostic algorithm. However, the "bench testing" compared Jazz Classic's "signal-to-noise ratio (SNR) and resolution" to the predicate device, which could be considered a form of standalone technical performance assessment on phantom images. But this is not specifically "algorithm-only diagnostic performance."

7. Type of Ground Truth Used:

• For the bench testing, "scientific phantom targets" were used, implying a known synthetic ground truth for evaluating technical image quality metrics like SNR and resolution.
• For the clinical evaluation, it was "Based on expert opinion," which suggests expert consensus was used as ground truth for assessing "operational and clinical needs." Pathology or outcomes data are not mentioned.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is typical for devices that are primarily image management and processing systems rather than complex AI models that require extensive training data.

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

Since no training set information is provided, how its ground truth was established is not applicable/not mentioned.

In summary, while the document confirms that Jazz Imaging conducted design verification, bench testing, and a clinical evaluation, it lacks the detailed quantitative information typically found in a robust study proving specific acceptance criteria. The focus is on demonstrating substantial equivalence and general safety/effectiveness through comparison to a predicate device and expert opinion, rather than presenting a detailed performance study against predefined numerical acceptance criteria.

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